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NCT Number: NCT07664423

BRIDGES: An HIV Doula Program

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.

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Key information

Conditions

Pregnant HIV Positive Women

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location contact

Lunthita M Duthely, Ed.D.

PRINCIPAL_INVESTIGATOR

VB Population Engagement Core, MA

CONTACT

[email protected]

305-243-5800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Enrollment into the HIV Doula Program

    Time frame: Baseline through 6 months

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

  2. Acceptability of the HIV Doula Program (Participant Retention)

    Time frame: Baseline through 6 months

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

  3. Uptake of the HIV Doula Program by Preferred Language

    Time frame: Baseline through 6 months

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

Secondary outcomes

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

    Time frame: 9 months

    Percentage of participants with undetectable HIV viral load, defined as <20 copies/mL. Data is obtained from clinically collected tests as part of routine care and abstracted from participants' medical records.

  2. Initiated Breastfeeding After Birth

    Time frame: 6 months

    Percentage of participants who initiated breastfeeding after babies' birth.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Duchatelier, MPH

CONTACT

[email protected]

305-243-5800

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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