In our ongoing series, “Track Changes,” we link to online content that we have found to be problematic in its assumptions, framing, or language and provide a question or thought(s) provoked by each piece. We ask how portrayals and representations need to be not only rephrased, but also reframed and rethought.
This is ours for this week. We invite our readers to contribute other articles and posts that could benefit from a critical eye.
“A Failed Trial in Africa Raises Questions About How to Test H.I.V. Drugs” (Donald G. McNeil, Jr. The New York Times)
This piece by Patience Lunga addresses critical issues involved in HIV Drug trials currently underway in the Southern African region, which is also the hardest hit by the HIV and AIDS epidemic. Major studies are being done in the region, especially in South Africa and Zimbabwe, for possible responses to the epidemic. HIV prevalence in Zimbabwe is currently at 15% (National AIDS Council Zimbabwe, 2015). Lunga discusses several serious problems both in the assumptions about participants and carrying out of the VOICE study, and in the reporting of the study by the New York Times.
Patience Lunga is a Zimbabwean researcher with extensive experience in similar drug trials in South Africa. She holds a Master’s Degree in Research Psychology from UKZN.
by Patience Lunga
The recent New York Times article by Donald G. McNeil, Jr. “A Failed Trial in Africa Raises Questions About How to Test H.I.V. Drugs” draws attention to what it calls “the elaborate deceptions employed by the women” in HIV/AIDS drug trials and discusses whether both the results of prophylaxis and paying women for their participation in the study are worthwhile. There are a number of problems with this piece and the assumptions of those involved in the study, however. First, the article fails to stress thatthe interventions used in the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study had been proven to be effective in the prevention of HIV transmission. The CAPRISA 004 study conducted in South Africa showed that tenofovir gel proved to be 39% effective in the prevention of HIV transmission in sexually active women between the ages of 18 and 40. This was an important finding that cannot be omitted in any discussion on HIV prevention interventions with women who are mostly at risk.
Second, instead of completely labeling the study as a failure, the experience actually highlights a number of serious issues that need to be addressed in the clinical trials that use bio-medical interventions. Often the self-reporting measures employed to assess adherence in clinical trials are done by clinical staff involved with the trials, which can prompt the participants to respond in what they think will be a socially desirable manner to appear to be adherent.
Third, neither the study nor this article takes into account how participants perceived themselves to be at risk of HIV infection at different stages of the trial, which is an extremely important factor in prevention. Considering that the clinical trials run for a number of years, an individual’s HIV risk perception can change throughout the study, from the time they enroll and exit the study. This dynamic highlights how important HIV risk reduction counselling is crucial at every study visit. As part of HIV risk reduction counselling, the disconnect between the perceived risk for acquiring HIV and the actual HIV risk-related behaviors among participants should be examined. In my opinion this disconnect could be argued to demonstrate the inability of participants to assess their own risk, even in the context of receiving an intervention that has been proven to be effective. For an individual to adopt self-protective measures they should be able to subjectively assess and evaluate their risk of exposure. If they fail to do so, they would fail to adopt protective measures and adhere to the use of the intervention. Hence HIV risk reduction counselling in clinical trials should focus on assisting participants to adequately assess their own risk and identify barriers to protective behaviors.
Lack of exposure to the culture and expectations of clinical trials in most of the greatly affected communities often acts as a barrier to the adoption of the interventions. Community members who don’t understand what exactly goes on in clinical trials could contribute to misconceptions and myths that discourage participants from using the intervention. Therefore extensive community engagement and information sharing to address this misconception and myths becomes important throughout the study; and the culture of these trials themselves – including the assumptions they make about participants – should be examined. Disclosure of participation in the clinical trials could influence adherence which highlights the need for the involvement of male partners and even close family members of participants in some educational programs during the trial.
Finally, every clinical trial goes through ethicalreviews and considerations are made including the issue of reimbursement. Participants are reimbursed with a small monetary incentive to compensate them for the time that they had given to the research process. It should be acknowledged that most clinical trial visits take long and participants have to devote a day to spend time at the trial site. Often the women would have left their family obligations and some travel long distances to make it for their study visits. Hence it is an ethical obligation for those conducting such trials to reimburse participants for their participation, and the value of that reimbursement is justified. Therefore it can never be implied that clinical trial participants are paid to participate in the study. Often the monetary compensation is not the only reason for study participation. Overall this study highlighted that social and behavioral factors play a critical role in the use of bio-medical interventions. Most importantly these factors that influence the adoption and adherence of these interventions by the women needed to be greatly explored. It would be interesting to know what results the sub studies VOICE C (looks at household and community factors associated with adherence) and VOICE D (looks to understand women’s actual use of the study products and sexual behavior during their study participation in VOICE) would highlight.