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NCT03254550

PrEP Demonstration Study in Swaziland

Completed NA Last updated 11 July 2019
What this trial tests

NA trial testing PrEP Promotion Package in HIV Negative People Identified at Substantial Risk for HIV Infection in 517 participants. Completed in 2 March 2019.

Timeline
1 August 2017
Primary endpoint
31 January 2019
2 March 2019

Quick facts

Lead sponsorClinton Health Access Initiative Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment517
Start date1 August 2017
Primary completion31 January 2019
Estimated completion2 March 2019
Sites6 locations across Eswatini

Drugs / interventions tested

Conditions studied

Sponsor

Clinton Health Access Initiative Inc.

Who can join

16 and older, any sex, with HIV Negative People Identified at Substantial Risk for HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A stepped-wedge randomized trial and qualitative survey of HIV pre-exposure prophylaxis uptake in the Eswatini population.
    Geldsetzer P, Bärnighausen K, Hettema A, McMahon SA, et al · · 2020 · cited 14× · PMID 32967974 · DOI 10.1126/scitranslmed.aba4487

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