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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464423
• Other study ID #: R01HD074977
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2020
• Source: Hektoen Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• Trauma-Informed Cognitive Behavioral Therapy enhanced (TI-CBTe)

Locations

Country	Name	City	State
Rwanda	Cental University Hospital of Kigali - CHUK	Kigali
Rwanda	WE-ACTx for Hope	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
Hektoen Institute for Medical Research	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV/AIDS/Sexually Transmitted Infection (STI)-risk	The AIDS-Risk Behavior Assessment (ARBA) measures self-reported sexual behavior and drug use.	Up to 12 months
Primary	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	Health Care Utilization (Number of Clinic Visits)	Track number of mental health and support services visits by youth in both treatment arms.	Up to 12 months