PrEP Demonstration Study in Swaziland

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Negative People Identified at Substantial Risk for HIV Infection

Intervention / Treatment
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* Other: PrEP Promotion Package


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a stepped-wedge randomized design (there was no option for stepped-wedge design in the drop-down menu) with two sequences (each consisting of three healthcare facilities) and three periods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control phase<br>This is the provision of PrEP without the use of the PrEP Promotion Package. PrEP promotion in the control phase consists of each clinic displaying posters that advertise PrEP, pamphlets, and palm cards that patients can take home from the clinic. | |
| Experimental: Intervention phase<br>This is the provision of PrEP as in the control phase plus the addition of five PrEP promotion components, which constitute the PrEP Promotion Package (PPP). These five additions are: 1) a PrEP promotion video to be played in the waiting room, 2) T-shirts advertising PrEP to be worn by healthcare workers, iii) a flipchart to support healthcare workers' PrEP counseling, iv) an informational booklet for clients to take home, and v) self-risk assessment forms to be displayed in the waiting room. | Other: PrEP Promotion Package<br>* A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake | The monthly number of clients who was initiated on PrEP | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk assessment | The monthly number of clients who underwent a risk assessment for PrEP eligibility | 18 months | 
| Substantial risk | The monthly number of clients who was identified as being at a substantial risk of acquiring HIV | 18 months | 
| Acceptance conditional on risk | % of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer | 18 months | 
| Linkage | The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy | 12 months | 
| Retention at 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. | 6 months | 
| HIV incidence | % of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP. | 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP