Skip to content

Integrating depression management in HIV care in Uganda

Integrating the management of depression into routine HIV care in Uganda: a cluster randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86760765
Enrollment
800
Registered
2017-09-07
Start date
2019-02-02
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorders in HIV/AIDS Mental and Behavioural Disorders

Interventions

This project will be organised under two broad phases: Formative phase: During this phase the HIV+D intervention will be developed. To do this, the MANAS intervention (which is a stepped care collabo

Sponsors

MRC/UVRI Uganda Research Unit on AIDS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients living with HIV attending the study clinics 2. Aged >18 years 3. An established resident of the study area 4. Medically stable (not too ill to require emergency admission) 5. Conversant in Luganda (the predominant language spoken in the study area) 6. ‘Screen positive’ for a depressive disorder (DD) (a score of =10 on the PHQ-9)

Exclusion criteria

Exclusion criteria: 1. Adults who screen below the DD threshold score on the PHQ-9 2. Those who have severe cognitive or sensory impairments which hinder engagement with the research procedures

Design outcomes

Primary

MeasureTime frame
1. Mean depressive disorder (DD) symptom severity scores, assessed using the PHQ-9 at 6 months 2. Proportion of participants who fail to achieve remission from DD; proportion with PHQ-9 scores =5 at 6 months

Secondary

MeasureTime frame
1. The primary outcome measures at 12 months 2. The proportion of participants who are on ART at baseline and who have virological failure (defined as a viral load of 1,000 copies/ML or more) at 6 and 12 months 3. The proportion of participants who report having missed at least one dose of cotrimoxazole prophylaxis in the past three days, assessed at 6 and 12 months 4. The mean CD4 count at 6 and 12 months 5. The proportion of participants who experience either a new WHO stage 3 or 4 event or death over the 12 months 6. Quality adjusted life years (QALYs), measured using the SF-6D (the Short-Form Six-Dimension) at quarterly intervals for 12 months 7. Days out of work and functional impairment, measured using the WHO-DAS29 at 6 and 12 months 8. Failure to recover from DD; proportion whose PHQ-9 scores are =5 on two consecutive occasions 3 months apart and who relapse after recovery

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026