Assessment of ASPIRE and HOPE Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 7
- 主要终点
- Factors affecting product use adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Factors affecting product use adherence
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Product use patterns(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(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(Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.)