PrEP Demonstration Study in Swaziland

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Negative People Identified at Substantial Risk for HIV Infection
• Intervention / Treatment: Other: PrEP Promotion Package

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 Type: Interventional
• Enrollment (Actual): 517
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Swaziland
  • Hhohho
    • Ndvwabangeni, Hhohho, Swaziland
      • Ndvwabangeni Nazarene Clinic
  • Hhohho Region
    • Hhukwini, Hhohho Region, Swaziland
      • Hhukwini Clinic
    • Horo, Hhohho Region, Swaziland
      • Horo Clini
    • Ndzingeni, Hhohho Region, Swaziland
      • Ndzingeni Nazarene Clinic
    • Nfontjeni, Hhohho Region, Swaziland
      • Nfontjeni Clinic
    • Siphocosini, Hhohho Region, Swaziland
      • Siphocosini Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control phase; 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; 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; A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinton Health Access Initiative Inc.
• Collaborators: Heidelberg University; World Health Organization; Ministry of Health, Swaziland; Mylan Laboratories
• Investigators: Principal Investigator: Sindy Matse, MPH, Eswatini National AIDS Program

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): March 2, 2019

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: PrEP
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: Swazi PrEP study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No