NCT03254550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

August 17, 2017

Last Update Submit

July 9, 2019

Conditions

HIV Negative People Identified at Substantial Risk for HIV Infection

Keywords

PrEP

Outcome Measures

Primary Outcomes (1)

  • Uptake

    The monthly number of clients who was initiated on PrEP

    18 months

Secondary Outcomes (6)

  • Risk assessment

    18 months

  • Substantial risk

    18 months

  • Acceptance conditional on risk

    18 months

  • Linkage

    12 months

  • Retention at 6 months

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Control phase

NO INTERVENTION

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.

Intervention phase

EXPERIMENTAL

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

Interventions

PrEP Promotion PackageOTHER

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

Intervention phase

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hhukwini Clinic

Hhukwini, Hhohho Region, Eswatini

Location

Horo Clini

Horo, Hhohho Region, Eswatini

Location

Ndvwabangeni Nazarene Clinic

Ndvwabangeni, Hhohho Region, Eswatini

Location

Ndzingeni Nazarene Clinic

Ndzingeni, Hhohho Region, Eswatini

Location

Nfontjeni Clinic

Nfontjeni, Hhohho Region, Eswatini

Location

Siphocosini Clinic

Siphocosini, Hhohho Region, Eswatini

Location

Study Officials

  • Sindy Matse, MPH

    Eswatini National AIDS Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Healthcare facilities will not be informed as to when they are expected to start implementing the intervention (the PrEP Promotion Package) until two weeks prior to the start of the intervention phase.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 18, 2017

Study Start

August 1, 2017

Primary Completion

January 31, 2019

Study Completion

March 2, 2019

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(6)