Clinical trial NCT06951542: HIV-Mental Illness Stigma Reduction and Outcomes in Malawi
Official title: Improving HIV and Depression Outcomes by Reducing HIV-Mental Illness Stigma in Salima and Mulanje Districts: Pilot Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression - Major Depressive Disorder
HIV
Health Condition Stigma
Keywords: Malawi
Health Condition Stigma
Stigma
Measurement-based Care (MBC)
Friendship Bench (FB) Therapy
Salima
Mulanje
Mental Illness Stigma
HIV Stigma
Stigma Reduction Counseling
Stigma Intervention
Multi-Level Stigma Reduction
HIV Care Engagement
HIV
Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a pilot trial, with a multiple baseline design to enroll 200 depressed PLHIV at the study sites who will either receive usual depression care during the pre-implementation phase or enhance usual depression care (+ stigma-reduction counseling) during the implementation phase. Using the multiple baseline design with two phases (a pre-implementation phase and an intervention implementation phase), the intervention launches earlier at Clinic A than Clinic B, based on random selection. Staggering the launch of the implementation phase will allow for assessment of and potential correction for any secular trend in outcomes.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Living with HIV and receiving ART at Salima or Mulanje District Hospital
* Adult (18+ years)
* Elevated depressive symptoms (PHQ-9 Score ≥5)

Exclusion Criteria:

* Pregnant women
* Severe mental or physical illness

Primary outcomes:
measure: Feasibility of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: Upon the completion of intervention delivery for all patients (assessed up to 6 months)
measure: Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: After completion of all intervention sessions, an average of 6 months
measure: Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: After completion of each intervention session
measure: Provider Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: Upon intervention delivery completion for all patients (assessed up to 6 months)
measure: Fidelity of the Content of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: Through study completion, an average of 6 months
measure: Fidelity of the Coverage of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: Through study completion, an average of 6 months
measure: Fidelity of the Frequency of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: Through study completion, an average of 6 months
measure: Fidelity of the Duration of the HIV-Mental Illness Stigma Reduction Intervention
timeFrame: Through study completion, an average of 6 months
measure: Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma
timeFrame: At enrollment, 3-months post enrollment, and 6-months post enrollment
measure: Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma
timeFrame: At enrollment, 3-months post enrollment, and 6-months post enrollment
measure: Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Address Depression
timeFrame: At enrollment, 3-months post enrollment, and 6-months post enrollment
measure: Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement
timeFrame: Through study completion, an average of 6 months
measure: Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mulanje
country: Malawi
facility: Mulanje District Hospital
city: Salima
country: Malawi
facility: Salima District Hospital
Study officials:
References: