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Project TEACH-Kenya

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by North Bronx Healthcare Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01850576
First received: May 2, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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 Intervention
HIV
Behavioral: Risk Reduction Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project Tailoring Effective And Community-based HIV Interventions in Kenya

Resource links provided by NLM:


Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:
  • Feasibility [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]

    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

  • Risk Reduction [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]
    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 ratings with the video-based pre-counseling and education/prevention post test using measures used by Calderon.


Estimated Enrollment: 300
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850576

Contacts
Contact: Esther Mwangi 718-862-1720 essymimo@yahoo.co.uk
Contact: John Y Rhee, BS 646-241-6792 jyr5@cornell.edu

Locations
United States, New York
Albert Einstein College of Medicine Not yet recruiting
Bronx, New York, United States, 10461
Contact: Yvette Calderon, MD, MS    718-918-5845    ycalderon@gmail.com   
Sub-Investigator: Lauri J Bauman, PhD         
Sub-Investigator: Ethan Cowan, MD, MS         
Principal Investigator: Rosy Chhabra, PsyD         
Principal Investigator: Yvette Calderon, MD, MS         
Sub-Investigator: Ellen Silver, PhD         
Sub-Investigator: Jill Raufman, MS, MPH         
Kenya
St. Francis Community Hospital Not yet recruiting
Nairobi, Kasarani, Kenya
Contact: Esther Mwangbi    718-918-5845    essymimo@yahoo.co.uk   
Sub-Investigator: Esther Mwangi         
Sub-Investigator: Oscar Shitero, MD         
Sub-Investigator: Erick O Nyambedha, PhD         
Sponsors and Collaborators
North Bronx Healthcare Network
Investigators
Principal Investigator: Rosy Chhabra, PsyD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Yvette Calderon, MD, MS Albert Einstein College of Medicine of Yeshiva University
Study Director: Erick Nyambedha St. Francis Community Hospital
  More Information

No publications provided

Responsible Party: Yvette Calderon,MD, MS, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01850576     History of Changes
Other Study ID Numbers: 2013-PA-12-231
Study First Received: May 2, 2013
Last Updated: May 8, 2013
Health Authority: United States: Federal Government
Kenya: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:
prevention
testing
counseling
linkage

ClinicalTrials.gov processed this record on November 25, 2014