Project TEACH-Kenya (TEACH)
|ClinicalTrials.gov Identifier: NCT01850576|
Recruitment Status : Withdrawn (We did not receive proper funding to complete this study)
First Posted : May 9, 2013
Last Update Posted : May 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Risk Reduction Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Project Tailoring Effective And Community-based HIV Interventions in Kenya|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
Those randomized to the intervention group will be invited to attend the risk reduction intervention.
Behavioral: Risk Reduction Intervention
STEP is based on social learning theory and provides age-appropriate and culturally acceptable HIV prevention information in a format that encourages information growth and skills enhancement. The program is delivered by 'Instructors,' undergraduate college students aged 18-24, one hour per week for 10 weeks.
No Intervention: Control
The control group will receive usual care. Both treatment and control groups will have received the video-based risk reduction intervention.
- Feasibility [ Time Frame: up to 15 months ]
Feasibility of implementing project STEP will be measured by acceptance and participation rates. Evaluation outputs include:
- Efficiency: Number of eligible participants, number randomized into each age and experimental group,
- Acceptance rates (number of people who agree to participate in program; number who complete the whole 10 week program);
- Population characteristics: We will describe the demographic and behavioural profiles of those who participated in the program and those who refuse; the level of HIV knowledge, self efficacy and satisfaction with the program.
- Satisfaction/acceptability: College student recruitment, receptivity and satisfaction with the project; implementation issues and resource use
- Risk Reduction [ Time Frame: up to 15 months ]HIV related knowledge will be measured using the HIV KQ-18; stigma will be measured using the AIDS-Related Stigma Scale. Sexual history will also be measured using the traditional Project B.R.I.E.F. survey. The questionnaire will be piloted for receptiveness. We will ask for ratings of satisfaction with the video-based pre-counseling and education/prevention post test using measures used by Calderon.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850576
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|St. Francis Community Hospital|
|Nairobi, Kasarani, Kenya|
|Principal Investigator:||Rosy Chhabra, PsyD||Albert Einstein College of Medicine, Inc.|
|Principal Investigator:||Yvette Calderon, MD, MS||North Central Bronx Healthcare Network|
|Study Director:||Erick Nyambedha||St. Francis Community Hospital|