Evaluating Healthy Families PrEP: an Intervention to Promote PrEP Use During Periconception, Pregnancy and Postpartum Periods for Women in Rural Uganda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- PrEP initiation - Women who start to use PrEP
研究概览
简要总结
Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy. They will now adapt the intervention to community clinics and postpartum women and test the intervention. The goal is to reduce HIV incidence among women and children.
详细描述
Women in Uganda who are planning for pregnancy, pregnant, or postpartum and have a partner living with HIV are vulnerable to acquiring HIV.
Adapting this intervention to community clinics and testing effectiveness aligns with global and Ugandan Ministry of Health goals to reduce HIV incidence among women of reproductive age and eliminate perinatal transmission. Additionally, costing analyses will be conducted to determine the cost of implementing HF-PrEP from both payer and societal perspectives. This work will inform future intervention implementation.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years and ≤45 years
- •Willing and able to participate in the informed consent process
- •HIV-uninfected by self-report, but have indications for HIV prevention strategies, such as having a partner living with HIV or who they think may be living with HIV
- •Reporting pregnancy in the past 2 years, and/or desire to have a child in the next year, and/or have a partner who desires to a child in the next year
- •Fluent in English or local language
- •Living within 60km of a healthcare center included in the trial
- •HIV Negative (onsite rapid testing)
排除标准
- •Not reporting pregnancy in the past 2 years
- •Does not report personal or partner desire to have a child in the next year
- •Not willing to provide informed consent
- •Not able to communicate in English or local language
- •Does not report pregnancy in the past 2 years and/or does not report personal or partner desire to have a child in the next year
- •Not able to communicate in English or local language
- •Living beyond 60km of the trial healthcare center
- •HIV-positive (onsite rapid testing)
研究组 & 干预措施
Healthy Families PrEP Counselling Intervention
Intervention Health Care Centers will offer the guideline-based PrEP standard of care plus trained staff will conduct the 3-session Healthy Families-PrEP intervention with HIV-uninfected women with plans for pregnancy in the next year and concerns about or exposure to HIV.
干预措施: Healthy Families PrEP Counselling Intervention (Drug)
结局指标
主要结局
PrEP initiation - Women who start to use PrEP
时间窗: Enrolment to 6 months
The primary effectiveness outcome will be proportion of women at 6 months with intracellular TFV-DP concentration consistent with taking at least 4 doses per week.
次要结局
- Women who continue to use PrEP when they become pregnant(Enrolment to 18 months)
研究者
Lynn T. Matthews
Professor of Medicine Medicine, Principal Investigator
University of Alabama at Birmingham