Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.
This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.
Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.
Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Central District
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Lilongwe、Central District、马拉维
- Bwaila District Hospital Antenatal Unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
18 years old or 16-17 years old and married
- Pregnant
- Received a positive HIV-test within the last day
- Will be in Lilongwe for the next month
- Able and willing to give locator information for >1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)
Exclusion Criteria:
- Enrolled/enrolling in the PROMISE study
- Initially Presenting with a male sex partner
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Patient referral
Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
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A patient agrees to recruit their partner using the invitation.
其他名称:
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实验性的:contract referral
Same as control.
However, if the male partner does not present, a community worker will trace the partner in the community.
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A patient agrees to recruit their partner using the invitation.
其他名称:
A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
大体时间:three months
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Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake.
We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.
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three months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Female First Option B+ Follow-up Visit
大体时间:three months
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It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records).
The number retained will be compared.
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three months
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Male Linkage to Care
大体时间:one month from male presentation to the clinic
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It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner.
This will be assessed from abstraction of routine clinic records at Martin Preuss Center.
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one month from male presentation to the clinic
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合作者和调查者
调查人员
- 首席研究员:Nora E Rosenberg, PhD、University of North Carolina, Chapel Hill
- 首席研究员:Mina Hosseinipour, MD、University of North Carolina, Chapel Hill
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 13-3707
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