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N/A N=515

Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana

Hiv

Enrolled (actual)
515
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Quality of Life/Well-being (Young People) — 4.77 score on a scale

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Sentebale Psychosocial Programme (Behavioral)
Age
Pediatric, Adult · 10+ yrs
Sex
All
Sponsor
Royal Holloway University
Primary completion
Jul 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Life/Well-being (Young People)
4.77
SECONDARY
HIV Knowledge (Young People)
SECONDARY
HIV Adjustment (Young People)
SECONDARY
ART Adherence Behaviour (Young People)
SECONDARY
ART Adherence Attitudes (Young People)
SECONDARY
ART Adherence Self-efficacy (Young People)
SECONDARY
HIV Onward Disclosure Cognitions and Affect (Young People)
SECONDARY
HIV Onward Disclosure (Young People)
SECONDARY
HIV Onward Disclosure Behaviour (Young People)
SECONDARY
HIV Communication Behaviour (Young People)
SECONDARY
HIV Communication Beliefs (Young People)
SECONDARY
Self-esteem (Young People)
SECONDARY
HIV Stigma (Young People)
SECONDARY
Social Support (Young People)
SECONDARY
Hope(Young People)
SECONDARY
HIV Knowledge (Caregivers)
SECONDARY
ART Adherence Attitudes (Caregivers)
SECONDARY
HIV Stigma (Caregivers)
SECONDARY
Viral Suppression (Young People)

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.

Eligibility Criteria

YOUNG PEOPLE

Inclusion Criteria

  • Aged 10 to 19 years at the time of study enrolment
  • Living with HIV and aware of HIV-positive status
  • Able to give informed consent if 18 or 19 years
  • Able to give informed assent if 10-17 years
  • Presence of a caregiver to give caregiver consent if 10-17 years
  • Attending Sentebale clubs with first attendance at club within previous month

Exclusion Criteria

  • Previous camp attendance
  • Any attendance at a different club/organisation providing a similar function
  • Planning to leave the area served by the club within the next year

CAREGIVERS

Inclusion Criteria

  • Primary caregiver for a young person attending Sentebale
  • Able to give informed consent
  • Attending Sentebale clubs with first attendance within previous month

Exclusion Criteria

  • Any attendance at a different club/organisation providing a similar function
  • Planning to leave the area served by the club within the next year
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03571555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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