CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 516 enrolled
Drug / intervention
Sentebale Psychosocial Programmebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03571555
NCT03571555N/ACompleted

A Prospective Cohort Study Evaluating a Psychosocial Programme for Adolescents Living With HIV and Their Caregivers in Botswana

Royal Holloway University·observational·Posted Jun 27, 2018·Updated Apr 26, 2021

In Brief

An observational study evaluating Sentebale Psychosocial Programme for Hiv. Completed, enrolled 516 participants across 1 site.

Detailed Summary

Adolescents/young adults with perinatally acquired HIV (PAH) face a number of antiretroviral (ART) adherence and well-being challenges. Two psychosocial interventions that have been developed to address a range of needs of this population (and their caregivers) are residential interventions (camps) and support groups (clubs). There has been little quantitative evaluation of the effects of attending camps for young people and clubs (for children or caregivers), globally. This study aims to investigate whether a package of psychosocial support (camps and clubs) offered to young people living with HIV and their caregivers in Botswana by the Sentebale organisation, is associated with improvements in psychological, behavioural and clinical outcomes from first attendance to one year follow-up. In addition, the study will explore how the psychosocial programme is experienced by young people and their caregivers, and what the perceived impact is. The project as a whole will take place over three years. There will be an initial six month preparatory phase that will include the adaptation of self-report measures for the study context. Subsequently, two studies will be undertaken. The main study will involve a single group within-participants prospective cohort design with two time points (baseline and one year follow-up) with young people and caregivers. The sub-study will involve a qualitative cross sectional design involving semi-structured interviews with young people and caregivers. Young people will be eligible to participate if they are aged 10 to 19 years at the time of study enrolment, are living with HIV and aware of HIV-positive status, have recently started attending the Sentebale programme, and are able to give informed assent/consent. We will aim to retain 175 young people (of 253 recruited) . We will also aim to retain 178 caregivers (of 263 recruited). The sample size for the sub-study will consist of ten young people and ten caregivers.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHiv
CountriesBotswana

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartMar 1, 2019
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.0 years ago

Interventions

Sentebale Psychosocial Programmebehavioral

Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.