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PrEP Demonstration Study in Swaziland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03254550
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : July 11, 2019
Ministry of Health, Swaziland
Heidelberg University
Mylan Laboratories
World Health Organization
Information provided by (Responsible Party):
Clinton Health Access Initiative Inc.

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.

Condition or disease Intervention/treatment Phase
HIV Negative People Identified at Substantial Risk for HIV Infection Other: PrEP Promotion Package Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 517 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Uptake [ Time Frame: 18 months ]
    The monthly number of clients who was initiated on PrEP

Secondary Outcome Measures :
  1. Risk assessment [ Time Frame: 18 months ]
    The monthly number of clients who underwent a risk assessment for PrEP eligibility

  2. Substantial risk [ Time Frame: 18 months ]
    The monthly number of clients who was identified as being at a substantial risk of acquiring HIV

  3. Acceptance conditional on risk [ Time Frame: 18 months ]
    % of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer

  4. Linkage [ Time Frame: 12 months ]
    The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy

  5. Retention at 6 months [ Time Frame: 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. HIV incidence [ Time Frame: 18 month ]
    % of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03254550

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Hhukwini Clinic
Hhukwini, Hhohho Region, Swaziland
Horo Clini
Horo, Hhohho Region, Swaziland
Ndzingeni Nazarene Clinic
Ndzingeni, Hhohho Region, Swaziland
Nfontjeni Clinic
Nfontjeni, Hhohho Region, Swaziland
Siphocosini Clinic
Siphocosini, Hhohho Region, Swaziland
Ndvwabangeni Nazarene Clinic
Ndvwabangeni, Hhohho, Swaziland
Sponsors and Collaborators
Clinton Health Access Initiative Inc.
Ministry of Health, Swaziland
Heidelberg University
Mylan Laboratories
World Health Organization
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Principal Investigator: Sindy Matse, MPH Eswatini National AIDS Program
  Study Documents (Full-Text)

Documents provided by Clinton Health Access Initiative Inc.:
Statistical Analysis Plan  [PDF] December 19, 2018

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Responsible Party: Clinton Health Access Initiative Inc. Identifier: NCT03254550    
Other Study ID Numbers: Swazi PrEP study
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinton Health Access Initiative Inc.:
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases