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临床试验/NCT07488221
NCT07488221已完成不适用

Assessing Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit Among Male Partners of HIV-negative Pregnant Women.

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月8日最近更新:
适应症
干预措施

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
Proportion of Male Partners Who Reported to Clinic

研究概览

简要总结

HIV testing uptake among male partners of pregnant women remains low. But the optimal way to engage the male partners is unknown. The antenatal setting, with nearly universal uptake of HIV testing for women, can serve as a way of reaching male partners. HIV self-testing (HIVST) is one approach to HIV testing that can be conducted out of health facility. HIVST is a rapid antibody test which can be performed by non-medical people and allows people to collect their own specimen, perform the test, and interpret the results in the privacy of their home or other preferred location. In this trial HIV-negative pregnant women who were attending antenatal care at Bwaila Hospital in Malawi will be randomized 1:1 to receive partner notification inviting their partners for clinic-based HIV testing (standard of care) or partner notification + HIV Self-test kit for partner testing at home (intervention).

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • HIV-negative pregnant woman
  • Must be available and willing to be contacted by phone within the next 30 days
  • Must be part of a heterosexual relationship for >3 months
  • Must expects their male sexual partner to be able to come to clinic in the next 30 days

排除标准

  • unable to provide informed consent

研究组 & 干预措施

Partner Notification Slip only

Active Comparator

Participants in this group receive standard of care (partner notification slip only)

干预措施: Partner Notification Slip only (Behavioral)

Partner Notification Slip plus HIV Self-test Kit

Experimental

Participants in this group receive the experimental intervention (Partner Notification Slip plus HIV Self-test Kit)

干预措施: Partner Notification Slip plus HIV Self-test kit (Other)

结局指标

主要结局

Proportion of Male Partners Who Reported to Clinic

时间窗: within 30 days of their female partner enrollment into the study

Proportion of male partners who reported to clinic within days of their female partner's enrollment into the study.

Proportion of male partners who reported to clinic

时间窗: within 30 days of their female partner enrollment into the study

次要结局

  • Time Taken for Male Partners to Report to Clinic(within 30 days from female partner enrollment into the study)
  • Prevalence of syphilis among male partners(within 30 days of their female partner enrollment into the study)
  • Time taken for male partners to report to clinic(within 30 days from female partner enrollment into the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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