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Trial record 1 of 2 for:    psychosocial | hiv | Botswana
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Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana

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ClinicalTrials.gov Identifier: NCT03571555
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
African Comprehensive HIV/AIDS Partnership
Sentebale
Information provided by (Responsible Party):
Dr. Michael Evangeli, Royal Holloway University

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 230 young people (of 253 recruited) currently taking antiretroviral mediation in the main study to detect a 5% increase in rate of viral suppression. We will also aim to retain 230 caregivers (of 253 recruited). The sample size for the sub-study will consist of ten young people and ten caregivers.

Condition or disease Intervention/treatment
Hiv Behavioral: Sentebale Psychosocial Programme

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 506 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study Evaluating a Psychosocial Programme for Adolescents Living With HIV and Their Caregivers in Botswana
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers HIV/AIDS

Group/Cohort Intervention/treatment
Young people with perinatally acquired HIV
Residential interventions (camps) and community based support (clubs)
Behavioral: Sentebale Psychosocial Programme
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
Community based support (clubs)
Behavioral: Sentebale Psychosocial Programme
Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.




Primary Outcome Measures :
  1. Viral suppression (young people) [ Time Frame: one year ]
    Most recent viral load in the six months before the baseline assessment and most recent viral load in the six months after the follow-up period, will be collected from participants' clinical records.

  2. Quality of life/well-being (young people) [ Time Frame: One year ]
    The 17 item Pediatric Symptom Checklist (PSY-Y-17) will be used.


Secondary Outcome Measures :
  1. HIV knowledge (young people) [ Time Frame: One year ]
    The Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002) and other measures (Aaro et al, 2011; Evangeli et al, 2016) will be adapted to produce a new measure of general HIV knowledge, transmission, medication and reproduction information.

  2. HIV adjustment (young people) [ Time Frame: One year ]
    The 18 item Illness Cognition Questionnaire will be used (Evers et al., 2001).

  3. ART adherence behaviour (young people) [ Time Frame: One year ]
    The total score of the CASE adherence index (Mannheimer et al., 2006) will be used. Higher scores indicate higher self-reported ART adherence

  4. ART adherence attitudes (young people) [ Time Frame: One year ]
    The total score of 15 item antiretroviral medication attitudes scale (Viswanathan, Anderson, & Thomas, 2005) will be used. Higher scores indicate more positive adherence attitudes.

  5. ART adherence self-efficacy (young people) [ Time Frame: One year ]
    The total score of the 12 item HIV medication self-efficacy scale (Erlen, Cha, Kim, Caruthers, & Sereika, 2010) will be used. Higher scores indicated higher adherence self-efficacy.

  6. HIV onward disclosure cognitions and affect (young people) [ Time Frame: One year ]
    The 18 item Adolescent HIV Disclosure Cognitions and Affect Scale (Evangeli, 2017) will be used to assess attitudes towards sharing one's status, normative disclosure beliefs, disclosure affect and disclosure self-efficacy.

  7. HIV onward disclosure (young people) [ Time Frame: One year ]

    The 18 item Adolescent HIV Disclosure Cognitions and Affect Scale (Evangeli, 2017) will be used to assess attitudes towards sharing one's status, normative disclosure beliefs, disclosure affect and disclosure self-efficacy. The total score will be used. Higher scores indicate more pro-disclosure beliefs. An additional item assessed the young person's intention to share their status with others over the next year will be added.

    HIV disclosure events will be assessed at baseline and follow-up through recording the frequency of new disclosures in last year (first hand or second hand) and the proportion in one's social network disclosed to (Serovich, Craft, & Reed, 2012; Serovich, Craft, & Yoon, 2007).


  8. HIV onward disclosure behaviour (young people) [ Time Frame: One year ]
    HIV disclosure events will be assessed at baseline and follow-up through recording the frequency of new disclosures in last year (first hand or second hand) and the proportion in one's social network disclosed to (Serovich, Craft, & Reed, 2012; Serovich, Craft, & Yoon, 2007).

  9. HIV communication behaviour (young people) [ Time Frame: One year ]
    The frequency of HIV communication will be measured.

  10. HIV communication beliefs (young people) [ Time Frame: One year ]
    The Adolescent HIV Communication Belief Scale (Evangeli, in press) will be used. An additional item will assess intention to communicate about HIV.

  11. Self-esteem (young people) [ Time Frame: One year ]
    The 10 item Rosenberg global self-esteem measure will be used (Rosenberg, 1965).

  12. HIV stigma (young people) [ Time Frame: One year ]
    The total score of the 10 item Stigma Scale - Revised (Wright, Naar-King, Lam, Templin, & Frey, 2007) will be used. Higher scores indicate more HIV stigma

  13. Social support (young people) [ Time Frame: One year ]
    The total score of the 11 item Child and Adolescent Social Support Scale (Malecki & Demaray, 2002) will be used. Higher scores indicate greater social support

  14. Hope(young people) [ Time Frame: One year ]
    The total score of the 5 item Botswana Adolescent Beliefs about the Future Scale will be used. Higher scores indicate greater hope.

  15. HIV knowledge (caregivers) [ Time Frame: One year ]
    The HIV-KQ-18 measure (Carey & Schroder, 2002) will be adapted for use in Botswana

  16. ART adherence attitudes (caregivers) [ Time Frame: One year ]
    The 15 item antiretroviral medication attitudes scale (Viswanathan et al., 2005) will be used. The measure will be adapted for use with Batswana caregivers.

  17. HIV stigma (caregivers) [ Time Frame: One year ]
    The total score of the 9 item HIV Stigma Scale will be used (Kalichman et al., 2005). Higher scores indicate higher levels of HIV stigma.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571555


Contacts
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Contact: Dr Evangeli, ClinPsyD 00441784443851 michael.evangeli@rhul.ac.uk

Locations
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Botswana
Sentebale Recruiting
Gaborone, Botswana
Contact    4958433      
Sponsors and Collaborators
Royal Holloway University
African Comprehensive HIV/AIDS Partnership
Sentebale

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Responsible Party: Dr. Michael Evangeli, Principal Investigator, Royal Holloway University
ClinicalTrials.gov Identifier: NCT03571555    
Other Study ID Numbers: Sentebale
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised electronic data from the study will be transferred to a data repository (eg.,Figshare or RHUL Research Data Archive) at the end of the study.
Supporting Materials: Study Protocol
Time Frame: At the end of the study. For 10 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Michael Evangeli, Royal Holloway University:
HIV
perinatal
adolescent
camp
psychosocial