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HIV doulas: a new way to support moms and babies?

NCT ID NCT07664423

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a doula support program for 15 pregnant women with HIV in South Florida. The doula will provide education, adherence support, and lactation counseling from pregnancy through 12 weeks after birth. The goal is to see if this program is feasible and acceptable, and to improve health outcomes for mothers and babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Doula support intervention (behavioral support including education, adherence support, and lactation counseling)
What this could lead to
If successful, this program could provide a model for supporting pregnant women with HIV in making informed infant feeding choices and improving maternal and child health.
What could go wrong
This is a very small early feasibility study with only 15 participants, so results may not apply broadly. The program may not be acceptable or feasible in other settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnant HIV positive women

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami School of Medicine

    Miami, Florida, 33136, United States

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