MTN-003C (VOICE Community Substudy)
Status:Completed
Phase:Other
Principal Investigator(s):Jonathan Stadler
Objective:The main objectives of the VOICE-C study were to explore the socio-cultural and contextual factors that influenced daily PrEP regimen in the VOICE trial, to determine whether these factors differed between participants randomized to gels versus tablets, and to better understand women’s perceptions of and experience with investigational product use.
Results: Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products.
Prevention Option(s):Microbicides, PrEP
Study Design:Randomized
Official Code:
MTN-003C
Trial Sponsors:
DAIDS, NIAID, NIH
Start Date
End Date
June 15, 2010
July 18, 2012
Enrollment:102
Age range:
↔
any
Population:Cisgender Women