NCT03868644

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,646

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

5.4 years

First QC Date

March 6, 2019

Last Update Submit

January 10, 2020

Conditions

HIV/AIDSHSV-2 Infection

Keywords

YouthKenyaVoluntary Counseling and Testing for HIVCondomsHIV preventionHSV-2

Outcome Measures

Primary Outcomes (1)

  • HSV-2 prevalence

    Assessed via a blood test

    2 years post-intervention

Secondary Outcomes (7)

  • % of youth who have high HIV knowledge

    2 years post-intervention

  • % of youth who did not use a condom at last intercourse

    2 years post-intervention

  • % of youth who reported having an STI or symptoms of an STI

    2 years post-intervention

  • % of youth who report ever being pregnant

    2 years post-intervention

  • Number of sexual partners

    2 years post-intervention

  • +2 more secondary outcomes

Study Arms (4)

Voluntary Counseling and Testing for HIV (VCT)

EXPERIMENTAL

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)

Condoms

EXPERIMENTAL

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

Behavioral: Condoms

VCT and Condoms

EXPERIMENTAL

Youth are offered both VCT and condoms.

Behavioral: Voluntary Counseling and Testing for HIV (VCT)Behavioral: Condoms

Control

NO INTERVENTION

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

Interventions

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).

VCT and CondomsVoluntary Counseling and Testing for HIV (VCT)
CondomsBEHAVIORAL

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

CondomsVCT and Condoms

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Youth sampled for the study who do not consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31361767DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

SeroconversionCondoms

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune System PhenomenaContraceptive Devices, MaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Esther Duflo

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Pascaline Dupas

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Vandana Sharma

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 11, 2019

Study Start

February 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 14, 2020

Record last verified: 2020-01