Clinical trial NCT03254550: PrEP Demonstration Study in Swaziland
Official title: Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Negative People Identified at Substantial Risk for HIV Infection
Keywords: PrEP
Lead sponsor: Clinton Health Access Initiative Inc.
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Swaziland
name: Heidelberg University
name: Mylan Laboratories
name: World Health Organization
First posted: 2017-08-18
Enrollment: 517
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Uptake
timeFrame: 18 months
Secondary outcomes:
measure: Risk assessment
timeFrame: 18 months
measure: Substantial risk
timeFrame: 18 months
measure: Acceptance conditional on risk
timeFrame: 18 months
measure: Linkage
timeFrame: 12 months
measure: Retention at 6 months
timeFrame: 6 months
measure: HIV incidence
timeFrame: 18 month
Other outcomes:
Locations:
city: Hhukwini
country: Swaziland
facility: Hhukwini Clinic
state: Hhohho Region
city: Horo
country: Swaziland
facility: Horo Clini
state: Hhohho Region
city: Ndzingeni
country: Swaziland
facility: Ndzingeni Nazarene Clinic
state: Hhohho Region
city: Nfontjeni
country: Swaziland
facility: Nfontjeni Clinic
state: Hhohho Region
city: Siphocosini
country: Swaziland
facility: Siphocosini Clinic
state: Hhohho Region
city: Ndvwabangeni
country: Swaziland
facility: Ndvwabangeni Nazarene Clinic
state: Hhohho
Study officials:
affiliation: Eswatini National AIDS Program
name: Sindy Matse, MPH
role: PRINCIPAL_INVESTIGATOR
References: