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临床试验/NCT04897737
NCT04897737已完成不适用

Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP)

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2020年11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
106
试验地点
1
主要终点
Recent PrEP Adherence

研究概览

简要总结

The postpartum PrEP study (PPS) seeks to evaluate how best to improve adherence to PrEP in postpartum women and to evaluate how acceptable it is to offer HIV self tests for the participant and partner, and provide enhanced adherence biofeedback following a urine test of recent PrEP use (measuring tenofovir). The primary outcome is recent PrEP adherence following the intervention. The secondary outcome is HIV testing uptake in participants' partners.

详细描述

Pregnant and breastfeeding women in South Africa are at very high risk of HIV acquisition and vertical HIV transmission during pregnancy, labour and breastfeeding. One-third to half of perinatal HIV transmission occurs in women who are seroconvert during the pregnancy and post-partum period. Effective use of pre-exposure prophylaxis (PrEP) could contribute to eliminating maternal HIV acquisition, and hence mother to child transmission (MTCT) of HIV. However, PrEP efficacy requires high levels of adherence, and adherence requires high levels of acceptability, yet there are few data on how best to promote adherence to PrEP in postpartum women.

We will conduct a study of the feasibility and acceptability of an adherence promotion package in n=100 postpartum women enrolled in an ongoing PrEP study (PrEP-PP; ongoing, R01MH116771) to evaluate the feasibility, acceptability and efficacy of a package of interventions to improve PrEP adherence in pregnancy and postpartum women. Specifically the package of interventions will include:

  • Offer of HIV self-test in women and their partners with counseling on use
  • Integrating urine based lateral flow assays in enhanced counseling using biofeedback on adherence levels to postpartum women on PrEP

The primary outcome is recent PrEP adherence at 1-month following the intervention. The secondary outcome is HIV testing uptake in participants' partners.

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

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

入选标准

  • Currently enrolled in PrEP-PP study and on PrEP
  • 18+ years old
  • confirmed HIV-negative (confirmed with a 4th generation antigen HIV test)
  • confirmed to be postpartum (1-6 months postpartum)
  • confirmed to currently have a male partner
  • confirmed to have a cell phone that can read and respond to SMS/Whatsapp messages

排除标准

  • Failure to meet all of inclusion criteria

结局指标

主要结局

Recent PrEP Adherence

时间窗: 1 month after intervention

The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.

次要结局

  • Participant Partners Who Tested for HIV(1 month after intervention)

研究者

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

Dvora Joseph Davey, PhD, MPH

Assistant Professor

University of California, Los Angeles

研究点 (1)

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