CompletedPhase 2/3

Maternal Depression Treatment in HIV

Uganda391 participantsStarted 2019-07-08

Plain-language summary

Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8 antenatal care (ANC) clinics in Uganda.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * detection of pregnancy through 24 weeks gestation (to ensure at least 12 weeks remaining antenatal period for assessing adherence to all stages of PMTCT care cascade) * HIV-positive * positive screen for potential depression on 2-item Patient Health Questionnaire (PHQ-2\>0) * on ART for at least 4 weeks Exclusion Criteria: * unstable health (about to start ART or on ART \< 4 weeks; active, untreated opportunistic infection)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Maternal HIV Viral Suppression

Timeframe: Two months post pregnancy

Mean Maternal Antiretroviral (ART) Adherence

Timeframe: Past 6 months, assessed at 2 months after the completion of pregnancy

Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention

Timeframe: through study completion, an average of 48 weeks

Rate of Delivery in Health Facility

Timeframe: two months post pregnancy

Rate of Infant Use of ART

Timeframe: First 6 weeks of life

Trial details

NCT IDNCT03892915

SponsorRAND

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

Results submitted2024-04-29

View on ClinicalTrials.gov More Depression trials