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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Mental Disorder
• Intervention / Treatment: Behavioral: Friendship bench intervention; Other: Enhanced Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zimbabwe
  • Masvingo, Zimbabwe
    • SolidarMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Problem-Solving Therapy; 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; 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.; Other: Enhanced Standard of Care; 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.
Active Comparator: Enhanced Standard of Care; Participants in the control group receive enhanced standard of care.	Other: Enhanced Standard of Care; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: SolidarMed
• Investigators: Principal Investigator: Andreas D Haas, PhD, Institute of Social and Preventive Medicine (ISPM), University of Bern; Principal Investigator: Cordelia Kunzekwenyika, MD, SolidarMed, Swiss Organisation for Health in Africa

Publications and helpful links

General Publications

• Haas AD, Kunzekwenyika C, Hossmann S, Manzero J, van Dijk J, Manhibi R, Verhey R, Limacher A, von Groote PM, Manda E, Hobbins MA, Chibanda D, Egger M; IeDEA Southern Africa. Symptoms of common mental disorders and adherence to antiretroviral therapy among adults living with HIV in rural Zimbabwe: a cross-sectional study. BMJ Open. 2021 Jul 7;11(7):e049824. doi: 10.1136/bmjopen-2021-049824.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2018
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: FB-ART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No