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THE IMPACT OF VCT AND CONDOM DISTRIBUTION AS HIV PREVENTION STRATEGIES AMONG YOUTH IN KENYA
Last registered on December 17, 2013

Pre-Trial

Trial Information
General Information
Title
THE IMPACT OF VCT AND CONDOM DISTRIBUTION AS HIV PREVENTION STRATEGIES AMONG YOUTH IN KENYA
RCT ID
AEARCTR-0000170
Initial registration date
December 17, 2013
Last updated
December 17, 2013 10:42 PM EST
Location(s)
Region
Primary Investigator
Affiliation
MIT
Other Primary Investigator(s)
PI Affiliation
J-PAL
PI Affiliation
Stanford University
Additional Trial Information
Status
Completed
Start date
2009-02-01
End date
2014-07-01
Secondary IDs
Abstract
The vast majority of new HIV infections occur in sub-Saharan Africa, where nearly 2 million people become infected with HIV/AIDS every year. Forty-five percent of these new HIV infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. Ensuring the adoption of safer sexual behavior among youth is critical to keeping the new generations free of HIV.

This research study aims to examine, through a large randomized controlled trial, the impact of two HIV prevention strategies among a youth population in Kenya: Voluntary Counseling and Testing for HIV (VCT), and condom distribution.
External Link(s)
Registration Citation
Citation
Duflo, Esther , Pascaline Dupas and Vandana Sharma. 2013. "THE IMPACT OF VCT AND CONDOM DISTRIBUTION AS HIV PREVENTION STRATEGIES AMONG YOUTH IN KENYA." AEA RCT Registry. December 17. https://doi.org/10.1257/rct.170-2.0
Former Citation
Duflo, Esther , Pascaline Dupas and Vandana Sharma. 2013. "THE IMPACT OF VCT AND CONDOM DISTRIBUTION AS HIV PREVENTION STRATEGIES AMONG YOUTH IN KENYA." AEA RCT Registry. December 17. https://www.socialscienceregistry.org/trials/170/history/716
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The study will evaluate two HIV/AIDS prevention strategies among youth in Kenya either alone or combined. Specifically, the following interventions are being evaluated:

Intervention 1: Voluntary Counseling and Testing for HIV (VCT)
VCT is a critical entry point for access to HIV/AIDS treatment and care, and is being scaled up in many countries. But VCT could also be a powerful prevention tool. By providing personalized counseling as well as information about high-risk behaviors, VCT could motivate people to adopt safer sexual behavior and prevent transmission of HIV. This could be particularly important for adolescents and young adults, who typically have had their sexual debut but might not have perfect information about HIV risk. They are often still HIV-negative, and might be better able to change their sexual behavior.

Intervention 2: Distribution of free condoms
Despite strong evidence of the biological effectiveness of the male condom as an HIV prevention strategy, condom use continues to remain low in many countries. Several factors, such as low availability, cost, lack of education about condoms and how to use them, and relationship factors contribute to low usage. This study examines whether free and easy access to a large quantity of condoms can result in a reduction of risky behaviors and a decline in transmission of STIs among youth.
Intervention Start Date
2009-02-01
Intervention End Date
2010-07-31
Primary Outcomes
Primary Outcomes (end points)
Herpes Simplex Virus Type 2 (HSV-2) prevalence, HIV knowledge, attitudes and behaviours
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study is an unblinded, individually randomized controlled trial. It has 4 study arms – a control arm and three treatment arms (VCT, Free Supply of Condoms, VCT and Free Supply of Condoms), with 25% of the sample allocated to each arm.

The study is being implemented in four districts of Kenya’s Western Province (Butere, Mumias and Bungoma South and Bungoma East), spanning an area of approximately 50,000 square kilometers. The study sample is composed of 10,306 youths (half of them female) who were 17 to 22 years old in 2009 at the start of this study. These youth participated in a baseline survey at the start of the study which involved a detailed questionnaire and blood sample collection for HSV-2 testing. Subjects were immediately offered their assigned intervention, and then were followed up two years later with an end line survey and another round of blood sample collection.
Experimental Design Details
Randomization Method
Randomization done in office by computer
Randomization Unit
individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
N/A
Sample size: planned number of observations
10,306 respondents
Sample size (or number of clusters) by treatment arms
approximately 2,550 per study arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
MIT
IRB Approval Date
2008-09-23
IRB Approval Number
0809002873
IRB Name
Kenya Medical Research Institute
IRB Approval Date
2008-10-17
IRB Approval Number
Non-SSC No. 038
IRB Name
Stanford University
IRB Approval Date
2012-06-18
IRB Approval Number
24687
IRB Name
UCLA
IRB Approval Date
2008-11-19
IRB Approval Number
G08-09-085-01
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers