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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS, HSV-2 Infection

Intervention / Treatment
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* Behavioral: Voluntary Counseling and Testing for HIV (VCT)
* Behavioral: Condoms


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voluntary Counseling and Testing for HIV (VCT)<br>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)<br>* 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).<br>|
| Experimental: Condoms<br>Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge. | Behavioral: Condoms<br>* Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.<br>|
| Experimental: VCT and Condoms<br>Youth are offered both VCT and condoms. | Behavioral: Voluntary Counseling and Testing for HIV (VCT)<br>* 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).<br>Behavioral: Condoms<br>* Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.<br>|
| No Intervention: Control<br>No intervention is provided (beyond the standard available HIV prevention services within the area) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSV-2 prevalence | Assessed via a blood test | 2 years post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of youth who have high HIV knowledge | Assessed via a questionnaire | 2 years post-intervention | 
| % of youth who did not use a condom at last intercourse | Assessed via a questionnaire | 2 years post-intervention | 
| % of youth who reported having an STI or symptoms of an STI | Assessed via a questionnaire | 2 years post-intervention | 
| % of youth who report ever being pregnant | Assessed via a questionnaire | 2 years post-intervention | 
| Number of sexual partners | Assessed via a questionnaire | 2 years post-intervention | 
| HIV prevalence | Assessed via a blood test | 2 years post-intervention | 
| % of youth who have accepting attitudes towards people living with HIV (PLHIV) | Assessed via a questionnaire | 2 years post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Youth, Kenya, Voluntary Counseling and Testing for HIV, Condoms, HIV prevention, HSV-2