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临床试验/NCT03058484
NCT03058484已完成不适用

Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial

University of California, Berkeley0 个研究点目标入组 1,830 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,830
主要终点
Retention in HIV care

研究概览

简要总结

The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community.

The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).

排除标准

  • Did not have sufficient information to link them across registers

结局指标

主要结局

Retention in HIV care

时间窗: 120 days postpartum

Binary variable taking the value of 1 if the women has had at least one clinic visit in the postpartum period (60-120 days after birth), and zero otherwise.

次要结局

  • Adherence to ARVs(Birth to 90 days postpartum)
  • Timing of ART initiation(ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks)
  • Initiation of ART(Through pregnancy and up to 90 days after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra McCoy

Assistant Adjunct Professor

University of California, Berkeley

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