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

June 5, 2020 updated by: Hektoen Institute for Medical Research
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
731

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda
        • Cental University Hospital of Kigali - CHUK
      • Kigali, Rwanda
        • WE-ACTx for Hope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hektoen Institute for Medical Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mardge Cohen, MD, We-ACTx
  • Principal Investigator: Sabin Nsanzimana, MD, Rwanda Biomedical Centre
  • Principal Investigator: Geri Donenberg, PhD, University of Illinois-Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HD074977 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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