Ignite Creation Date:
2024-05-06 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03571555
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2018-05-31
Brief Title:
Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana
Sponsor:
Royal Holloway University
Organization:
Royal Holloway University
Study Overview
Official Title:
A Prospective Cohort Study Evaluating a Psychosocial Programme for Adolescents Living With HIV and Their Caregivers in Botswana
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adolescentsyoung 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 assentconsent 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 Adolescentsyoung 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 eg 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 Childrens 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 66 in 15-19 year olds and an estimated adult prevalence rate of 185 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
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 Childrens 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 66 in 15-19 year olds and an estimated adult prevalence rate of 185 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None