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Can Trauma-Focused coping skills boost HIV suppression in women?

NCT ID NCT04793217

Disease control Sponsor: Columbia University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests a counseling program called ImpACT+ for women in South Africa who have HIV and a history of sexual trauma. The program combines HIV treatment adherence support with coping skills to address traumatic stress. Researchers will compare viral suppression rates and care engagement between women who receive ImpACT+ and those who do not. The goal is to see if addressing trauma can help women stay on treatment and achieve better health outcomes.

What this could mean

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

Active substance
ImpACT+, a behavioral coping intervention that combines HIV treatment adherence support with trauma coping skills
What this could lead to
If it works, this could offer a practical, low-cost way to help women with HIV and trauma histories stay engaged in care and achieve viral suppression.
What could go wrong
This is a behavioral intervention, so results may vary by individual. The trial is not yet complete, and the intervention may not be easy to scale beyond the study clinics.

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

350 people

The number who actually took part.

Started

Feb 2021

Finished

Jul 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

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: * Women with HIV who receive care at either study clinic * \>2 weeks to \<4 months since ART initiation * History of sexual trauma * Meets criteria for traumatic stress * Xhosa speaking Exclusion Criteria: \- High suicide risk

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Conditions

The condition(s) this trial relates to.

HIV infectious disease injury Psychological Well-Being

As listed by the trial registrant

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

HIV Trauma exposure

Contacts and locations

Locations

  • University of Cape Town

    Cape Town, South Africa

More trials for these conditions

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