Pregnant HIV Positive WomenNCT07664423
BRIDGES: An HIV Doula Program
A study testing Doula Support Intervention in people with Pregnant HIV Positive Women, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant HIV Positive Women
- What is being tested?
- Doula Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Under 18
- Not able to read/write English, Spanish or Haitian Creole at the 6th grade level
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami School of Medicine
Miami, Florida, 33136
VB Population Engagement Core, MA, 305-243-5800, mCARES@miami.edu
Lunthita M Duthely, Ed.D.
About this study
Official title: BRIDGES: A Patient-Centered, Community-Informed HIV Doula Program That Supports Infant Feeding Choice
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
- Being tested
- Doula Support Intervention
- Keywords
- Doula, Infant Feeding, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula Support InterventionBehavioural
A trained study doula provides behavioral support, including prenatal education, adherence support, and lactation counseling, from pregnancy through 12 weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Doula Support Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment into the HIV Doula Program
Percentage of eligible participants approached for participation who enroll in the HIV Doula Program
Measured: 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.
Measured: 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.
Measured: Baseline through 6 months
Secondary outcomes (2)
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.
Measured: 9 months
Initiated Breastfeeding After Birth
Percentage of participants who initiated breastfeeding after babies' birth.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant HIV Positive WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunthita M. Duthely, University of Miami
- Investigators
- Lunthita M Duthely, Ed.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664423
- Sponsor's protocol ID
- 20250702
- Status last verified
- Jun 2026
- First submitted
- 10 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to confidentiality
Publications
Mpanu-Mpanu R, Francis M, Garcia KN, Duthely LM. BRIDGES: a patient-centered, community-informed HIV doula program that supports infant feeding choice among Hispanic and Caribbean families: a study protocol. Front Reprod Health. 2026 Aug 28;8:1896729. doi: 10.3389/frph.2026.1896729. eCollection 2026.
PubMed 42729342
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIDGES: A Patient-Centered, Community-Informed HIV Doula Program That Supports Infant Feeding Choice
- ClinicalTrials.gov ID
- NCT07664423
- Acronym / sponsor ID
- 20250702
- Conditions
- Pregnant HIV Positive Women
- Keywords
- Doula, Infant Feeding, HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doula Support Intervention | Experimental | Behavioral: Doula Support InterventionPregnant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Under 18
- Not able to read/write English, Spanish or Haitian Creole at the 6th grade level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula Support InterventionA trained study doula provides behavioral support, including prenatal education, adherence support, and lactation counseling, from pregnancy through 12 weeks postpartum. | Behavioural | Doula Support Intervention |
Primary outcome
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
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.
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.
2 secondary outcomes
Participants with Undetectable HIV Viral Load (<20 copies/mL)
Time frame: 9 months
Initiated Breastfeeding After Birth
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 42729342Mpanu-Mpanu R, Francis M, Garcia KN, Duthely LM. BRIDGES: a patient-centered, community-informed HIV doula program that supports infant feeding choice among Hispanic and Caribbean families: a study protocol. Front Reprod Health. 2026 Aug 28;8:1896729. doi: 10.3389/frph.2026.1896729. eCollection 2026.
- Individual participant dataSharing planned: No. Due to confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lunthita M Duthely, Ed.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula Support Intervention in people with Pregnant HIV Positive Women, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Duchatelier, MPH (305-243-5800, cxd1461@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment into the HIV Doula Program (time frame: Baseline through 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07664423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.