Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model
1 other identifier
interventional
731
1 country
2
Brief Summary
Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic, accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health priority, but Rwandan youth are more than twice as likely to be on second line therapy than adults, and with a median population age of 18.7 years old, adherence is essential for Rwanda's future. Resources to provide youth-centered medical and psychosocial care are limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the long-term consequences of genocide, depression, and gender-based violence, as well as logistical issues, negative attitudes, and insufficient parent/caregiver support. Preliminary data underscore the utility of culturally-adapted, trauma-informed cognitive behavioral therapy (TI-CBT) in reducing depression and traumatic distress among youth and adults in Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test and compare the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (i.e., TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two clinics caring for the largest number of youth with HIV in Rwanda. This proposal answers a compelling need for innovative programs to increase ART adherence among HIV+ youth. If effective, the study will build Rwanda's capacity to provide much needed services; and, involvement by the Rwanda Biomedical Center will ensure wide dissemination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJune 9, 2020
June 1, 2020
6 years
April 10, 2015
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
ART Adherence Behavior Composite Self Report
ART adherence behavior measured by self report. Report is a composite of several validated internationally used measures (7 day recollection, 6 month judgement of overall adherence and appreciation of stopping medications).
Up to 12 months
Secondary Outcomes (1)
Health Care Utilization (Number of Clinic Visits)
Up to 12 months
Other Outcomes (1)
HIV/AIDS/Sexually Transmitted Infection (STI)-risk
Up to 12 months
Study Arms (2)
Control
NO INTERVENTIONUsual care: WE-ACTx For Hope and CHUK offer a host of services for HIV+ young people, and these will represent the "usual care" condition for the study. Both clinics provide adolescent-friendly environments with multidisciplinary teams that offer weekly or monthly support groups, peer education, medical services, mental health screenings, sports activities, HIV and health education sessions, and outreach to parents and guardians. The services youth in the "usual care" condition receive will be carefully tracked.
Treatment
ACTIVE COMPARATORCulturally-adapted, trauma-informed cognitive behavioral therapy (TI-CBT) intervention: The components of the TI-CBT include a) psychosocial health education b) relaxation training c) cognitive restructuring d) adherence barriers e) caregiver psycho-education. The TI-CBTe will be administered in groups of 8-10 weekly for 2 hours for 3 Sundays each month over 2 months. Two IYL will co-lead each intervention, and two IYL will rate fidelity.
Interventions
Eligibility Criteria
You may qualify if:
- male or female
- years old
- seeking HIV care and treatment
- enrolled in support groups at CHUK or We-ACTx For Hope
- able to understand the informed consent process.
You may not qualify if:
- are unable to understand the consent/assent process
- do not speak Kinyarwanda (all instruments will be translated and back-translated)
- are not HIV+
- received an HIV diagnosis in the past week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cental University Hospital of Kigali - CHUK
Kigali, Rwanda
WE-ACTx for Hope
Kigali, Rwanda
Related Publications (1)
Donenberg GR, Fitts J, Ingabire C, Nsanzimana S, Fabri M, Emerson E, Remera E, Manzi O, Bray B, Cohen MH. Results of the Kigali Imbereheza Project: A 2-Arm Individually Randomized Trial of TI-CBT Enhanced to Address ART Adherence and Mental Health for Rwandan Youth Living With HIV. J Acquir Immune Defic Syndr. 2022 May 1;90(1):69-78. doi: 10.1097/QAI.0000000000002911.
PMID: 35013089DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mardge Cohen, MD
We-ACTx
- PRINCIPAL INVESTIGATOR
Sabin Nsanzimana, MD
Rwanda Biomedical Centre
- PRINCIPAL INVESTIGATOR
Geri Donenberg, PhD
University of Illinois Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
June 8, 2015
Study Start
January 1, 2013
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
June 9, 2020
Record last verified: 2020-06