NCT02702895

Assessment of ASPIRE and HOPE Adherence

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: Microbicide Trials Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR), as well as male partner attitudes towards and experiences with the dapivirine VR and their perspective of their female partner's attitudes and experiences.

Detailed description

The MTN-032 trial is a two-phase exploratory sub-study of the ASPIRE and HOPE trials. A total of 187 former ASPIRE participants aged 19-48 years were enrolled in Phase 1 of this study. Up to 156 HOPE participants and up to 120 male partners of HOPE participants will be selected for participation in Phase 2 of this study. There were approximately 4-6 months allotted for recruitment and follow-up at each site for Phase 1, and 9-12 months allotted for recruitment and follow-up at each site for Phase 2.. MTN-032, an observational study, using interviews and focus group discussions, is primarily designed to identify factors that may have affected participant adherence to study product in ASPIRE and HOPE, including male partner attitudes. MTN-032 will also elicit perceptions about various participant engagement and adherence promotion interventions implemented in ASPIRE and may also explore the potential use of incentives to promote adherence to VR use. MTN-032 will use study product adherence results from ASPIRE and HOPE, qualitative in-depth interviews (IDI) and focus group discussions (FGD) to explore study product adherence behaviors and strategies used to overcome adherence challenges. An in-depth understanding of the various socio-behavioral factors that contribute to product use adherence may assist in the interpretation of past and ongoing study results and inform implementation of future studies.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	In-depth Interview (IDIs) or Focus Group Discussion (FGD)

Timeline

• Start date: 2016-06-13
• Primary completion: 2018-12-19
• Completion: 2019-12-19
• First posted: 2016-03-09
• Last updated: 2022-10-13

Locations

7 sites across 4 countries: Malawi, South Africa, Uganda, Zimbabwe