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

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

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; HSV-2 Infection
• Intervention / Treatment: Behavioral: Voluntary Counseling and Testing for HIV (VCT); Behavioral: Condoms

• Study Type: Interventional
• Enrollment (Actual): 10646
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abdul Latif Jameel Poverty Action Lab
• Collaborators: Innovations for Poverty Action
• Investigators: Principal Investigator: Esther Duflo, Massachusetts Institute of Technology; Principal Investigator: Pascaline Dupas, Stanford University; Principal Investigator: Vandana Sharma, Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2009
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Kenya; HIV prevention; Youth; HSV-2; Condoms; Voluntary Counseling and Testing for HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 0809002873R010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No