Phase 3
N=391
Maternal Depression Treatment in HIV
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03892915 ↗Enrolled (actual)
391
Serious AEs
7.9%
Results posted
Nov 2024
Primary outcome: Primary: Rate of Maternal HIV Viral Suppression — 128; 132 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- evidence-based depression treatment (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- RAND
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Maternal HIV Viral Suppression |
128; 132 | — |
| PRIMARY Mean Maternal Antiretroviral (ART) Adherence |
95.2; 90.8 | — |
| PRIMARY Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention |
184; 185 | — |
| PRIMARY Rate of Delivery in Health Facility |
171; 165 | — |
| PRIMARY Rate of Infant Use of ART |
174; 164 | — |
| SECONDARY Depression Status |
37; 102 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03892915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.