More research needed: statement on microbicide study results

The SANAC Women’s Sector would like to thank the researchers that pioneered this important study. As a women’s interest group we honour all the women who participated in this study, their partners and families who supported them during the trail. The FACTS 001 trial participants are the heroes in this case we cannot be more grateful for their commitment and endurance during this period. We also are extremely proud that the LEAD research teams on this trial are all women well-known for their passion and commitment for prevention methods that focus on women.

The Tenofovir gel, designed to reduce risk for HIV and Herpes Simplex (HSV) viruses presents an opportunity for a woman-controlled intervention, in a context where this is desperately needed. Herpes infection is an established risk factor which increases risk for HIV infection in exposed women, and behavioural interventions such as Stepping Stones have an impact in the reduction of HSV (Jewkes et al., 2008).

The results  of a confirmatory trial of 1% Tenofovir gel used before and after sex announced at CROI yesterday proved not effective in preventing HIV in women when used before and after vaginal sex. FACTS 001 was conducted in South Africa with 2,059 women between the ages of 18-30 enrolled in the study and most were single and lived at home. The results of the trial report that the use of the gel by study participants was not optimum and hence no reduction of HIV in the intervention arm was recorded.

The findings of this study should be studied within the broader context of health behaviours and adherence among young women. Consistency in use of HIV prevention methods, including barrier methods remains a problem (Shai, Jewkes, Nduna, Levin, & Dunkle, 2010). Similarities can be drawn between condom use and the use of the gel. Both need to be administered before and after sex; with a condom put on before sex and carefully removed after sex. The gel is also applied before and after sex. What this means is that the user should have access to the product at a point of possible sexual encounter. It is this scenario that creates a challenge for some.

With biomedical interventions allegiance and adherence are critical for effectiveness to be achieved; however, for many young women, sexual encounters are often unplanned and unpredicted, though anticipated and expected. It is precisely this was should guide the development of HIV prevention interventions.

One positive aspect of this process is that at least this intervention was tested. Results, though not favourable, are reported and challenges associated with its failure will be interrogated. This is the correct step and should be a platform for us to use to advocate for delivery of interventions that are evidence based. Though we are all disappointed now; this scientific exercise will save millions of Rands that should, frankly, not be spent on interventions that do not have a public health effect. For instance, with condoms, the public-wide effects of condom use in preventing HIV infections does not have scientific base. There is no report of randomised controlled trials to demonstrate the effects of condoms on the country’s HIV incidence. At an individual level, yes, condoms work and should be promoted, vigilantly. However, consistently spending millions of Rands on a technology that does not dent HIV incidence on the most at risk group remains questionable.

Young women are the group highest at risk for HIV in South Africa. Male condoms present similar challenges to this ge’ and yet support for male condoms is unwavering. The commitment shown by the South African government for research development in the field of HIV/AIDS should be applauded. This is a great shift from our history as women and for HIV. However the question remains: is it fast enough to keep up with the continued new infections among women 16-24? Can South Africa afford the 365 000 new infections among this age group annually? Hence we remain concerned about the slow pace our government is moving in relation to implementing proven options that work for women. Female condoms and their accessibility, oral PrEP (Pre-Exposure Prophylaxis) has proven to work in many countries. We urge our government and the National Department of Health to prioritize the access and policy around these options.

Vuyseka Dubula, a HIV positive mother to an eight year old girl said

“…the possibility of a microbicide gave me hope that my daughter will not have the same challenges as I did…”

She needs choices and that is what we need, choices for women in this prevention basket.

Perhaps we can reiterate a couple of lessons to be learnt by us all, in particular, scientists who are at the forefront of the development of HIV prevention technologies:

  • Technologies that work for longer than at every sexual act, could be the answer for young women.
  • Clandestine technologies that you do not need to insert before and after sex with your partner’s knowledge, are preferred by young women.
  • Interventions that are not perceived, or experienced, to interfere with fertility and the menstrual cycle, are more easily welcomed.
  • The technology should also be easily accessible.
  • The product is proving to be not in-sync with women’s living conditions and lifestyle demands of this age group. Researchers need to develop biomedical interventions with women than interventions for women.
  • Young women are faced with poverty, unemployment, social inequality, violence, rape or unsolicited sex, poor health services or access to health, poor housing and many other socio-economic factors. These have an influence on how women participate in research and clinical trials.
  • Whilst efforts to involve communities in research are a feature in the design and conduct of trials, a lot more needs to be done to understand how these affect participation of women in trials.
  • A multi-sector approach in a trial community context is important when trials are designed and implemented to ensure that the above factors are considered as much as possible.
  • As much as resources are put in research infrastructure, equally, resources are needed in community involvement before and during the conduct of clinical trials.

The fact that the gel is not a practical method for women is an issue that we need to give urgent attention to. The trial participants are a snap shot of the picture of HIV in South Africa. This shows clearly that we cannot continue to look for solution for woman without taking socio-structural factors into consideration. We need to seriously give attention to who is this young woman 16-24 and we hope that research will give some answers. We look forward to the results of the RING and ASPIRE studies that will be released in 2015/2016.

We demand more research with a focus on young women and girls. The current status quo cannot continue.

References

Jewkes, R., Nduna, M., Levin, J., Jama, N., Dunkle, K. L., Puren, A., & Duvvury, N. (2008). Impact of Stepping Stones on incidence of HIV and HSV-2 and sexual behaviour in rural South Africa: cluster randomised controlled trial. British Medical Journal, 337(7666). doi: a506 10.1136/bmj.a506

Shai, N. J., Jewkes, R., Nduna, M., Levin, J., & Dunkle, K. (2010). Factors associated with consistent condom use among rural young women in South Africa. AIDS Care, iFirst.