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

NCT03704805 | Completed

• 1 other identifier: FB-ART
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder; HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difference in mean antiretroviral therapy adherence between 1 and 12 months

  1-12 months

• Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score

  At month 3, 6, 9, and 12

• Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score

  At month 3, 6, 9, and 12

• 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)

Study Arms (2)

Problem-Solving Therapy

EXPERIMENTAL

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; Other: Enhanced Standard of Care

Enhanced Standard of Care

ACTIVE COMPARATOR

Participants in the control group receive enhanced standard of care.

Other: Enhanced Standard of Care

Interventions

Friendship bench intervention BEHAVIORAL

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.

Problem-Solving Therapy

Enhanced Standard of Care OTHER

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.

Enhanced Standard of Care; Problem-Solving Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bern: lead
• SolidarMed: collaborator

Study Sites (1)

Solidarmed

Masvingo, Zimbabwe

Location

Related Publications (3)

• Haas AD, Kunzekwenyika C, Manzero J, Hossmann S, Limacher A, van Dijk JH, Manhibi R, von Groote P, Hobbins MA, Verhey R, Egger M; Friendship Bench ART trial group. Effect of the Friendship Bench Intervention on Antiretroviral Therapy Outcomes and Mental Health Symptoms in Rural Zimbabwe: A Cluster Randomized Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2323205. doi: 10.1001/jamanetworkopen.2023.23205.

  PMID: 37440230 DERIVED

• Haas AD, Kunzekwenyika C, Manzero J, Hossmann S, Limacher A, van Dijk JH, Manhibi R, von Groote P, Hobbins MA, Verhey R, Egger M; Friendship Bench ART trial group. Effect of the Friendship Bench intervention on antiretroviral therapy outcomes and mental health symptoms in rural Zimbabwe: A cluster randomized trial. medRxiv [Preprint]. 2023 Jan 22:2023.01.21.23284784. doi: 10.1101/2023.01.21.23284784.

  PMID: 36711671 DERIVED

• 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.

  PMID: 34233999 DERIVED

MeSH Terms

Conditions

Mental Disorders; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized, controlled, two-arm multicenter, superiority trial

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: October 5, 2018
• Primary Completion: July 15, 2020
• Study Completion: February 5, 2021
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

ZI (1)