Project TEACH-Kenya (TEACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (We did not receive proper funding to complete this study)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
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network

Brief Summary:
Public health programs and policies have utilized the "combination prevention" model of bringing together tailored, proven interventions in order to reduce the global impact of HIV. Project TEACH-Kenya adapts two effective HIV interventions, Project BRIEF (Behavioral intervention, Rapid HIV test, Innovative video, Efficient cost and health care savings, Facilitated seamless care) and STEP (Skill-based Teenage Education Program for HIV prevention) to increase HIV testing and counseling rates, implement proven risk reduction programs, and improve rates of linkage to care and ART initiation among adolescents in Kenya. The collaboration with St. Francis Community Hospital and input from the Kasarani community will increase the breadth, reach, and impact of this HIV prevention intervention in Kenya.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Risk Reduction Intervention Not Applicable

Detailed Description:
In 2010, HIV/AIDS accounted for up to 29% of all deaths and 24% of all disabilities in Kenya. There is a particular need to concentrate HIV education, testing, and linkage-to-care efforts among high-risk adolescents; by age 18, 47% of women and 58% of men have had sexual intercourse. Only one in four young Kenyans used condoms the first time they had sex, and only half of 15-24 year olds had comprehensive HIV knowledge. The goal of this intervention, Project TEACH-Kenya, is to adapt two proven HIV interventions, Project BRIEF and STEP, to an urban setting in the Kasarani District of the Nairobi Province, Kenya. According to the US President's Emergency Plan for AIDS Relief (PEPFAR) Five-Year Strategy, a successful prevention program brings together a combination of evaluated, tailored interventions, to stem the spread of HIV infection among high-risk populations. This synergistic model, referred to as combination prevention, serves as the basis for adapting the current intervention encompassing HIV testing and counseling, risk behavior reduction programs, and linkage to care and ART initiation to the Kenyan context. Project TEACH-Kenya will develop tailored, theory-based educational videos, linkage procedures, and a tailored prevention program for adolescents 13-18 years old and pilot and test the intervention at St. Francis Community Hospital, a high volume community-based hospital in Kasarani. The majority of adolescents that access St. Francis's services are orphan and vulnerable children affected by HIV/AIDS (OVC-HIV) who are disproportionately poor and malnourished and are at increased risk for acquiring HIV, stressing the need for this intervention. The outcome of this project will be a feasible, evidence-based, cost- and time-effective program to improve HIV education and increase testing and linkage-to-care rates among adolescents in Kenya.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
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.

Primary Outcome Measures :
  1. Feasibility [ Time Frame: up to 15 months ]

    Feasibility of implementing project STEP will be measured by acceptance and participation rates. Evaluation outputs include:

    1. Efficiency: Number of eligible participants, number randomized into each age and experimental group,
    2. Acceptance rates (number of people who agree to participate in program; number who complete the whole 10 week program);
    3. 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.
    4. Satisfaction/acceptability: College student recruitment, receptivity and satisfaction with the project; implementation issues and resource use

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women and minorities will not be excluded from this research study. We will include only adolescents ages 13-18 at time of recruitment in this study, because that is the age group that we are targetting for this intervention. Residents must be of the St. Francis Hospital catchment area

Exclusion Criteria:

  • Over the age of 18 and under the age of 13. Unable to understand the consent process for the study; or otherwise unable to consent to HIV testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its 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
Sponsors and Collaborators
North Bronx Healthcare Network
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

Responsible Party: Yvette Calderon,MD, MS, Principal Investigator, North Bronx Healthcare Network Identifier: NCT01850576     History of Changes
Other Study ID Numbers: 2013-PA-12-231
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network: