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New tool aims to empower pregnant women in HIV prevention choices

NCT ID NCT06394323

Prevention Sponsor: University of North Carolina, Chapel Hill 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a counseling tool called MyChoice to help pregnant women in Malawi decide whether to use oral PrEP or condoms for HIV prevention. 100 HIV-negative pregnant women were randomly assigned to receive either the MyChoice shared decision-making intervention or standard counseling. The study measured how acceptable, appropriate, and feasible the intervention was, as well as its impact on decision-making confidence.

What this could mean

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

Active substance
My Choice for HIV Prevention (MyChoice) – a counselor-delivered shared decision-making approach
What this could lead to
If successful, this approach could help pregnant women make more informed choices about HIV prevention, potentially increasing PrEP uptake and reducing HIV transmission.
What could go wrong
This is a small pilot study focused on feasibility, not effectiveness. Results may not apply to other settings or populations.

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

132 people

The number who actually took part.

Started

Aug 2024

Finished

Mar 2025

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

The criteria for pregnant women participants is as follows: Inclusion Criteria: * Age 18 or older * Documented pregnancy by urine pregnancy test or physical exam * Documented negative HIV status within the past three months * Identified factor(s) for elevated risk for HIV acquisition per PrEP national eligibility guidelines * Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule * Ability and willingness to provide informed consent Exclusion Criteria: * Positive HIV test at time of screening * No identified HIV risk factors per national PrEP guidelines * Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel Investigators will also conduct interviews with male partners and study staff to assess exploratory qualitative outcomes. All study staff will be eligible to participate in an interview. Male partners will be eligible to participate if they meet the following criteria: * Referred by a study participant as her romantic partner * Age 18 or older * Able and willing to provide informed consent

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Conditions

The condition(s) this trial relates to.

Breast Feeding HIV infectious disease prevention target

As listed by the trial registrant

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

HIV prevention

Contacts and locations

Locations

  • Bwaila Hospital

    Lilongwe, Central Region, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.