This morning’s Washington Post featured a story concerning another setback in HIV/AIDS prevention research. The article stated that, “The abrupt closure last week of one part of a complicated study called VOICE marked the third time in eight months that antiÂretroviral drugs did not prevent infection in those assigned to use them.” Ironically, the interventions had proven effective in smaller scale trials.Â What happened during scale up?
The answers may lie in subtle differences between the groups being studied and the designs of the experiments. For example, the volunteers in Partners PrEP (pre-exposure prophylaxis study) were long-term couples in which one person was infected and the other not. Itâ€™s possible they may have been more motivated to take the pills every day. In CAPRISA (the South African PrEP study), the women inserted the vaginal gel before and after sexual intercourse rather than every day â€” a targeted approach that may have helped them stick to the program.
Such differences in the social and behavioral context of research make all the difference – basic research on drug effectiveness cannot be divorced from the people who receive the medications. The Post contacted experts who offered the following opinions about why there were problems.
- The daily regimen just probably was not acceptable; if the gel were being used according to instructions some differences between groups should have emerged.
- Other studies of vaginal microbÂicides and pre-exposure prophylaxis have shown that few people use prevention tools as regularly as they say they do, but the more â€œadherentâ€ people are, the more protection they get.
- What we have to face up to is that everything in HIV prevention is based in human behavior.
The article concluded by saying, “What seems clear is that this strategy, once viewed as the easiest and most certain, is going to require a lot of fine-tuning even if it works.”
With malaria interventions, similar lessons apply. ACTs do not protect is people do not adhere to the 3-day regimen. LLINs do not protect if people use them to cover their vegetable gardens. IPTp is not effective unless pregnant women attend antenatal care regularly. Rapid diagnostic tests are wasted if health workers do not believe in their efficacy.
Often we wait until problems of non- or inappropriate utilization of health interventions occur before we start looking at social and behavioral factors. The Post quoted one epidemiologist who said, “People are upset. Itâ€™s a big head-scratcher as to why it didnâ€™t work.” Researchers should be embarrassed to admit such, as this means they did not do adequate formative research in advance to understand the social and cultural context into which they were introducing their innovations.
Certainly similar mistakes have been made in malaria research and intervention, but now with international donor funding severely threatened, we cannot waste resources pushing interventions that are not socially and culturally acceptable.