Back to resultsThe Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya
Primary Purpose
HIV/AIDS, HSV-2 Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Voluntary Counseling and Testing for HIV (VCT)
Condoms
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS focused on measuring Youth, Kenya, Voluntary Counseling and Testing for HIV, Condoms, HIV prevention, HSV-2
Eligibility Criteria
Inclusion Criteria:
Youth previously participated in an earlier study by Duflo, Dupas and Kremer in 328 primary schools in the same study site in Western Province, Kenya who consent to participate.
Exclusion Criteria:
Youth sampled for the study who do not consent to participate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Voluntary Counseling and Testing for HIV (VCT)
Condoms
VCT and Condoms
Control
Arm Description
Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP).
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.
Youth are offered both VCT and condoms.
No intervention is provided (beyond the standard available HIV prevention services within the area)
Outcomes
Primary Outcome Measures
HSV-2 prevalence
Assessed via a blood test
Secondary Outcome Measures
% of youth who have high HIV knowledge
Assessed via a questionnaire
% of youth who did not use a condom at last intercourse
Assessed via a questionnaire
% of youth who reported having an STI or symptoms of an STI
Assessed via a questionnaire
% of youth who report ever being pregnant
Assessed via a questionnaire
Number of sexual partners
Assessed via a questionnaire
HIV prevalence
Assessed via a blood test
% of youth who have accepting attitudes towards people living with HIV (PLHIV)
Assessed via a questionnaire
Full Information
NCT ID
NCT03868644
First Posted
March 6, 2019
Last Updated
January 10, 2020
Sponsor
Abdul Latif Jameel Poverty Action Lab
Collaborators
Innovations for Poverty Action
1. Study Identification
Unique Protocol Identification Number
NCT03868644
Brief Title
The Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya
Official Title
HIV Prevention Among Youth: A Randomized Controlled Trial of Voluntary Counseling and Testing for HIV and Male Condom Distribution in Rural Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2009 (Actual)
Primary Completion Date
July 1, 2014 (Actual)
Study Completion Date
July 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abdul Latif Jameel Poverty Action Lab
Collaborators
Innovations for Poverty Action
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HSV-2 Infection
Keywords
Youth, Kenya, Voluntary Counseling and Testing for HIV, Condoms, HIV prevention, HSV-2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10646 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voluntary Counseling and Testing for HIV (VCT)
Arm Type
Experimental
Arm Description
Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP).
Arm Title
Condoms
Arm Type
Experimental
Arm Description
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.
Arm Title
VCT and Condoms
Arm Type
Experimental
Arm Description
Youth are offered both VCT and condoms.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention is provided (beyond the standard available HIV prevention services within the area)
Intervention Type
Behavioral
Intervention Name(s)
Voluntary Counseling and Testing for HIV (VCT)
Intervention Description
Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP).
Intervention Type
Behavioral
Intervention Name(s)
Condoms
Intervention Description
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.
Primary Outcome Measure Information:
Title
HSV-2 prevalence
Description
Assessed via a blood test
Time Frame
2 years post-intervention
Secondary Outcome Measure Information:
Title
% of youth who have high HIV knowledge
Description
Assessed via a questionnaire
Time Frame
2 years post-intervention
Title
% of youth who did not use a condom at last intercourse
Description
Assessed via a questionnaire
Time Frame
2 years post-intervention
Title
% of youth who reported having an STI or symptoms of an STI
Description
Assessed via a questionnaire
Time Frame
2 years post-intervention
Title
% of youth who report ever being pregnant
Description
Assessed via a questionnaire
Time Frame
2 years post-intervention
Title
Number of sexual partners
Description
Assessed via a questionnaire
Time Frame
2 years post-intervention
Title
HIV prevalence
Description
Assessed via a blood test
Time Frame
2 years post-intervention
Title
% of youth who have accepting attitudes towards people living with HIV (PLHIV)
Description
Assessed via a questionnaire
Time Frame
2 years post-intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Youth previously participated in an earlier study by Duflo, Dupas and Kremer in 328 primary schools in the same study site in Western Province, Kenya who consent to participate.
Exclusion Criteria:
Youth sampled for the study who do not consent to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Duflo
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascaline Dupas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vandana Sharma
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
31361767
Citation
Duflo E, Dupas P, Ginn T, Barasa GM, Baraza M, Pouliquen V, Sharma V. HIV prevention among youth: A randomized controlled trial of voluntary counseling and testing for HIV and male condom distribution in rural Kenya. PLoS One. 2019 Jul 30;14(7):e0219535. doi: 10.1371/journal.pone.0219535. eCollection 2019.
Results Reference
derived
Learn more about this trial
The Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya
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