VOICE C: VOICE Community and Adherence Sub-study
Overview
VOICE C is a sub-study within a larger trial called VOICE – Vaginal and Oral Interventions to Control the Epidemic, which is looking at whether some of the same antiretroviral (ARV) medicines used successfully for treatment of HIV are safe and effective for HIV prevention, as either a vaginal microbicide or an oral tablet used daily. VOICE also seeks to determine which of these regimens women are more likely to follow: taking a tablet by mouth once a day, an approach known as oral pre-exposure prophylaxis (PrEP), or applying a vaginal gel every day. Toward this end, VOICE C, also called the Community and Adherence Sub-study, aims to identify specific factors within a participant’s household, her social environs or the broader community that can influence her willingness or ability to correctly and consistently follow either regimen. VOICE C will include a subset of women enrolled in VOICE, but also their male partners, members of a clinical research site Community Advisory Board (CAB) and community stakeholders. In total, about 275 participants will take part. The sub-study is being conducted at a VOICE study site affiliated with the Reproductive Health and HIV Research Unit (RHRU) in Johannesburg, South Africa. To optimize adherence in the larger VOICE study, VOICE C is designed so that what is learned along the way can be applied immediately across all 16 VOICE sites.
VOICE C is funded by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH). Both VOICE and VOICE C are studies being conducted by a team of researchers working in the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network established and funded in 2006 by DAIDS/NIAID with co-funding from NIMH and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all components of the U.S. National Institutes of Health. Leading the Community and Adherence Sub-study are Jonathan Stadler, M.A., of RHRU, and Ariane van der Straten, Ph.D., M.P.H., of RTI International in San Francisco. It started in July 2010 and will continue in parallel until VOICE concludes, which is expected to be some time in 2012.
Why this Study is Important
Clinical trials like VOICE, which is testing two different approaches, are important not only for determining the effectiveness of the interventions under study but also whether they will be acceptable for use in the “real world.” Indeed, even the most effective prevention method will do no good if it is not used or not used properly. At the same time, it is difficult to know how effective a product or approach really is if in a trial a high percentage of participants fail to follow the study’s regimen. Understanding the impediments to adherence will be critical to the success of HIV prevention efforts, especially those involving methods intended for women, who account for 60 percent of those getting infected in sub-Saharan Africa.
VOICE C will provide important insights about the specific factors that can determine whether a woman is willing and able to commit to using a vaginal gel or tablets to reduce her risk of HIV, be they cultural, social, or practical in nature. False rumors, what a partner understands of the trial, or simply the look and feel of study products could affect a participant’s adherence to either regimen. Findings from VOICE C will be useful for the design and implementation of new HIV prevention trials and the eventual rollout of products found to be effective and approved for use. In the short term, the Community and Adherence Sub-study may suggest new strategies to make daily product use easier for the 5,000 women who will be followed in VOICE. High adherence will, in turn, enhance the credibility of the study’s results about the safety and efficacy of the gel or tablet for preventing HIV as well as the approach women most prefer.
How the Study is Being Conducted
VOICE C is an exploratory study that uses a combination of research methods for understanding the factors within the household, clinic setting or community likely to influence women’s adherence to daily use of a gel or tablet for preventing HIV. One method, called ethnography, affords social scientists a closer look at the daily lives of people as well as the local surroundings and household dynamics that can shape different behaviors. It often involves informal, conversational interview and direct observation of people and events.
In one phase of the sub-study, researchers will enroll 150 women who have completed their first three months in VOICE and randomly assign them to one of three study groups: ethnographic visits, in-depth interviews or focus group discussions. Sixty of the 150 women will be randomized to either the group that involves a series of ethnographic interviews or to the group that involves a single in-depth interview and will participate in VOICE C while in the parent study. The 90 other women will be asked to take part in a one-time focus group discussion after their participation in VOICE has ended. While in the parent study, women will continue to use their assigned study product: tenofovir gel, placebo gel (which looks the same but has no active ingredient), tenofovir tablet, Truvada® tablet or placebo tablet.
For those randomized to ethnographic visits, a researcher will spend about three hours at the woman’s home or venue of her choice and engage in informal conversation about her being in VOICE and with using her assigned study product, and in particular, whether she has found a daily regimen difficult in any way. Researchers will also ask her to talk about her living quarters, her relationships with different family members; the HIV status of family members, especially those living at home. In addition, there will be discussion about how sex is negotiated with her partner(s), whether he approves her use of the study product and what friends, neighbors or others in the community may feel about her being in a study testing an ARV-based gel and ARV tablets for preventing HIV. Four such sessions will take place over the course of a year. Those randomized to the in-depth interview group will be administered a single one-on-one interview conducted at the clinic or another location of the woman’s choosing that is designed to cover many of the same types of questions but in more structured fashion.
The 90 women who will take part in focus group discussions will do so at the end of their participation in VOICE. A focus group discussion will include an average of eight participants and be facilitated by a female researcher. Separate focus groups will be conducted with the women who had been assigned to use gel during VOICE and with the women who were to use tablets.
Male partners, CAB members, and community stakeholders will also take part in either a one-time focus group discussion or in-depth interview.
Although similar information will be collected from each of the groups, the use of these different approaches will enable researchers to piece together the most salient issues, identify discrepancies or sources of misunderstandings and help to understand where attitudes may converge or conflict to influence a women’s ability and willingness to use the gel or tablets.
Confidentiality and Informed Consent
All participants taking part in VOICE C provide written informed consent. For women in VOICE, a separate written consent is obtained for the sub-study. An extensive education process ensures that participants understand the procedures, as well as possible risks and benefits of the study, and continues throughout the study. Participation is voluntary and participants may withdraw at any time. VOICE C researchers will make every effort to protect the participants’ privacy. For instance, all participants taking part in in-depth interviews and focus group discussions will be asked not to use their real names when referring to themselves or others in focus group discussions.
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More information about the both VOICE C and the VOICE Study can be found at http://www.mtnstopshiv.org/news/studies/mtn003
10-Sept-2010
See also
