1.  Title: Prevention of invasive pneumococcal disease in HIV-infected children: expanding the toolbox [editorial] Author: Abzug MJ; Pelton SI Source: Journal of Infectious Diseases. 2009 Apr 15;199(8):1109-11. Abstract: Invasive pneumococcal disease (IPD) remains a threat to HIV-infected children, adolescents, and adults in both developed and emerging nations. In the pre-highly active antiretroviral therapy (HAART) era, Mao et al. identified a cumulative incidence of 6.1 cases per 100 patient-years through age 7 years among HIV-infected children in Massachusetts, a rate 100-300-fold that seen in HIV-uninfected immunocompetent children in the United States. Similarly, Westwood et al. reported an IPD rate of 13 cases per 100 patient-years in Capetown, South Africa, a large proportion of which were lower respiratory tract infections. With widespread use of HAART in the United States, the rate of pneumococcal bacteremia declined by 80%, to 1.9 cases per 100 patient-years; this residual rate still remained at least 10-fold greater than that among HIV-uninfected children, and children who suffered an episode of pneumococcal bacteremia were more likely to die during follow-up than were HIV-infected children without an episode. These data identify the need to protect HIV-infected children from infection with Streptococcus pneumoniae, even in populations treated with HAART. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | MASSACHUSETTS | SOUTH AFRICA | SUMMARY REPORT | CLINICAL TRIALS | PERSONS LIVING WITH HIV/AIDS | CHILDREN | ADULTS | ADOLESCENTS | ANTIRETROVIRAL THERAPY | DISEASE PREVENTION | VACCINES | Developed Countries | North America | Americas | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Clinical Research | Research Methodology | HIV Infections | Viral Diseases | Diseases | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | HIV | Prevention and Control | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341354 |
| 2. Title: Interventions for pain with intrauterine device insertion. Author: Allen RH; Bartz D; Grimes DA; Hubacher D; O'Brien P Source: Cochrane Database of Systematic Reviews. 2009;(3):CD007373. Abstract: BACKGROUND: Fear of pain during intrauterine device (IUD) insertion is a barrier to use of this contraceptive method. Interventions for pain during IUD insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol. OBJECTIVES: To review all randomized controlled trials that have evaluated a treatment for IUD insertion-related pain. SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, and EMBASE for relevant trials. We also examined reference lists of pertinent articles and wrote to known investigators for information about other published or unpublished trials. SELECTION CRITERIA: We included all randomized controlled trials in any language that evaluated a treatment for IUD insertion-related pain. The intervention could be compared to a placebo or another active intervention. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from relevant trials and data were entered into RevMan 5.0 for analysis. For dichotomous variables, the Peto odds ratios with 95% confidence intervals was calculated. For continuous variables, the mean differences with 95% confidence interval was computed. MAIN RESULTS: Four trials met the inclusion criteria; the total number of participants was 2204. Nonsteroidal anti-inflammatory drugs of varying types and doses were not effective for reducing pain during IUD insertion. Misoprostol for cervical ripening did not reduce pain with IUD insertion in nulliparous women. Two trials evaluated pain that occurs after IUD insertion using nonsteroidal anti-inflammatory drugs. In one trial, naproxen taken prior to IUD insertion was effective in reducing pain compared with placebo in the first two hours after IUD insertion in mostly nulliparous women. However, this trial utilized the Dalkon Shield, an IUD with a wider diameter than modern IUDs. In another trial, ibuprofen 600 mg taken before IUD insertion did not show evidence of an effect on pain four to six hours after IUD insertion. AUTHORS' CONCLUSIONS: No interventions that have been properly evaluated reduce pain during or after IUD insertion. One poorly controlled trial suggested that topical lidocaine gel may reduce insertion-related pain and warrants further investigation. Language: English Keywords: UNITED STATES OF AMERICA | CHILE | DENMARK | SWEDEN | LITERATURE REVIEW | CLINICAL TRIALS | IUD | INSERTION | PAIN | DRUGS | ADMINISTRATION AND DOSAGE | MISOPROSTOL | Developed Countries | North America | Americas | Developing Countries | South America, Southern | South America | Latin America | Europe, Northern | Europe | Clinical Research | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Signs and Symptoms | Diseases | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology Document Number: 342475 |
| 3. Peer Reviewed Title: Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Author: Allen RH; Fitzmaurice G; Lifford KL; Lasic M; Goldberg AB Source: Obstetrics and Gynecology. 2009 Feb;113(2 Pt 1):276-83. Abstract: OBJECTIVE: To test the equivalency of oral sedation and intravenous sedation for pain control in first-trimester surgical abortion. METHODS: Women undergoing suction curettage at less than 13 weeks of gestation were randomly assigned to oral sedation, 10 mg of oxycodone and 1 mg of lorazepam, or intravenous sedation, 100 micrograms fentanyl and 2 mg midazolam. All patients received 800 mg of preoperative ibuprofen and a 20-mL paracervical block with 1% lidocaine. The primary outcome was intraoperative pain as measured on a 21-point verbal rating scale that had a range from 0 to 100 (0=no pain and 100=worst pain ever) with an equivalence margin for the treatment group comparison of +/-10. RESULTS: Of 130 women, 65 were randomly assigned to oral sedation and 65 to intravenous sedation. The groups differed at baseline by age and preoperative ratings of depression, stress, and anxiety; however, when adjusted for these differences, the primary results were unaffected. Mean intraoperative pain scores, controlling for age and preoperative depression, stress, and anxiety, were 61.2 for oral sedation and 36.3 for intravenous sedation (mean difference 24.9, 95% confidence interval 15.9-33.9). Other findings included no difference in postoperative adverse effects and less satisfaction with pain control with oral sedation compared with intravenous sedation. CONCLUSION: Oral sedation, as studied, is not equivalent to intravenous sedation for pain control during first-trimester surgical abortion. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00337792 LEVEL OF EVIDENCE: I. Language: English Keywords: MASSACHUSETTS | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | EVALUATION INDEXES | KAP SURVEYS | PREGNANT WOMEN | ANESTHESIA | ABORTION | PREGNANCY, FIRST TRIMESTER | CURETTAGE | ADMINISTRATION AND DOSAGE | PAIN | SIDE EFFECTS | SATISFACTION | Developed Countries | United States of America | North America | Americas | Clinical Research | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Surveys | Sampling Studies | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Pregnancy | Reproduction | Obstetrical Surgery | Surgery | Drugs | Signs and Symptoms | Diseases | Psychological Factors | Behavior Document Number: 330360 Notification |
| 4. Peer Reviewed Title: Sexual risk behaviour of the first cohort undergoing screening for enrollment into Phase I/II HIV vaccine trials in South Africa. Author: Andersson KM; Van Niekerk RM; Niccolai LM; Mlungwana ON; Holdsworth IM; Bogoshi M; McIntyre JA; Gray GE; Vardas E Source: International Journal of STD and AIDS. 2009 Feb;20(2):95-101. Abstract: We assessed risk behaviour in a heterosexual cohort undergoing prescreening for the first Phase I/II HIV vaccine trials in Soweto. We developed a survey and collected self-reported data from HIV-negative potential volunteers. Of 488 participants, most were single and approximately half were from households with incomes below the poverty level. Males reported higher rates of heavy alcohol use (P < 0.001), marijuana use (P < 0.001) and other recreational drug use (P < 0.01). Males reported more sex partners than females in the previous six months (P < 0.001), as well as more casual/anonymous partners (P < 0.001) and one-night stands (P < 0.001). Multivariate analyses revealed substance use and male gender predicted higher risk behaviours, including <100% condom use with known/suspected HIV-positive partners, having casual/anonymous partners and having more than two partners. For this population, male volunteers may need increased risk-reduction counselling during Phase I/II trials and additional recruitment methods may be necessary to identify high-risk female volunteers for Phase III efficacy trials. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | KAP SURVEYS | CLINICAL TRIALS | MULTIVARIATE ANALYSIS | HETEROSEXUALS | SEXUAL PARTNERS | SEX BEHAVIOR | RISK BEHAVIOR | VACCINES | ALCOHOL USE AND ABUSE | SCREENING | POVERTY | DRUG USE AND ABUSE | SEX FACTORS | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Surveys | Sampling Studies | Studies | Research Methodology | Clinical Research | Data Analysis | Behavior | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Examinations and Diagnoses | Socioeconomic Factors | Economic Factors | Population Characteristics | Demographic Factors | Population Document Number: 331093 |
| 5. Title: Combined oral contraceptive pills for treatment of acne. Author: Arowojolu AO; Gallo MF; Lopez LM; Grimes DA; Garner SE Source: Cochrane Database of Systematic Reviews. 2009;(3):CD004425. Abstract: BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placeboor another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan. MAIN RESULTS: The search yielded 25 trials: 7 placebo-controlled trials made 4 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found the COC groups were similar. AUTHORS' CONCLUSIONS: The four COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN | ACNE | TREATMENT | ORAL CONTRACEPTIVES, COMBINED | ADMINISTRATION AND DOSAGE | ANTIBIOTICS | HORMONES | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Endocrine System | Physiology | Biology Document Number: 341912 |
| 6. Peer Reviewed Title: Effect of male circumcision on the prevalence of high-risk human papillomavirus in young men: results of a randomized controlled trial conducted in orange farm, South Africa. Author: Auvert B; Sobngwi-Tambekou J; Cutler E; Nieuwoudt M; Lissouba P; Puren A; Taljaard D Source: Journal of Infectious Diseases. 2009 Jan 1;199(1):14-9. Abstract: The authors used data from a male circumcision (MC) trial conducted in Orange Farm, South Africa among men aged 18-24 years to investigate the association between male circumcision (MC) and the prevalence of high-risk human papillomavirus (HR-HPV) among young men. Urethral swab samples were collected during a period of 262 consecutive days from participants in the intervention (circumcised) and control (uncircumcised) groups who were reporting for a scheduled follow-up visit. Swab samples were analyzed using polymerase chain reaction. HR-HPV prevalence rate ratios were assessed using univariate and multivariate log Poisson regression. In an intention-to-treat analysis, the prevalence of HR-HPV among the intervention group was 14.8% (94/637) and in the control group was 22.3% (140/627). Controlling for propensity score and confounders (ethnic group, age, education, sexual behavior [including condom use], marital status, and human immunodeficiency virus status) had no effect on the results. This is the first randomized controlled trial to show a reduction in the prevalence of urethral HR-HPV infection after MC. This finding explains why women with circumcised partners are at a lower risk of cervical cancer than other women. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL TRIALS | EPIDEMIOLOGIC METHODS | YOUTH | MULTIVARIATE ANALYSIS | MEN | MALE CIRCUMCISION | HPV | PREVALENCE | RISK FACTORS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Data Analysis | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Viral Diseases | Diseases | Measurement | Biology Document Number: 328586 |
| 7. Peer Reviewed Title: Return to fertility after cessation of a continuous oral contraceptive. Author: Barnhart K; Mirkin S; Grubb G; Constantine G Source: Fertility and Sterility. 2009 May;91(5):1654-6. Abstract: OBJECTIVE: To evaluate the return to fertility among women planning to become pregnant after the use of a continuous regimen of levonorgestrel 90 microg and ethinyl E(2) 20 microg. DESIGN: Descriptive analysis of pregnancy outcomes after participation in a contraceptive trial. SETTING: Multicenter trial. SUBJECT(S): Participants in a phase 3 contraceptive trial who discontinued to become pregnant. INTERVENTION(S): Eligible subjects were contacted at 3 and 12 months after treatment discontinuation to determine if and when they had conceived. MAIN OUTCOME MEASURE(S): Kaplan-Meier analysis displaying the time until conception after oral contraceptive discontinuation. RESULT(S): In the phase 3 trial, 34 of 2,134 subjects cited a desire for pregnancy as a reason for discontinuation. Of these, 4 were already pregnant before stopping treatment, 4 initiated other contraception, and 5 were lost to follow-up. Of the remaining 21 subjects at risk of pregnancy, the pregnancy rate was 57% at 3 months, 81% at 12 months, and 86% (18 of 21) (95% confidence interval 64% to 97%) at 13 months after discontinuation of treatment. CONCLUSION(S): These findings suggest that a continuous oral contraceptive with levonorgestrel 90 microg and ethinyl E(2) 20 microg does not delay the return to fertility. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | ORAL CONTRACEPTIVES, LOW-DOSE | REVERSIBILITY | CONTRACEPTIVE USE-EFFECTIVENESS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Effectiveness Document Number: 341245 |
| 8. Peer Reviewed Title: Right conclusion, wrong method [letter] Author: Berger VW Source: European Journal of Contraception and Reproductive Health Care. 2009 Aug;14(4):317-8; author reply 319-20. Abstract: This letter to the editor takes issue with an article written by Ferreira et al regarding contraceptive counseling after an abortion. It agrees that there is no evidence indicating contraceptive counseling is effective in increasing acceptance and use of contraceptive methods after an abortion, but disagrees with the method used to arrive at that conclusion. It specifically finds the combination of the Jadad score to evaluate trial quality and the cutoff of three as indicating a high quality trial as flawed. Language: English Keywords: UNITED STATES OF AMERICA | CRITIQUE | RESEARCH METHODOLOGY | CLINICAL TRIALS | POSTABORTION CARE | COUNSELING | CONTRACEPTIVE USAGE | CONTRACEPTIVE METHOD ACCEPTABILITY | VALIDITY | Developed Countries | North America | Americas | Clinical Research | Health Services | Delivery of Health Care | Health | Clinic Activities | Program Activities | Programs | Organization and Administration | Contraception | Family Planning | Measurement Document Number: 342949 |
| 9. Peer Reviewed Title: Uptake of male circumcision in an HIV vaccine efficacy trial [letter] Author: Bruyn G; Martinson NA; Nkala BD; Tshabangu N; Shilaluka G; Kublin J; Corey L; Gray GE Source: Journal of Acquired Immune Deficiency Syndromes. 2009 May 1;51(1):108-10. Abstract: Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL TRIALS | MEN | HIV PREVENTION | MALE CIRCUMCISION | HIV INFECTIONS | VACCINES | SEX BEHAVIOR | RISK BEHAVIOR | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Clinical Research | Research Methodology | Demographic Factors | Population | Viral Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Behavior Document Number: 342348 |
| 10. Peer Reviewed Title: Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. Author: Bussmann H; Wester CW; Thomas A; Novitsky V; Okezie R; Muzenda T; Gaolathe T; Ndwapi N; Mawoko N; Widenfelt E; Moyo S; Musonda R; Mine M; Makhema J; Moffat H; Essex M; Degruttola V; Marlink RG Source: Journal of Acquired Immune Deficiency Syndromes. 2009 May 1;51(1):37-46. Abstract: BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa. METHODS: The Tshepo Study is a completed, open-labeled, randomized study that enrolled 650 ARV-naive adults between December 2002 and 2004. The study is a 3 x 2 x 2 factorial design comparing the efficacy and tolerability among factors: (1) 3 combinations of nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine (ZDV) + lamivudine (3TC), ZDV + didanosine (ddI), and stavudine (d4T) + 3TC; (2) 2 different nonnucleoside reverse transcriptase inhibitors (NNRTIs): nevirapine and efavirenz; and (3) 2 different adherence strategies: the current national "standard of care" versus an "intensified adherence strategy" incorporating a "community-based directly observed therapy." Study patients were stratified into 2 balanced CD4 T-cell count groups: less than 201 versus 201-350 cells per cubic millimeter with viral load greater than 55,000 copies per milliliter. Following Data Safety Monitoring Board recommendations in April 2006, ZDV/ddI-containing arms were discontinued due to inferiority in primary end point, namely, virologic failure with resistance. We report both overall data and pooled data from patients receiving ZDV/ddI- versus ZDV/3TC- and d4T/3TC-containing cART through April 1, 2006. RESULTS: Four hundred fifty-one females (69.4%) and 199 males with a median age of 33.3 years were enrolled into the study. The median follow-up as of April 1, 2006, was 104 weeks, and loss to follow-up rate at 2 years was 4.1%. The median baseline CD4 T-cell count was 199 cells per cubic millimeter [interquartile ratio (IQR) 136-252], and the median plasma HIV-1 RNA level was 193,500 copies per milliliter (IQR 69-250, 472-500). The proportion of participants with virologic failure and genotypic resistance mutations was 11% in those receiving ZDV/ddI-based cART versus 2% in those receiving either ZDV/3TC- or d4T/3TC-based cART (P = 0.002). The median CD4 T-cell count increase at 1 year was 137 cells per cubic millimeter (IQR 74-223) and 199 cells per cubic millimeter (IQR 112-322) at 2 years with significantly lower gain in the ZDV/ddI arm. At 1 and 2 years, respectively, 92.0% and 88.8% of patients had an undetectable plasma HIV-1 RNA level (< or = 400 copies/mL). Kaplan-Meier survival estimates at 1 and 2 years were 96.6% and 95.4%. One hundred twenty patients (18.2%) had treatment-modifying toxicities, of which the most common were lipodystrophy, anemia, neutropenia, and Stevens-Johnson syndrome. There was a trend toward difference in time to treatment-modifying toxicity by pooled dual-NRTI combination and no difference in death rates. CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART. Language: English Keywords: BOTSWANA | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | PERSONS LIVING WITH HIV/AIDS | ADULTS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | USER COMPLIANCE | DRUG RESISTANCE | IMMUNOLOGICAL EFFECTS | SIDE EFFECTS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Studies | HIV Infections | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Behavior | Immunity | Immune System | Physiology | Biology Document Number: 342371 |
| 11. Peer Reviewed Title: Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial. Author: Cagnacci A; Ferrari S; Tirelli A; Zanin R; Volpe A Source: Contraception. 2009 Feb;79(2):111-6. Abstract: BACKGROUND: Second-generation and third-generation oral contraceptives containing 30 mcg or more of ethinylestradiol (EE) decrease insulin sensitivity (SI). In this study, we investigated whether SI is decreased by contraceptives containing lower doses EE or by progestins with antiandrogenic properties. STUDY DESIGN: Twenty-eight young healthy women were randomly allocated to receive 20 mcg of EE and 150 mcg of desogestrel (DSG) (n=14) or 30 mcg of EE and 2 mg of chlormadinone acetate (CMA) (n=14) for 6 months. SI and glucose utilization independent of insulin (Sg) were investigated by the minimal model method. Lipid modifications were also analyzed. RESULTS: SI decreased with EE/DSG (7.09+/-1.4 vs. 4.30+/-0.91; p=.04; n=12), but not with EE/CMA (5.79+/-0.93 vs. 6.79+/-1.1; p=.48; n=12). SI modifications observed in the two groups were significantly different (-2.79+/-1.15 vs. 1.0+/-1.38; p=.05). Sg did not vary with either treatment. The response of C-peptide to glucose increased, but significantly so only with EE/CMA (p=.01). The C-peptide/insulin response increased with both EE/DSG (p=.05) and EE/CMA (p=.04). High-density lipoprotein (HDL) cholesterol (p=.02) and triglycerides (p=.02 and p=.01) increased in both groups, but HDL/low-density lipoprotein cholesterol (p=.02), apoprotein A1 (Apo-A1) (p=.04) and Apo-A1/apoprotein B (p=.048) increased significantly only with EE/CMA. CONCLUSIONS: The present study confirms that DSG, even when associated with low EE dose, decreases SI. By contrast, EE/CMA does not deteriorate SI and induces a favorable lipid profile. Language: English Keywords: ITALY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | PROGESTERONE | DESOGESTREL | CONTRACEPTION | ORAL CONTRACEPTIVES | LIPIDS | METABOLIC EFFECTS | SIDE EFFECTS | Developed Countries | Europe, Southern | Europe | Clinical Research | Research Methodology | Demographic Factors | Population | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Family Planning | Contraceptive Methods | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 329611 |
| 12. Title: Mifepristone plus vaginal misoprostol vs vaginal misoprostol alone for medical abortion in gestation 63 days or less in Nepalese women: a quasi-randomized controlled trial. Author: Chawdhary R; Rana A; Pradhan N Source: Journal of Obstetrics and Gynaecology Research. 2009 Feb;35(1):78-85. Abstract: AIM: To compare the efficacy of mifepristone and vaginal misoprostol with misoprostol alone for pregnancy termination up to 63 days. METHOD: This exploratory study was conducted in the Department of Obstetrics and Gynecology, Tribhuvan University Teaching Hospital, Kathmandu, Nepal as a part of a thesis study for a period of one year from April 2005-2006. After confirming a pregnancy < or =63 days gestation by transvaginal ultrasound, an equal number of women (50) were randomized into (i) group A, women who received 200 mg oral mifepristone (RU 486) on day 1 and vaginal misoprostol 800 microg on day 3; and (ii) group B, women who received vaginal misoprostol (800 microg) on day 1 and 3 (total dose 1600 microg). The primary study outcome measure was complete abortion without surgical intervention making comparisons between these two groups in terms of complete abortion rate, need for manual vacuum aspiration for incomplete abortion and pregnancy continuation after reconfirming the diagnosis on transvaginal ultrasound, besides comparing the side effects/complications. RESULTS: Fewer side effects and a more complete abortion rate (94%) was observed in group A (mifepristone and vaginal misoprostol) in comparison to vaginal misoprostol alone (total dose 1600 microg) giving a complete abortion rate of 86% along with a significant hematocrit drop on follow-up day 10 (P = 0.03) besides having increased duration of bleeding (P = 0.017). CONCLUSION: Mifepristone oral (200 mg) followed by vaginal misoprostol (800 microg) on day 3 provides a better success rate (94%) with fewer complications than vaginal misoprostol 800 microg used on days 1 and 3 for medical abortion of pregnancies up to 63 days. Language: English Keywords: NEPAL | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN IN DEVELOPMENT | PREGNANT WOMEN | RU-486 | MISOPROSTOL | ABORTION | VAGINA | ULTRASONICS | ADMINISTRATION AND DOSAGE | TIME FACTORS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | PREGNANCY, FIRST TRIMESTER | Developing Countries | Asia, Southern | Asia | Clinical Research | Research Methodology | Studies | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Prostaglandins, Synthetic | Prostaglandins | Fertility Control, Postconception | Family Planning | Genitalia, Female | Genitalia | Urogenital System | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Population Dynamics | Contraceptive Agents | Contraception | Pregnancy | Reproduction Document Number: 341125 |
| 13. Title: Women's health and gender-based clinical trials on etoricoxib: methodological gender bias. Author: Chilet-Rosell E; Ruiz-Cantero MT; Horga JF Source: Journal of Public Health. 2009 Sep;31(3):434-45. Abstract: BACKGROUND: The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. METHODS: The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). RESULTS: Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | CONTRACEPTIVE AGENTS, FEMALE | HORMONE REPLACEMENT THERAPY | SIDE EFFECTS | THROMBOSIS | SEX FACTORS | PREGNANCY | VALIDITY | Clinical Research | Research Methodology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Thromboembolism | Embolism | Vascular Diseases | Diseases | Population Characteristics | Demographic Factors | Population | Reproduction | Measurement Document Number: 342950 |
| 14. Title: Effects of prenatal micronutrient supplementation on complications of labor and delivery and puerperal morbidity in rural Nepal. Author: Christian P; Khatry SK; Leclerq SC; Dali SM Source: International Journal of Gynaecology and Obstetrics. 2009 Apr 13; Abstract: OBJECTIVE: To examine the effect of supplemental prenatal folic acid, folic acid-iron, folic acid-iron-zinc, and multiple micronutrients on maternal morbidity in rural Nepal. METHODS: A cluster-randomized double-masked controlled trial of pregnant women who received daily supplements from early pregnancy through 3 months post partum as per the treatment allocation. Women were interviewed at birth about labor and delivery complications and for 9 days post partum to obtain 24-hour histories of morbidity. RESULTS: A total of 3986 (97.3%) women completed an interview regarding labor and delivery; morbidity history was available for 3564 (87.0%) women. Folic acid-iron reduced the risk of postpartum hemorrhage (relative risk [RR] 0.59; 95% confidence interval [CI] 0.35-0.98). Risk of dysfunctional labor increased with multiple micronutrient supplementation (RR 1.28; 95% CI, 1.01-1.60), although preterm premature rupture of membrane decreased (RR 0.40; 95% CI, 0.21-0.79). Puerperal sepsis was lower in those receiving folic acid-iron, folic acid-iron-zinc, and multiple micronutrients compared with controls (P<0.05). CONCLUSION: Prenatal folic acid-iron supplementation reduced the risk of obstetric complications in this South Asian setting. Language: English Keywords: NEPAL | RESEARCH REPORT | CLINICAL TRIALS | DOUBLE-BLIND STUDIES | EPIDEMIOLOGIC METHODS | WOMEN IN DEVELOPMENT | RURAL POPULATION | PREGNANT WOMEN | CHILDBIRTH | PREGNANCY COMPLICATIONS | MATERNAL NUTRITION | FOOD SUPPLEMENTATION | PUERPERAL DISORDERS | VITAMINS AND MINERALS | FOLIC ACID | Developing Countries | Asia, Southern | Asia | Clinical Research | Research Methodology | Studies | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Pregnancy Outcomes | Pregnancy | Reproduction | Diseases | Nutrition | Health | Nutrition Programs | Primary Health Care | Health Services | Delivery of Health Care | Physiology | Biology Document Number: 341459 |
| 15. Peer Reviewed Title: In utero HIV infection is associated with an increased risk of nevirapine resistance in ugandan infants who were exposed to perinatal single dose nevirapine. Author: Church JD; Mwatha A; Bagenda D; Omer SB; Donnell D; Musoke P; Nakabiito C; Eure C; Bakaki P; Matovu F; Thigpen MC; Guay LA; McConnell M; Fowler MG; Jackson JB; Eshleman SH Source: AIDS Research and Human Retroviruses. 2009 Jul;25(7):673-7. Abstract: Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis. We combined results from four clinical trials to analyze predictors of NVP resistance in sdNVP-exposed Ugandan infants. Samples were tested with the ViroSeq HIV Genotyping System and a sensitive point mutation assay (LigAmp, for detection of K103N, Y181C, and G190A). NVP resistance was detected at 6-8 weeks in 36 (45.0%) of 80 infants using ViroSeq and 33 (45.8%) of 72 infants using LigAmp. NVP resistance was more frequent among infants who were infected in utero than among infants who were diagnosed with HIV infection after birth by 6-8 weeks of age. Detection of NVP resistance at 6-8 weeks was not associated with HIV subtype (A vs. D), pre-NVP maternal viral load or CD4 cell count, infant viral load at 6-8 weeks, or infant sex. NVP resistance was still detected in some infants 6-12 months after sdNVP exposure. In this study, in utero HIV infection was the only factor associated with detection of NVP resistance in infants 6-8 weeks after sdNVP exposure. Language: English Keywords: UGANDA | RESEARCH REPORT | CLINICAL TRIALS | INFANT | TREATMENT | HIV PREVENTION | ANTIRETROVIRAL DRUGS | DRUG RESISTANCE | PERSONS LIVING WITH HIV/AIDS | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV Infections | Viral Diseases | Diseases Document Number: 342890 |
| 16. Title: Access to medications and medical care after participation in HIV clinical trials: a systematic review of trial protocols and informed consent documents. Author: Ciaranello AL; Walensky RP; Sax PE; Chang Y; Freedberg KA; Weissman JS Source: HIV Clinical Trials. 2009 Jan-Feb;10(1):13-24. Abstract: BACKGROUND: Expectations regarding receipt of medications and medical care after clinical trials conclude may inform decisions about trial participation. We describe the frequency with which these posttrial services are described in the protocols and informed consent forms (ICFs) of antiretroviral drug (ARV) trials. METHOD: We systematically reviewed protocols and ICFs from Phase 3 and 4 antiretroviral trials in adults (> or = 12 years) from 1987 to 2006. Pharmaceutical industry-sponsored trials were selected from US Food and Drug Administration (FDA) documentation and Clinicaltrials.gov. Trials administered by the AIDS Clinical Trials Group (ACTG) were selected from the ACTG online registry. ACTG- and industry-provided protocols and ICFs were reviewed in full. The primary outcome was any mention of posttrial services, defined as any text regarding posttrial medications or medical care. RESULTS: Complete trial documents were available for 31 (48%) of 65 trials meeting inclusion criteria. Documents from 14 trials (45%) mentioned any posttrial service: 12 (39%) mentioned medications, and 5 (16%) mentioned medical care. Payment for trial participation (74%) and for care for trial-related injury (94%) were mentioned more often than were posttrial services. CONCLUSIONS: Posttrial medications or medical care was mentioned in the trial documents of <50% of reviewed antiretroviral trials. Improved efforts are needed to clearly describe posttrial services in clinical trial protocols and ICFs. Language: English Keywords: GLOBAL | RESEARCH REPORT | CLINICAL TRIALS | ADULTS | HUMAN VOLUNTEERS | ANTIRETROVIRAL DRUGS | INFORMED CONSENT | PARTICIPATION | ETHICS | ANTIRETROVIRAL THERAPY | PROGRAM ACCESSIBILITY | Clinical Research | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Social Behavior | Behavior | Sociocultural Factors | HIV | HIV Infections | Viral Diseases | Diseases | Program Evaluation | Programs | Organization and Administration Document Number: 341817 |
| 17. Peer Reviewed Title: Two-months-off, four-months-on antiretroviral regimen increases the risk of resistance, compared with continuous therapy: A randomized trial involving West African adults. Author: Danel C; Moh R; Chaix ML; Gabillard D; Gnokoro J; Diby CJ; Toni T; Dohoun L; Rouzioux C; Bissagnene E; Salamon R; Anglaret X Source: Journal of Infectious Diseases. 2009 Jan 1;199(1):66-76. Abstract: A randomized trial was launched in Côte d'Ivoire in 2002 to compare continuous antiretroviral treatment (hereafter, "C-ART") to an ART regimen of 2 months off and 4 months on therapy (hereafter, "2/4-ART"). We report the final analysis. A total of 435 adults who were receiving successful ART ((median CD4 cell count prior to ART, 272 cells/mm3; 88% were receiving a zidovudine-lamivudine-efavirenz regimen) were randomized to receive C-ART or 2/4-ART. The main primary end point was the percentage of patients with <350 CD4 cells/mm3 at 24 months. The sample size ensured 80% power to demonstrate noninferiority (noninferiority bound, -15%), assuming that 30% of the patients in the C-ART arm would have <350 CD4 cells/mm3. Other end points were mortality, morbidity, cost of care, genotypic resistance, adherence, and toxicity. The percentage of patients with <350 CD4 cells/mm3 at 24 months was 5.6% (6 of 107) in the C-ART arm and 14.6% (46 of 315) in the 2/4-ART arm (lower bound of the 95% CI for the difference, -14%). Cost was 18% higher in the C-ART arm, and resistance to nonnucleoside reverse-transcriptase inhibitors (NNRTIs) was 20% higher in the 2/4-ART arm. Other end points were nonconclusive. Although 2/4-ART met the predetermined criteria for noninferiority, the percentage of patients with <350 CD4 cells/mm3 in the C-ART arm was lower than anticipated, which makes the clinical significance of this noninferiority uncertain. In addition, 2/4-ART led to an unacceptable additional risk of selecting for drug-resistant virus. This new argument against episodic ART strategies is also a caveat against any unplanned ART interruptions in Africa, where most patients receive NNRTIs. Language: English Keywords: COTE D'IVOIRE | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | ADULTS | TIME FACTORS | ADMINISTRATION AND DOSAGE | RISK ASSESSMENT | DRUG RESISTANCE | ANTIRETROVIRAL DRUGS | IMMUNITY, CELLULAR | GENETICS | Developing Countries | Africa, Western | Africa, Sub Saharan | Africa | Clinical Research | Research Methodology | Studies | Age Factors | Population Characteristics | Demographic Factors | Population | Population Dynamics | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Evaluation | Immunity | Immune System | Physiology | Biology Document Number: 328597 |
| 18. Peer Reviewed Title: Quinacrine sterilization for human immunodeficiency virus-positive women. Author: de Magalhaes DR; de Carvalho Ferreira CR; Barbosa Magalhaes E; Camargos AF; Lippes J; Carvalho Ferreira D Source: Fertility and Sterility. 2009 Jul;92(1):108-15. Abstract: OBJECTIVE: To evaluate the safety of nonsurgical quinacrine sterilization for HIV-positive (HIV+) women. DESIGN: An open trial of quinacrine sterilization was carried out in women infected with HIV and women who were HIV negative (HIV-). Comparison of the results with the two groups provided an assessment of the safety and effectiveness of quinacrine sterilization for HIV+ women. SETTING: University Medical School outpatient services. PATIENT(S): A total of 258 women who desired sterilization were offered quinacrine sterilization as a means of limiting family size. Sixty-four were HIV+, and 194 were HIV-. Women who were HIV+ had CD4 counts >200 and were otherwise healthy. INTERVENTION(S): A modified Copper T intrauterine device inserter was used to place 252 mg of quinacrine, divided into seven pellets (36 mg each) into the uterine cavity. Three insertions of this formulation were performed, 1 month apart. Viral load and CD8 and CD4 lymphocytes were measured both before and after quinacrine sterilization and at follow-up visits. Pregnancies and adverse events were recorded carefully. A decrement life table was made to statistically analyze results. RESULT(S) AND MAIN OUTCOME MEASURE(S): No serious adverse event occurred in any patient in this study. Adverse effects related to quinacrine sterilization were abdominal cramping, vulvar itching, nausea, and vaginal bleeding. Vaginal bleeding was the only short-term side effect noted to occur more frequently in HIV-infected women after quinacrine sterilization. Among HIV+ women, 35.9% had complaints of increased bleeding, whereas only 8.2% of those who were HIV- had such complaints, which probably were insertion related. Viral load and the CD4+ and CD8+ lymphocyte measures displayed no statistically significant difference after quinacrine sterilization. CONCLUSION(S): Quinacrine sterilization is a safe method for the sterilization of HIV-infected women and has no short-term effect on the pathology of the disease. Language: English Keywords: BRAZIL | RESEARCH REPORT | CLINICAL TRIALS | PERSONS LIVING WITH HIV/AIDS | WOMEN | QUINACRINE STERILIZATION | SAFETY | ANTIRETROVIRAL THERAPY | SIDE EFFECTS | INSERTION | ULTRASONICS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Clinical Research | Research Methodology | HIV Infections | Viral Diseases | Diseases | Demographic Factors | Population | Female Sterilization | Sterilization, Sexual | Family Planning | Public Health | Health | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 342325 |
| 19. Peer Reviewed Title: HIV vaccine preparedness studies in the non-organization for economic co-operation and development (non-OECD) countries. Author: Dhalla S; Nelson KE; Singer J; Poole G Source: AIDS Care. 2009 Mar;21(3):335-48. Abstract: HIV vaccine development remains an urgent priority. Vaccine preparedness studies to assess feasibility are an important precursor to HIV vaccine trials. Studies such as these have taken place in many non-Organization for Economic Co-operation and Development (non-OECD) countries using diverse cohorts. This article is a systematic review of retention rates and willingness to participate (WTP) in HIV vaccine trials. Studies took place in Brazil, the Democratic Republic of Congo, Haiti, India, Russia, Thailand, and several sub-Saharan African countries. Studies generally reported recruitment of high-risk individuals. Of 33 studies we identified, retention was assessed in 16 studies, and the 12-month retention ranged from 77 to 85%. Willingness to participate was assessed in 21 studies. Willingness to participate ranged from 23 to 100%, and increased knowledge was associated with an increased WTP. Vaccine preparedness studies have taken place using diverse cohorts in the non-OECD countries. In general, retention rates and WTP have been adequate to conduct HIV vaccine trials. Educational programs to improve knowledge about HIV vaccines may contribute to better follow-up and an increased WTP in these countries. Language: English Keywords: DEVELOPING COUNTRIES | LITERATURE REVIEW | CLINICAL TRIALS | RESEARCH ACTIVITIES | HIV PREVENTION | VACCINES | EPIDEMIOLOGY | PARTICIPATION | MOTIVATION | OBSTACLES | Clinical Research | Research Methodology | HIV Infections | Viral Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health | Social Behavior | Behavior | Psychological Factors | Organization and Administration Document Number: 341856 |
20.  Title: Termination of missed abortion in a combined procedure: a randomized controlled trial. Author: Fang AF; Chen QF; Zheng W; Li YH; Chen RY Source: Journal of Reproduction and Contraception. 2009 Mar;20(1):45-49. Abstract: Objective To access an ideal procedure terminating missed abortion within 12 weeks of gestational age. Methods Women with intrauterine fetal death were randomized into 3 groups. Group A (n=30): vaginal misoprostol (MP) 0.4 mg, 3 h before vacuum aspiration; group B(n=15): vaginal MP 0.4 mg every 3 h, up to 5 doses; group C(n=30): oral mifepristone (MF) 200 mg 36-48 h before vaginal MP 0.4 mg, MP was given every 3 h, up to 5 doses. Results Women in group A had the shortest interval of gestation tissue expulsion (3.2 - 0.5 h) and the bleeding (3.2 + 5.7 ml) during medical procedure, which were statistically significant in comparison with the other two groups (P<0.001, P<0.01, respectively). Success rates of groups A, B and C were 100%, 33.3% and 90.0%, respectively. Percentages of women need surgical interventions were similar in group B and group C(80.0%,76.7%, respectively). Bleeding during operation, pain after medical procedure and satisfaction presented no statistical significance among the 3 groups. Conclusion Vaginal MP followed by vacuum aspiration was valuable in safety, and efficacy, which led to less bleeding and a faster recovery. Language: English Keywords: CHINA | RESEARCH REPORT | CLIENTS | CLINICAL TRIALS | FETAL DEATH | ABORTION | MISOPROSTOL | RU-486 | ADMINISTRATION AND DOSAGE | Asia, Eastern | Asia | Developing Countries | Program Activities | Programs | Organization and Administration | Clinical Research | Research Methodology | Mortality | Population Dynamics | Demographic Factors | Population | Fertility Control, Postconception | Family Planning | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341510 |
| 21. Title: [Descriptive study on contraceptive requirements for clinical trials in Spain. Do we need a debate?] Estudio descriptivo de las recomendaciones anticonceptivas en los ensayos Author: Gastaminza Lasarte G; Algorta Pineda J Source: Medicina Clinica. 2009 Jan 24;132(2):70-4. Abstract: Among the measures that seek to avoid the toxic effects on reproduction (teratogenic, embryotoxic, fetotoxic or otherwise) include the obligation to conduct preclinical tests to investigate this aspect in different animal species before marketing a new drug, although its application in time differs Europe-European Medicines Agency (EMEA) and US-Food and Drug Administration (FDA). In Europe requires that prior to including women in phase I of clinical trials have been completed preclinical studies on embryo-fetal development, without any mention of contraception. In contrast, U.S. can include women in the fertile clinical trials have not completed initial pre-clinical tests on the safety play, if they practice a pregnancy test before participation in contraception and take some action "highly effective". Are considered "highly effective" (by both the FDA and the EMEA, to be included in a document of the International Conference on Harmonization) methods with low failure rate (<1% per year) when used properly, such as implants, injectables, combined oral, some intrauterine devices (IUDs), sexual abstinence or a vasectomy for the partner. (excerpt) Language: Spanish Keywords: SPAIN | RESEARCH REPORT | CLINICAL TRIALS | PREGNANCY TESTS | ORAL CONTRACEPTIVES, COMBINED | IUD | INJECTABLES | CONTRACEPTIVE IMPLANTS | VASECTOMY | Europe, Southwestern | Europe | Developed Countries | Clinical Research | Research Methodology | Laboratory Procedures | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Male Sterilization | Sterilization, Sexual Document Number: 329576 |
| 22. Peer Reviewed Title: A human immunodeficiency virus risk reduction intervention for incarcerated youth: a randomized controlled trial. Author: Goldberg E; Millson P; Rivers S; Manning SJ; Leslie K; Read S; Shipley C; Victor JC Source: Journal of Adolescent Health. 2009 Feb;44(2):136-45. Abstract: PURPOSE: To evaluate, by gender, the impact of a structured, comprehensive risk reduction intervention with and without boosters on human immunodeficiency virus (HIV) knowledge, attitudes and behaviors in incarcerated youth; and to determine predictors of increasing HIV knowledge and reducing high-risk attitudes and behaviors. METHODS: This randomized controlled trial involved participants completing structured interviews at 1, 3, and 6 months. Repeated measures analysis of variance was used to analyze changes over time. The study was conducted in secure custody facilities and in the community. The study sample comprising 391 incarcerated youth, 102 female and 289 male aged 12-18, formed the voluntary sample. Participants were randomly assigned to one of three conditions: education intervention; education intervention with booster; or no systematic intervention. The outcome and predictor measures included the Rosenberg Self-Esteem Scale, Youth Self Report, Drug Use Inventory, and HIV Knowledge, Attitudes and Behavior Scale. RESULTS: The 6-month retention rate was 59.6%. At 6 months, males in the education and booster groups sustained increases in knowledge scores (p < 0.001). Females in these groups sustained increased condom attitude scores (p = 0.004). Males in the booster group sustained increased prevention attitude scores (p = 0.017). Females in the booster group reported more consistent condom use (odds ratio [OR] = 4.20; 95% confidence interval [CI] = 1.81, 9.77). Age, gender, drug use, and psychological profiles were predictive of outcome. CONCLUSIONS: The intervention and boosters led to gender-specific improvements in knowledge, attitudes, and condom use. Result variations by gender underline the importance of gender issues in prevention interventions. Predictors of success were identified to inform future HIV education interventions. Language: English Keywords: CANADA | RESEARCH REPORT | CLINICAL TRIALS | KAP SURVEYS | PRISONERS | YOUTH | HIV PREVENTION | SEX FACTORS | KNOWLEDGE | ATTITUDES | SEX BEHAVIOR | RISK BEHAVIOR | TIME FACTORS | HEALTH EDUCATION | SEX EDUCATION | Developed Countries | North America, Northern | Americas | Clinical Research | Research Methodology | Surveys | Sampling Studies | Studies | Crime | Social Problems | Sociocultural Factors | Age Factors | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Psychological Factors | Behavior | Population Dynamics | Education Document Number: 331072 |
| 23. Title: Oral contraceptives for functional ovarian cysts. Author: Grimes DA; Jones LB; Lopez LM; Schulz KF Source: Cochrane Database of Systematic Reviews. 2009;(2):CD006134. Abstract: BACKGROUND: Functional ovarian cysts are a common gynecological problem among women of reproductive age worldwide. When large, persistent, or painful, these cysts may require operations, sometimes resulting in removal of the ovary. Since early oral contraceptives were associated with a reduced incidence of functional ovarian cysts, many clinicians inferred that birth control pills could be used to treat cysts as well. This became a common clinical practice in the early 1970s. OBJECTIVES: This review examined all randomized controlled trials that studied oral contraceptives as therapy for functional ovarian cysts. SEARCH STRATEGY: We searched the databases of CENTRAL, MEDLINE, POPLINE, and EMBASE, as well as clinical trials databases (ClinicalTrials.gov and ICTRP). We also examined the reference lists of articles and wrote to authors of identified trials to seek articles we had missed. SELECTION CRITERIA: We included randomized controlled trials in any language that included oral contraceptives used for treatment and not prevention of functional ovarian cysts. Criteria for diagnosis of cysts were those used by authors of trials. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from the articles. One entered the data into RevMan and a second verified accuracy of data entry. For dichotomous outcomes, we used Peto odds ratios with 95% confidence intervals (CI). For continuous outcomes, we calculated mean differences with 95% CI. MAIN RESULTS: We identified seven randomized controlled trials from four countries; the studies included a total of 500 women. Treatment with combined oral contraceptives did not hasten resolution of functional ovarian cysts in any trial. This held true for cysts that occurred spontaneously as well as those that developed after ovulation induction. Most cysts resolved without treatment within a few cycles; persistent cysts tended to be pathological (e.g., endometrioma or para-ovarian cyst) and not physiological. AUTHORS' CONCLUSIONS: Although widely used fortreating functional ovarian cysts, combined oral contraceptives appear to be of no benefit. Watchful waiting for two or three cycles is appropriate. Should cysts persist, surgical management is often indicated. Language: English Keywords: LITERATURE REVIEW | CLINICAL TRIALS | WOMEN | OVARIAN CYSTS | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | TREATMENT | Clinical Research | Research Methodology | Demographic Factors | Population | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330972 |
| 24. Peer Reviewed Title: Multicenter Contraceptive Efficacy Trial of Injectable Testosterone Undecanoate in Chinese Men. Author: Gu Y; Liang X; Wu W; Liu M; Song S; Cheng L; Bo L; Xiong C; Wang X; Liu X; Peng L; Yao K Source: Journal of Clinical Endocrinology and Metabolism. 2009 Jun;94(6):1910-1915. Abstract: Context: Hormonal male contraceptive regimens effectively and reversibly suppress sperm production but there are few large-scale efficacy studies. Objective: The safety, contraceptive efficacy, reversibility and feasibility of injectable testosterone undecanoate (TU) in tea seed oil as a hormonal male contraceptive was assessed. Design: This was a mutilcenter, phase III, contraceptive efficacy clinical trial. Participants: 1045 healthy fertile Chinese men were recruited throughout China into the study. Intervention(s): Monthly injections of 500 mg TU, administered for 30 months. A definition of severe oligozoospermia (Language: English Keywords: CHINA | RESEARCH REPORT | CLINICAL TRIALS | MEN | INJECTABLES | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE AGENTS, MALE | CONTRACEPTIVE SAFETY | REVERSIBLE STERILIZATION | ADMINISTRATION AND DOSAGE | SPERMATOGENESIS BLOCKING AGENTS | TESTIS | SEMEN | HORMONES | TIME FACTORS | Asia, Eastern | Asia | Developing Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Safety | Public Health | Health | Sterilization, Sexual | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Genitalia, Male | Genitalia | Urogenital System | Physiology | Biology | Seminal Vesicles | Endocrine System | Population Dynamics Document Number: 330735 |
| 25. Peer Reviewed Title: Interaction of contraceptive antimicrobial peptide nisin with target cell membranes: implications for use as vaginal microbicide. Author: Gupta SM; Aranha CC; Bellare JR; Reddy KV Source: Contraception. 2009 Sep;80(3):299-307. Abstract: BACKGROUND: Nisin, a naturally occurring antimicrobial peptide (AMP), is currently the focus of clinical trials as an intravaginal microbicide. Therefore its mechanism of interaction with various cell membranes was studied. STUDY DESIGN: Flow cytometry was used for quantitative estimation of membrane damage by nisin which was further determined by scanning electron microscopy (SEM). Affinity of nisin for different unilamellar liposome vesicles was determined spectroflurometrically and confirmed using laser scanning confocal microscopy (LSCM). RESULTS: Propidium iodide (PI) staining by flow cytometry exhibited selective membrane permeabilizing effect of nisin on sperm and bacterial membranes which correlated with ultrastructural changes. In vitro interaction of nisin with liposome model vesicles revealed significant leakage of calcein from liposomes composed of phosphatidylcholine/phosphatidylglycerol (POPC/POPG) (e.g., bacteria) and phosphatidylcholine/phosphatidylserine (POPC/POPS) (e.g., spermatozoa) as compared to phosphatidylcholine/phosphatidylethanolamine (POPC/POPE) vesicles (e.g., red blood corpuscles). LSCM results were in complete agreement with cell membrane affinity studies. CONCLUSION: This unique property of nisin can be exploited in the development of a safe and effective vaginal microbicide for the prevention of sexually transmitted infections/acquired immunodeficiency syndrome (STIs/AIDS) and unplanned pregnancies. Language: English Keywords: INDIA | RESEARCH REPORT | QUANTITATIVE RESEARCH | CLINICAL TRIALS | LABORATORY ANIMALS | SPERMATOZOA | IN VITRO | MICROBICIDES | AIDS PREVENTION | SEXUALLY TRANSMITTED DISEASES | PREGNANCY, UNPLANNED | PROGRAM EVALUATION | Asia, Southern | Asia | Developing Countries | Research Methodology | Clinical Research | Germ Cells | Genitalia | Urogenital System | Physiology | Biology | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | AIDS | HIV Infections | Viral Diseases | Diseases | Reproductive Tract Infections | Infections | Reproductive Behavior | Fertility | Population Dynamics | Demographic Factors | Population | Programs | Organization and Administration Document Number: 342572 |
| 26. Title: Strategies and ethical considerations for the recruitment of young men who have sex with men: challenges of a vaccination trial in Mexico. Author: Gutierrez-Lund A; Angeles-Llerenas A; Wirtz VJ; Del Rio AA; Zamilpa-Mejia L Source: Clinical Trials. 2009;6(4):365-372. Abstract: The aim of this study was to describe and analyze recruitment strategies, ethical considerations, and recruitment outcomes from a study to evaluate the efficacy the human papilloma virus vaccine in young men who have sex with men (MSM). The recruitment settings were university and community sites in the state of Morelos, Mexico. To be eligible, participants had to be men between 18 and 23 years old who were free of anal-genital lesions as confirmed by clinical exploration, HIV negative, with no history of sexual relations with female partners, and with fewer than five male lifetime sexual partners. Recruitment goals were 25 study participants in a four and a half month period. In addition to traditional recruitment strategies (flyers and media advertising, specific training of the recruitment team, and adequate choice of recruitment sites), local leaders in the MSM community were engaged in the process. In total, 723 MSM were initially contacted, 243 filled out the recruitment questionnaire, of which 151 met the criteria to be invited to the clinical examination. After clinical examination and interviews with the recruitment team, 131 fulfilled the inclusion criteria, of whom 73 were enrolled in the study. Attending meetings with MSM activist organizations was the most successful recruitment strategy (326), followed by recruitment at bars and dance clubs (107). Language: English Keywords: MEXICO | SUMMARY REPORT | CLINICAL TRIALS | YOUTH | MEN HAVING SEX WITH MEN | VACCINATION | HPV | ETHICS | PARTICIPATION | QUESTIONNAIRES | CONFIDENTIAL INFORMATION | SOCIAL DISCRIMINATION | North America | Americas | Developing Countries | Clinical Research | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Sex Behavior | Behavior | Immunization | Primary Health Care | Health Services | Delivery of Health Care | Health | Viral Diseases | Diseases | Sociocultural Factors | Social Behavior | Social Problems Document Number: 339912 |
| 27. Peer Reviewed Title: Community response to intermittent preventive treatment of malaria in infants (IPTi) delivered through the expanded programme of immunization in five African settings. Author: Gysels M; Pell C; Mathanga DP; Adongo P; Odhiambo F; Gosling R; Akweongo P; Mwangi R; Okello G; Mangesho P; Slutsker L; Kremsner PG; Grobusch MP; Hamel MJ; Newman RD; Pool R Source: Malaria Journal. 2009 Aug 10;8(1):191. Abstract: ABSTRACT: BACKGROUND: IPTi delivered through EPI has been shown to reduce the incidence of clinical malaria by 20-59%. However, new health interventions can only be effective if they are also socially and culturally acceptable. It is also crucial to ensure that attitudes to IPTi do not negatively influence attitudes to and uptake of immunization, or that people do not misunderstand IPTi as immunization against malaria and neglect other preventive measures or delay treatment seeking. METHODS: These issues were studied in five African countries in the context of clinical trials and implementation studies of IPTi. Mixed methods were used, including structured questionnaires (1,296), semi-structured interviews (168), in-depth interviews (748) and focus group discussions (95) with mothers, fathers, health workers, community members, opinion leaders, and traditional healers. Participant observation was also carried out in the clinics. RESULTS: IPTi was widely acceptable because it resonated with existing traditional preventive practices and a general concern about infant health and good motherhood. It also fit neatly within already widely accepted routine vaccination. Acceptance and adherence were further facilitated by the hierarchical relationship between health staff and mothers and by the fact that clinic attendance had a social function for women beyond acquiring health care. Type of drug and regimen were important, with newer drugs being seen as more effective, but potentially also more dangerous. Single dose infant formulations delivered in the clinic seem to be the most likely to be both acceptable and adhered to. There was little evidence that IPTi per se had a negative impact on attitudes to EPI or that it had any affect on EPI adherence. There was also little evidence of IPTi having a negative impact on health seeking for infants with febrile illness or existing preventive practices. CONCLUSIONS: IPTi is generally acceptable across a wide range of settings in Africa and involving different drugs and regimens, though there is a strong preference for a single dose infant formulation. IPTi does not appear to have any negative effect on attitudes to EPI, and it is not interpreted as immunization against malaria. Language: English Keywords: AFRICA | RESEARCH REPORT | CLINICAL TRIALS | INCIDENCE | INFANT HEALTH | SAFE MOTHERHOOD | MATERNAL HEALTH | MALARIA | IMMUNIZATION | PREVENTIVE HEALTH CARE | PROGRAM ACCEPTABILITY | Developing Countries | Clinical Research | Research Methodology | Measurement | Child Health | Health | Parasitic Diseases | Diseases | Primary Health Care | Health Services | Delivery of Health Care | Program Evaluation | Programs | Organization and Administration Document Number: 342542 |
| 28. Title: Interim data monitoring to enroll higher-risk participants in HIV prevention trials. Author: Halpern V; Obunge O; Ogunsola F; Otusanya S; Umo-Otong J; Wang CH; Mehta N Source: BMC Medical Research Methodology. 2009;9:44. Abstract: BACKGROUND: Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria. METHODS: We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses. RESULTS: A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study. CONCLUSION: Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial. TRIAL REGISTRATION: The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770. Language: English Keywords: NIGERIA | RESEARCH REPORT | CLINICAL TRIALS | DATA ANALYSIS | WOMEN | RECRUITMENT ACTIVITIES | HIV INFECTIONS | INCIDENCE | PREVALENCE | MONITORING | SEXUALLY TRANSMITTED DISEASES | SEX BEHAVIOR | Developing Countries | Africa, Western | Africa, Sub Saharan | Africa | Clinical Research | Research Methodology | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Viral Diseases | Diseases | Measurement | Evaluation | Reproductive Tract Infections | Infections | Behavior Document Number: 342632 |
| 29. Peer Reviewed Title: Scheduled and unscheduled bleeding patterns with two combined hormonal contraceptives: application of new recommendations for standardization. Author: Hampton RM; Fisher AC; Pagano S; LaGuardia KD Source: Fertility and Sterility. 2009 Aug;92(2):434-40. Abstract: OBJECTIVE: To reassess and compare cycle control attained with two combined hormonal contraceptives, norgestimate (NGM)/ethinyl estradiol (EE) 25 microg and norethindrone acetate (NETA)/EE 20 microg, by new general criteria recommendations for all combined hormonal contraceptives. DESIGN: Analysis of bleeding data for cycles 1-6 from a randomized, multicenter trial. SETTING: 221 North American centers. PATIENT(S): Healthy, sexually active women (18-45 years old). INTERVENTION(S): NETA/EE: 1 mg NETA/20 microg EE, days 1-21 of each cycle and 75 mg of ferrous fumarate, days 22-28; NGM/EE: triphasic NGM in 7-day increments (days 1-7: 180 microg; days 8-14: 215 microg; days 15-21: 250 microg) and 25 microg EE, placebo on days 22-28. MAIN OUTCOME MEASURE(S): Cycle control evaluated from patients' daily diaries. RESULT(S): For cycles 1-6, there was a statistically significant lower incidence of unscheduled bleeding/spotting with NGM/EE 25 microg (range 21.0%-34.4%) than with NETA/EE 20 microg (range 33.0%-46.6%). Of the women who had unscheduled bleeding/spotting, the mean number of days per cycle of bleeding/spotting was comparable. A statistically significant higher incidence of scheduled bleeding was seen with NGM/EE 25 microg (95.2%-97.5%) than with NETA/EE 20 microg (78.5%-84.2%). CONCLUSION(S): The NGM/EE 25 microg has a lower incidence and comparable length of unscheduled bleeding and a higher incidence of scheduled bleeding than NETA/EE 20 microg in this post hoc analysis. Language: English Keywords: NORTH AMERICA | RESEARCH REPORT | CLINICAL TRIALS | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | NORETHINDRONE ACETATE | BLEEDING | STANDARDS | EVALUATION | RECOMMENDATIONS | Developed Countries | Americas | Clinical Research | Research Methodology | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | |