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 range18 Years

SexFEMALE

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)

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

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