Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model
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|ClinicalTrials.gov Identifier: NCT02464423|
Recruitment Status : Unknown
Verified August 2016 by Hektoen Institute for Medical Research.
Recruitment status was: Recruiting
First Posted : June 8, 2015
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: Trauma-Informed Cognitive Behavioral Therapy enhanced (TI-CBTe)||Not Applicable|
This study proposes a 2-arm, RCT to test and compare adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (TI-CBTe) to usual care on ART adherence among HIV+ Rwandan youth. Based on a well-grounded theoretical framework, TI-CBTe blends a culturally adapted empirically-supported intervention (TI-CBT) with strategies to increase ART adherence by reducing depression, trauma, and gender based violence (GBV). 350 HIV+ 14-21 year olds will be randomly assigned to TI-CBTe or usual care and the intervention will be delivered in small groups of 8 - 10 over eight consecutive Sundays. Adult caregivers (where available) will participate in two sessions to address adherence support for youth. Caregivers and youth will complete assessments at baseline, 6 and 12 months. Consistent with the Indigenous Leader Outreach Model (ILOM), HIV+ young adults who are > 95% ART adherent will be trained to deliver TI-CBTe. An intent-to-treat analysis will be used and a combination of regression techniques and other inferential statistical tests for contrasting means and proportions. Treatment effects on adherence and mediators for youth participants will be examined, as well as indigenous youth leaders. Treatment outcomes will be analyzed using logistic and linear multiple regression models examining effects at 6- and 12- months separately, as well as a combined model with random effects for repeated measurements across time.
Participants will be recruited from two clinics: WE-ACTx For Hope and Central University Hospital of Kigali (CHUK), which are the primary providers of HIV care for infected adolescents, and both have long-standing relationships with the community. Youth and caregivers will be invited to meet with research staff if they are interested to inform them about the project and request permission to be contacted by the research team. The assent/consent forms will be reviewed with IYL, youth and caregivers, and trained staff will administer questionnaires and interviews. Both sites have a staff psychologist who will provide clinical backup in cases of mental health distress. Consent/assent forms will state the exceptions to confidentiality, and where a youth reports child abuse or neglect or suicidal ideation or attempts, the psychologist will be consulted. Indigenous youth leaders (IYL), youth and caregivers will each complete the baseline and two follow-up assessments. A month before follow-ups, IYL, youth and caregivers will be contacted to request their participation in the next wave of data collection. Transportation will be offered and interviews will be conducted at the clinics in a confidential location.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
No Intervention: Control
Usual 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.
Active Comparator: Treatment
Culturally-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.
Behavioral: Trauma-Informed Cognitive Behavioral Therapy enhanced (TI-CBTe)
- ART Adherence Behavior Composite Self Report [ Time Frame: Up to 12 months ]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).
- Health Care Utilization (Number of Clinic Visits) [ Time Frame: Up to 12 months ]Track number of mental health and support services visits by youth in both treatment arms.
- HIV/AIDS/Sexually Transmitted Infection (STI)-risk [ Time Frame: Up to 12 months ]The AIDS-Risk Behavior Assessment (ARBA) measures self-reported sexual behavior and drug use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464423
|Contact: Kathleen Weberfirstname.lastname@example.org|
|Cental University Hospital of Kigali - CHUK||Recruiting|
|Contact: Chantal Umurungi|
|WE-ACTx for Hope||Recruiting|
|Contact: Aimee Ndorimana|
|Principal Investigator:||Mardge Cohen, MD||We-ACTx|
|Principal Investigator:||Sabin Nsanzimana, MD||Rwanda Biomedical Center|
|Principal Investigator:||Geri Donenberg, PhD||University of Illinois-Chicago|