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Can HIV-Positive mothers breastfeed without passing the virus to their babies?

NCT ID NCT02295800

Prevention Sponsor: Elizabeth Glaser Pediatric AIDS Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers follow more than 1,200 HIV-positive pregnant and postpartum women in Kigali, Rwanda, who receive standard HIV care through prevention of mother-to-child transmission programs. The study tracks whether their babies remain HIV-free through 18 to 24 months of age while monitoring breastfeeding, growth, and adherence to antiretroviral therapy. A smaller set of mothers and health care workers also take part in interviews, and study staff survey the clinics each year to understand how care is delivered.

What this could mean

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

Active substance
standard HIV care with antiretroviral therapy during pregnancy and breastfeeding
What this could lead to
If the approach works well, it could strengthen programs that help mothers with HIV breastfeed safely and protect their babies from infection.
What could go wrong
This is an observational study, so it cannot prove that one treatment approach causes better outcomes. Results may not apply to settings with different health systems or resources.

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.

Participants

1,216 people

The number who actually took part.

Started

Apr 2013

Finished

Dec 2016

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.

Who is studied

Pregnant women identified as HIV infected during antenatal care and receiving PMTCT services (regardless of ARV regimen received) in the selected antenatal clinics in Kigali, Rwanda are eligible for study enrollment. The infants born to enrolled study women during the study pregnancy will also be study participants up to the age of 18 - 24 months.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Documented HIV infection * Pregnant, in the last trimester of pregnancy or within two weeks post-delivery. * Participation in the PMTCT program during antenatal care at one of the study sites * Planning on remaining in the Kigali area after delivery * Able and willing to give informed consent for study participation for herself and her infant(s). If a pregnant woman is less than 18 years of age and still living with her parents, informed consent will also be required from one of her parents Exclusion Criteria: * Women not willing to provide informed consent to participate

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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.

Mother-to-child HIV transmission

Contacts and locations

Locations

  • Elizabeth Glaser Pediatric AIDS Foundation

    Kigali, BP 2788, Rwanda

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