Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
研究概览
简要总结
The overall objective of this study is to evaluate whether the addition of secondary distribution HIV self-test kits to existing partner notification guidelines increases the proportion of male partners who access facility-based HIV testing services, when compared to the partner notification strategy alone
详细描述
Pregnant women 18 years of age or older who enter antenatal care at Chipata Level 1 Hospital in Lusaka, Zambia will participate.
HIV-positive and HIV-negative pregnant women will be randomized to one of two groups: partner notification alone or partner notification plus secondary distribution of HIV self-test kits. Women will return to the clinic 30 days after enrollment for an exit visit during which time information about their experience with the partner notification strategies will be collected.
A random sample of women and health care workers will also participate in qualitative interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Pregnant at time of enrollment based on antenatal record
- •Documented HIV status (either positive or negative) in antenatal record
- •Reports at least one current sexual partner
- •Willingness to provide her own contact information
- •Ability and willingness to provide informed consent
- •Intent to remain in current geographical area of residence for the duration of follow-up activities
- •Willingness to adhere to study procedures
排除标准
- •Women who express concerns about IPV or social harms as a result of participation during the screening process will not be included.
- •Women who have previously enrolled in the study will not be permitted to enroll again.
研究组 & 干预措施
Intervention
In addition to standard partner notification services, the intervention arm will receive HIV self-test kits and structured counseling about HIVST, regardless of HIV status.
干预措施: HIV self-testing with partner notification. (Behavioral)
Control
Standard partner notification services, regardless of HIV status.
结局指标
主要结局
Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
时间窗: Enrollment - 30 days post enrollment of study participant
The number of participants who report their primary male partners getting tested for HIV at a healthcare facility when presented with partner notification plus secondary distribution of HIV self-test kits compared to partner notification alone
次要结局
- Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility(Enrollment - 30 days post enrollment of study participant)
- Number of Participants Reporting Social Harms(Enrollment - 30 days post enrollment of study participant)
- Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)(6 months after the start of enrollment)
- Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)(In the first two months of enrollment)