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

NCT03571555 | Completed Results

• 1 other identifier: Sentebale
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv

Keywords

HIV; perinatal; adolescent; camp; psychosocial

Outcome Measures

Primary Outcomes (1)

• Quality of Life/Well-being (Young People)

  The 17 item Pediatric Symptom Checklist (PSY-Y-17) will be used. Minimum value 0, maximum 51. Higher scores, worse outcome.

  One year

Secondary Outcomes (18)

• HIV Knowledge (Young People)

  One year

• HIV Adjustment (Young People)

  One year

• ART Adherence Behaviour (Young People)

  One year

• ART Adherence Attitudes (Young People)

  One year

• ART Adherence Self-efficacy (Young People)

  One year

Study Arms (2)

Young people with perinatally acquired HIV

Residential interventions (camps) and community based support (clubs)

Behavioral: Sentebale Psychosocial Programme

Caregivers of young people with perinatally acquired HIV

Community based support (clubs)

Behavioral: Sentebale Psychosocial Programme

Interventions

Sentebale Psychosocial Programme BEHAVIORAL

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

Caregivers of young people with perinatally acquired HIV; Young people with perinatally acquired HIV

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10-19 year olds living with HIV, new attenders to the Sentebale psychosocial programme Primary caregivers of 10-19 year olds living with HIV attending Sentebale, who are also attending Sentebale themselves

You may qualify if:

• 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

You may not qualify if:

• 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
• Primary caregiver for a young person attending Sentebale
• Able to give informed consent
• Attending Sentebale clubs with first attendance within previous month
• Any attendance at a different club/organisation providing a similar function
• Planning to leave the area served by the club within the next year

Sponsors & Collaborators

• Royal Holloway University: lead
• African Comprehensive HIV/AIDS Partnership: collaborator
• Sentebale: collaborator

Study Sites (1)

Sentebale

Gaborone, Botswana

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Muscle Cramp

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Evangeli
• Organization: Royal Holloway University of London

michael.evangeli@rhul.ac.uk

00447801543681

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 27, 2018
• Study Start: March 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 26, 2021
• Results First Posted: April 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At the end of the study. For 10 years.

Locations

BO (1)