Assessment of ASPIRE and HOPE Adherence

Completed

• Conditions: HIV Prevention

• Registration Number: NCT02702895
• Lead Sponsor: Microbicide Trials Network

Brief 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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Study Start: 2016-06-13
• Primary Completion: 2018-12-19
• Study Completion: 2019-12-19
• Status Verified: 2021-06
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factors affecting product use adherence	Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.	Socio-contextual and trial specific issues which affected participants' adherence to the dapivirine VR will be captured by IDI and/or FGD.
Male partner attitudes affecting product use adherence	Phase 2: Nine to twelve months during Q2 2018/Q2 2019.	male partner attitudes towards and experiences with the dapivirine VR, and their perspective of their female partner's attitudes and experienceswill be captured by FGD and/or IDI.

Secondary Outcome Measures

Name	Time	Method
Perceptions of HIV risk	Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.	HIV risk and perceptions of HIV risk in general and specific to participants' and their male partners' motivation to participate in the ASPIRE and/or HOPE trial(s), to use study product (or not) during their participation in ASPIRE and/or HOPE, and male partner support (or lack thereof) of participants' product use in HOPE will be captured by IDI and/or FGD.
Product use patterns	Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.	Factors influencing product initiation and patterns of use during ASPIRE and/or HOPE will be captured by IDI and/or FGD.
Perceptions of various adherence support interventions	Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.	Participants' perceptions of various adherence support interventions and engagement activities implemented (or not implemented) during ASPIRE and/or HOPE will be captured by IDI and/or FGD.
Understanding of ASPIRE results and ring efficacy	Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.	Participants' and their male partners' understanding of the ASPIRE results and ring efficacy, and the impact of this understanding on participants' intention and/or ability to join HOPE and continue in follow-up, on their adherence to the dapivirine VR as part of an open label extension trial as compared to adherence in a Phase 3 safety and effectiveness trial, and male partner support (or lack thereof) of participants' trial participation and product use in HOPE will be captured by IDI and/or FGD.

Trial Locations

Locations (7)

Malawi Clinical Research Site; 🇲🇼 Lilongwe, Malawi

Botha's Hill Clinical Research Site; 🇿🇦 Durban, KwaZulu-Natal, South Africa

CAPRISA eThekwini Clinical Research Site; 🇿🇦 Durban, KwaZulu-Natal, South Africa

Wits Reproductive Health and HIV Institute Clinical Research Site; 🇿🇦 Johannesburg, South Africa

Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site; 🇺🇬 Kampala, Uganda

Spilhaus Clinical Research Site; 🇿🇼 Harare, Zimbabwe

Zengeza Clinical Research Site; 🇿🇼 Harare, Zimbabwe