xml: <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/NCT06030856</url>
    </required_header>
    <id_info>
      <org_study_id>PALESA</org_study_id>
      <nct_id>NCT06030856</nct_id>
    </id_info>
    <brief_title>PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk</brief_title>
    <acronym>PALESA</acronym>
    <official_title>A Pilot Randomized Controlled Trial to Assess a Model of Decentralised STI-Self Testing and Risk Self-Assessment Among Adolescent Girls and Young Women in South Africa to Trigger PrEP Re-start</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wits RHI Research Centre Clinical Research Site</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Wits RHI Research Centre Clinical Research Site</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 is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use&#xD;
        within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits&#xD;
        (Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)) with&#xD;
        in-person instruction at enrolment and telephone/video-based instructions for home use&#xD;
        coupled with self-administered behavioural risk assessment or 2) self-administered&#xD;
        behavioural risk assessment only (standard of care). All participants will receive&#xD;
        comprehensive sexual and reproductive health (SRH) services during their study visits&#xD;
        including choice of family planning method initiation and support, and behavioural HIV/STI&#xD;
        risk reduction counselling.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The PALESA study aims to determine the feasibility of conducting a randomized controlled&#xD;
        trial (RCT) to determine the impact of decentralized sexually transmitted infection (STI)&#xD;
        point of care (POC) self-testing and risk self-assessment interventions to trigger&#xD;
        pre-exposure prophylaxis (PrEP) re-start among adolescent girls and young women (AGYW) in&#xD;
        South Africa at potential ongoing risk of re- acquiring STIs and HIV.&#xD;
  &#xD;
        This overall study comprises two components that include a formative research study enrolling&#xD;
        ~60 participants for qualitative in-depth interviews (IDIs) (this has been completed) and a&#xD;
        prospective cohort study (Pilot randomized controlled trial - RCT) enrolling 50 AGYW with&#xD;
        both clinical, diagnostic laboratory and nested qualitative methodologies.&#xD;
  &#xD;
        The RCT seeks to establish the feasibility of conducting a randomized controlled trial among&#xD;
        AGYW in South Africa to determine the impact of decentralized or at-home STI testing [(for&#xD;
        Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)] on&#xD;
        restarting PrEP relative to a self-administered behavioural risk assessment. Additionally&#xD;
        qualitative interviews will be conducted to assess adolescent girls experiences of at-home&#xD;
        STI testing, behavioural risk assessment, and re-starting PrEP while participating in the&#xD;
        pilot trial through exit interviews.&#xD;
  &#xD;
        Objective 1: To determine the feasibility and acceptability of conducting a RCT among South&#xD;
        African AGYW to determine the impact of STI self-testing coupled with a self-administered&#xD;
        behavioural risk assessment on restarting PrEP relative to a self-administered behavioural&#xD;
        risk assessment only&#xD;
  &#xD;
        Objective 2: To assess AGYW acceptability of and experiences with use at-home STI testing,&#xD;
        self-administered behavioural risk assessment, and re-starting PrEP while participating in&#xD;
        the pilot RCT&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants enrolled and retained in the PALESA study</measure>
      <time_frame>1 year</time_frame>
      <description>A recruitment target of 50 adolescent girls and young women and over 90% retention of those participants is achieved</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing Risk of Acquiring HIV and STIs</measure>
      <time_frame>1 year</time_frame>
      <description>A self administered behavioural risk assessment questionnaire with 16 - 20 questions (which include questions on STI test results), which will tally up a score, will be used to measure how much counselling and guidance will the participants need to restart PrEP.&#xD;
  A score of 0 - 7 means medium recommendation to restart PrEP. A score 8-15 means a strong recommendation to restart PrEP. Test results of STIs from the self-testing STI kit are shared on the self-administered behavioural risk assessment questionnaire.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants that restarted PrEP</measure>
      <time_frame>1 year</time_frame>
      <description>There will be a dispensation form for every participant, this form will indicate if PrEP was restarted by the participant, and it will calculate include pill counts when PrEP bottles are returned to the research site</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PrEP continuation 1 month after re-start</measure>
      <time_frame>1 year</time_frame>
      <description>Dried Blood Spot (DBS) collected to measure tenofovir diphosphate (TFV-DP) level as an objective assessment of adherence to PrEP.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Experiences of at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP</measure>
      <time_frame>1 year</time_frame>
      <description>In-Depth Interviews will be conducted to collect participant's experience while in the study and tools used during the study.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>HIV Prevention</condition>
    <arm_group>
      <arm_group_label>STI test kits for home use coupled with self-administered behavioural risk assessment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The adolescent will receive STI test kits (NG, CT and TV) for home use coupled with self-administered behavioural risk assessment at the screening and enrolment visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Self-administered behavioural risk assessment only (standard of care)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The adolescent will receive a self-administered behavioural risk assessment at the screening and enrolment visit</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>STI test kits (NG, CT and TV) for home use</intervention_name>
      <description>The adolescent randomized to the at-home STI testing arm will be provided with in-person instruction at enrollment and flyers (in English and isiZulu) with printed step-by-step instructions for kit use. Information will include details on how to store the kits, criteria for adequate specimen collection and preparation, how to run the test, and how to interpret the test results. Video-based instructions with accompanying text subtitles and audio options may also be provided for home use.</description>
      <arm_group_label>STI test kits for home use coupled with self-administered behavioural risk assessment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Self Administered Behavioural Risk Assessment</intervention_name>
      <description>Self Administered assessment to determine risk of HIV, STIs and pregnancy</description>
      <arm_group_label>STI test kits for home use coupled with self-administered behavioural risk assessment</arm_group_label>
      <arm_group_label>Self-administered behavioural risk assessment only (standard of care)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For the full cohort, all participants must:&#xD;
  &#xD;
                 -  Be cis-gender adolescent females (16-20 years of age)&#xD;
  &#xD;
                 -  Be literate&#xD;
  &#xD;
                 -  Currently sexually active&#xD;
  &#xD;
                 -  Be willing to participate in in-person and virtual study visits&#xD;
  &#xD;
                 -  Not be pregnant or planning to be pregnant for the next 6 months&#xD;
  &#xD;
                 -  Be HIV-negative but not ready to initiate PrEP at the screening and enrolment&#xD;
                    visit&#xD;
  &#xD;
                 -  Have used PrEP with subsequent discontinuation within the last 6 months&#xD;
  &#xD;
                 -  Have no contraindications to oral PrEP per self-report&#xD;
  &#xD;
                 -  Have no indication of possible acute HIV infection, according to South African&#xD;
                    PrEP guidelines&#xD;
  &#xD;
                 -  Have their own personal smart phone&#xD;
  &#xD;
                 -  Willing to provide written informed consent/assent to participate in this study&#xD;
  &#xD;
          For the subset invited to qualitative interviews, all participants must be:&#xD;
  &#xD;
          • Willing to participate in an IDI at/before their month 6 visit (study exit visit)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Potential AGYW participants who meet any of the following criteria will be excluded&#xD;
               from the study:&#xD;
  &#xD;
                 -  At Screening and Enrollment, parent/guardian (for those participants &lt;18 years)&#xD;
                    is unwilling to provide written informed consent&#xD;
  &#xD;
                 -  At Screening and Enrollment, is already participating in another research study&#xD;
                    involving drugs, medical devices, or vaccines for STI prevention or treatment.&#xD;
  &#xD;
                 -  Is not willing to comply with study procedures&#xD;
  &#xD;
                 -  As determined by the PIs/designee, any current or historical physical health,&#xD;
                    mental health or social issue or condition that the site investigator or designee&#xD;
                    determines should exclude participation.&#xD;
  &#xD;
                 -  Has any other condition that, in the opinion of the PIs/designee, would preclude&#xD;
                    informed consent, make study participation unsafe, or otherwise interfere with&#xD;
                    achieving the study objectives.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thesla Palanee-Phillips</last_name>
      <phone>11 358 5471</phone>
      <phone_ext>+27</phone_ext>
      <email>TPalanee@wrhi.ac.za</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Krishnaveni Reddy</last_name>
      <phone>11 358 5470</phone>
      <phone_ext>+27</phone_ext>
      <email>KReddy@wrhi.ac.za</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Wits RHI Research Centre</name>
        <address>
          <city>Hillbrow</city>
          <state>Gauteng</state>
          <zip>2038</zip>
          <country>South Africa</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thesla Palanee-Phillips</last_name>
        <phone>11 358 5471</phone>
        <phone_ext>+27</phone_ext>
        <email>TPalanee@wrhi.ac.za</email>
      </contact>
      <contact_backup>
        <last_name>Krishnaveni Reddy</last_name>
        <phone>11 358 5470</phone>
        <phone_ext>+27</phone_ext>
        <email>KReddy@wrhi.ac.za</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>South Africa</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Wits RHI Research Centre Clinical Research Site</investigator_affiliation>
      <investigator_full_name>Thesla Palanee-Phillips</investigator_full_name>
      <investigator_title>Director:Clinical Trials</investigator_title>
    </responsible_party>
    <keyword>Pre-Exposure Prophylaxis</keyword>
    <keyword>HIV</keyword>
    <keyword>Sexually Transmitted Infection (STI)</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified individual participant data for all outcome measures will be made available after study completion.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_access_criteria>A data request from the PI needs to be made before the data can be released</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>October 13, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT06030856/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>December 19, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT06030856/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030856
  org study id: PALESA
  nct id: NCT06030856
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use
        within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits
        (Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)) with
        in-person instruction at enrolment and telephone/video-based instructions for home use
        coupled with self-administered behavioural risk assessment or 2) self-administered
        behavioural risk assessment only (standard of care). All participants will receive
        comprehensive sexual and reproductive health (SRH) services during their study visits
        including choice of family planning method initiation and support, and behavioural HIV/STI
        risk reduction counselling.
  The PALESA study aims to determine the feasibility of conducting a randomized controlled
        trial (RCT) to determine the impact of decentralized sexually transmitted infection (STI)
        point of care (POC) self-testing and risk self-assessment interventions to trigger
        pre-exposure prophylaxis (PrEP) re-start among adolescent girls and young women (AGYW) in
        South Africa at potential ongoing risk of re- acquiring STIs and HIV.
  
        This overall study comprises two components that include a formative research study enrolling
        ~60 participants for qualitative in-depth interviews (IDIs) (this has been completed) and a
        prospective cohort study (Pilot randomized controlled trial - RCT) enrolling 50 AGYW with
        both clinical, diagnostic laboratory and nested qualitative methodologies.
  
        The RCT seeks to establish the feasibility of conducting a randomized controlled trial among
        AGYW in South Africa to determine the impact of decentralized or at-home STI testing [(for
        Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)] on
        restarting PrEP relative to a self-administered behavioural risk assessment. Additionally
        qualitative interviews will be conducted to assess adolescent girls experiences of at-home
        STI testing, behavioural risk assessment, and re-starting PrEP while participating in the
        pilot trial through exit interviews.
  
        Objective 1: To determine the feasibility and acceptability of conducting a RCT among South
        African AGYW to determine the impact of STI self-testing coupled with a self-administered
        behavioural risk assessment on restarting PrEP relative to a self-administered behavioural
        risk assessment only
  
        Objective 2: To assess AGYW acceptability of and experiences with use at-home STI testing,
        self-administered behavioural risk assessment, and re-starting PrEP while participating in
        the pilot RCT
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of participants enrolled and retained in the PALESA study
  time frame: 1 year
  description: A recruitment target of 50 adolescent girls and young women and over 90% retention of those participants is achieved
  measure: Assessing Risk of Acquiring HIV and STIs
  time frame: 1 year
  description: A self administered behavioural risk assessment questionnaire with 16 - 20 questions (which include questions on STI test results), which will tally up a score, will be used to measure how much counselling and guidance will the participants need to restart PrEP.
  A score of 0 - 7 means medium recommendation to restart PrEP. A score 8-15 means a strong recommendation to restart PrEP. Test results of STIs from the self-testing STI kit are shared on the self-administered behavioural risk assessment questionnaire.
  measure: Number of participants that restarted PrEP
  time frame: 1 year
  description: There will be a dispensation form for every participant, this form will indicate if PrEP was restarted by the participant, and it will calculate include pill counts when PrEP bottles are returned to the research site
  measure: PrEP continuation 1 month after re-start
  time frame: 1 year
  description: Dried Blood Spot (DBS) collected to measure tenofovir diphosphate (TFV-DP) level as an objective assessment of adherence to PrEP.
  measure: Experiences of at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP
  time frame: 1 year
  description: In-Depth Interviews will be conducted to collect participant's experience while in the study and tools used during the study.
  arm group label: STI test kits for home use coupled with self-administered behavioural risk assessment
  arm group type: Experimental
  description: The adolescent will receive STI test kits (NG, CT and TV) for home use coupled with self-administered behavioural risk assessment at the screening and enrolment visit.
  arm group label: Self-administered behavioural risk assessment only (standard of care)
  arm group type: Active Comparator
  description: The adolescent will receive a self-administered behavioural risk assessment at the screening and enrolment visit
  intervention type: Device
  intervention name: STI test kits (NG, CT and TV) for home use
  description: The adolescent randomized to the at-home STI testing arm will be provided with in-person instruction at enrollment and flyers (in English and isiZulu) with printed step-by-step instructions for kit use. Information will include details on how to store the kits, criteria for adequate specimen collection and preparation, how to run the test, and how to interpret the test results. Video-based instructions with accompanying text subtitles and audio options may also be provided for home use.
  arm group label: STI test kits for home use coupled with self-administered behavioural risk assessment
  intervention type: Behavioral
  intervention name: Self Administered Behavioural Risk Assessment
  description: Self Administered assessment to determine risk of HIV, STIs and pregnancy
  arm group label: STI test kits for home use coupled with self-administered behavioural risk assessment
  arm group label: Self-administered behavioural risk assessment only (standard of care)
  criteria: 
  gender: Female
  minimum age: 16 Years
  maximum age: 20 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Thesla Palanee-Phillips
  phone: 11 358 5471
  phone ext: +27
  email: TPalanee@wrhi.ac.za
  last name: Krishnaveni Reddy
  phone: 11 358 5470
  phone ext: +27
  email: KReddy@wrhi.ac.za
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: South Africa
  responsible party type: Principal Investigator
  investigator affiliation: Wits RHI Research Centre Clinical Research Site
  investigator full name: Thesla Palanee-Phillips
  investigator title: Director:Clinical Trials
  sharing ipd: Yes
  ipd description: De-identified individual participant data for all outcome measures will be made available after study completion.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd access criteria: A data request from the PI needs to be made before the data can be released
  provided document: 
  provided document: 