PACTR202006601935462.
| Study name | Promoting adherence to anti‐retroviral therapy and viral suppression among HIV positive young people in Uganda through group support psychotherapy: study protocol for a pilot randomized controlled trial |
| Methods |
Study design: RCT Country: Uganda |
| Participants | Dyads of HIV seropositive young persons (10‐18 years) and a caregiver Inclusion criteria: a. participant dyads must consist of an HIV seropositive young person (10‐18 years) with ≥ 1000 viral copies/mL 6 months after initiating first‐line ART and a caregiver aged 19 years and older. Exclusion criteria: a. participant dyads will be excluded if they have visual or hearing impairments, active untreated major mental illness (untreated psychosis or mania or high suicide risk) or severe medical conditions (active tuberculosis or pneumonia) that would interfere with participation in interventions. Stated purpose: to assess the feasibility, acceptability and preliminary effectiveness and cost‐effectiveness of GSP in promoting ART adherence and viral suppression amongst HIV‐positive young people with non‐viral suppression 6 months after initiating first‐line ART at the Kitgum Hospital HIV clinic (for pilot randomized controlled trial) |
| Interventions |
Intervention: Group support psychotherapy 8 weekly sessions of group support psychotherapy. GSP sessions for caregivers will proceed as previously described in the SEEK‐GSP trial. GSP sessions for the young people will follow the same format but with a focus on challenges faced by young people living with HIV. Besides being gender‐specific, they will also be age‐specific with participants being grouped into the following age categories: 13‐14; 15‐16 and 17‐18). Control: Usual care: intensive adherence counselling (4 individual adherence counselling sessions of intensive adherence counselling (IAC) for 3–6 months and repeat VL testing before switching to second‐line therapy) |
| Outcomes |
Participants'outcomes of interest for this review
Economic outcomes Cost‐effectiveness Time points: baseline, post‐intervention (6 months and 12 months) |
| Starting date | 1 August 2020 |
| Contact information | Etheldreda Nakimuli Mpungu, ethelmpungu@gmail.com |
| Notes |
Source of funding: CRI Foundation Prospective trial registration number: PACTR202006601935462 |