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New HIV prevention shots could protect breastfeeding moms and their babies

NCT ID NCT05986084

Prevention Sponsor: Beth Israel Deaconess Medical Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study looks at whether long-acting HIV prevention shots (CAB-LA) are safe and work well for breastfeeding mothers after childbirth. About 500 new mothers in Botswana will get the shots and be followed for 24 months along with their babies. The goal is to see if this method can prevent HIV infection in a high-risk group while keeping both mom and infant healthy.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

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

Started

Nov 2023

Expected to finish

Aug 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: 1. Mother 18 years of age or older and willing and able to provide an informed consent 2. \< 14 days after delivery (calendar day of birth = day 0) 3. Negative HIV screening test (conducted at the time of enrollment) 4. Mother \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy) 5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months Exclusion Criteria: 1. Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort 2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin) 3. Previous hypersensitivity reaction to CAB or other INSTI 4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks 5. Plan for pediatric and post-partum care outside the government system (private clinics) 6. Inflammatory skin condition that compromises the safety of the intramuscular injection 7. Weight \<35kg

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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.

Breast feeding Pre-exposure prophylaxis (PREP)

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Botswana Harvard AIDS Institute Partnership

    Gaborone, Botswana

More trials for these conditions

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