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PrEP Demonstration Study in Swaziland

NCT03254550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2019-07-11

No results posted yet for this study

Summary

This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention method among individuals at high risk of HIV infection. The trial aims to determine the effect of a healthcare facility-based PrEP promotion package on the number of clients who take up PrEP.

Conditions

  • HIV Negative People Identified at Substantial Risk for HIV Infection

Interventions

OTHER

PrEP Promotion Package

A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

Sponsors & Collaborators

  • Ministry of Health, Swaziland

    collaborator OTHER_GOV

  • Heidelberg University

    collaborator OTHER

  • Mylan Laboratories

    collaborator INDUSTRY

  • World Health Organization

    collaborator OTHER

  • Clinton Health Access Initiative Inc.

    lead OTHER

Principal Investigators

  • Sindy Matse, MPH · Eswatini National AIDS Program

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-01-31
Completion
2019-03-02

Countries

  • Eswatini

Study Locations

More Related Trials

Entities

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 NCT03254550 on ClinicalTrials.gov