HIV Infections, Mental Disorder
Conditions
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.
Interventions
BEHAVIORALFriendship 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.
OTHEREnhanced 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.
Sponsors
SolidarMed
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster-randomized, controlled, two-arm multicenter, superiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average difference in mean antiretroviral therapy adherence between 2 and 6 months | 2-6 months | Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean antiretroviral therapy adherence between 1 and 12 months | 1-12 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 | 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. |
| Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score | 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. |
| 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) | Categorical (yes, no, invalid or missing). |
Countries
Zimbabwe
Outcome results
None listed