Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme
研究概览
简要总结
The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in South Africa. To do this, the investigative team will analyze PrEP initiation and retention data from the study's implementing partner, TB HIV Care, a non-profit organization providing PrEP to marginalized young women in South Africa. The effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (CRT).
详细描述
The cluster randomized trial (CRT) will not engage in PrEP provision to individuals, but instead employs geographical regions to serve as units of randomization where social media content and community engagement will be targeted. TB HIV Care employs a large team to provide routine service delivery while the CRT tests strategies including a social media campaign and community engagement that may amplify PrEP uptake and persistence among the community, leveraging the programme infrastructure to actually provide services as it is already doing. Embedding strategies within the programme ensures that the existing results come from real world contexts and focuses on implementation of support strategies rather than clinical care provision. The CRT will be implemented across 10 districts, with 5 districts serving as control sites and 5 as intervention sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible to take PrEP per TB HIV Care programmatic criteria
- •Engaged in TB HIV Care HIV prevention program
排除标准
- •Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria
结局指标
主要结局
Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme
时间窗: 12 months
De-identified aggregate counts of female sex workers (FSW) and adolescent girls and young women (AGYW) service-users within the TB HIV Care programme database who initiate PrEP during the intervention period. Number of service users in the program database who initiated prep are reported.
次要结局
- Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme(Month 1)
- Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme(Month 4)
- Number of Participants Who Found Intervention Acceptable(Month 12)
- Fidelity as Assessed by Percentage of On-Schedule Posts(Month 12)
- Adoption as Assessed by Number of Facebook Page Visits by Unique Users(Month 12)
- Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks(Month 12)
- Adoption as Assessed by Number of Views by Unique Users(12 months)
- Adoption as Assessed by Number of Ad Clicks(12 months)
- Fidelity as Assessed by Programme Logs Completed(12 months)
- Total Cost(Month 12)