PrEP Demonstration Study in Swaziland

Not Applicable

Completed

• Conditions: HIV Negative People Identified at Substantial Risk for HIV Infection

• Registration Number: NCT03254550
• Lead Sponsor: Clinton Health Access Initiative Inc.

Brief 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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-18
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Uptake	18 months	The monthly number of clients who was initiated on PrEP

Secondary Outcome Measures

Name	Time	Method
Substantial risk	18 months	The monthly number of clients who was identified as being at a substantial risk of acquiring HIV
Risk assessment	18 months	The monthly number of clients who underwent a risk assessment for PrEP eligibility
Acceptance conditional on risk	18 months	% of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer
Linkage	12 months	The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy
HIV incidence	18 month	% of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.
Retention at 6 months	6 months	% of clients taking PrEP who were retained at six months after PrEP initiation. Retention was defined as attending all follow-up visits during the first 180 days after PrEP initiation not more than seven days after the scheduled appointment.

Trial Locations

Locations (6)

Hhukwini Clinic; 🇸🇿 Hhukwini, Hhohho Region, Swaziland

Horo Clini; 🇸🇿 Horo, Hhohho Region, Swaziland

Ndzingeni Nazarene Clinic; 🇸🇿 Ndzingeni, Hhohho Region, Swaziland

Nfontjeni Clinic; 🇸🇿 Nfontjeni, Hhohho Region, Swaziland

Siphocosini Clinic; 🇸🇿 Siphocosini, Hhohho Region, Swaziland

Ndvwabangeni Nazarene Clinic; 🇸🇿 Ndvwabangeni, Hhohho, Swaziland