Part I: Microbicide: a magic bullet in HIV prevention strategies for women?
By Veronica Noseda, Social sciences project officer, Sidaction, Paris
Every international Aids Conference needs a big announcement to go down in history (and, incidentally, to map out the research agenda for the following years). The 2010 IAS international conference, which was held in Vienna last July, was no exception.
The results of CAPRISA 004, a trial which tested the safety and effectiveness of an antiretroviral-based vaginal gel among nearly 900 women at two sites in South Africa, were announced as a major breakthrough: this 1% tenofovir gel prevented four out of ten HIV infections (39% efficacy), and avoided more than half of the infections in women who used the gel more than 80% of the time (54% efficacy). For the first time, after years of disappointing trial results and ethical controversies, we have the proof that microbicides can work.
If we look at results more carefully, though, we realize that there is no space for triumphalism. 39% reduction is, on the whole, a rather moderate rate. 54% is undoubtedly a more consistent reduction, but it needs a very high adherence to the protocol. Of course, these figures must be interpreted in the framework of the so-called “combined prevention,” where microbicides do not substitute but are used in addition to traditional prevention tools, like condoms. But, still, would you be satisfied if a contraceptive pill would reduce the risk of an unwanted pregnancy only by half?
To fully understand why the results of CAPRISA were interpreted as a milestone, we have to go back to the great expectations surrounding microbicides. Several international women’s health organizations, like Global Campaign for Microbicides have been advocating in favor of vaginal gel since “many women do not have the social or economic power necessary to insist on condom use and fidelity or to abandon partnerships that put them at risk. Because microbicides would not require a partner’s cooperation, they would put the power to protect into women’s hands”.
To have different prevention strategies for men and women is currently the dominant approach – and microbicides are no exception to the rule. But is it really a visionary solution for future HIV prevention strategies? Of course, common sense dictates that, in many situations, women cannot use condoms in the way most government programs recommend. Instead they must persuade men to do so, and this can be an extremely difficult task, since they are not always expected to discuss or make decisions about sexuality. In such contexts, microbicides can play an important role at an individual level, and we should promote them, as well as any other possible measure that can enhance women’s protection.
But is this what we want in the end? Sex-specific devices (like antenatal counseling and testing, circumcision or microbicides) do not facilitate communication between partners regarding their HIV status. Yet, this dialogue is critical for the adoption of preventive behaviors within the couple. As a result, microbicides should not divert us from exploring potential couple-centered testing, counseling and prevention strategies, which have been broadly neglected despite the fact that they have showed a positive impact on both men and women in several programs carried out in sub-Saharan African countries.
Just like circumcision or pre-exposure prophylaxis, microbicides are not just neutral biomedical prevention tools: their meaning, use and effectiveness depend on the context in which they are promoted. It’s about time to think about this context in order to make it more favorable to women’s empowerment. Microbicides per se probably won’t be enough: the fact that women can choose a means to protect themselves without being obliged to get their male partner’s approval is indeed excellent news – the fact that women can decide what is the most suitable prevention strategy for them without hiding or being scared of their partner’s reaction is even better.
We have some time to think about all this: microbicides are not available yet. Broader trials are needed to confirm CAPRISA results, and it will most likely be years before the product is publicly available. In the meantime, other major issues will be put at stake (How will adherence be promoted? How will microbicides be provided and distributed? What might they cost? How will they be marketed to people who would be benefit? Who will pay?), confirming that prevention is not just a question of technical efficiency or availability but a complex social and political phenomenon.
In conclusion, while the microbicides are a positive development, it’s an illusion to think that a biomedical tool (a gel, or a pill, or a cut) will solve all HIV prevention problems. Tools in themselves do not determine their use, and the use depends on a complex bulk of factors, such as gender relations, socio-economic inequalities, and education.
Part II: HIV/AIDS: The gel, daily pills…or a vaccine?
By Dr. Akindiran Akintunde, Health Initiative for Safety & Stability in Africa, Nigeria
Scientists all over are now beginning to look beyond behavioral methods of HIV prevention focusing more on biomedical methods. In 2010 breakthroughs were recorded in the field of biomedical HIV prevention research. Two of these were proof-of-concept trials to prove that some of the antiretroviral (ARV) drugs currently being used in the treatment of HIV/AIDS could prevent infection with HIV when taken before infection occurs. The CAPRISA 004 and iPrEx trials demonstrated that the use of existing antiretroviral drugs either topically or systemically can provide some protection from HIV infection.
The CAPRISA 004, a phase IIb trial found that vaginal microbicide tenofovir gels resulted in 39% fewer infections among women who used it before and after sex than those who used placebo gels (1). iPrEx – a multinational phase III trial showed that once-daily oral truvada (a combination of two antiretroviral drugs-Emtricitabine and Tenofovir ) provided 44% additional protection from HIV among men or transgender women who have sex with men who also received a comprehensive package of prevention services (2).
These results are impressive and serve as a beacon of hope to many of us. It proves that HIV/AIDS can be cured if we indeed set our minds to unraveling the mystery surrounding the virus. There are however, multiple associated questions for me as a Nigerian when I think of these studies and the prospects of access and affordability: Will individuals have to go to the hospital regularly to get them, will individuals have to buy these drugs or vaccines, how much will they cost, will the drugs be taken daily over a long period of time in order to prevent infection, will they be taken by individuals at higher risk of getting infected by HIV or by everybody, how will the possible side effects be monitored, what about the development of resistance…?
Both agents require new behaviours for demonstrated effectiveness, such as adherence over a long period of time to both medication use & safer sex counseling. How do you achieve this in a community that finds adherence to treatment regimens already difficult? How do you address pill use in a community that prefers injectables? How do you address the concept of ARV drugs for prevention when ARV drugs are already associated with HIV treatment, including its attendant stigma. How do sex workers and men who have sex with men access pre-exposure prophylaxiswhen identifying as either has negative legal implications in Nigeria? Will pre-exposure prophylaxis access also be associated with new forms of stigma?
For Nigeria, Africa and the developing world a vaccine might be the ultimate. The idea of a HIV vaccine is more palatable to me because a vaccine can be taken just once or in booster doses like the hepatitis B vaccine, versus drugs that have to be taken daily considering the fact that the person taking the drug might not be at high risk of contracting the virus. A vaccine will reduce the financial burden on the individuals, it will eliminate regular visits to the hospital for the purchase/collection of drugs & monitoring of the development of possible side effects and it will also eliminate the issue of poor adherence.
In Nigeria, a vaccine is more agreeable mainly because it will mitigate the effect of factors like the low standard of health care, poverty, poor adherence to treatment regimen, illiteracy and irregular hospital visits on HIV prevention using daily medications. The results of the two trials have given hope: a hope that we can collectively harness and use to bolster our desire to finding a cure for HIV.
References
1. http://www.fhi.org/en/Research/HIVAIDS_Prevention/CAPRISA004.htm
2. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010. DOI: 10.1056/NEJMoa1011205.
I thank you for addressing the many methodological caveats with the news of CAPRISA 004. Although the research is encouraging, the actual application and practicality of African women using a microbiocidal vaginal gel cannot be a realistic approach as a singular module for HIV/AIDS prevention for women.
You have discussed some of the most immediate contraindications of both the research study and the use of vaginal gels with the 1% tenofovir pharmaceutical inclusion. Adherence will depend on the clarity of the message in a culturally appropriate environment but even if there is an ‘applicator’ to inject the gel, most African women will not touch ‘their private parts’ as this is taboo in most societies. With time, the applicator will become unhygienic and the women will be injecting bacterial infections and other viruses directly into their vaginas. This taboo of ‘touching’ is also a barrier for the use of the female condom. How will the women get the shillings for the transportation to the clinic for the gel? Will they be able to avoid the stigmas as the purchase is an admission that their partner is probably living with HIV/AIDS and/or they are admitting to the practice of prostitution?
There is mention that the use of the gel has an advantage in that there is no need to negotiate prevention between the partners. There will always be a denial of HIV positivity and there is rarely any communication about sexual practices.
I’d like to suggest that the most resourceful and effective approach would be to provide HIV/AIDS prevention through peer education to both the young women and young men. Students are having sex at age 9, 10 years. When we train students (12-16 years) to educate their comparably aged peers, there is a discussion of female anatomy, menstruation, hygienic measures, healthy relationships, negotiation, decision-making skills and interpersonal respect. I have had great success keeping the girls and boys together in the workshops because then we can get into situational role plays that will include abstinence, postponement and proper condom use (please see attached photos of 12 year olds in Ituha, Tanzania, Sept. 2010).
Prevention is open, honest and effective when the students are empowered with accurate alternatives to modifying the risk-taking behaviors that can lead to an exposure to HIV. We heighten the urgency of taking precautions with the inclusion of local community members who live with HIV/AIDS. We also heighten the urgency to provide care, compassion and hope to our friends and family members who are in isolation because of the fears of discrimination and stigmas. Young students are fantastically effective as educators to their parents! The ‘Baba-Father’ will be encouraged to use condoms because he loves his children so much. Yes, the best way to influence the ‘Baba’ is through his children!
Let’s continue to combine and coordinate the efforts of pharmaceutical research, anti-retroviral studies, and innovative educational strategies that involve peer education. It is through this multi-disciplinary approach that we will decrease the rising incidence of HIV infections globally.
Respectfully submitted,
Wendy Arnold, MPH
President
Peer Education Program of Los Angeles
PEP/International
http://www.pepla.org