Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Male partner HIV testing
研究概览
简要总结
It is critical to evaluate strategies that leverage women's engagement in antenatal care to increase male partner testing while alleviating the burden on pregnant women to encourage their male partners to HIV test. A peer-delivered status-neutral approach to male partners of pregnant women may be an innovative strategy to overcome barriers to men's reluctance to test for HIV and initiate HIV prevention or treatment services. For pregnant women living with HIV, partner testing and disclosure could facilitate women's continuation of ART post-partum, and for HIV-negative women at risk of HIV acquisition, this could facilitate women's initiation of PrEP during pregnancy. Thus, multiple public health goals could be achieved through increasing the proportion of men who know their HIV status.
详细描述
Overall design
This is a randomized trial of pregnant women and their male partners. The overall goal is to evaluate the impact of innovative strategies to increase male partner HIV testing and engagement in HIV care and prevention through ANC services provided to pregnant women. The intervention consists of a phone call from a trained peer father to encourage male partners of pregnant women to test for HIV. Men will first be encouraged to come to the clinic for HIV testing and counseling. Those who are not willing/able to attend the clinic will be offered the option of meeting a male counselor to receive HIV testing in a convenient location in the community. The study team will recruit pregnant women to be randomized to: 1) the intervention arm (peer father phone call) or 2) the delayed intervention arm, standard of care standard of care invitation letter to provide to their partner for fast-track HIV testing and male peer father phone calls after a 3 month delay. Women in both arms will receive an HIVST kit from the ANC clinic per standard of care guidelines. In the delayed intervention arm, men who have not HIV tested after 3 months of female partner enrollment will receive the intervention of a peer father phone call. This is being done for ethical reasons since preliminary data show phone calls from men may be effective in increasing men's HIV testing. All study outcomes will be collected by 3 months post female partner enrollment so providing the delayed intervention will not impact the study team's ability to measure the study's effectiveness. The study team will recommend that all HIV-positive participants initiate ART, and all HIV-negative participants who are eligible, initiate PrEP.
Objectives
Aim 1: To assess whether a male peer-delivered, status-neutral outreach to male partners of pregnant women increases the proportion of partners who test compared to the standard of care (invitation letters for fast-track testing and HIVST delivered by the pregnant woman).
Rationale: Innovations are needed to address the challenges associated with reaching male partners of pregnant women with HIV testing and linkage to ART or PrEP depending on their HIV serostatus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •-Age ≥18 years or if 14-17 years, qualified as emancipated minors (individuals below the age of majority who are pregnant)
- •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
- •At low risk of intimate partner violence
- •Has a female partner enrolled in the Okutuuka study
- •Able and willing to provide written informed consent
排除标准
- •not meeting all of the above inclusion criteria
结局指标
主要结局
Male partner HIV testing
时间窗: 3 months from female partner enrollment
The outcome for Aim 1 is the proportion of men who test for HIV in the intervention arm compared to those who test in the control arm. Endpoint: Site verified HIV test in a male partner of an enrolled women within three months of the women's enrollment
Linkage to PrEP
时间窗: 3 months from female partner
The outcome for Aim 2 is the proportion of male partners who test HIV-negative and have an indication for PrEP who initiate PrEP compared to the SOC arm.
Linkage to ART
时间窗: 3 months from female partner
The outcome for Aim 3 is the proportion of male partners who test HIV-positive and initiate ART compared to the SOC arm.
次要结局
未报告次要终点
研究者
Connie Celum
Professor: Global Health
University of Washington