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

Completed

Conditions: Hiv

Interventions: Behavioral: Sentebale Psychosocial Programme

Registration Number: NCT03571555

Lead Sponsor: 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 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.

Detailed Description: There are approximately two million young people between 10 and 19 years, living with HIV (UNAIDS, 2013). Many of this population have been living with HIV since birth. Adolescents/young adults with perinatally acquired HIV (PAH) face a number of antiretroviral (ART) adherence and well-being challenges. They often have long histories of ART use with suboptimal regimens (Sohn \& Hazra, 2013) and rates of viral suppression are variable, often associated with poor ART adherence (Kim, Gerver, Fidler, \& Ward, 2014). Challenges to positive well-being in young people with PAH include some experiencing multiple caretaking transitions, loss due to parental illness or death, and other stressors associated with living with a chronic and stigmatised illness (e.g., hospitalisations, missed school and social opportunities, HIV disclosure challenges and pain). There is evidence of lower levels of wellbeing in young people living with PAH compared to their HIV unaffected peers (Mellins \& Malee, 2013).

Offering psychosocial interventions for young people living with HIV has the potential for enhancing well-being, HIV adjustment, ART adherence, self-esteem and increasing HIV knowledge and HIV disclosure. There are a small number of quantitative studies evaluating interventions to enhance antiretroviral adherence in young people with HIV (Shaw \& Amico, 2016) but few robust quantitative evaluations of psychosocial interventions to enhance well-being in this population (King, De Silva, Stein, \& Patel, 2009). There are no interventions on enhancing onward HIV disclosure in adolescents living with HIV (Evangeli \& Foster, 2014).

Two psychosocial interventions that have been developed to address a range of needs of this population (and their caregivers) are residential interventions and support groups. Regarding residential interventions, there is quantitative evidence in other chronic conditions of increased youth self-esteem after attendance (Odar, Canter, \& Roberts, 2013). There is also some qualitative literature on evaluating residential interventions (support camps) for young people living with HIV in the US (Gillard \& Allsop, 2016; Gillard, Witt, \& Watts, 2011; Pearson, Johnson, Simpson, \& Gallagher, 1997). Interviews with Camp attendees have revealed that this intervention can elicit a sense of belonging, enjoyment, escape, personal growth, being oneself, and caring connections, as well as increasing HIV knowledge, attitudes and skills. A recent quantitative evaluation of a residential intervention in the UK showed evidence for increases in HIV knowledge and pro-HIV disclosure attitudes and cognitions that were maintained at six month follow-up (Evangeli, Lut, \& Ely, 2016).

There is also some global evidence of positive benefits of support groups for children living with HIV, who report that groups provide a sense of belonging, normality, confidence and safety; supportive relationships; and a place to learn about treatment adherence and living healthily (Brothers, Harper, Fernandez, Hosek, \& Adolescent Trials Network for, 2014; Funck-Brentano et al., 2005; Midtbo, Shirima, Skovdal, \& Daniel, 2012; Mupambireyi, Bernays, Bwakura-Dangarembizi, \& Cowan, 2014; Muskat, Salter, Shindler, Porter, \& Bitnum, 2016). There has been little quantitative evaluation of the effects of attending support groups (for children or caregivers), although one pilot study using non-random allocation, showed some evidence of decreased worry about illness, less negative perception about treatment and greater rates of viral suppression in adolescents living with HIV (Funck-Brentano et al., 2005).

Sentebale is an organisation that has been providing residential interventions (camps) to adolescents living with HIV, and follow up support groups (clubs) for these adolescents and their caregivers, amongst other psychosocial interventions, in Lesotho for a number of years. Sentebale is now offering a similar package of psychosocial services to young people and caregivers in Botswana, partnering with Serious Fun Children's Network. The aims of Sentebale are to provide support that will enable young people to living healthy and hopeful lives, increase confidence, improve educational and occupational functioning, increase care and support, enhance HIV communication, increase caregiver support, reduce onward transmission, and increase remembering to take medication. We will evaluate the above psychosocial programme, given the need to investigate the psychosocial, behavioural and clinical outcomes of this type of intervention in high HIV prevalence contexts. Botswana has an estimated HIV prevalence of 6.6% in 15-19 year olds, and an estimated adult prevalence rate of 18.5%, and despite high levels of ART adherence, psychological difficulties in this population are common (Gupta et al., 2010).

Aims and objectives

This three year study aims to answer the following questions in a population of adolescents living with HIV and their caregivers:

1. Is the package of support offered by Sentebale (camps for young people, clubs for young people and caregivers) associated with improvements in psychological, behavioural and clinical outcomes from first attendance to one year follow-up?

2. How is the package of support experienced by young people and their caregivers, and what is the perceived impact for young people and their caregivers?

Study Design

1. Main study - single group within-participants prospective cohort design with two time points (baseline and one year follow-up) with 175 young people and 178 caregivers retained in the study (Study Aim 1).

2. Sub-study - qualitative cross sectional design involving semi-structured interviews with 10 young people and 10 caregivers (Study Aim 2).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 516

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caregivers of young people with perinatally acquired HIV	Sentebale Psychosocial Programme	Community based support (clubs)
Young people with perinatally acquired HIV	Sentebale Psychosocial Programme	Residential interventions (camps) and community based support (clubs)

Primary Outcome Measures

Name	Time	Method
Quality of Life/Well-being (Young People)	One year	The 17 item Pediatric Symptom Checklist (PSY-Y-17) will be used. Minimum value 0, maximum 51. Higher scores, worse outcome.

Secondary Outcome Measures

Name	Time	Method
ART Adherence Behaviour (Young People)	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
ART Adherence Attitudes (Young People)	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.
HIV Onward Disclosure Cognitions and Affect (Young People)	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.
Social Support (Young People)	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
HIV Knowledge (Young People)	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.
HIV Adjustment (Young People)	One year	The 18 item Illness Cognition Questionnaire will be used (Evers et al., 2001).
ART Adherence Self-efficacy (Young People)	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.
HIV Stigma (Young People)	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
HIV Onward Disclosure (Young People)	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).
HIV Onward Disclosure Behaviour (Young People)	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).
HIV Communication Beliefs (Young People)	One year	The Adolescent HIV Communication Belief Scale (Evangeli, in press) will be used. An additional item will assess intention to communicate about HIV.
Self-esteem (Young People)	One year	The 10 item Rosenberg global self-esteem measure will be used (Rosenberg, 1965).
Hope(Young People)	One year	The total score of the 5 item Botswana Adolescent Beliefs about the Future Scale will be used. Higher scores indicate greater hope.
HIV Communication Behaviour (Young People)	One year	The frequency of HIV communication will be measured.
Viral Suppression (Young People)	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.
HIV Knowledge (Caregivers)	One year	The HIV-KQ-18 measure (Carey \& Schroder, 2002) will be adapted for use in Botswana
ART Adherence Attitudes (Caregivers)	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.
HIV Stigma (Caregivers)	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.