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NCT03555669
Project SOAR-Mental Health Malawi: Depression and HIV Integration
NA trial testing Depression Treatment in Depression in 2,082 participants. Completed in 31 May 2019.
31 May 2019
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 2,082 |
| Start date | 24 April 2017 |
| Primary completion | 31 May 2019 |
| Estimated completion | 31 May 2019 |
| Sites | 2 locations across Malawi |
Drugs / interventions tested
- Depression Treatment
Conditions studied
- Depression — all drugs for Depression →
- HIV/AIDS — all drugs for HIV/AIDS →
Sponsor
University of North Carolina, Chapel Hill
Who can join
18 and older, any sex, with Depression or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. However, the potential for depression treatment to improve HIV care outcomes has received little attention in the region, in part because of limited mental health infrastructure. In this study, the investigators will evaluate the impact of a depression treatment program integrated within existing HIV clinics on depression response, retention in HIV care, and viral suppression. It is expected that this evaluation will yield important evidence on the impact of depression treatment integrated with HIV care for improving HIV care and mental health outcomes in Malawi.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program.
Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, et al · · 2018 · cited 50× · PMID 30064418 · DOI 10.1186/s12913-018-3388-z -
The effectiveness of depression management for improving HIV care outcomes in Malawi: protocol for a quasi-experimental study.
Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, et al · · 2019 · cited 15× · PMID 31242877 · DOI 10.1186/s12889-019-7132-3 -
The acceptability of antidepressant treatment in people living with HIV in Malawi: A patient perspective.
Kulisewa K, Minnick CE, Stockton MA, Gaynes BN, et al · · 2023 · cited 1× · PMID 37088107 · DOI 10.1080/17441692.2023.2201327
Verify or expand the search:
- PubMed search for NCT03555669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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- NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
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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 NCT03555669 (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 North Carolina, Chapel Hill
- Last refreshed: 31 May 2023
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/NCT03555669.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing