Clinical trial NCT03704805: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
HIV Infections
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: SolidarMed
First posted: 2018-10-15
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized, controlled, two-arm multicenter, superiority trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average difference in mean antiretroviral therapy adherence between 2 and 6 months
timeFrame: 2-6 months
Secondary outcomes:
measure: Difference in mean antiretroviral therapy adherence between 1 and 12 months
timeFrame: 1-12 months
measure: Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score
timeFrame: At month 3, 6, 9, and 12
measure: Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score
timeFrame: At month 3, 6, 9, and 12
measure: Viral load suppression (<1000 copies per milliliter)
timeFrame: At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days)
Other outcomes:
Locations:
city: Masvingo
country: Zimbabwe
facility: Solidarmed
Study officials:
affiliation: Institute of Social and Preventive Medicine (ISPM), University of Bern
name: Andreas D Haas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SolidarMed, Swiss Organisation for Health in Africa
name: Cordelia Kunzekwenyika, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.