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The VOICE Community Substudy was implemented at a single VOICE site in Johannesburg, South Africa. VOICE-C assessed the impact of household factors and community perspectives on reported product adherence by women, utilizing both behavioral research and ethnographic approaches. The VOICE-C study collected data from VOICE participants, male partners of participants, members of the site’s Community Advisory Boards (CABs), and key community stakeholders.  Study staff members solicited the input of external stakeholders on developing and implementing strategies to improve product adherence in the trial, and collected feedback on participants’ experiences with implementation strategies via exit focus group discussions. 

The use of qualitative methods in VOICE-C provided insight into the context in which women were asked by VOICE researchers to use their study products. The study also provided information on the complex relationships among those who conduct clinical research, participate in the research, and live in the communities where clinical research takes place. The VOICE-C primary results were first presented at the International Conference on HIV Treatment and Prevention Adherence conference in Miami, FL on June 3, 2013.

Protocol Chair(s)
van der Straten, Ariane (Protocol Co-Chair)
Protocol Title
Household and Community Level Factors Associated with Study Product Adherence in VOICE: A Substudy of MTN-003
DAIDS Protocol ID
10746
Status
Participants off Study and Primary Analysis Completed
Formulation
Gel
Oral Tablet
Drug
Placebo
Tenofovir   
Truvada® (emtricitabine +tenofovir disoproxil fumarate)
Viread®  (tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Vaginal
Study Type
Behavioral
Countries
South Africa
Population
Women (cisgender women, non‐transgender women)
Funder(s)
DAIDS/NIAID/NIH
6700 B Rockledge Drive
Bethesda, MD 20892 USA

US NIMH
6001 Executive Boulevard
Rockville, MD 20852
Other Study Info

Exploratory substudy of VOICE using qualitative research methods, including focus group discussions (FGDs), in-depth interview (IDI), ethnography, and observation and note-taking at male partner activities (in the VOICE trial) at participating VOICE-C site(s).