Health TrialsbyHealthPanel

BRIDGES: An HIV Doula Program

ConditionPregnant HIV Positive Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Under 18

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Doula Support InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Enrollment into the HIV Doula Program

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

Time frame
Baseline through 6 months
2

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.

Time frame
Baseline through 6 months
3

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.

Time frame
Baseline through 6 months

Secondary outcomes

1

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

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.

Time frame
9 months
2

Initiated Breastfeeding After Birth

Percentage of participants who initiated breastfeeding after babies' birth.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: