Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04528732
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2020-08-03
Brief Title:
Suubi4Stigma Addressing HIV-Associated Stigma Among Adolescents
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Suubi4Stigma Addressing HIV-Associated Stigma Among Adolescents
Status:
COMPLETED
Status Verified Date:
2023-12
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:
The study seeks to reduce HIVAIDS-associated stigma and its negative impact on adolescent health and psychosocial well-being This study will examine two evidence-informed interventions 1 group cognitive behavior therapy G-CBT that aims at cognitive restructuring and strengthening coping skills at the individual level and 2 multiple family group MFG that strengthens family relationships intended to address HIVAIDS-associated stigma at the individual level and within families Adolescents between 10-14 years will be randomly assigned -at the clinic level to one of three study arms 1 Usual care to receive the currently implemented usual care addressing HIVAIDS-associated stigma educational materials from the Ugandan Ministry of Health 2 G-CBT intervention Usual care and 3 MFG intervention Usual care The interventions will be delivered over a 3-month period Assessments will be collected at baseline 3 months and 6 months post intervention initiation The study will also explore participants caregivers and facilitators intervention experiences as well as multi-level facilitators and barriers to intervention implementation and participation
Detailed Description:
Sub-Saharan Africa SSA is heavily burdened by HIV with 85 of new infections among adolescents and youth globally happening in the region Recent statistics indicate that HIV prevalence among adolescents and young people is rising in Uganda While availability and access to free antiretroviral therapy ART has decreased child mortality it has increased the likelihood that a number of children living with HIV CLWH will transition into adulthood with HIV as a chronic highly stigmatized illness Unfortunately the stigma this group experiences results in much lower quality of life Stigma a common experience characterized by public blame moral condemnation and discrimination has been documented to be one of the greatest challenges to slowing the spread of HIVAIDS It perpetuates the culture of silence and fear and prevents individuals from testing and seeking health care Research has shown that HIVAIDS-associated stigma predicts depression and PTSD poor treatment and adherence loneliness and social isolation HIV-related physical health and HIV sexual risk behavior It is critical for HIV interventions to target stigma in order to reduce HIV spread Yet stigma-reduction interventions targeting children and adolescents living with HIVAIDS in SSA are almost non-existent Thus there is a need for research that will generate knowledge to address HIVAIDS-associated stigma especially among CLWH as they transition to adolescence The proposed exploratory study R21 will Aim 1 Pilot test the feasibility acceptability and preliminary impact of an innovative Group Cognitive Behavior Therapy G-CBT and Multiple Family Group MFG interventions on reducing HIVAIDS-associated stigma and its impact on targeted participant outcomes stigma post-trauma symptoms depression sexual risk behavior familysocial support and adherence to medication in comparison to 1a usual care vs G-CBT 1b Usual care vs MFG 1c G-CBT vs MFG Aim 2 Qualitatively examine participants and facilitators intervention experiences and identify individual family and institutional-level facilitators and barriers to G-CBT and MFG intervention implementation and participation The study will be conducted in 9 health clinics n 90 children ages 10-14 and their caregivers total 90 child- caregiver dyads in Masaka Clinics will be randomized to one of three study arms n3 clinics 30 child-caregiver dyads each arm 1 Usual care to receive the currently implemented usual care addressing HIVAIDS-associated stigma educational materials developed by the Ugandan Ministry of Health 2 G-CBT intervention usual care and 3 MFG intervention usual care Participants will be followed over a 6-month period with data collected at baseline 3 months and 6 months post intervention initiation to assess feasibility acceptability and preliminary impact The long-term goal of the proposed research is to develop culturally appropriate feasible acceptable and effective interventions that address HIVAIDS-associated stigma and its impact on CLWHs wellbeing and their families in SSA
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