Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

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.
    

Intervention name(s): Trauma-Informed Cognitive Behavioral Therapy enhanced (TI-CBTe)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment