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Peer Reviewed

Title: Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid.
Author: Anderson DJ; Williams DL; Ballagh SA; Barnhart K; Creinin MD; Newman DR; Bowman FP; Politch JA; Duerr AC; Jamieson DJ
Source: American Journal of Reproductive Immunology. 2009 Feb;61(2):121-9.
Abstract: OBJECTIVE: Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. METHOD OF STUDY: Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14 days in combination with one of the two acid-buffering microbicide gels [ACIDFORM (Instead Inc., La Jolla, CA, USA) or BufferGel(trade mark) (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly); Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA. RESULTS: Use of diaphragms with placebo ormicrobicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group. CONCLUSION: Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | CASE CONTROL STUDIES | MICROBICIDES | VAGINAL GEL | LUBRICANTS | IMMUNITY, NATURAL | CONTRACEPTIVE SAFETY | VAGINAL DIAPHRAGM | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Studies | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Ingredients and Chemicals | Immunity | Immune System | Physiology | Biology | Safety | Public Health | Vaginal Barrier Methods | Barrier Methods
Document Number: 330234

Title: Nitric oxide-dependent human acrosomal loss induced by PPCM (SAMMA) and by nitric oxide donors occurs by independent pathways: basis for synthesis of an improved contraceptive microbicide.
Author: Anderson RA; Feathergill KA; Chany CJ 2nd; Jain S; Krunic A
Source: Journal of Andrology. 2009 Mar-Apr;30(2):168-82.
Abstract: PPCM (previously designated sulfuric acid-modified mandelic acid [SAMMA]) is a contraceptive microbicide in preclinical development. Its contraceptive activity is attributable in part to its ability to promote premature acrosomal loss. Prior studies showed that PPCM-induced human acrosomal loss (PAL) is Ca(2+)-dependent. This study was carried out to determine transduction elements downstream from Ca(2+) entry. PAL is inhibited by inhibitors selective for endothelial-type nitric oxide synthase. PAL is completely inhibited by 0.1 microM ODQ (soluble guanylate cyclase inhibitor). PAL is inhibited by protein kinase G inhibitors with selectivity for the type II isotype. Several inhibitors of the nitric oxide/cyclic guanosine monophosphate (cGMP)/protein kinase G pathway induce Ca(2+)-dependent acrosomal loss when added alone. These responses are inhibited by nifedipine, a blocker of Ca(v1.x) voltage-dependent channels. Acrosomal loss induced by the nitric oxide donor SNAP (SNAL) does not require added Ca(2+). Sperm production of nitric oxide is increased by PPCM, an effect inhibited by nitro-L-arginine (nitric oxide synthase inhibitor). Although inhibited by ODQ, SNAL and acrosomal loss induced by other nitric oxide donors are unaffected by KT5823 (protein kinase G inhibitor). Unlike PAL, SNAL is partially inhibited by KT5720 (protein kinase A inhibitor) and genistein (protein tyrosine kinase inhibitor). Acrosomal loss response to PPCM and SNAP added in combination suggests that these agents act by independent mechanisms. A PPCM derivative was synthesized, in which a nitric oxide donor was esterified to PPCM (NOSPPA-23). NOSPPA-23 induces acrosomal loss with or without added Ca(2+). The ED(50) of NOSPPA-23 (4.8 nM) in the presence of Ca(2+) is 35-fold less than that of PPCM. These findings suggest the following: 1) elements responsible for PAL include endothelial nitric oxide synthase, soluble guanylate cyclase, and type II protein kinase G; 2) the resting state of the nitric oxide/cGMP/protein kinase G pathway is a determinant of acrosomal status; 3) PPCM and nitric oxide donors induce acrosomal loss via nitric oxide, but through independent pathways; and 4) covalent attachment of a nitric oxide donor to PPCM provides synergistic efficacy as a stimulus of acrosomal loss. Further studies with this novel prototype as an improved contraceptive microbicide are warranted.
Language: English
Keywords:
UNITED STATES OF AMERICA | ILLINOIS | RESEARCH REPORT | MICROBICIDES | DRUGS | CONTRACEPTION RESEARCH | Developed Countries | North America | Americas | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraception | Family Planning
Document Number: 331202

Title: RISUG: a potential candidate for the entry inhibitor group of antiretroviral drugs.
Author: Banerjee S; Guha SK
Source: Medical Hypotheses. 2009 Aug;73(2):150-2.
Abstract: Entry inhibitors are a group of antiretroviral drug which prevents HIV from entering human immune cells. They include both fusion and attachment inhibitors. A hypothesis is put forward in which a new male contraceptive drug with proven antimicrobial property is proposed as a possible candidate for the entry inhibitor group of antiretroviral drugs. The proposed mechanism of action involves (i) interaction with gp120 and thereby preventing binding to CD4 and (ii) competitive binding with the viral glycoprotein and inhibit the glycoprotein - cell surface glyocosaminoglycan Heparan Sulfate (HS) interaction. A new drug RISUG (Reversible Inhibition of Sperm Under Guidance) presently undergoing Phase III clinical trials throughout India for its contraceptive effect in male has also antimicrobial actions. RISUG is a chemical complex of styrene maleic anhydride (SMA(AN)) and dimethyl sulfoxide. On injection into the vas deferens, it reacts with the components of intravas fluid, the spermatic fluid and gets converted to styrene maleic acid (SMA(AC)) and breakdown products like mandelic acid. An anti HIV activity of RISUG is likely due to its electrical charge and mandelic acid generation. For experimental validation HIV in vitro assays can be performed which will involve infectivity assays, luciferase assay and soluble gp120 assays. A positive result from the studies will validate the hypothesis.
Language: English
Keywords:
INDIA | RESEARCH PROPOSAL | DRUGS | CONTRACEPTIVE AGENTS, MALE | MICROBICIDES | ANTIRETROVIRAL DRUGS | HIV INFECTIONS | IMMUNE SYSTEM | ANTIGEN-ANTIBODY REACTIONS | Asia, Southern | Asia | Developing Countries | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Viral Diseases | Diseases | Physiology | Biology | Antibodies | Immunologic Factors | Immunity
Document Number: 342410

Peer Reviewed

Title: Potential acceptability of microbicides in HIV prevention in stable marital relationships in Malawi.
Author: Bisika T
Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):115-7.
Abstract: BACKGROUND: The XVII International Conference on AIDS held in Mexico City in August 2008 emphasised the importance of dual prevention using both vaccines and microbicides in the fight against HIV and AIDS. Microbicides are important because they constitute one of the potentially important female-controlled methods of HIV and sexually transmitted infection prevention, especially in Malawi where the use of the female condom has not yet been fully embraced. METHODS: A qualitative study utilising focus group discussions was used to assess the acceptability of the microbicide nonoxynol-9 (N-9) as part of the ongoing Preparatory AIDS Vaccine Evaluation (PAVE) studies. RESULTS: The study observed that men oppose the use of N-9, and that although women consider themselves at risk for HIV they caution against the unintended consequence of altering the vaginal environment with the use of microbicides, which can interfere with the men's preference for dry sex. DISCUSSION AND CONCLUSIONS: Although N-9 did not produce the desired results, these can inform the development of other promising microbicide candidates. The study concludes that it is important to pay attention to how new microbicides are formulated rather than just concentrating solely on an individual product's effectiveness.
Language: English
Keywords:
MALAWI | RESEARCH REPORT | FOCUS GROUPS | CURRENTLY MARRIED | HIV PREVENTION | SEXUALLY TRANSMITTED DISEASE PREVENTION | MICROBICIDES | NONOXYNOL-9 | HUSBAND-WIFE COMPARISONS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Data Collection | Research Methodology | Marital Status | Nuptiality | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Spermicidal Contraceptive Agents | Contraceptive Agents | Contraception | Family Planning | Comparative Studies | Studies
Document Number: 341651

Peer Reviewed

Title: Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard gel: a randomized, cross-over, pharmacokinetic study.
Author: Brache V; Croxatto H; Kumar N; Sitruk-Ware R; Cochon L; Schiappacasse V; Sivin I; Munoz C; Maguire R; Faundes A
Source: Contraception. 2009 Feb;79(2):150-4.
Abstract: BACKGROUND: The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner. STUDY DESIGN: This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner. RESULTS: Time concentration curves for serum LNG levels showed a mean C(max) of 7.8+/-5.5 and 8.3+/-5.7 nmol/L, a mean T(max) of 6.2+/-5.9 and 7.5+/-5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners. CONCLUSION: Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible.
Language: English
Keywords:
DOMINICAN REPUBLIC | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | SEXUAL PARTNERS | SEXUAL INTERCOURSE | PHYSIOLOGY | LEVONORGESTREL | VAGINAL GEL | MICROBICIDES | TIME FACTORS | CONTRACEPTIVE EFFECTIVENESS | EMERGENCY CONTRACEPTION | Developing Countries | Caribbean | Americas | Research Methodology | Economic Development | Economic Factors | Sex Behavior | Behavior | Reproduction | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Vaginal Spermicides | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics | Demographic Factors | Population
Document Number: 331015

Peer Reviewed

Title: How much could a microbicide's sexually transmitted infection efficacy contribute to reducing HIV risk and the level of condom use needed to lower risk? Model estimates.
Author: Foss AM; Vickerman PT; Alary M; Watts CH
Source: Sexually Transmitted Infections. 2009 Aug;85(4):276-82.
Abstract: OBJECTIVE: This study explores the potential contribution of a microbicide's sexually transmitted infection (STI) efficacy in reducing a female sex worker's (FSW) risk of STI and HIV infection. The study then investigates whether the threshold for the reduction in condom use following microbicide introduction that can be tolerated without increasing HIV risk is affected by STI efficacy. METHODS: A dynamic model describing the transmission of a bacterial STI between FSW and their clients was coupled with a static HIV model. The model uses data from Cotonou, Benin (1998-9), for illustration, to estimate the change in risk following the introduction of 50% HIV efficacious microbicides of different STI efficacies, used in 50% of sex acts when a condom is not used. The condom migration thresholds were estimated. The degree to which the findings are influenced by STI prevalence was explored. RESULTS: For highly transmissible STI, there is a non-monotonic relationship between STI prevalence and microbicide impact on HIV with the relative reduction in HIV risk first increasing, due to the proportion of HIV risk attributable to the STI increasing, but then decreasing at high prevalences as the STI becomes harder to control. A less transmissible STI can still be impacted upon with a moderate/high STI efficacy microbicide even at high STI prevalences. This relationship is also reflected in the condom migration thresholds. CONCLUSIONS: A microbicide's STI efficacy may have a substantial impact on STI and HIV incidence among high-risk groups. The variation in the condom migration thresholds for different STI efficacies and STI prevalences may be difficult to measure accurately.
Language: English
Keywords:
BENIN | RESEARCH REPORT | PREVALENCE | SEX WORKERS | WOMEN | MICROBICIDES | CONDOM USE | SEXUALLY TRANSMITTED DISEASE PREVENTION | HIV INFECTIONS | Africa, Western | Africa, Sub Saharan | Africa | Developing Countries | Measurement | Research Methodology | Sex Behavior | Behavior | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Risk Reduction Behavior | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases | Viral Diseases
Document Number: 342720

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

Title: The spermostatic and microbicidal actions of quinones and maleimides: towards a dual purpose contraceptive agent.
Author: Hughes LM; Griffith R; Carey A; Butler T; Donne SW; Beagley KW; Aitken RJ
Source: Molecular Pharmacology. 2009 Mar 31;
Abstract: There is an urgent need to develop safe, effective dual-purpose contraceptive agents that combine the prevention of pregnancy with protection against sexually transmitted disease. Here we report the identification of a group of compounds that on contact with human spermatozoa induce a state of 'spermostasis', characterized by the extremely rapid inhibition of sperm movement without compromising cell viability. These spermostatic agents were more active and significantly less toxic than the reagent in current clinical use, nonoxynol 9, giving therapeutic indices (ratio of spermostatic to cytotoxic activity) that were orders of magnitude greater than this traditional spermicide. Although certain compounds could trigger reactive oxygen species generation by spermatozoa, this activity was not correlated with spermostasis. Rather, the latter was associated with alkylation of two major sperm tail proteins that were identified as A Kinase Anchoring Proteins (AKAP3 and AKAP4) by mass spectrometry. As a consequence of disrupted AKAP function, the abilities of cAMP to drive PKA-dependent activities in the sperm tail such as the activation of SRC and the consequent stimulation of tyrosine phosphorylation, were suppressed. Furthermore, analysis of microbicidal activity using Chlamydia, revealed powerful inhibitory effects at the same low micromolar doses that suppressed sperm movement. In this case, the microbicidal action was associated with alkylation of MOMP, a major Chlamydial membrane protein. Taken together, these results have identified for the first time a novel set of cellular targets and chemical principles capable of providing simultaneous defense against both fertility and the spread of sexually transmitted disease.
Language: English
Keywords:
AUSTRALIA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | MICROBICIDES | SPERM IMMOBILIZING AGENTS | CONTRACEPTIVE AGENTS, FEMALE | SEXUALLY TRANSMITTED DISEASE PREVENTION | NONOXYNOL-9 | SPERMICIDAL CONTRACEPTIVE AGENTS | Oceania | Developed Countries | Research Methodology | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases
Document Number: 330928

10.

Peer Reviewed

Title: HIV Incidence Rates and Risk Factors for Urban Women in Zambia: Preparing for a Microbicide Clinical Trial.
Author: Kapina M; Reid C; Roman K; Cyrus-Cameron E; Kwiecien A; Weiss S; Vermund SH
Source: Sexually Transmitted Diseases. 2009 Feb 9;
Abstract: OBJECTIVES:: A preparedness study was conducted to evaluate the suitability of sites and populations following the same study procedures intended for a larger scale microbicide efficacy trial. In the process the study evaluated human immunodeficiency virus (HIV) incidence, prevalence, and risk profiles for HIV-acquisition among young women in urban Zambia. METHODS:: Women aged 16 to 49 years were screened for participation in the study that involved HIV/sexually transmitted infection testing and the assessment of sexual behavioral characteristics. Two hundred thirty-nine eligible women were enrolled and followed up for 12 months. RESULTS:: Baseline HIV prevalence at screening was 38.7% (95% CI: 34.2%-43.3%). The highest age-specific prevalence of HIV was 54.1% (95% CI: 46.3%-61.8%) seen in women aged 26 to 34 years. HIV incidence was 2.6% per 100 woman years. Pregnancy rates were high at 17.4 per 100 woman years (95% CI: 12.2-24.1). CONCLUSION:: It was concluded that our general population sample, characterized by high HIV prevalence and ongoing incidence rates despite receiving regular risk reduction counseling and free condoms qualifies for future microbicide studies.A microbicide preparedness study conducted in Lusaka, Zambia found high HIV prevalence and appreciable HIV incidence in a population of women in an urban setting.
Language: English
Keywords:
ZAMBIA | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL TRIALS | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | URBAN POPULATION | PREVALENCE | RISK FACTORS | MICROBICIDES | HIV PREVENTION | HIV INFECTIONS | INCIDENCE | CONDOMS | COUNSELING | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Measurement | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Viral Diseases | Diseases | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Clinic Activities | Program Activities | Programs | Organization and Administration
Document Number: 341501

11.

Peer Reviewed

Title: Adding the female condom to the public health agenda on prevention of HIV and other sexually transmitted infections among men and women during anal intercourse.
Author: Kelvin EA; Smith RA; Mantell JE; Stein ZA
Source: American Journal of Public Health. 2009 Jun;99(6):985-7.
Abstract: Legal barriers to conducting public health research on methods of protection for anal intercourse were lifted in the United States in 2003 when the US Supreme Court invalidated all state antisodomy laws. Although research funding has been available for the development of rectal microbicides, the female condom, which has already been approved for vaginal use, has not been evaluated for anal use. Although there is no evidence that the female condom is safe for anal intercourse, it has already been taken up for off-label use by some men who have sex with men. This demonstrates the urgent need for more protection options for anal intercourse and, more immediately, the need to evaluate the safety and efficacy of the female condom for anal intercourse.
Language: English
Keywords:
UNITED STATES OF AMERICA | CRITIQUE | PUBLIC HEALTH | COURT DECISION | ANAL SEX | HIV PREVENTION | SEXUALLY TRANSMITTED DISEASE PREVENTION | FEMALE CONDOMS | SAFETY | MICROBICIDES | Developed Countries | North America | Americas | Health | Litigation | Political Factors | Sociocultural Factors | Sex Behavior | Behavior | HIV Infections | Viral Diseases | Diseases | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care
Document Number: 341644

12.

Peer Reviewed

Title: Sexual risk behaviour for women working in recreational venues in Mwanza, Tanzania: considerations for the acceptability and use of vaginal microbicide gels.
Author: Lees S; Desmond N; Allen C; Bugeke G; Vallely A; Ross D
Source: Culture, Health and Sexuality. 2009 May 14;:1.
Abstract: Qualitative research was conducted to explore the social context of sexual-risk behaviour among women working in recreational occupations, during a feasibility study in preparation for the Phase III clinical trial of vaginal microbicides in Mwanza, Tanzania. Participant observation was conducted in 68 recreational venues. Six focus group discussions were conducted with women working in recreational occupations and two with male customers at these venues. Findings revealed that these women are at risk of HIV due their dependence on sexual transactions to improve their economic circumstances, which take place in environments and relationships where condom use is difficult. However, the findings revealed that, in spite of constraints, women did take actions to prevent HIV by negotiating for condom use or avoiding perceived risky practices or partnerships, in particular moving to more casual partnerships where condom negotiation is more acceptable. This indicates that, given their perception of their own risk, women working in recreational occupations will welcome an effective microbicide. However, sustained use will depend on how formulations overcome the difficulties women currently experience with condom negotiation and the specific environments and relationships in which they engage in sex.
Language: English
Keywords:
TANZANIA | RESEARCH REPORT | FOCUS GROUPS | WOMEN IN DEVELOPMENT | WORKERS | PARKS AND RECREATIONAL FACILITIES | MICROBICIDES | VAGINAL GEL | CONDOM USE | HIV PREVENTION | SEX BEHAVIOR | RISK ASSESSMENT | PERCEPTION | PARTNER COMMUNICATION | SELF-PERCEPTION | Developing Countries | Africa, Eastern | Africa, Sub Saharan | Africa | Data Collection | Research Methodology | Economic Development | Economic Factors | Labor Force | Human Resources | Natural Resources | Environment | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Risk Reduction Behavior | Behavior | HIV Infections | Viral Diseases | Diseases | Evaluation | Psychological Factors | Interpersonal Relations
Document Number: 341493

13.

Peer Reviewed

Title: Biomarkers for evaluating vaginal microbicides and contraceptives: discovery and early validation.
Author: Mauck CK
Source: Sexually Transmitted Diseases. 2009 Mar;36(3 Suppl):S73-5.
Abstract: A biomarker has been defined as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, pharmacological responses to a therapeutic intervention." Biomarkers can reduce the costs and time required to get a drug from discovery to market. Topical microbicides are new drugs designed to prevent HIV and other sexually transmitted infections (STIs). Biomarkers that may be important in microbicide development include biomarkers of semen exposure, biomarkers of cervicovaginal inflammation, and biomarkers of HIV and STIs. The development of biomarkers for use in microbicide development is a high priority. This supplement reports on a meeting entitled "Biomarkers for Evaluating Vaginal Microbicides and Contraceptives: Discovery and Early Validation," held in Reston, VA on November 16 to 17, 2006. It was sponsored by CONRAD and the Alliance for Microbicide Development with funding from the Bill and Melinda Gates Foundation and the United States Agency for International Development (USAID). The meeting was convened to look at the ways in which biomarkers could be used to attenuate the challenges alluded to above. Availability of key biomarkers could expedite the development of microbicides, for which there is a pressing need, especially in developing countries where combinations of cultural and socioeconomic pressures on women constrain their ability to protect themselves from STIs. Although the meeting was held 2 years ago, the material reviewed and conclusions drawn are still relevant.
Language: English
Keywords:
DEVELOPING COUNTRIES | RESEARCH REPORT | MICROBICIDES | HIV PREVENTION | SEXUALLY TRANSMITTED DISEASE PREVENTION | RESEARCH AND DEVELOPMENT | NEEDS ASSESSMENT | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV Infections | Viral Diseases | Diseases | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Technology | Economic Factors | Evaluation
Document Number: 330814

14.

Title: Microbicides in India-present and future.
Author: Nath A; Garg S
Source: Indian Journal of Medical Microbiology. 2009 Jul-Sep;27(3):251-3.
Abstract: India continues to wage a battle against the human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) epidemic. Despite an array of preventive and control efforts directed against the disease, it continues to finds its way from the high risk groups to the general population. Women are more vulnerable to HIV/AIDS because of biological as well as socio-cultural factors. Microbicides appear to provide an attractive option as a means of protection to be used by women. At present, microbicide trials are in study phases I and II in India. The development of an ideal microbicide candidate which would be effective and confirms to user satisfaction poses a major challenge to researchers.
Language: English
Keywords:
INDIA | SUMMARY REPORT | RESEARCH ACTIVITIES | CLINICAL TRIALS | MICROBICIDES | HIV PREVENTION | VAGINAL GEL | PRODUCT APPROVAL | SAFETY | SOCIOCULTURAL FACTORS | ADVOCACY | Asia, Southern | Asia | Developing Countries | Research Methodology | Clinical Research | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV Infections | Viral Diseases | Diseases | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Legislation | Political Factors | Public Health | Communication
Document Number: 342628

15.

Title: An African perspective on mucosal immunity and HIV-1.
Author: Pala P; Gomez-Roman VR; Gilmour J; Kaleebu P
Source: Mucosal Immunology. 2009 Jul;2(4):300-14.
Abstract: HIV prevention mandates an understanding of the mechanisms of mucosal immunity with attention to some unique features of the epidemic and mucosal environment in the developing world. An effective vaccine will have to induce mucosal protection against a highly diverse virus, which is equipped with a number of immune evasion strategies. Its development will require assessment of mucosal immune responses, and it will have to protect a mucosal environment where inflammation and altered immune responses are common because of the presence of other mucosal infections, such as sexually transmitted infections and parasites, and where nutritional status may also be compromised. Ideally, not only prevention methods would protect adults but also provide cover against gastrointestinal transmission through maternal milk. Prevention might also be complemented by microbicides and circumcision, two alternative approaches to mucosal protection. It seems unlikely that a single solution will work in all instances and intervention might have to act at multiple levels and be tailored to local circumstances. We review here some of the mucosal events associated with HIV infection that are most relevant in an African setting.
Language: English
Keywords:
AFRICA | RESEARCH REPORT | HIV PREVENTION | MICROBICIDES | VAGINAL APPROACH | AUTOIMMUNE RESPONSE | GASTROINTESTINAL EFFECTS | Developing Countries | HIV Infections | Viral Diseases | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Female Sterilization | Sterilization, Sexual | Family Planning | Antibodies | Immunologic Factors | Immunity | Immune System | Physiology | Biology
Document Number: 342694

16.

Title: Vaginal drug delivery systems for HIV prevention.
Author: Rohan LC; Sassi AB
Source: AAPS Journal. 2009 Mar;11(1):78-87.
Abstract: Microbicides have become a principal focus for HIV prevention strategies. The successful design of drug delivery systems for vaginal microbicide drug candidates brings with it a multitude of challenges. It is imperative that the chemical and physical characteristics of the drug candidate and its mechanism of action be clearly understood and considered to successfully deliver and target drug candidates efficiently. In addition, an understanding of the dynamic nature of the vaginal environment, the tissue and innate barriers present, as well as patient preferences are critical considerations in the design of effective microbicide products. Although the majority of drug candidates clinically evaluated to date have been delivered using conventional semisolid aqueous-based gel dosage forms, drug delivery system design has recently been extended to include advanced delivery systems such as vaginal rings, quick-dissolve films, and tablets. Ultimately, it may be necessary to develop multiple dosage platforms for a single active agent to provide users with options that can be used within the constraints of their social environment, personal choice, and environmental conditions.
Language: English
Keywords:
GLOBAL | LITERATURE REVIEW | RESEARCH AND DEVELOPMENT | HIV PREVENTION | SEXUALLY TRANSMITTED DISEASE PREVENTION | MICROBICIDES | ADMINISTRATION AND DOSAGE | VAGINA | PHYSIOLOGY | SAFETY | IMMUNOLOGIC FACTORS | Technology | Economic Factors | HIV Infections | Viral Diseases | Diseases | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Genitalia, Female | Genitalia | Urogenital System | Biology | Public Health | Immunity | Immune System
Document Number: 342190

17.

Title: Young women's use of a vaginal microbicide surrogate: the role of individual and contextual factors in acceptability and sexual pleasure.
Author: Tanner AE; Zimet G; Fortenberry JD; Reece M; Graham C; Murray M
Source: Journal of Sex Research. 2009 Jan-Feb;46(1):15-23.
Abstract: Currently in clinical trials, microbicides have historically been promoted as a woman-controlled (although more recently woman initiated) method of sexually transmitted infection (STI) prevention. The contradicition that exists in this rationale is that women's bodies, specifically the genitals, have been constructed as a negotiated space within sexual interactions. This study qualitatively explored the factors influencing 40 young women's use of a vaginal moisturizer (VM), utilized as a microbicide surrogate. The results indicated that use of the VM was dependent upon product characteristics (i.e., the lubricating qualities affect on sexual pleasure, timing of insertion), individual factors (i.e., reproductive health goals, experiences with side effects of existing contraceptive methods), and contextual factors (i.e., social norms). An understanding of these bodily and social issues may be beneficial in designing targeted educational campaigns and effective instructional materials as well as in facilitating positive dialogue around women's bodies and their sexuality.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | KAP SURVEYS | WOMEN | URBAN POPULATION | MICROBICIDES | ACCEPTANCE PROCESS | SATISFACTION | SEX BEHAVIOR | LUBRICANTS | VAGINAL GEL | TIME FACTORS | SIDE EFFECTS | VALUE ORIENTATION | SEXUALITY | Developed Countries | North America | Americas | Surveys | Sampling Studies | Studies | Research Methodology | Demographic Factors | Population | Population Characteristics | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Decision Making | Behavior | Psychological Factors | Ingredients and Chemicals | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Population Dynamics | Personality
Document Number: 341137

18.

Peer Reviewed

Title: Predictors of adherent use of diaphragms and microbicide gel in a four-arm, randomized pilot study among female sex workers in Madagascar.
Author: Turner AN; Van Damme K; Jamieson DJ; Khan MR; Pettifor AE; Swezey TA; Bell AJ; Newman DR; Penman-Aguilar A; Raharinivo MS; Randrianasolo B; Ramiandrisoa FN; Behets FM
Author: Mad STI Prevention Group
Source: Sexually Transmitted Diseases. 2009 Apr;36(4):249-57.
Abstract: BACKGROUND: Participants' protocol adherence may influence assessments of the effectiveness of new female-controlled methods for sexually transmitted infection prevention. METHODS: In 2005 we conducted a randomized pilot study among female sex workers (FSWs) in Madagascar in preparation for sexually transmitted infection prevention trial of diaphragms and a vaginal microbicide. Participants (n = 192) were randomized into 4 arms: diaphragm plus microbicide (Acidform), diaphragm plus placebo gel hydroxyethyl cellulose (HEC), Acidform alone, or HEC alone. FSWs were seen weekly for 4 weeks. Using multivariable regression with generalized estimating equations, we assessed predictors of adherent product use during all sex acts in the last week. We collapsed the gel-diaphragm arms together and the gel-only arms together for this analysis. RESULTS: Between 43% and 67% of gel-diaphragm users (varying by visit) reported using study products during all sex acts in the last week, compared with 20% to 45% of gel-only users. Adherence increased with follow-up [visit 4 vs. visit 1 risk ratio (RR) for gel-diaphragm users: 1.55, P <0.01; for gel-only users, RR: 1.58, P = 0.01]. Gel-diaphragm users whose casual partners were never aware of products (RR: 2.02, P = 0.03) and who had experienced partner violence after requesting condom use (RR: 1.45, P <0.01) were more adherent. Gel-only users reporting lower sexual frequency (1-9 weekly acts vs. >or=19 acts, RR: 1.98, P <0.01) and no sex with primary partners in the past week (RR: 1.54, P = 0.02) were more adherent. CONCLUSIONS: Gel-diaphragm users had better adherence than gel-only users, and predictors of adherence differed between groups. Addressing modifiable factors during counseling sessions may improve adherence.
Language: English
Keywords:
MADAGASCAR | RESEARCH REPORT | KAP SURVEYS | PILOT PROJECTS | MULTIVARIATE ANALYSIS | SEX WORKERS | WOMEN IN DEVELOPMENT | CONTRACEPTIVE USAGE | VAGINAL DIAPHRAGM | MICROBICIDES | VAGINAL GEL | VIOLENCE AGAINST WOMEN | DOMESTIC VIOLENCE | USER COMPLIANCE | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Surveys | Sampling Studies | Studies | Research Methodology | Data Analysis | Sex Behavior | Behavior | Economic Development | Economic Factors | Contraception | Family Planning | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Vaginal Spermicides | Crime | Social Problems | Sociocultural Factors
Document Number: 341119

19.

Title: HIV-prevention science at a crossroads: advances in reducing sexual risk.
Author: Vermund SH; Allen KL; Karim QA
Source: Current Opinion In HIV and AIDS. 2009 Jul;4(4):266-73.
Abstract: PURPOSE OF REVIEW: We review the current state of evidence-based prevention strategies for reducing sexual transmission of HIV. The combined programmatic and scientific efforts through 2008 to reduce sexual transmission of HIV have failed to reduce substantially the global pandemic. RECENT FINDINGS: Prevention interventions to reduce HIV infection target behavioral, biomedical, and structural risk factors. Some of these prevention strategies have been evaluated in randomized clinical trials (RCTs) with HIV seroincidence endpoints. When RCTs are not feasible, a variety of observational and quasiexperimental research approaches can provide insight as to program effectiveness of specific strategies. Only five RCTs have demonstrated a notable decrease in sexually acquired HIV incidence. These include the Mwanza study of syndromic management of sexually transmitted diseases and three male circumcision trials in East Africa; a microbicide trial reported in 2009 shows substantial promise for the efficacy of PRO 2000 (0.5% gel). SUMMARY: The combined programmatic and scientific efforts to reduce sexual transmission of HIV have made incremental progress. New prevention tools are needed to stem the continued spread of HIV, though microbicides and vaccines will take many more years to develop, test, and deploy. Combination strategies of existing modalities should be tested to evaluate the potential for more proximate prevention benefits.
Language: English
Keywords:
GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | EPIDEMICS | HIV PREVENTION | SEX BEHAVIOR | SEXUALLY TRANSMITTED DISEASES | PREVENTION AND CONTROL | MICROBICIDES | MALE CIRCUMCISION | ANTIRETROVIRAL THERAPY | VACCINES | BEHAVIOR CHANGE | Clinical Research | Research Methodology | Diseases | HIV Infections | Viral Diseases | Behavior | Reproductive Tract Infections | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV
Document Number: 342340

20.

Title: Saving lives now. Female condoms and the role of U.S. foreign aid.
Author: Center for Health and Gender Equity [CHANGE]
Source: Takoma Park, Maryland, Center for Health and Gender Equity [CHANGE], 2008. 56 p.
Abstract: "Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid" relies on peer reviewed literature and interviews with reproductive health commodities programming and policy experts to outline the importance of female condoms as part of comprehensive sexual and reproductive health and HIV prevention programs. "Saving Lives Now" presents an in-depth overview of the female condom -- the only available HIV prevention method designed for women to initiate and control. The report explains the products, their many benefits and proven acceptability among women and men, and the challenges to making female condoms accessible to women and men. The report also describes the U.S. role in the procurement, distribution and programming of female condoms, and identifies policy and financial barriers within the U.S. government that inhibit successful integration of female condoms into reproductive health and HIV prevention interventions. In conclusion, the report offers policy and program recommendations aimed at improving U.S. support for increased global access to female condoms.
Language: English
Keywords:
UNITED STATES OF AMERICA | DEVELOPING COUNTRIES | PROGRESS REPORT | RECOMMENDATIONS | EVALUATION | WOMEN IN DEVELOPMENT | FEMALE CONDOMS | FOREIGN AID | MICROBICIDES | ANAL SEX | PARTNER COMMUNICATION | LOGISTICS | COORDINATION | PROGRAM DEVELOPMENT | Developed Countries | North America | Americas | Economic Development | Economic Factors | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Financial Activities | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Sex Behavior | Behavior | Interpersonal Relations | Management | Organization and Administration | Programs
Document Number: 326043

21.

Title: Annual report, July 1, 2007 - June 30, 2008 and work plan, July 1, 2008 - June 30, 2009, Contraceptive and Reproductive Health Technologies Research and Utilization Program, Cooperative Agreement GPO-A-00-05-00022-00.
Author: Family Health International [FHI]
Source: Research Triangle Park, North Carolina, FHI, 2008. [460] p. (USAID Cooperative Agreement No. GPO-A-00-05-00022-00)
Abstract: The Contraceptive and Reproductive Health Technologies Research and Utilization (CRTU) Program is a five-year, almost $175 million cooperative agreement between USAID and Family Health International (FHI). This agreement, awarded on April 29, 2005, builds on more than 35 years of FHI's experience and accomplishments in contraceptive technology and reproductive health research to advance and support USAID's family planning and reproductive health programs worldwide. The purpose of this cooperative agreement is to increase the range of available choices and the use of safe, effective, acceptable, and affordable contraceptive methods and reproductive health technologies, including microbicides, delivered through high-quality family planning and reproductive health services in developing countries. This annual report provides a comprehensive picture of 169 subprojects that were fully or partially funded by the CRTU for the July 1, 2007-June 30, 2008 (Year 3) reporting period. The Workplan reports on all those activities that continued, as well as 9 new activities to be implemented during the period July 1, 2008- June 2009 (Year 4). (Excerpt)
Language: English
Keywords:
DEVELOPING COUNTRIES | ANNUAL REPORT | YOUTH | BARRIER METHODS | ORAL CONTRACEPTIVES | HIV | AIDS | CONTRACEPTIVE METHODS | MICROBICIDES | FAMILY PLANNING | REPRODUCTIVE HEALTH | DELIVERY OF HEALTH CARE | PROGRAM ACTIVITIES | Age Factors | Population Characteristics | Demographic Factors | Population | Contraception | HIV Infections | Viral Diseases | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Health | Programs | Organization and Administration
Document Number: 331582

22.

23.

24.

25.

26.

27.

Title: Microbicides for HIV prevention.
Author: Family Health International [FHI]
Source: Family Health Research. 2008 Jul;2(2):1-8.
Abstract: This issue of the newsletter describes efforts to develop a safe, effective, and acceptable microbicide to prevent HIV. Advocacy and support for microbicide research are strong, and an effective product -- although likely years away -- could help alleviate the HIV epidemic in sub-Saharan Africa and around the world. Women have an especially high risk of HIV infection because of biologic susceptibility, economic dependence on their male partners, and difficulties negotiating condom use in their sexual relationships. A method of HIV prevention that a woman could control, such as a vaginal microbicide, could help overcome some of these disparities and save many lives.
Language: English
Keywords:
GLOBAL | SUMMARY REPORT | CLINICAL RESEARCH | HIV PREVENTION | MICROBICIDES | RESEARCH AND DEVELOPMENT | SEXUALLY TRANSMITTED DISEASE PREVENTION | ANTIRETROVIRAL DRUGS | VAGINAL GEL | SAFETY | Research Methodology | HIV Infections | Viral Diseases | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Technology | Economic Factors | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Public Health
Document Number: 341513

28.

Title: Interim report, July 1, 2007 - December 31, 2007, Contraceptive and Reproductive Health Technologies Research and Utilization Program. Cooperative Agreement GPO-A-00-05-00022-00.
Author: Family Health International [FHI]. Contraceptive and Reproductive Health Technologies Research and Utilization Program [CRTU]
Source: Research Triangle Park, North Carolina, FHI, CRTU, [2008]. [227] p. (USAID Cooperative Agreement No. GPO-A-00-05-00022-00)
Abstract: This interim report covers work carried out by Family Health International (FHI) between July 1, 2007 and Decerrlber 31, 2007 under the Contraceptive and Reproductive Health Technologies and Research Utilization (CRTU) Cooperative Agreement with the United States Agency for International Development. The Agreement No. GPO-A-00-05-00022-00 was awarded to FHI on April 29, 2005 and covers a five-year program of work. We are currently in Year 3 of program implementation. Since its founding in 1971, Family Health International has worked with USAID to advance and support family planning and reproductive health programs worldwide. The CRTU Program continues this tradition with the goal of increasing the range of available choices and the use of safe, effective, acceptable, and affordable contraceptive methods and reproductive health technologies, including microbicides, delivered through high-quality family planning and reproductive health services in developing countries. A primary focus of the current cooperative agreement is research utilization. (Excerpt)
Language: English
Keywords:
GLOBAL | PROGRESS REPORT | RESEARCH ACTIVITIES | USAID | FAMILY PLANNING | REPRODUCTIVE HEALTH | CONTRACEPTIVE METHODS | MICROBICIDES | RESEARCH AND DEVELOPMENT | PRODUCT APPROVAL | HIV/FP INTEGRATION | PREVENTION OF MOTHER-TO-CHILD TRANSMISSION | COUNSELING | FUNDS | Research Methodology | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Health | Contraception | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Technology | Economic Factors | Legislation | Programs | Organization and Administration | Disease Transmission Control | Prevention and Control | Diseases | Clinic Activities | Program Activities | Financial Activities
Document Number: 331620

29.

Title: Symposium to Develop a Comprehensive Strategy for IUD Repositioning. Venue: Hotel Taj Residency, Lucknow, October 3-4, 2007.
Author: Symposium to Develop a Comprehensive Strategy for IUD Repositioning (2007: Lucknow)
Source: Lucknow, India, Family Health International [FHI], 2008 Mar 3. 46 p.
Abstract: This symposium report synopsizes the discussions and contributions of FHI and other organizations, and documents the conclusions reached for repositioning family planning, especially the IUD. Participants also discussed ways to develop and implement strategies that are evidence-based; include strong monitoring, evaluation, and operations research; and lead to quality services and increased IUD use.
Language: English
Keywords:
INDIA | SUMMARY REPORT | REPRODUCTIVE TECHNOLOGIES | CONTRACEPTIVE USAGE | PREGNANCY, UNPLANNED | PREVENTION AND CONTROL | SEXUALLY TRANSMITTED DISEASE PREVENTION | HIV PREVENTION | CONTRACEPTIVE AVAILABILITY | MICROBICIDES | FAMILY PLANNING PROGRAMS | Asia, Southern | Asia | Developing Countries | Reproduction | Contraception | Family Planning | Reproductive Behavior | Fertility | Population Dynamics | Demographic Factors | Population | Diseases | Sexually Transmitted Diseases | Reproductive Tract Infections |