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

• ClinicalTrials.gov Identifier: NCT04531605
• Recruitment Status: Completed
• First Posted: August 28, 2020
• Last Update Posted: August 28, 2020
• Sponsor: Youth Development Labs, Inc dba YLabs
• Information provided by (Responsible Party): Youth Development Labs, Inc dba YLabs

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.

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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus	Behavioral: YBank program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: February 1, 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention; 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.

Behavioral: YBank program; 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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Youth Development Labs, Inc dba YLabs
• ClinicalTrials.gov Identifier: NCT04531605
• Other Study ID Numbers: 001
• First Posted: August 28, 2020
• Last Update Posted: August 28, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases