search
Back to results

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

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
YBank program
Sponsored by
Youth Development Labs, Inc dba YLabs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    12-week program of combined life-skills training and financial incentives (YBank program) described in more detail below. Life-skills training: Every 4 weeks through the 12 week program, life-skills training sessions will be delivered during peer-group sessions at the clinic. Topics include economic empowerment, financial literacy, healthy relationships, and anti-retroviral therapy (ART) adherence. Financial incentives: The incentives program combines an immediate financial reward with a long-term savings opportunity. For clinic attendance, 500 RWF (~$0.50) will be deposited into participants' mobile money short-term account, where funds will be immediately accessible, and 1500 RWF (~$1.50) will be deposited into their savings account upon completing the program. If participants demonstrate a suppressed viral load at a clinic appointment, an additional 1000 RWF (~$1) will be deposited to their short-term account and 3000 RWF (~$3) into their saving account.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 21, 2020
    Last Updated
    August 25, 2020
    Sponsor
    Youth Development Labs, Inc dba YLabs
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04531605
    Brief Title
    Optimizing Retention in Care and Adherence to Anti-retroviral Therapy Amongst Adolescents Living With HIV in Rwanda
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Youth Development Labs, Inc dba YLabs

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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. 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.
    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    12-week program of combined life-skills training and financial incentives (YBank program) described in more detail below. Life-skills training: Every 4 weeks through the 12 week program, life-skills training sessions will be delivered during peer-group sessions at the clinic. Topics include economic empowerment, financial literacy, healthy relationships, and anti-retroviral therapy (ART) adherence. Financial incentives: The incentives program combines an immediate financial reward with a long-term savings opportunity. For clinic attendance, 500 RWF (~$0.50) will be deposited into participants' mobile money short-term account, where funds will be immediately accessible, and 1500 RWF (~$1.50) will be deposited into their savings account upon completing the program. If participants demonstrate a suppressed viral load at a clinic appointment, an additional 1000 RWF (~$1) will be deposited to their short-term account and 3000 RWF (~$3) into their saving account.
    Intervention Type
    Behavioral
    Intervention Name(s)
    YBank program
    Intervention Description
    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 Outcome Measure Information:
    Title
    Experiences and views of adolescents, caregivers of participants, and health care professionals caring for participants of receiving the YBank intervention
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs