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New program aims to boost HIV prevention in pregnant women

NCT ID NCT06226155

Prevention Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a program called TENDAI4PrEP, which uses problem-solving techniques to help pregnant women in Zimbabwe take PrEP, a daily pill that prevents HIV. The program also involves their partners and healthcare providers. Researchers will enroll 132 HIV-negative pregnant women with psychological distress to see if the program is feasible and acceptable. If it works, it could be tested on a larger scale to reduce HIV infections.

What this could mean

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

Active substance
problem-solving behavioral intervention
What this could lead to
If successful, this program could help pregnant women in Zimbabwe better use PrEP to prevent HIV, reducing new infections in a high-risk population.
What could go wrong
This is a small, early-stage study focused on feasibility and acceptability, not yet testing effectiveness. The 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

About 165 people

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

Started

Oct 2024

Expected to finish

Mar 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

15 to 55 years

Sex

Anyone

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: Across all aims participants must be 1. Pregnant 2. Presenting at the Chitungwiza Central Hospital ANC 3. Aged 15+ 4. Willing to provide informed consent or assent 5. Have HIV negative status 6. At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and/or recent condomless sexual activity) 7. Score \>5 on the Shona Symptom Questionnaire For the RCT, eligible participants must also be willing to 8. Initiate PrEP prior to randomization 9. Bring their pregnancy partner (if they are safe doing so). Exclusion Criteria: 1. Inability to provide informed consent/assent and/or complete procedures in Shona or English 2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression pregnancy disorder HIV infectious disease prevention target

As listed by the trial registrant

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

Depression, anxiety HIV infections Pregnancy related

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 Zimbabwe

    RECRUITING

    Harare, Zimbabwe

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