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NCT Number: NCT04531605

Optimizing Retention in Care and Adherence to Anti-retroviral Therapy Amongst Adolescents Living With HIV in Rwanda

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.

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Key information

About this study

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.

  • Life-skills training: Adolescents receive training on economic empowerment, financial literacy, healthy relationships and adherence during the peer group sessions.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-positive adolescents 12 to 19-years-old who are aware of their HIV-positive serostatus
  • Prescribed anti-retroviral therapy for more than 1 year
  • Has given informed consent with full capacity to study participation (plus parent/guardian consent as all participants will be under 21 years)
  • Enrolled in care at one of the study site

Exclusion criteria

  • HIV-negative
  • HIV-positive but not prescribed ART or on ART for less than 1 year
  • Not enrolled in care at the HIV clinic; younger than 12 years and older than 19 years
  • No parent or named guardian who is over the age of 19 years

Treatment and study plan

YBank program

Behavioral

Adolescents participated in a 12-week peer-led life skills trainings at clinics and received financial incentives via mobile money upon clinic attendance and demonstration of suppressed viral load.

Primary outcomes

  1. Experiences and views of adolescents, caregivers of participants, and health care professionals caring for participants of receiving the YBank intervention

    Time frame: 3 months

    Semi-structured interviews will be conducted with adolescents, caregivers and two health workers randomly selected from each site during and directly following the 12-week intervention period. Themes to be explored in the interviews include experiences with receiving incentives and attending trainings, the impact of the intervention on caregivers and adolescents, and how the incentives will be spent. Face-to-face interviews will be conducted in Kinyarwanda or French by trained interviewers.

Sponsors and collaborators

Lead sponsor

Youth Development Labs, Inc dba YLabs

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 28, 2020
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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