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Can a simple support program keep HIV-positive moms healthy?

NCT ID NCT05841797

Disease control Sponsor: University of Colorado, Denver 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether screening pregnant women with HIV for their risk of dropping out of care, then offering tailored support (counseling sessions in person or by phone), could help them stay in treatment and keep the virus under control. The study involved 120 women in Kisumu County, Kenya, and measured retention and viral suppression up to 6 months after birth. The goal is to find a practical way to improve health for mothers and babies in low-resource settings.

What this could mean

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

Active substance
behavioral intervention (Program Management Plus, delivered in-person or by phone)
What this could lead to
If successful, this approach could help pregnant women with HIV stay in care and keep the virus under control, reducing health risks for mothers and babies.
What could go wrong
This is a small pilot study (120 participants) in one region of Kenya, so results may not apply elsewhere. The intervention is behavioral, not a new drug, so it won't cure HIV.

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

120 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 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

15 years and older

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: * Pregnant woman living with HIV attending an ANC clinic in Kisumu County, on/initiating ART * At least 15 years of age * At least 20 weeks estimated gestational age * At moderate or critical risk of the combined outcome of treatment disengagement or viral failure according to the risk calculator * Access to a cell phone (for those who share phones, have disclosed their HIV status to whomever individuals share the phone with. Exclusion Criteria: * Imminent plans of suicide and severe impairment due to severe mental, neurological or substance use disorders * Less than 15 years of age * Less than 20 weeks estimated gestational age or not currently pregnant * Not HIV-infected at time of first ANC visit

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease Psychological Well-Being

As listed by the trial registrant

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

Human immunodeficiency virus

Contacts and locations

Locations

  • Kenya Medical Research Institute

    Nairobi, Kenya

More trials for these conditions

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