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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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ClinicalTrials.gov Identifier: NCT03704805
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
SolidarMed
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mental Disorder HIV Infections Behavioral: Friendship bench intervention Other: Enhanced Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized, controlled, two-arm multicenter, superiority trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : July 15, 2020
Estimated Study Completion Date : February 5, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Average difference in mean antiretroviral therapy adherence between 2 and 6 months [ Time Frame: 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 :
  1. Difference in mean antiretroviral therapy adherence between 1 and 12 months [ Time Frame: 1-12 months ]
    Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)

  2. Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score [ Time Frame: 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.

  3. Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704805


Locations
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Zimbabwe
Solidarmed
Masvingo, Zimbabwe
Sponsors and Collaborators
University of Bern
SolidarMed
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03704805    
Other Study ID Numbers: FB-ART
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders