VOICE C: VOICE Community and Adherence Sub-study
1. What is the aim of VOICE C, or the VOICE Community and Adherence Sub-study?
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 key community stakeholders. In total, about 275 participants will take part. 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.
2. Why is this sub-study 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 insight 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, information that will be essential 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.
3. When did the VOICE C sub-study begin and how long will it last?
VOICE C sub-study started in July 2010 and will continue in parallel until VOICE concludes, which is expected to be some time in 2012.
4. Who is conducting and funding the study?
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). The MTN is 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 (NIH). Leading the study are Jonathan Stadler, M.A., and Ariane van der Straten, Ph.D., M.P.H.
5. Where is VOICE C being conducted?
VOICE C is being conducted at a VOICE Study site affiliated with the Reproductive Health and HIV Research Unit (RHRU) in Johannesburg, South Africa.
6. How is the VOICE C sub-study designed?
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. Ethnography can involve informal, conversational interviews, direct observation of people and events, and recording of people’s life histories. In the Community and Adherence Sub-study, researchers will visit the homes of some women to conduct ethnographic interviews, while other women will be asked to take part in a one-time in-depth interview or focus group discussion. Male partners, CAB members and community stakeholders enrolled in the sub-study will also participate in either in-depth interview or focus group discussions. 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. The VOICE C researchers will also conduct observations in the community, including at events promoting recruitment into VOICE.
7. How exactly are VOICE participants involved in VOICE C?
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 women will be randomized to either ethnographic visits or in-depth interviews to take place while they are in the VOICE Study and 90 women will be randomized 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 women 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 experience being in VOICE and with using her assigned study product, and in particular, whether she’s 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 with her; and about her work or other activities outside the 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 that is testing an ARV-based gel and ARV tablets for preventing HIV. Four such sessions will take place over the course of a year.
Women randomized to in-depth interviews will be administered a single interview designed to cover many of the same types of questions but in more structured fashion. The interview will be conducted at the clinic or another location of the woman’s choosing.
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. Discussion will center on participants’ use of gel or tablets and household- or community-related issues that may have influenced their adherence to a daily regimen during their time in VOICE, which for most women, will be an average of 12 months. 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.
8. How are male partners involved in the VOICE C?
With the permission of the women participating in VOICE C, researchers will identify 12 male partners to take part in either an in-depth interview or focus group discussion. Another 48 men will be asked to participate in focus group discussions after their partner has completed the VOICE Study. Each group will include an average of eight men who will talk about their and their partners’ experience with the study, and what they liked and disliked about the tablets or gel that were used. Both the interviews and the group discussions will be conducted by male staff working on the VOICE C study.
9. Why include Community Advisory Board (CAB) members and community stakeholders?
To get a better sense about community-level factors that could affect women’s adherence to product regimens, VOICE C will ask about 15 members of the trial site CAB to participate in a series of focus group discussions over the course of the study. Each focus group discussion will last about two to three hours and cover a range of topics about VOICE and community issues. In addition, approximately 50 community stakeholders –including local leaders, advocates, media and educators – will be identified to participate in one of four or five focus group discussions, each to involve an average of eight participants. By including both CAB members and key community stakeholders in the sub-study, VOICE C researchers hope to gain better insight about the opinions and feelings of people who are outside the study or more removed from the research site. These discussions will help to parse out rumors about the study and assess the community’s overall acceptance and understanding of the trial. Researchers will also be able to better understand cultural norms and traditions and how practices around marriage, gender, sexual relationships, and in particular, the insertion of vaginal products or the taking of medicine by mouth, may be influencing participants’ adherence to either regimen.
10. Do participants in VOICE C provide 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 is employed to ensure that participants understand the procedures, as well as possible risks and benefits of the study. This process continues throughout the study. Participation is voluntary and participants may withdraw at any time. Moreover, women who decide not to join VOICE C can still be in the VOICE Study.
11. Does taking part in VOICE or VOICE subject women to potential harm or stigma?
The researchers conducting VOICE and VOICE C recognize that women who participate in an HIV prevention trial can sometimes be subjected to stigma and discrimination by friends, family or others in the community. Women in VOICE might be assumed by others to be HIV positive, for example, or feel pressured into sharing the gel or tablets. Participation in a trial could exacerbate problems at home or with relationships or cause some women to fear or experience physical harm by an abusive partner. While participating in VOICE C is unlikely to cause immediate harm to women, the researchers will make every effort to protect the participants’ privacy and to minimize the potential that such harm could occur. 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 group discussions. Focus group participants will be asked and strongly encouraged to respect each other’s confidentiality. All study-related information will be stored securely at the study site. Notes will not contain any identifying information, and will also be stored on a password protected computer. Should women experience social harm while in VOICE or VOICE C, they will be referred by study staff for specialized counseling as needed.
12. What approvals were required to conduct VOICE C?
As with all MTN studies, VOICE C underwent extensive and rigorous review by NIAID. Moreover, the study was reviewed by the RTI International Ethics Committee and the Witwatersrand University Human Research Ethics Committee, which must approve all clinical research being conducted at RHRU.
# # #
Additional information about both VOICE C and the VOICE Study can be found at http://www.mtnstopshiv.org/news/studies/mtn003
10-Sept-2010
See also
