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BRIDGES: An HIV Doula Program

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07664423
Enrollment
15
Registered
2026-06-24
Start date
2026-09-01
Completion date
2027-09-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant HIV Positive Women

Keywords

Doula, Infant Feeding, HIV

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.

Interventions

BEHAVIORALDoula Support Intervention

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

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Enrollment into the HIV Doula ProgramBaseline through 6 monthsPercentage of eligible participants approached for participation who enroll in the HIV Doula Program
Acceptability of the HIV Doula Program (Participant Retention)Baseline through 6 monthsPercentage 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 LanguageBaseline through 6 monthsPercentage of eligible individuals approached for participation who enroll in the HIV Doula Program, stratified by participant reported preferred language.

Secondary

MeasureTime frameDescription
Participants with Undetectable HIV Viral Load (<20 copies/mL)9 monthsPercentage 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.
Initiated Breastfeeding After Birth6 monthsPercentage of participants who initiated breastfeeding after babies' birth.

Countries

United States

Contacts

CONTACTChristine Duchatelier, MPH
cxd1461@med.miami.edu305-243-5800
PRINCIPAL_INVESTIGATORLunthita M Duthely, Ed.D.

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 30, 2026