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临床试验/NCT05841797
NCT05841797已完成不适用

Piloting Risk Stratification and Tailored Interventions With Pregnant and Postpartum Women With HIV in Kenya to Prevent Disengagement From Care and Viral Failure

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月5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
120
试验地点
1
主要终点
Combined retention and treatment failure outcome

研究概览

简要总结

This study includes secondary quantitative analysis, qualitative methods, and hybrid type 2 implementation-effectiveness pilot trial. The overall goal of this protocol is to determine whether risk stratification of PWLWH in conjunction with a tailored psychosocial support intervention can optimize health outcomes for the vulnerable women and infants. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties.

详细描述

Among pregnant/postpartum women living with HIV (PWLWH) in low resource, high HIV prevalence settings, access to antiretroviral treatment (ART) has increased dramatically and mother-to-child transmission (MTCT) of HIV has decreased substantially, yet successful outcomes are not universal. Despite a 52% decline in new HIV infections among children under five from 2010-2019, recent UNAIDS data indicate global targets were missed by wide margins, with an estimated 160,000 new pediatric HIV infections annually. Sub-optimal retention of PWLWH is a major contributor to new pediatric infections. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties. As PMTCT programs in sub-Saharan Africa (SSA) aim for the elimination of MTCT in the context of decreased funding, there is need for research geared towards identifying and supporting the most vulnerable PWLWH with tailored interventions that can be implemented using available resources. This study aims to build on a previous study, Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE, R01HD080477), to develop and implement interventions that can promote proper taking of HIV drugs among PWLWH, namely a risk calculator to identify women at high risk for treatment failure and an adapted Problem Management Plus (PM+) intervention specifically geared towards women identified as high risk. Such interventions are critical in order to identify the most vulnerable PWLWH as early as possible to intervene with effective targeted interventions that will help improve maternal and child health outcomes.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Participants and care providers will not be blinded to study arm, however investigators and analyst will be.

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Imminent plans of suicide and severe impairment due to severe mental, neurological or substance use disorders
  • Less than 15 years of age
  • Less than 20 weeks estimated gestational age or not currently pregnant
  • Not HIV-infected at time of first ANC visit

结局指标

主要结局

Combined retention and treatment failure outcome

时间窗: Baseline, 3 months postpartum, 6 months postpartum

Failure will be outcome of a missed visit (\>30 days) OR treatment failure (elevated VL\>= 200 copies/ml among PWLWH assessed through medical records from baseline to 6 months postpartum.

次要结局

  • Fidelity - Content(6 months postpartum)
  • Feasibility - Recruitment(Enrollment)
  • Fidelity - Coverage(6 months postpartum)
  • Acceptibility(6 months postpartum)
  • Depression(Baseline, 3 months postpartum, 6 months postpartum)
  • Psychological Outcome Profiles(Baseline, 3 months postpartum, 6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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