- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850576
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
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:
|
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.
Sponsor
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
Keywords
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.
Clinical Trials on HIV
-
Duke UniversityGilead SciencesRecruitingHIV Prevention | HIV Pre-exposure Prophylaxis | HIV Prevention Program | HIV Prevention and Care | HIV Pre-exposure Prophylaxis UseUnited States
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RecruitingPrEP | HIV | HIV Prevention | PrEP UptakeUnited States
-
Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)RecruitingHIV Prevention | PrEP Adherence | HIV Related StigmaThailand
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RecruitingFeasibility | HIV Prevention | PrEP Uptake | Acceptability | HIV Self-testing | Male Partners of HIV-negative Postpartum WomenSouth Africa
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRecruitingPregnancy | HIV | Post-partum | HIV Antiretroviral Therapy (ART) AdherenceBotswana
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingHIV Prevention | HIV Risk Behavior | HIV Counseling and TestingUnited States
Clinical Trials on Risk Reduction Intervention
-
University of PennsylvaniaNational Institute on Minority Health and Health Disparities (NIMHD)CompletedHuman Immunodeficiency Virus (HIV) | Sexually Transmitted Disease (STD)United States
-
University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMaternal Cytomegalovirus Infections | Cytomegalovirus CongenitalUnited States
-
Emory UniversityAmerican University of ArmeniaCompletedHIV Infections | HIV PreventionArmenia
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedHIV Infections | Sexually Transmitted DiseasesUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse... and other collaboratorsCompleted
-
Temple UniversityColumbia University; Centers for Disease Control and Prevention; Nova Southeastern...Unknown
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedSexually Transmitted Disease (STD) | Human Immunodeficiency Virus Infection (HIV)United States
-
Aga Khan UniversityRoyal Society of Tropical Medicine and Hygiene (RSTMH) funded by NIHRNot yet recruitingCardiovascular Diseases | Lung Diseases | Diabetes Mellitus | Cancer
-
University of New MexicoWithdrawnAlcohol Use | Drug Use | Sexual Risk BehaviorUnited States