Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi: Examining the Benefits, Acceptability, and Associated Costs of a Systems-navigator-delivered Integrated Prevention Package
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
研究概览
简要总结
To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult and adolescent men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating PrEP:
- •Age ≥18 years, or age 15-17 (with assent and parent/guardian consent)
- •Able to provide informed consent
- •No plans to move outside study area for at least 26 weeks after study enrollment
- •Willing to provide contact/locator information, including phone number, to facilitate tracing
- •Willing to participate in study activities, including specimen collection
- •Willing to participate in study activities, including systems navigation, counseling, and point of contact STI testing
- •Sought STI clinic services within 7 days of enrollment
- •Initiated on PrEP at STI clinic within 7 days of enrollment
- •Reports at least one female sex partner in the 6 months prior to enrollment
- •Self-identifies as heterosexual
- •Individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders:
- •Age ≥18 years at the enrollment visit
- •Able to provide informed consent
- •Involved in provision of clinical service navigation, systems navigation, STI or HIV care or prevention (including clinic management or oversight), or development of HIV prevention policy or programs at local or national level
排除标准
- •Adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating PrEP:
- •Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators
- •Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the conduct of the study
- •Current participation in any HIV prevention study or other study considered to interfere the interpretation of study outcomes.
- •Individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder:
- •Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators
- •Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the study activities
结局指标
主要结局
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
时间窗: 26 weeks
Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants. LAI: Receive on-time injections (+/- 7-day window for the first injection and 14-day window thereafter)
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
时间窗: 26 weeks
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Proportion of intervention arm participants engaged by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.
To assess the effect of a systems-navigator facilitated HIV prevention package on PrEP persistence among heterosexual men seeking STI clinical services in Lilongwe, Malawi
时间窗: 26 weeks
Consistent with this primary study objective, the following endpoint will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing proportions in intervention and control arm participants. Event-driven: Self-reported PrEP adherence (2+1+1), in the past 30 days, assessed through intraerythrocytic Tenofovir-diphosphate concentrations.
To assess acceptability and barriers of implementing a systems-navigator delivered HIV prevention package among key stakeholders in the clinic and heterosexual men initiating PrEP at STI clinics
时间窗: 26 weeks
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews.
次要结局
- To assess the feasibility of a future randomized controlled trial(52 weeks)