This is the first clinical trial indicating the effectiveness of a vaginal microbicide in reducing HIV infection in women. Nearly 900 sexually active women aged 18 to 40 in Durban and Vulindlela, South Africa, were randomized to receive tenofovir or placebo within 12 hours before having sex and as soon as possible within 12 hours after having sex. Monthly support meetings with participants highlighted the importance of consistent and correct microbicide use, identified ways to overcome obstacles to use, and set goals for perfect adherence for each month. Despite this, 40 percent of the study participants used the gel for less than 50 percent of sex acts. After 12 and 24 months of follow-up, HIV incidence in the tenofovir arm was 50 percent and 40 percent lower than the placebo arm, respectively. HIV incidence among women with the best adherence was 54 percent lower than placebo, indicating that effectiveness was linked to adherence. Furthermore, the study found tenofovir safe. Despite the small sample size, this study provided “proof of concept” for tenofovir microbicide prophylaxis. More studies are needed to corroborate these findings.

This document contains the abstracts of all oral presentations and poster sessions given at the 2010 International Microbicides Conference. Organized by conference days, readers can browse through the content, search the document for authors or keywords, or scroll to the author index at the back of the document. The theme of this conference was “Building Bridges to HIV Prevention,” which is reflected in the abstracts.

An in-depth review of the history of microbicide development for HIV prevention, this article also presents new microbicides under development. These include antiretroviral drugs and drug combinations that can be administered in different ways, including daily delivery and sustained delivery mechanisms. In addition to specifically targeted HIV replication, new product options related to timing of use can potentially improve product effectiveness. Potential new microbicides, however, come with concerns about toxicity and resistance. Additional challenges to microbicide development, such as need to remain stable in a tropical environment, are also addressed in the article. The author details concerns and further challenges to introducing a microbicide widely in a population, including knowing its safety profile among pregnant women or women who want to become pregnant. Despite recent encouraging news about microbicides, the road to their widespread and effective use for HIV prevention remains long.

This press release from the Microbicides Development Program (MDP) summarizes the outcome of the MDP 301 trial that tested the effectiveness of PRO 2000 vaginal microbicide gel against placebo for HIV prevention. Disappointingly, data from over 9,000 women in four countries in Africa over 12 months (24 months in Uganda) found no difference in HIV acquisition rates between microbicide and placebo users. HIV incidence was 4.5 per 100 women years in the PRO 2000 group and 4.3 per 100 in the placebo group. Readers can find links to PDF files after the press release with additional information, including questions and answers about the trial, the results, quick facts, a technical fact sheet, and “Women’s Voices,” a sheet with study participants’ perspectives of the trial.

Researchers undertook this pilot study to identify ways to maximize adherence to diaphragms and microbicide gel ahead of a future study on microbicide effectiveness. Nearly 200 female sex workers (FSWs) in four cities in Madagascar were randomized into four groups: the gel microbicide Acidform plus diaphragm; placebo gel plus diaphragm; placebo gel; and Acidform gel. These were collapsed into two arms for data analysis: diaphragm plus gel or gel alone. Weekly follow-up meetings over one month collected information on product use and sexual practices with clients and regular partners. A statistically significant difference was found in adherence among women randomized to diaphragms (43 percent at first follow-up and 67 percent at last follow-up) compared to gel-only users (28 percent at first follow-up and 45 percent at last follow-up). Compliance improved over time in both groups. The authors believe this was due to the product protocol: diaphragm insertion was a daily event independent of sex, while the gel was to be used prior to coitus. Study findings will help develop counseling messages for future microbicides studies, helping women understand that discreet use is possible, but also indicating that some women choose to disclose product use to their partners.

This review of 118 studies—45 clinical and 73 preclinical—from a biomedical perspective assesses the state of microbicide development for HIV prevention. The authors first discuss the sexual HIV transmission pathways and how microbicides are being developed to address them. The different types of microbicides (e.g., viral entry inhibitors) are described, along with the current state of research for each type. The authors also discuss epidemiological and biological issues that make microbicide research challenging. Epidemiologic issues include HIV incidence, study populations, and discreet use of microbicides. Among biologic challenges are developing combination microbicides when each component must be first tested individually. The authors conclude that while the development of effective microbicides is difficult, the potential benefits are so great that they greatly outweigh any known risks—and possibly unforeseen risks as well.

This article describes the progress made in recent years to develop microbicides—gels, suppositories, or other topical formulations that prevent HIV—for rectal use. The design and results of early vaginal microbicide trials informed the research direction for evaluating potential rectal microbicide candidates, as did early acceptability studies among men who have sex with men, who are highly vulnerable to HIV because of the common practice of unprotected receptive anal intercourse. Most rectal microbicides in the pipeline have reached only the preclinical study stage. Only two products—UC781, a non-nucleoside reverse transcriptase inhibitor, and tenofovir, a nucleotide inhibitor—have reached the clinical study stage, although L’644, a promising fusion inhibitor, is now also being evaluated. Qualitative and clinical studies of acceptability for different rectal microbicide formulations have found gels to be most acceptable. Rectal safety became the focus of research soon after researchers found that vaginal microbicide candidates were not optimal for rectal use, causing mucosal damage in the rectum; recent research findings show that reducing the glycerin in the formulation may be less harmful. The author describes the preclinical evaluation of four rectal microbicide candidates that have undergone Phase I trials: HIVNET-008 (N9 gel), RMP-01 (UC781 gel), RMP-02/MTN-006 (tenofovir gel), and MTN-007 (tenofovir gel with reduced glycerin). In his conclusion, the author suggests that Phase I studies on rectal microbicides will continue to produce important data on safety, acceptability, and pharmacokinetics that will contribute to early product development.

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.

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.

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.

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.

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 the full study protocol for a clinical trial of tenofovir gel as a vaginal microbicide for preventing HIV. In addition to a detailed description of the study design, population, objectives, and regimens, information on eligibility, principal investigators, study sites, and collaborating institutions is available, including contact information. The page also provides links to publications related to this research and additional information on the study.

This short brief provides useful and practical information on how to organize a successful community forum on microbicides. Broken down into 10 steps, the following are included: consideration of partners to co-host, deciding on an agenda that the community would find interesting and engaging, logistics, budget, and spreading the word about the event. Readers can find excellent tips on engaging the media and following actionable steps to ensure ample participation from the local community and members of the media alike.

There is much potential for misunderstanding and controversy surrounding clinical trials. This handbook helps researchers, program managers, and others understand these communication challenges and guides readers on how to best share information with local communities and partners. It includes general communication guidelines, lessons learned from other country experiences, and multiple tools, such as risk assessment tools and sample templates that can sharpen staff skills in accurately answering questions about the research taking place. Sample communication plans as well as tips and techniques on communicating effectively in various fora are also included in the handbook.