Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT04531605
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2020-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Retention in Care and Adherence to Anti-retroviral Therapy Amongst Adolescents Living With HIV in Rwanda
Sponsor:
Youth Development Labs, Inc dba YLabs
Organization:
Study Overview
Official Title:
Feasibility and Acceptability of an Intervention to Optimize Retention in Care and Adherence to Anti-retroviral Therapy Amongst Adolescents Living With HIV in Rwanda
Status:
COMPLETED
Status Verified Date:
2020-08
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:
HIV has now become the leading cause of death amongst adolescents in Africa with over 2.1 million adolescents (aged 10-19 years old) living with HIV today. Poor adherence to anti-retroviral therapy (ART) leads to suppressed immune function, treatment failure, increased morbidity and mortality with significant costs to households and health systems.
The investigators aim to undertake a feasibility study of an intervention targeting adolescents living with HIV in Rwanda built on two components.
1. Life-skills training: Adolescents receive training on economic empowerment, financial literacy, healthy relationships and adherence during the peer group sessions.
2. Financial incentives: Combined short-term and long-term incentives for clinic attendance and suppressed viral load that will be delivered through mobile banking.
The investigators aim to undertake a feasibility study of an intervention targeting adolescents living with HIV in Rwanda built on two components.
1. Life-skills training: Adolescents receive training on economic empowerment, financial literacy, healthy relationships and adherence during the peer group sessions.
2. Financial incentives: Combined short-term and long-term incentives for clinic attendance and suppressed viral load that will be delivered through mobile banking.
Detailed Description:
HIV has now become the leading cause of death amongst adolescents in Africa with over 2.1 million adolescents (aged 10-19 years old) living with HIV today. Increased mortality amongst HIV-infected adolescents is primarily caused by poor adherence to anti-retroviral therapy (ART). Adherence to ART is critical to suppress HIV viral load, sustain immune function, and avoid opportunistic infections and death. Poor adherence leads to suppressed immune function, treatment failure, increased morbidity and mortality with significant costs to households and health systems. In our clinic population in Rwanda, 29% of 12-19 years olds have a non-suppressed viral load due to poor adherence. These findings have been reflected in studies throughout the US, Europe and sub-Saharan Africa.
The evidence base for effective adherence interventions that successfully address the multiple barriers to adherence is very limited. Conditional cash transfers have shown promise as a potential strategy. The investigators aim to undertake a feasibility study of an intervention targeting adolescents living with HIV in Rwanda built on two components.
1. Life-skills training: Adolescents receive training on economic empowerment, financial literacy, healthy relationships and adherence during the peer group sessions.
2. Financial incentives: Combined short-term and long-term incentives for clinic attendance and suppressed viral load that will be delivered through mobile banking. On admission to the program adolescents are provided with a bank account. The rewards delivered to the adolescent are divided into a long-term and short term component. The long-term incentive accrues and can only be accessed on graduation from the program. The short-term component can be accessed immediately.
The aim of this preliminary study is not to assess for efficacy of the intervention (virological suppression and clinic attendance). This preliminary study aims to assess the feasibility of the program and data collection strategy in preparation for a large scale multi-center evaluation.
The evidence base for effective adherence interventions that successfully address the multiple barriers to adherence is very limited. Conditional cash transfers have shown promise as a potential strategy. The investigators aim to undertake a feasibility study of an intervention targeting adolescents living with HIV in Rwanda built on two components.
1. Life-skills training: Adolescents receive training on economic empowerment, financial literacy, healthy relationships and adherence during the peer group sessions.
2. Financial incentives: Combined short-term and long-term incentives for clinic attendance and suppressed viral load that will be delivered through mobile banking. On admission to the program adolescents are provided with a bank account. The rewards delivered to the adolescent are divided into a long-term and short term component. The long-term incentive accrues and can only be accessed on graduation from the program. The short-term component can be accessed immediately.
The aim of this preliminary study is not to assess for efficacy of the intervention (virological suppression and clinic attendance). This preliminary study aims to assess the feasibility of the program and data collection strategy in preparation for a large scale multi-center evaluation.
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?: