NCT03254550

PrEP Demonstration Study in Swaziland

Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: Clinton Health Access Initiative Inc. · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will assess who will be reached with an introduction to and an offer of PrEP - and who will take up PrEP - when PrEP becomes available through different delivery points in the public-sector health system, including outpatient department (OPD), antenatal care (ANC), postnatal care (PNC) , family planning (FP) , and following HIV counseling and testing (VCT). In addition to PrEP reach and PrEP uptake, the study aims to establish PrEP retention and average costs per client, by different health systems delivery points and to assess the effectiveness of a feasible and low-cost PrEP Promotion Package (PPP). The exact composition of PPP will be informed by findings from in-depth- interviews with clients, providers, and PrEP stakeholders. The effect of the PPP on the monthly number of clients who are initiated on PrEP will be studied using a stepped-wedge cluster-randomized design. Specifically, the trial will have two sequences with three healthcare facilities in each sequence, and three periods. In the first period, all healthcare facilities will be in the control phase; in the second period three healthcare facilities will implement the PPP; and in the third period all six healthcare facilities will implement the PPP.

Conditions

• HIV Negative People Identified at Substantial Risk for HIV Infection

Interventions

Type	Name	Description
OTHER	PrEP Promotion Package	A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-01-31
• Completion: 2019-03-02
• First posted: 2017-08-18
• Last updated: 2019-07-11

Locations

6 sites across 1 country: Eswatini