Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
研究概览
简要总结
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or 16-17 years old and married
- •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)
排除标准
- •Enrolled/enrolling in the PROMISE study
- •Initially Presenting with a male sex partner
研究组 & 干预措施
Patient referral
Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
干预措施: patient referral (Behavioral)
contract referral
Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
干预措施: contract referral (Behavioral)
contract referral
Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
干预措施: patient referral (Behavioral)
结局指标
主要结局
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
时间窗: three months
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.
次要结局
- Female First Option B+ Follow-up Visit(three months)
- Male Linkage to Care(one month from male presentation to the clinic)