PrEP Demonstration Study in Swaziland

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

NCT03254550•Clinton Health Access Initiative Inc.

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.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Confirmed HIV negative by rapid antibody test following the National HIV testing services (HTS) algorithm on the day of PrEP initiation
•\> 16 years of age
•Willing and able to provide written informed consent
•Identified at substantial risk of acquiring HIV infection
•No current or recent illness (within past month) consistent with acute HIV infection in combination with a preceding high risk exposure for HIV
•No contraindications to the use of Tenofovir(TDF)/Lamivudine (3TC)
•Ready to adhere to PrEP and willing to attend the follow up evaluations including repeat HIV testing and monitoring for side-effects

Exclusion Criteria

•Younger than 16 years of age
•Currently having symptoms of acute HIV infection
•Suspicion of window period following a potential exposure to HIV
•Body weight \< 40 kg
•Creatinine clearance \<60 ml/min
•Using other nephrotoxic drugs (e.g. aminoglycosides)
•Not willing to come for follow up visits every 3 months which will include HIV testing and counselling and monitoring for side-effects.

Locations (6)

Hhukwini Clinic

Hhukwini, Hhohho Region, Eswatini

Horo Clini

Horo, Hhohho Region, Eswatini

Ndvwabangeni Nazarene Clinic

Ndvwabangeni, Hhohho Region, Eswatini

Ndzingeni Nazarene Clinic

Ndzingeni, Hhohho Region, Eswatini

Nfontjeni Clinic

Nfontjeni, Hhohho Region, Eswatini

Siphocosini Clinic

Siphocosini, Hhohho Region, Eswatini

Key Dates

Start Date

August 1, 2017

Primary Completion Date

January 31, 2019

Completion Date

March 2, 2019

Last Updated

July 11, 2019

Enrollment

517

ACTUAL participants

Conditions

HIV Negative People Identified at Substantial Risk for HIV Infection

Interventions

PrEP Promotion Package

OTHER