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临床试验/NCT07664423
NCT07664423尚未招募不适用

BRIDGES: A Patient-Centered, Community-Informed HIV Doula Program That Supports Infant Feeding Choice

University of Miami1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
1
主要终点
Feasibility of Enrollment into the HIV Doula Program

研究概览

简要总结

The purpose of BRIDGES (BReast and Infant feeding Doulas to address Gaps in Education and Support) is to develop, test and disseminate an HIV Doula education and support program to improve maternal/child health outcomes and reduce perinatal transmission.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
否

入选标准

  • •Pregnant and postnatal women, followed at the institutional clinic for women with HIV
  • •> = 18 years old, with an HIV diagnosis
  • •Pregnant or postnatal
  • •Reside in South Florida
  • •Able to communicate at the 6th grade level in English, Spanish or Haitian Creole.

排除标准

  • •Not able to read/write English, Spanish or Haitian Creole at the 6th grade level

研究组 & 干预措施

Doula Support Intervention

Experimental

Pregnant women with HIV will receive a structured doula support intervention in addition to routine clinical care. Participants will be paired with a trained study doula who provides prenatal and postnatal support from pregnancy through 12 weeks postpartum.

干预措施: Doula Support Intervention (Behavioral)

结局指标

主要结局

Feasibility of Enrollment into the HIV Doula Program

时间窗: Baseline through 6 months

Percentage of eligible participants approached for participation who enroll in the HIV Doula Program

Acceptability of the HIV Doula Program (Participant Retention)

时间窗: Baseline through 6 months

Percentage of enrolled participants who are retained at each protocol defined study visit during the 6-month follow-up period.

Uptake of the HIV Doula Program by Preferred Language

时间窗: Baseline through 6 months

Percentage of eligible individuals approached for participation who enroll in the HIV Doula Program, stratified by participant reported preferred language.

次要结局

  • Initiated Breastfeeding After Birth(6 months)
  • Participants with Undetectable HIV Viral Load (<20 copies/mL)(9 months)

研究者

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

Lunthita M. Duthely

Research Associate Professor

University of Miami

研究点 (1)

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