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Kenya HIV Self-Testing in PrEP Delivery

NCT03593629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 790

Last updated 2024-06-04

Study results available
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Summary

In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.

Conditions

Interventions

COMBINATION_PRODUCT

6-month PrEP + blood-based HIV self-test

Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.

COMBINATION_PRODUCT

6-month PrEP + oral fluid HIV self-test

Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.

Sponsors & Collaborators

Principal Investigators

  • Jared Baeten, MD, PhD · University of Washington

  • Kenneth Ngure, PhD, MPH · Jomo Kenyatta University of Agriculture and Technology

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2020-12-10
Completion
2021-05-25

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593629 on ClinicalTrials.gov