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OpenTrials
Completed

NCT Number: NCT03868644

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HSV-2 Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voluntary Counseling and Testing for HIV (VCT)

Behavioral

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).

Condoms

Behavioral

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

Primary outcomes

  1. HSV-2 prevalence

    Time frame: 2 years post-intervention

    Assessed via a blood test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abdul Latif Jameel Poverty Action Lab

Other

Collaborators

  • Innovations for Poverty Action

Registry information

Official study title

HIV Prevention Among Youth: A Randomized Controlled Trial of Voluntary Counseling and Testing for HIV and Male Condom Distribution in Rural Kenya

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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