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

NCT04531605 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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. 1.Life-skills training: Adolescents receive training on economic empowerment, financial literacy, healthy relationships and adherence during the peer group sessions.
2. 2.Financial incentives: Combined short-term and long-term incentives for clinic attendance and suppressed viral load that will be delivered through mobile banking.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

12-week program of combined life-skills training and financial incentives (YBank program) described in more detail below. 1. 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. 2. 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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Youth Development Labs, Inc dba YLabs: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; 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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: February 1, 2017
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share