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

Primary Purpose

Mental Disorder, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
Friendship bench intervention
Enhanced Standard of Care
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Solidarmed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Problem-Solving Therapy

Enhanced Standard of Care

Arm Description

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

Participants in the control group receive enhanced standard of care.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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.
Viral load suppression (<1000 copies per milliliter)
Categorical (yes, no, invalid or missing).

Full Information

First Posted
October 10, 2018
Last Updated
April 27, 2023
Sponsor
University of Bern
Collaborators
SolidarMed
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1. Study Identification

Unique Protocol Identification Number
NCT03704805
Brief Title
Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe
Official Title
Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
SolidarMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-randomized, controlled, two-arm multicenter, superiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem-Solving Therapy
Arm Type
Experimental
Arm Description
Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care.
Arm Title
Enhanced Standard of Care
Arm Type
Active Comparator
Arm Description
Participants in the control group receive enhanced standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Friendship bench intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average difference in mean antiretroviral therapy adherence between 2 and 6 months
Description
Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
Time Frame
2-6 months
Secondary Outcome Measure Information:
Title
Difference in mean antiretroviral therapy adherence between 1 and 12 months
Description
Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
Time Frame
1-12 months
Title
Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score
Description
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.
Time Frame
At month 3, 6, 9, and 12
Title
Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score
Description
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.
Time Frame
At month 3, 6, 9, and 12
Title
Viral load suppression (<1000 copies per milliliter)
Description
Categorical (yes, no, invalid or missing).
Time Frame
At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas D Haas, PhD
Organizational Affiliation
Institute of Social and Preventive Medicine (ISPM), University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cordelia Kunzekwenyika, MD
Organizational Affiliation
SolidarMed, Swiss Organisation for Health in Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solidarmed
City
Masvingo
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34233999
Citation
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.
Results Reference
derived

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

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