NCT01850576

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

May 2, 2013

Last Update Submit

May 7, 2015

Conditions

HIV

Keywords

preventiontestingcounselinglinkage

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    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 Outcomes (1)

  • Risk Reduction

    up to 15 months

Study Arms (2)

Intervention

EXPERIMENTAL

Those randomized to the intervention group will be invited to attend the risk reduction intervention.

Behavioral: Risk Reduction Intervention

Control

NO INTERVENTION

The control group will receive usual care. Both treatment and control groups will have received the video-based risk reduction intervention.

Interventions

Risk Reduction InterventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

St. Francis Community Hospital

Nairobi, Kasarani, Kenya

Location

Study Officials

  • Rosy Chhabra, PsyD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Yvette Calderon, MD, MS

    North Central Bronx Healthcare Network

    PRINCIPAL INVESTIGATOR

  • Erick Nyambedha

    St. Francis Community Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 9, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

US(1)KE(1)