HIV Prevention Knowledge Base
Biomedical Interventions: Microbicides
Next Steps 1% Tenofovir Gel: Meeting Report
The excitement among the international microbicide development community resulting from the positive one-percent tenofovir trial results has given way to a sense of urgency—urgency to rapidly make available an approved, affordable, and easily obtainable microbicide to the world’s women. This meeting brought together researchers, advocates, program implementers, funders, and regulatory agencies to identify concrete actions these actors can take to bring the one-percent tenofovir microbicide to women as quickly as possible. The report reviews discussions taking place during the meeting and presents the decisions made on what confirmatory studies should move forward, who will lead licensure efforts, and other necessary steps. Appendix 2 includes a summary of completed, ongoing, and planned microbicide clinical studies of one-percent tenofovir gel.
Sexual Communication Among Married Couples in the Context of a Microbicide Clinical Trial and Acceptability Study in Pune, India
Ten married couples in Pune, India, participating in a microbicide clinical trial formed the basis for separate in-depth interviews on spousal communication about sex and sexual matters. Most couples reported nonverbal communication or using code words about sex because they often lived with extended families and usually did not sleep alone. Lack of knowledge about sex and sexuality as well as a lack of privacy limited couple communication. Five couples reported communicating about sex as a “side effect” of being in the clinical trial, despite this not being a part of the intervention. In addition to initiating discussions about HIV, these couples also reported appreciating having a space to talk about sex openly in the interviews. Many couples reported that their improved communication had a positive effect on their overall relationship. While this sample is not representative of Indian couples at large, it does indicate starting a dialogue about sex and sexuality encourages more communication about sex among the couple. Such communication is the crucial first step to reducing one’s risk of HIV.
Standards of Prevention in HIV Prevention Trials: Consultation Report and Recommendation
This report of a consultation attempts to clarify 2007 Joint U.N. Programme on HIV/AIDS and World Health Organization guidance on prevention standards in HIV prevention trials. As new research and evidence emerge about what is effective in preventing HIV, studies and trials will have to include these new technologies as standards of care in their work. Thus this report tries to translate ethical guidance into day-to-day research practice, taking into account that the guidelines were intentionally written to be flexible, given vastly differing circumstances, epidemics, and access to care. This report reviews the evidence on “what works,” realities of implementing prevention trials, and the current standard of care for HIV prevention trials. It also presents points of agreement and disagreement among the participants of the consultation, and identifies needs for additional guidelines and criteria for those undertaking HIV prevention research.
Women's Empowerment? Contradictory Reports of Female Autonomy towards Female-Initiated HIV Prevention Methods in Zimbabwe
This poster presentation explores women’s attitudes to discreet use (use without their partner’s knowledge) of a cervical barrier together with a microbicide. Among 83 married women in the trial, all had told their primary male partners about their use of the method by the end of the four-week trial. Focus group discussions among 41 women, however, indicated that they would use the barrier/microbicide without telling their primary partner if necessary. The rationale for telling their partners was to facilitate communication between the couple and avoid any problems should the use be found out. When probed about the reasons for discreet use, however, the women stated that they would indeed use a method that would protect them from HIV, given that most men are likely to have partners on the side. They felt it was important to safeguard their health, and therefore, that of their family. Telling partners about microbicide use may be a way to enlist male support for women’s protection from HIV. Furthermore, the trial demonstrated to women that the method can indeed be used without their partners knowing about it.
Towards Microbicide Rollout in Sub-Saharan Africa: Ensuring Microbicides are an Effective Tool for HIV Prevention and Women’s Empowerment
This brief focuses on the potential of microbicides to integrate HIV prevention and the empowerment of sub-Saharan African women. The authors argue that empowering women can help offset the social, cultural, and economic factors that place women at disproportionate risk of acquiring HIV. Microbicides, they posit, can help become tools of women’s empowerment if women’s rights are at the forefront of microbicide development, strategy, and roll-out. The authors present four issues that must be addressed if microbicides are to become a tool for both HIV prevention and women’s empowerment: effectiveness, availability, stigma, and partner communication.
The First 55 Steps: A Report of the Microbicide Development Strategy’s Civil Society Working Group
Full and active engagement of the civil society in microbicide development can benefit everyone from researchers to the women who stand to benefit from microbicide use. A small working group identified seven priority gaps in microbicide research and development that civil society organizations could fill. The gaps were then broken down into concrete, actionable steps, resulting in 55 action steps for civil society, government/policymakers, researchers, and funders/sponsors. These “interlocking” steps show how each group’s work complements and enhances the other groups’ efforts. The report also highlights the importance of having an enabling environment to advance microbicide research, and what can be done to create such an environment.
Identifying Optimal Strategies for Microbicide Distribution in India and South Africa: Modelling and Cost-Effectiveness Analyses
Developing an effective microbicide is only the first step in saving women’s lives. To truly be effective for HIV prevention, microbicides must be made widely available—entailing licensing, regulatory, and service delivery considerations—and be affordable and acceptable to all potential users. Researchers considered these factors when modeling how long it would take to see widespread microbicide use in southern India and South Africa. Stakeholder meetings reviewed women’s reproductive health product introduction experiences and identified other key inputs for the models such as approval time and target audience penetration. Fully 120 scenarios were modeled and considered for India, while 156 were considered for South Africa. This paper describes the process and scenarios and juxtaposes the 10 most effective scenarios with the cost-effectiveness of each. While potential exists for microbicides to become another tool for HIV prevention, their widespread use can take significant time and resources.
Awareness and Attitudes Regarding Microbicides and Nonoxynol-9 Use in a Probability Sample of Gay Men
Nearly 900 men who have sex with men in San Francisco participated in this random-digit dialing telephone survey about microbicides and Nonoxynol-9 (N-9). Nearly 4 of every 10 respondents sexually active in the last year reported unprotected receptive anal intercourse, while 45 percent reported unprotected insertive anal intercourse. Only 39 percent of the sample knew that N-9 could injure rectal tissue, thus potentially creating an entryway for HIV. N-9 use among these men in the last year was 26 percent. Men reporting recent unprotected anal intercourse were more likely to use N-9, which may indicate risk compensation or that these men are seeking alternatives to condom use for HIV prevention. Only 7 percent believed that N-9 could prevent HIV transmission. Although an effective microbicide was not on the market, 59 percent of the sample understood that a microbicide could reduce the risk of HIV. Interestingly, compared to uninfected men, those with HIV were more willing to use a microbicide that was less effective at preventing HIV than condoms.
Risk Compensation in HIV Prevention: Implications for Vaccines, Microbicides, and other Biomedical HIV Prevention Technologies
Risk compensation theory posits that individuals will maintain a constant level of risk over time. As risk reduction behaviors are implemented (e.g., condom use), people will adjust other risky behaviors upward to compensate for the safety behaviors (e.g., have more sex partners), thus maintaining the same level of risk as before. This literature review examined whether study participants reported risk compensation behaviors when participating in trials of HIV vaccines, microbicides, male circumcision, and antiretroviral therapy (ART). Evidence was available for ART, HIV vaccines, and circumcision. Although limited, the few studies focusing on risk compensation among HIV vaccine trial participants found evidence of increased risky behaviors. A meta-analysis of highly active ART (HAART) also found more unprotected sex among HAART users who thought that HAART reduced the likelihood of HIV transmission. Similarly, circumcised men had riskier sexual behaviors (more partners and less condom use) compared to men who were not circumcised. The authors conclude that HIV prevention interventions must include risk compensation considerations into their programs.
Hope Against HIV: Microbicide Trials in Your Community
This video was developed to help with microbicide advocacy efforts, particularly in countries and communities where such research is taking place. It answers basic questions about microbicides (what they are, how they work, how effective they are) as well as addresses HIV prevention and transmission. It also covers essential information about clinical trials. The video is available as a 100-second summary or as the full 20-minute version in English, French, kiSwahili, isiXhosa, and isiZulu.
This webpage contains brief descriptions of the Population Council’s microbicide research projects taking place worldwide, with links to more in-depth information about each study. Older trials also have links to documents containing results, while ongoing trials provide descriptions of the work done to date. The research portfolio includes studies that assess ways to improve adherence to product use, different modes of microbicide delivery such as vaginal rings, and user acceptability research. Some novel approaches include computer-assisted self interviews being used in Malawi, South Africa, Uganda, the United States, Zambia, and Zimbabwe. This technique provides interviewees more privacy and confidentiality than answering aloud in face-to-face interviews.
High Acceptability of a Vaginal Ring Intended as a Microbicide Delivery Method for HIV Prevention in African Women
The study sought to quantitatively and qualitatively explore the acceptability of a vaginal ring (VR) among sexually active women in Tanzania and South Africa. The ring could be used for the delivery of microbicides for HIV prevention if acceptability was high. The VR was provided to 158 women in the randomized trial. The ring had no active ingredient and was, therefore, a placebo. Participants were taught how to insert and remove the VR in the clinic. The women visited the clinic four times throughout the twelve-week trial for an exam and were asked about their comfort levels and experiences with the VR using a questionnaire. Focus group discussions and in-depth interviews were conducted with the women and their male partners, if the women gave the researchers permission. It was found that the majority of the women were able to successfully insert the VR (81 percent), and that retention over the twelve-week study period was high (97 percent). The women reported few concerns or problems about the VR during the study. The most frequently reported concern (20 percent at week 4) was that it would get lost in their body. The three most favorable characteristics of the VR at the 12-week point for the women was that it may be used someday to prevent HIV, does not interfere with sex, and that you can still use a condom with the VR. The three least liked characteristics of the VR were that it may get lost in the body, may come out during sex, and may change the feeling of sex for the partner. The VR was found to be highly acceptable for both the women and their partners in this study.