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Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Hektoen Institute for Medical Research

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Trauma-Informed Cognitive Behavioral Therapy enhanced (TI-CBTe) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female
  • 14-21 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02464423

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Contact: Kathleen Weber 312.953.1486

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Cental University Hospital of Kigali - CHUK Recruiting
Kigali, Rwanda
Contact: Chantal Umurungi         
WE-ACTx for Hope Recruiting
Kigali, Rwanda
Contact: Aimee Ndorimana         
Sponsors and Collaborators
Hektoen Institute for Medical Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Mardge Cohen, MD We-ACTx
Principal Investigator: Sabin Nsanzimana, MD Rwanda Biomedical Center
Principal Investigator: Geri Donenberg, PhD University of Illinois-Chicago

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Responsible Party: Hektoen Institute for Medical Research Identifier: NCT02464423     History of Changes
Other Study ID Numbers: R01HD074977 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases