Project TEACH-Kenya (TEACH)

May 7, 2015 updated by: Yvette Calderon,MD, MS, North Bronx Healthcare Network

Project Tailoring Effective And Community-based HIV Interventions in Kenya

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.

Study Overview

Status

Withdrawn

Conditions

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

Phase

  • 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

    • Kasarani
      • Nairobi, Kasarani, Kenya
        • St. Francis Community Hospital
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

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

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Those randomized to the intervention group will be invited to attend the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 15 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Rosy Chhabra, PsyD, Albert Einstein College of Medicine
  • Principal Investigator: Yvette Calderon, MD, MS, North Central Bronx Healthcare Network
  • Study Director: Erick Nyambedha, St. Francis Community Hospital

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

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2013-PA-12-231

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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