Last reviewed · How we verify
NCT06659315
Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
NA trial testing Couples Problem Solving Therapy in HIV Antiretroviral Therapy (ART) Adherence in 180 participants. Currently enrolling.
31 March 2027
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 180 |
| Start date | 11 November 2025 |
| Primary completion | 31 March 2027 |
| Estimated completion | 1 July 2027 |
| Sites | 1 location across Malawi |
Drugs / interventions tested
- Couples Problem Solving Therapy
Conditions studied
- HIV Antiretroviral Therapy (ART) Adherence — all drugs for HIV Antiretroviral Therapy (ART) Adherence →
- Perinatal Mental Health — all drugs for Perinatal Mental Health →
- Depression During Pregnancy — all drugs for Depression During Pregnancy →
- PMTCT — all drugs for PMTCT →
Sponsor
University of California, San Francisco
Who can join
18 and older, any sex, with HIV Antiretroviral Therapy (ART) Adherence or Perinatal Mental Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from sub-Saharan Africa (SSA) showing suboptimal adherence and persistent viremia among perinatal women. Perinatal depression (PD) is a major driver of women's poor adherence to PMTCT. Interventions that involve male partners to provide social and food/economic support could be a promising approach for addressing PD and PMTCT, yet few interventions have intervened with couples to improve systems of support, communication, and other dyadic processes. The investigators propose to develop and test a couple-based approach to intervene on the mother's perinatal depressive symptoms and to strengthen the relationship and support system for partners to work together around depression to improve PMTCT adherence. The study will take place in antenatal and HIV care settings in Zomba, Malawi. The specific aims are: (1) to develop a couple-based intervention to target perinatal depression (PD) based on an evidence-based approach using problem-solving therapy (PST), augmented with content on couple communication and problem-solving skills; and (2) to assess the feasibility and acceptability (F\&A) of the intervention via a pilot randomized controlled trial (RCT). Our short-term goal is the produce a couple-focused PST intervention that can be added to the global health toolkit for treating depression in perinatal women. Our long-term goal is to produce a high-impact and sustainable intervention leveraging the couple relationship that can be scaled-up to address depression, PMTCT adherence, and family health.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Couples problem-solving therapy for perinatal women living with HIV and male partners in Malawi: a study protocol for a pilot trial of <i>Mphatso</i>.
Conroy AA, Butterfield RM, Mkandawire J, Mulauzi N, et al · · 2026 · PMID 42152436 · DOI 10.1136/bmjopen-2025-115210
Verify or expand the search:
- PubMed search for NCT06659315
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV Antiretroviral Therapy (ART) Adherence
Currently open trials in the same condition.
- NCT07226492 — Cash Transfers to Pregnant Women With HIV · NA · recruiting
- NCT07370298 — Developing and Testing a Digital Health Tool for INterseCtional Stigma Assessment and Reduction at Multiple Levels and m · NA · recruiting
- NCT06902142 — Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Pat · recruiting
Other University of California, San Francisco trials
Trials by the same sponsor.
- NCT05284773 — Screening for Acute Malnutrition · NA · withdrawn
- NCT04634851 — Video Home Visits for Dietary Counselling · NA · not yet recruiting
- NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M · Phase 1, PHASE2 · not yet recruiting
- NCT07534098 — Intervention for Hearing Health Among Native Americans · NA · not yet recruiting
- NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT) · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06659315 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 30 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06659315.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing