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Trial record 44 of 126 for:    HSV-2

The Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868644
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Innovations for Poverty Action
Information provided by (Responsible Party):
Abdul Latif Jameel Poverty Action Lab

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.


Condition or disease Intervention/treatment Phase
HIV/AIDS HSV-2 Infection Behavioral: Voluntary Counseling and Testing for HIV (VCT) Behavioral: Condoms Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10646 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HIV Prevention Among Youth: A Randomized Controlled Trial of Voluntary Counseling and Testing for HIV and Male Condom Distribution in Rural Kenya
Actual Study Start Date : February 1, 2009
Actual Primary Completion Date : July 1, 2014
Actual Study Completion Date : July 1, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Voluntary Counseling and Testing for HIV (VCT)
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).
Behavioral: Voluntary Counseling and Testing for HIV (VCT)
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).

Experimental: Condoms
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.
Behavioral: Condoms
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.

Experimental: VCT and Condoms
Youth are offered both VCT and condoms.
Behavioral: Voluntary Counseling and Testing for HIV (VCT)
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).

Behavioral: Condoms
Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.

No Intervention: Control
No intervention is provided (beyond the standard available HIV prevention services within the area)



Primary Outcome Measures :
  1. HSV-2 prevalence [ Time Frame: 2 years post-intervention ]
    Assessed via a blood test


Secondary Outcome Measures :
  1. % of youth who have high HIV knowledge [ Time Frame: 2 years post-intervention ]
    Assessed via a questionnaire

  2. % of youth who did not use a condom at last intercourse [ Time Frame: 2 years post-intervention ]
    Assessed via a questionnaire

  3. % of youth who reported having an STI or symptoms of an STI [ Time Frame: 2 years post-intervention ]
    Assessed via a questionnaire

  4. % of youth who report ever being pregnant [ Time Frame: 2 years post-intervention ]
    Assessed via a questionnaire

  5. Number of sexual partners [ Time Frame: 2 years post-intervention ]
    Assessed via a questionnaire

  6. HIV prevalence [ Time Frame: 2 years post-intervention ]
    Assessed via a blood test

  7. % of youth who have accepting attitudes towards people living with HIV (PLHIV) [ Time Frame: 2 years post-intervention ]
    Assessed via a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868644


Sponsors and Collaborators
Abdul Latif Jameel Poverty Action Lab
Innovations for Poverty Action
Investigators
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Principal Investigator: Esther Duflo Massachusetts Institute of Technology
Principal Investigator: Pascaline Dupas Stanford University
Principal Investigator: Vandana Sharma Harvard School of Public Health

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Responsible Party: Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT03868644     History of Changes
Other Study ID Numbers: 0809002873R010
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdul Latif Jameel Poverty Action Lab:
Youth
Kenya
Voluntary Counseling and Testing for HIV
Condoms
HIV prevention
HSV-2