<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03254550</url>
  </required_header>
  <id_info>
    <org_study_id>Swazi PrEP study</org_study_id>
    <nct_id>NCT03254550</nct_id>
  </id_info>
  <brief_title>PrEP Demonstration Study in Swaziland</brief_title>
  <official_title>Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinton Health Access Initiative Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Swaziland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mylan Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinton Health Access Initiative Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort&#xD;
      study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis&#xD;
      (PrEP) in Swaziland as an additional HIV combination prevention method among individuals at&#xD;
      high risk of HIV infection. The trial aims to determine the effect of a healthcare&#xD;
      facility-based PrEP promotion package on the number of clients who take up PrEP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will assess who will be reached with an introduction to and an offer of PrEP - and&#xD;
      who will take up PrEP - when PrEP becomes available through different delivery points in the&#xD;
      public-sector health system, including outpatient department (OPD), antenatal care (ANC),&#xD;
      postnatal care (PNC) , family planning (FP) , and following HIV counseling and testing (VCT).&#xD;
&#xD;
      In addition to PrEP reach and PrEP uptake, the study aims to establish PrEP retention and&#xD;
      average costs per client, by different health systems delivery points and to assess the&#xD;
      effectiveness of a feasible and low-cost PrEP Promotion Package (PPP). The exact composition&#xD;
      of PPP will be informed by findings from in-depth- interviews with clients, providers, and&#xD;
      PrEP stakeholders. The effect of the PPP on the monthly number of clients who are initiated&#xD;
      on PrEP will be studied using a stepped-wedge cluster-randomized design. Specifically, the&#xD;
      trial will have two sequences with three healthcare facilities in each sequence, and three&#xD;
      periods. In the first period, all healthcare facilities will be in the control phase; in the&#xD;
      second period three healthcare facilities will implement the PPP; and in the third period all&#xD;
      six healthcare facilities will implement the PPP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">March 2, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake</measure>
    <time_frame>18 months</time_frame>
    <description>The monthly number of clients who was initiated on PrEP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk assessment</measure>
    <time_frame>18 months</time_frame>
    <description>The monthly number of clients who underwent a risk assessment for PrEP eligibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substantial risk</measure>
    <time_frame>18 months</time_frame>
    <description>The monthly number of clients who was identified as being at a substantial risk of acquiring HIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance conditional on risk</measure>
    <time_frame>18 months</time_frame>
    <description>% of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linkage</measure>
    <time_frame>12 months</time_frame>
    <description>The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>% 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV incidence</measure>
    <time_frame>18 month</time_frame>
    <description>% of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">517</enrollment>
  <condition>HIV Negative People Identified at Substantial Risk for HIV Infection</condition>
  <arm_group>
    <arm_group_label>Control phase</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PrEP Promotion Package</intervention_name>
    <description>A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge</description>
    <arm_group_label>Intervention phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed HIV negative by rapid antibody test following the National HIV testing&#xD;
             services (HTS) algorithm on the day of PrEP initiation&#xD;
&#xD;
          -  &gt; 16 years of age&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Identified at substantial risk of acquiring HIV infection&#xD;
&#xD;
          -  No current or recent illness (within past month) consistent with acute HIV infection&#xD;
             in combination with a preceding high risk exposure for HIV&#xD;
&#xD;
          -  No contraindications to the use of Tenofovir(TDF)/Lamivudine (3TC)&#xD;
&#xD;
          -  Ready to adhere to PrEP and willing to attend the follow up evaluations including&#xD;
             repeat HIV testing and monitoring for side-effects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 16 years of age&#xD;
&#xD;
          -  Currently having symptoms of acute HIV infection&#xD;
&#xD;
          -  Suspicion of window period following a potential exposure to HIV&#xD;
&#xD;
          -  Body weight &lt; 40 kg&#xD;
&#xD;
          -  Creatinine clearance &lt;60 ml/min&#xD;
&#xD;
          -  Using other nephrotoxic drugs (e.g. aminoglycosides)&#xD;
&#xD;
          -  Not willing to come for follow up visits every 3 months which will include HIV testing&#xD;
             and counselling and monitoring for side-effects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sindy Matse, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eswatini National AIDS Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hhukwini Clinic</name>
      <address>
        <city>Hhukwini</city>
        <state>Hhohho Region</state>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horo Clini</name>
      <address>
        <city>Horo</city>
        <state>Hhohho Region</state>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ndzingeni Nazarene Clinic</name>
      <address>
        <city>Ndzingeni</city>
        <state>Hhohho Region</state>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nfontjeni Clinic</name>
      <address>
        <city>Nfontjeni</city>
        <state>Hhohho Region</state>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siphocosini Clinic</name>
      <address>
        <city>Siphocosini</city>
        <state>Hhohho Region</state>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ndvwabangeni Nazarene Clinic</name>
      <address>
        <city>Ndvwabangeni</city>
        <state>Hhohho</state>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Swaziland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 9, 2019</last_update_submitted>
  <last_update_submitted_qc>July 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PrEP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03254550/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254550
org study id: Swazi PrEP study
nct id: NCT03254550
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Health Services Research
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.
measure: Uptake
time frame: 18 months
description: The monthly number of clients who was initiated on PrEP
measure: Risk assessment
time frame: 18 months
description: The monthly number of clients who underwent a risk assessment for PrEP eligibility
measure: Substantial risk
time frame: 18 months
description: The monthly number of clients who was identified as being at a substantial risk of acquiring HIV
measure: Acceptance conditional on risk
time frame: 18 months
description: % of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer
measure: Linkage
time frame: 12 months
description: The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy
measure: Retention at 6 months
time frame: 6 months
description: % 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.
measure: HIV incidence
time frame: 18 month
description: % of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.
arm group label: Control phase
arm group type: No Intervention
description: 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.
arm group label: Intervention phase
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: PrEP Promotion Package
description: A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge
arm group label: Intervention phase
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sindy Matse, MPH
role: Principal Investigator
affiliation: Eswatini National AIDS Program
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Swaziland
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: No
provided document: 