PrEP Demonstration Study in Swaziland

NCT ID: NCT03254550

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 517 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-03-02

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.

Conditions

HIV Negative People Identified at Substantial Risk for HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

PrEP Promotion Package

Intervention Type: OTHER

A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

Interventions

PrEP Promotion Package

A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge

Intervention Type: OTHER

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Swaziland

OTHER_GOV

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Mylan Laboratories

INDUSTRY

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sindy Matse, MPH

Role: PRINCIPAL_INVESTIGATOR

Eswatini National AIDS Program

Locations

Hhukwini Clinic

Hhukwini, Hhohho Region, Eswatini

Horo Clini

Horo, Hhohho Region, Eswatini

Ndvwabangeni Nazarene Clinic

Ndvwabangeni, Hhohho Region, Eswatini

Ndzingeni Nazarene Clinic

Ndzingeni, Hhohho Region, Eswatini

Nfontjeni Clinic

Nfontjeni, Hhohho Region, Eswatini

Siphocosini Clinic

Siphocosini, Hhohho Region, Eswatini

Countries

Eswatini

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Swazi PrEP study

Identifier Type: -

Identifier Source: org_study_id