Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe

University of Bern

Status: Completed

Conditions: Mental Disorder; HIV Infections

Treatments: Behavioral: Friendship bench intervention; Other: Enhanced Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03704805

FB-ART

Details and patient eligibility

About

The aim of the study is to examine the effect of a psychological intervention on antiretroviral therapy outcomes and symptoms of common mental health disorders among adults living with HIV and common mental disorders in rural Zimbabwe.

Full description

Common mental disorders are highly prevalent among people living with HIV. Left untreated, common mental disorders cause substantial disability and undermine individuals' ability to adhere to antiretroviral therapy, leading to poor antiretroviral therapy outcomes.

A recent cluster-randomized controlled trial from Harare, Zimbabwe showed that the friendship bench intervention (i.e. six sessions of problem-solving therapy delivered by lay health workers followed by a peer support group) effectively reduced symptoms of common mental disorders, but the effect of the intervention on antiretroviral therapy outcomes and its effectiveness in the rural setting has not been studied.

To examine the effect of the friendship bench intervention on antiretroviral therapy outcomes and symptoms of common mental disorders among adults living with HIV and common mental disorders in rural Zimbabwe, a cluster-randomized trial is conducted.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Use of first-line antiretroviral therapy for at least 6 months
• Resident in Bikita District
• Knowledge of English or Shona language
• Ability to comprehend the information on the study
• Positive screening for common mental disorders (SSQ-14 score ≥9)
• Providing informed consent

Exclusion criteria

• Current psychosis / cognitive impairment
• Clinical AIDS (WHO clinical stage 4)
• Known pregnancy or ≤3 months postpartum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Problem-Solving Therapy

Experimental group

Description:

Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care.

Treatment:

Behavioral: Friendship bench intervention

Other: Enhanced Standard of Care

Enhanced Standard of Care

Active Comparator group

Description:

Participants in the control group receive enhanced standard of care.

Treatment:

Other: Enhanced Standard of Care