ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02464423
Date of registration:	10/04/2015
Prospective Registration:	No
Primary sponsor:	Hektoen Institute for Medical Research
Public title:	Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model
Scientific title:	Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model
Date of first enrolment:	January 2013
Target sample size:	731
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02464423
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Rwanda

Contacts

Name:	Mardge Cohen, MD
Address:
Telephone:
Email:
Affiliation:	We-ACTx

Name:	Sabin Nsanzimana, MD
Address:
Telephone:
Email:
Affiliation:	Rwanda Biomedical Center

Name:	Geri Donenberg, PhD
Address:
Telephone:
Email:
Affiliation:	University of Illinois-Chicago

Key inclusion & exclusion criteria

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

Age minimum: 14 Years
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus

Intervention(s)

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

Primary Outcome(s)

ART Adherence Behavior Composite Self Report [Time Frame: Up to 12 months]

Secondary Outcome(s)

Health Care Utilization (Number of Clinic Visits) [Time Frame: Up to 12 months]

Secondary ID(s)

R01HD074977

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.