Kingasa Study: Interventions for Improved Post-partum ART Continuation and HIV Testing of Male Partners of Women in PMTCT B+ in Uganda
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Male partner linkage
研究概览
简要总结
Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT.
详细描述
Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT. Approach: Leveraging the staff and infrastructure of an ongoing study, Kingasa (R01MH113434), this study will evaluate the impact of phone calls from a male counselor to encourage male partners to link to HIV care or prevention services after HIV testing. The intervention will provide male counselor follow-up to 100 male partners of pregnant women in the intervention arm of the Kingasa study. Exit interviews will be conducted with men and their female partners to assess acceptability and challenges associated with the intervention. Outcomes assessed include ART initiation among HIV-positive men and PrEP by HIV-negative men at 6 months.
Hypothesis
The intervention of a phone call from a male counselor to provide counseling and encourage linkage to HIV care or prevention will be feasible and acceptable. It will result in a higher proportion of men linking to treatment and prevention compared to the standard of care arm of the Kingasa pilot study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 or 14-17 years if an emancipated minor (pregnant or have a child), Currently pregnant, Not currently enrolled in an HIV treatment study, Male partner not known to be HIV-positive or has not tested in the past 3 months, Able and willing to provide written informed consent, Able and willing to provide adequate locator information for study retention purposes, Screening negative for any indication of intimate partner violence or social harm
- •Inclusion Criteria for men:
- •Female partner enrolled in Kingasa pilot study.
排除标准
- 未提供
研究组 & 干预措施
Female SOC/Male SOC arm
Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing at enrollment and every 6 months until 6 months postpartum
Female intervention/Male SOC arm
Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and POC VL tests for women at enrollment, delivery, and 6 months post-partum
干预措施: POC viral load testing (Diagnostic Test)
Female SOC/Male intervention arm
Women will be provided an invitation letter for male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment, delivery, and 6 months post-partum
干预措施: Wellness visit services for male partners (Other)
Female intervention/male intervention arm
Women will be provided an invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum
干预措施: POC viral load testing (Diagnostic Test)
Female intervention/male intervention arm
Women will be provided an invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum
干预措施: Wellness visit services for male partners (Other)
结局指标
主要结局
Male partner linkage
时间窗: 6 months from female partner enrollment
To assess the proportion of HIV-negative male partners who initiate PrEP and HIV positive men who initiate ART among male partners who test for HIV and are provided male counselor phone follow up or who receive standard of care.
次要结局
未报告次要终点
研究者
Monisha Sharma
Assistant Professor, School of Medicine: Global Health
University of Washington