BRIDGES: An HIV Doula Program

NCT07664423 | Not Yet Recruiting

• 1 other identifier: 20250702
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnant HIV Positive Women

Keywords

Doula; Infant Feeding; HIV

Outcome Measures

Primary Outcomes (3)

• Feasibility of Enrollment into the HIV Doula Program

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

  Baseline through 6 months

• Acceptability of the HIV Doula Program (Participant Retention)

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

  Baseline through 6 months

• Uptake of the HIV Doula Program by Preferred Language

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

  Baseline through 6 months

Secondary Outcomes (2)

• Participants with Undetectable HIV Viral Load (<20 copies/mL)

  9 months

• Initiated Breastfeeding After Birth

  6 months

Study Arms (1)

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.

Behavioral: Doula Support Intervention

Interventions

Doula Support Intervention BEHAVIORAL

A trained study doula provides behavioral support, including prenatal education, adherence support, and lactation counseling, from pregnancy through 12 weeks postpartum.

Doula Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Under 18
• Not able to read/write English, Spanish or Haitian Creole at the 6th grade level

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Study Officials

• Lunthita M Duthely, Ed.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Duchatelier, MPH

CONTACT

305-243-5800; cxd1461@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)