Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe
- Conditions
- Mental DisorderHIV Infections
- Interventions
- Behavioral: Friendship bench interventionOther: Enhanced Standard of Care
- Registration Number
- NCT03704805
- Lead Sponsor
- University of Bern
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- 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
- Current psychosis / cognitive impairment
- Clinical AIDS (WHO clinical stage 4)
- Known pregnancy or ≤3 months postpartum
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Problem-Solving Therapy Friendship bench intervention Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care. Enhanced Standard of Care Enhanced Standard of Care Participants in the control group receive enhanced standard of care. Problem-Solving Therapy Enhanced Standard of Care Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care.
- Primary Outcome Measures
Name Time Method Average difference in mean antiretroviral therapy adherence between 2 and 6 months 2-6 months Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
- Secondary Outcome Measures
Name Time Method Difference in mean antiretroviral therapy adherence between 1 and 12 months 1-12 months Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score At month 3, 6, 9, and 12 The Shone Symptoms Questionnaire is a 14 item tool. The reported total score is between 0 and 14. 14 is the highest level of mental disorder. Each item adds a score of 0 or 1 to the total score.
Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score At month 3, 6, 9, and 12 The Patient Health Questionnaire is a 9 item tool. The reported total score is between 0 and 27. 27 is the highest level of depression. Each item adds a score of 0 to 3 to the total score.
Viral load suppression (<1000 copies per milliliter) At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days) Categorical (yes, no, invalid or missing).
Trial Locations
- Locations (1)
Solidarmed
🇿🇼Masvingo, Zimbabwe