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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe

Conditions
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Mental Disorder, HIV Infections

Intervention / Treatment
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* Behavioral: Friendship bench intervention
* Other: Enhanced Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized, controlled, two-arm multicenter, superiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem-Solving Therapy<br>Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care. | Behavioral: Friendship bench intervention<br>* The friendship bench intervention consists of six individual counseling sessions and a peer-led group activity. Individual counseling is based on problem-solving therapy and delivered by lay health workers. During individual counseling, participants will be actively encouraged to identify and tackle problems leading to sub-optimal antiretroviral therapy adherence. In the group activity, participants are taught an income generating skill and have the opportunity to share personal experience with former participants of the intervention.<br>Other: Enhanced Standard of Care<br>* Study participants receive information on available routine services for common mental disorders, a nurse-led brief support counseling, assessment for antidepressant medication (fluoxetine) by the clinic nurse, and referral to a psychiatric facility if needed, in addition to the standard of care provided according to national antiretroviral therapy guidelines.<br>|
| Active Comparator: Enhanced Standard of Care<br>Participants in the control group receive enhanced standard of care. | Other: Enhanced Standard of Care<br>* Study participants receive information on available routine services for common mental disorders, a nurse-led brief support counseling, assessment for antidepressant medication (fluoxetine) by the clinic nurse, and referral to a psychiatric facility if needed, in addition to the standard of care provided according to national antiretroviral therapy guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average difference in mean antiretroviral therapy adherence between 2 and 6 months | Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS) | 2-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean antiretroviral therapy adherence between 1 and 12 months | Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS) | 1-12 months | 
| Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score | 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. | At month 3, 6, 9, and 12 | 
| Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score | 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. | At month 3, 6, 9, and 12 | 
| Viral load suppression (<1000 copies per milliliter) | Categorical (yes, no, invalid or missing). | At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days) |