HIV/AIDS
Conditions
Interventions
REFINE FCC intervention
Sponsors
United Kingdom Department of Health and Social Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cluster randomised trial (AIM 1, AIM 2, AIM 3): All children aged 1-10 years living with HIV who are accessing ART from one of 16 study clinics and their caregivers will be invited to be screened for eligibility for the trial. At screening, caregivers will also be asked for consent to review their children’s clinic records. Inclusion criteria (children): 1. Aged 1 to 10 years at enrolment 2. Receiving ART for at least six months 3. Children aged 7-10 years will be expected to have age-appropriate awareness of their HIV status to provide assent. Children aged 1-6 years are not required to know their diagnosis, and caregiver consent alone will be obtained. Inclusion criteria (caregivers): 1. Caregivers will not be excluded based on PHQ-9 or GAD-7 scores. These measures will be used to identify a subgroup of caregivers experiencing elevated psychological distress who may benefit from additional psychosocial support within the FCC intervention. 2. Families experiencing economic hardship based on household survey data Inclusion criteria (Healthcare providers): 1. Healthcare provider or CHW 2. Working at one of the designated clinics or serving one or more communities being served by one of the designated clinics 3. Involvement with CLHIV
Exclusion criteria
Exclusion criteria: Exclusion Criteria (all participants): 1. Inability to read and/or speak English or isiZulu. 2. Severe mental or physical illness preventing participation in informed consent activities. 3. Anticipate moving out of the clinic area in the next 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| two core clinical outcomes: retention in care and virological suppression | — |
Secondary
| Measure | Time frame |
|---|---|
| RE-AIM framework to evaluate the implementation of the REFINE intervention across urban and rural clinics;Assess whether the family-centred intervention leads to measurable improvements in treatment literacy and associated psychosocial outcomes among CLHIV aged 1-10 years and their caregivers | — |
Countries
South Africa
Contacts
Public ContactSashin Harilall
Head of Department Research Grants and Contracts
Outcome results
None listed