Assessment of ASPIRE and HOPE Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of ASPIRE and HOPE Adherence

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Phase 1 - Former ASPIRE participants): Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment. Able and willing to provide written informed consent in one of the study languages. Able and willing to complete the required study procedures. For participants who did not acquire an HIV infection while taking part in ASPIRE, evidence of study product dispensation at a minimum of three consecutive ASPIRE scheduled clinic visits. For participants who acquired an HIV infection while taking part in ASPIRE, evidence of study product dispensation in the month prior to the participant's acquisition of HIV infection. For participants who did not acquire an HIV infection while taking part in ASPIRE, have a minimum of three ASPIRE PK data measurement points available. For participants who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE PK data measurement available. Inclusion Criteria (Phase 2 - HOPE participants): Participated in the HOPE protocol. Able and willing to provide written informed consent in one of the study languages. Able and willing to complete the required study procedures. For participants who did not acquire an HIV infection while taking part in HOPE, evidence of study product dispensation for a minimum of three consecutive months. For participants who acquired an HIV infection while taking part in HOPE, evidence of study product dispensation in the month prior to the participant's acquisition of an HIV infection. Inclusion Criteria (Phase 2 - Male partners of HOPE participants): Identifies as a male sexual partner of a HOPE participant for whom the HOPE participant has given permission to contact. Was a male sexual partner of a HOPE participant during her participation in HOPE (regardless of whether she used the ring or not). Able and willing to provide written informed consent in one of the study languages. Able and willing to complete the required study procedures. Is above the age of 18 at the time of study participation. Exclusion Criteria (Phase 1 and Phase 2): 1. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1<br>Former ASPIRE participants | Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)<br> <br> |
| Phase 2 HOPE participants<br>Former HOPE participants | Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)<br> <br> |
| Phase 2 Male Partners<br>Male partners of HOPE participants | Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting product use adherence | Socio-contextual and trial specific issues which affected participants' adherence to the dapivirine VR will be captured by IDI and/or FGD. | Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019. | 
| Male partner attitudes affecting product use adherence | 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. | Phase 2: Nine to twelve months during Q2 2018/Q2 2019. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions of HIV risk | 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. | Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019. | 
| Product use patterns | Factors influencing product initiation and patterns of use during ASPIRE and/or HOPE will be captured by IDI and/or FGD. | Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019. | 
| Perceptions of various adherence support interventions | 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. | Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019. | 
| Understanding of ASPIRE results and ring efficacy | 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. | Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019. |