NCT06951542

HIV-Mental Illness Stigma Reduction and Outcomes in Malawi

Improving HIV and Depression Outcomes by Reducing HIV-Mental Illness Stigma in Salima and Mulanje Districts: Pilot Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to assess the acceptability, feasibility, fidelity, and effectiveness of a depression treatment intervention augmented with counseling to address stigma. Using a multiple-baseline design, 200 depressed adults living with HIV will be enrolled in the trial. Participant surveys and abstracted clinical data related to HIV and depression care will assess the effectiveness of the intervention.

Detailed description

Stigma and depression are associated with increased HIV-related mortality and morbidity; as depression treatment is increasingly integrated into HIV care, addressing HIV stigma, mental illness stigma, and intersectional HIV-mental illness stigma is crucial. The Malawi Ministry of Health has recently integrated depression screening and treatment into the antiretroviral therapy (ART) departments of 12 District Hospitals across the country, including Salima and Mulanje District Hospital. Through this program, adults living with HIV are now screened with the Patient Health Questionnaire-9 (PHQ-9) and depressed patients are prescribed antidepressants using Measurement-based Care (MBC) or referred for Friendship Bench (FB) problem-solving therapy. With this study the investigators aim to augment the existing depression treatment program at Salima and Mulanje District Hospitals with counselling to help address and reduce stigma. The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Ultimately, this study will evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the HIV-mental illness stigma-reduction intervention as part of depression treatment integrated into HIV care at Salima and Mulanje district hospitals using a pilot trial, with a multiple-baseline design. To achieve this goal, the investigators will enroll 200 depressed adults living with HIV in the trial, survey patient participants at enrollment, 3-months and 6-months, abstract clinical data related to HIV and depression care, track engagement in the stigma reduction intervention, assess intervention sessions for fidelity to the intervention protocol and conduct qualitative interviews with a sub-set of patients who received the stigma-reduction intervention (n=20) and healthcare providers including HTC counselors (N=4), ART providers (N=10), Friendship Bench counselors (N=6), and counselors (n=4) who deliver the stigma-reduction intervention. This innovative research will a) address HIV, MI and intersectional stigma while leveraging existing mental health services for people living with HIV, b) lay the ground-work for a multi-level stigma-reduction intervention package, and c) yield detailed insights into barriers and facilitators of implementing stigma-reduction interventions in low-resource settings.

Conditions

• Depression - Major Depressive Disorder
• HIV
• Health Condition Stigma

Interventions

Type	Name	Description
BEHAVIORAL	Stigma Reduction Counseling	The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-09-01
• Completion: 2027-04-01
• First posted: 2025-04-30
• Last updated: 2026-01-15

Locations

2 sites across 1 country: Malawi