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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704805
• Other study ID #: FB-ART
• Status: Completed
• Phase: N/A
• Start date: October 5, 2018
• Est. completion date: February 5, 2021

Study information

• Verified date: April 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: February 5, 2021
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
Zimbabwe	Solidarmed	Masvingo

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	SolidarMed

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)