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临床试验/NCT03892915
NCT03892915已完成2 期

Depression Care to Improve Adherence to Prevention of Mother-to-Child-Transmission (PMTCT) Care Continuum & Pregnancy Outcomes

RAND1 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2019年7月8日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
RAND
入组人数
391
试验地点
1
主要终点
Rate of Maternal HIV Viral Suppression

研究概览

简要总结

Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8 antenatal care (ANC) clinics in Uganda.

详细描述

This study is a cluster randomized controlled trial (RCT) to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the PMTCT care cascade at 8 ANC clinics in Uganda. At 4 experimental sites, task-shifted, depression care will include (1) depression screening and psychoeducation, (2) depression diagnosis, and (3) provision of evidence-based problem solving therapy (PST), or antidepressant therapy (ADT) for those with severe and refractory depression (or who decline PST), to be implemented by trained peer mothers and midwife nurses, respectively. The 4 control sites will use usual care services for managing depression, which consist of referrals to a mental health specialist and access to the Family Support Group program (comprehensive, monthly multi-session psychosocial program to enhance pregnancy management and PMTCT adherence). At each site, 50 HIV-positive newly pregnant women (total n=400) who screen positive for potential depression will be enrolled and followed until 18-months post-delivery to assess how depression and depression alleviation relate to primary (adherence to each component of the PMTCT care continuum, maternal virologic suppression) and secondary (infant HIV status; post-natal maternal and child health outcomes) outcomes, as well as processes of depression care (treatment uptake and depression alleviation among clinically depressed patients). A cost-effectiveness analysis will be used to compare the two study arms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • detection of pregnancy through 24 weeks gestation (to ensure at least 12 weeks remaining antenatal period for assessing adherence to all stages of PMTCT care cascade)
  • HIV-positive
  • positive screen for potential depression on 2-item Patient Health Questionnaire (PHQ-2>0)
  • on ART for at least 4 weeks

排除标准

  • unstable health (about to start ART or on ART < 4 weeks; active, untreated opportunistic infection)

结局指标

主要结局

Rate of Maternal HIV Viral Suppression

时间窗: Two months post pregnancy

Percentage of participants who achieve undetectable HIV viral load as measured by blood assay

Mean Maternal Antiretroviral (ART) Adherence

时间窗: Past 6 months, assessed at 2 months after the completion of pregnancy

Group mean percentage of prescribed ART doses taken as measured by pharmacy refill data

Rate of Infant Use of ART

时间窗: First 6 weeks of life

Percentage of delivered infants who receive ART as measured by chart abstraction

Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention

时间窗: through study completion, an average of 48 weeks

Percentage of participants who continue to attend antenatal care (ANC) visits as measured by chart abstraction

Rate of Delivery in Health Facility

时间窗: two months post pregnancy

Percentage of participants who delivery their baby of in a health facility as measured by chart abstraction

次要结局

  • Depression Status(2 months postpartum)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (1)

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