PrEP Demonstration Study in Swaziland

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.

• PrEP Promotion Package (Other): A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

Primary outcomes

• Uptake [18 months]: The monthly number of clients who was initiated on PrEP

Secondary outcomes

• Risk assessment [18 months]: The monthly number of clients who underwent a risk assessment for PrEP eligibility
• Substantial risk [18 months]: The monthly number of clients who was identified as being at a substantial risk of acquiring HIV
• 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
• 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.
• HIV incidence [18 month]: % of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.

Sex: All, ages: 16 Years to any, accepts healthy volunteers

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.

• Statistical Analysis Plan (PDF, 2018-12-19)

• Sindy Matse, MPH, Principal investigator, Eswatini National AIDS Program