<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/NCT03805451</url>
  </required_header>
  <id_info>
    <org_study_id>ATN 158</org_study_id>
    <nct_id>NCT03805451</nct_id>
  </id_info>
  <brief_title>Life Steps for PrEP for Youth</brief_title>
  <acronym>LSPY</acronym>
  <official_title>Life Steps for PrEP for Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fenway Community Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cook County Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fenway Community Health</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 formative study, designed to provide information required to tailor Life-Steps for&#xD;
      Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence&#xD;
      intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with&#xD;
      men (YMSM) and young transgender women who have sex with men (YTWSM).&#xD;
&#xD;
      Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention&#xD;
      based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the&#xD;
      intervention to focus on the greatest challenges that they perceive in maintaining optimal&#xD;
      adherence to PrEP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1:&#xD;
&#xD;
      To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and&#xD;
      appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have&#xD;
      sex with men (TWSM). The investigators will conduct in-depth qualitative interviews with up&#xD;
      to 20 HIV-uninfected, at risk YMSM/TWSM at Fenway Health, an Adolescent Trials Network (ATN)&#xD;
      clinical center. The investigators will also conduct in-depth, individual qualitative&#xD;
      interviews with up to 10 key informants, including PrEP providers and staff at&#xD;
      community-based organizations that work with YMSM/TWSM. Through these interviews, perceived&#xD;
      facilitators and barriers to initiating and adhering to PrEP will be identified, and&#xD;
      potential strategies to optimize adherence to PrEP for YMSM/TWSM. The investigators will&#xD;
      explore youth perspectives on the use of nurses to deliver health messages and weekly text&#xD;
      messages. YMSM/TWSM will be recruited at various points in the PrEP continuum of care,&#xD;
      including those have opted not to initiate PrEP despite recommendations from clinicians,&#xD;
      those who are using PrEP who report high levels of adherence and those who report adherence&#xD;
      challenges through clinician referrals and direct recruitment in clinic waiting areas.&#xD;
      Interviews will last approximately 60 minutes and will be digitally-recorded. Recordings will&#xD;
      be transcribed and analyzed rapidly to inform the design of the youth-tailored Life-Steps for&#xD;
      PrEP for YMSM/TWSM that we will test in Aim 2.&#xD;
&#xD;
      Aim 2:&#xD;
&#xD;
      To conduct a 2-arm pilot randomized control trial (RCT) to assess feasibility and&#xD;
      acceptability of the Life-Steps for PrEP for youth intervention and preliminary efficacy of&#xD;
      the intervention to improve PrEP adherence and retention in PrEP care compared to the&#xD;
      standard of PrEP care at three different clinical sites. Investigators will enroll 50&#xD;
      YMSM/TWSM in the RCT (randomized 1:1 to the 2 arms) across the 3 sites. The primary efficacy&#xD;
      outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in&#xD;
      PrEP care-as measured by attendance at quarterly clinic appointments-at 3 and 6 months post&#xD;
      baseline. Secondary outcomes include changes in sexual behaviors, retention in prevention&#xD;
      services, and acceptability of the interventions which will be assessed at each major visit.&#xD;
      Investigators will also conduct a brief, 15-minute semi-structured exit interview with&#xD;
      participants in the Life-Steps for PrEP for youth intervention arm to provide an opportunity&#xD;
      for more in-depth (open-ended) feedback on intervention satisfaction and acceptability. These&#xD;
      data will be used to finalize the intervention manual to enhance participant acceptability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2019</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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>Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation</measure>
    <time_frame>Blood sample collected at 3 month visit post baseline</time_frame>
    <description>Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation</measure>
    <time_frame>blood sample collected at 6 month visit post baseline</time_frame>
    <description>Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services</measure>
    <time_frame>Records will be abstracted at the end of the study period for each participant to determine if they attended a clinic appointment at 3 and 6 months post baseline</time_frame>
    <description>Attendance at quarterly clinic appointments obtained through medical record abstraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LifeSteps for PrEP for Youth Intervention Acceptability</measure>
    <time_frame>Measured at each study visit (3 and 6 months post baseline)</time_frame>
    <description>To measure acceptability, participants will be asked to self-report the degree to which they find the intervention appropriate and useful using Likert-type agreement scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LifeSteps for PrEP for Youth Intervention Satisfaction</measure>
    <time_frame>Measured at each study visit (3 and 6 months post baseline)</time_frame>
    <description>Satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily scored and administered measurement designed to measure client satisfaction with services.&#xD;
The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment, or outcome, it does elicit the client's perspective on the value of services received. The CSQ-8 seems to operate about the same across all ethnic groups.&#xD;
The CSQ-8 is scored by summing the item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.&#xD;
Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207. Instrument reproduced with permission of C. Clifford Attkisson. Attkisson, C. C., &amp; Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adapt Life-Steps for PrEP to be appropriate for at-risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM)</measure>
    <time_frame>one time qualitative interviews will be conducted</time_frame>
    <description>Study Investigators will conduct qualitative interviews with up to 20 HIV-uninfected YMSM/TWSM at Fenway Health and with up to 10 key informants, including PrEP providers and staff at community-based organizations that work with YMSM/TWSM. Interviews will be transcribed and analyzed using content analysis to identify changes that should be made to the Life-Steps intervention.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>HIV</condition>
  <condition>Pre-exposure Prophylaxis</condition>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Life Steps for PrEP for Youth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Life Steps for PrEP for Youth was derived from our prior PrEP work supported by the National Institute of Mental Health and will be tailored for YMSM/TWSM based on the findings from 20 qualitative interviews with YMSM and TWSM and 10 qualitative interviews with key informants. It will likely consist of four weekly sessions at the time of PrEP initiation and two booster sessions, which occur two and three months after PrEP initiation. Overall, the core components of the intervention will focus on medication adherence, sexual behavior, and problem solving barriers to adherence, using motivational interviewing when needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After being prescribed PrEP, participants will receive standard-of-care adherence support for PrEP. They will have blood collected for medication adherence measures and will complete computer assisted behavioral surveys during study visits. Participants in this arm will also be followed for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Life Steps for PrEP for Youth</intervention_name>
    <description>Life-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis.</description>
    <arm_group_label>Life Steps for PrEP for Youth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 16-24&#xD;
&#xD;
          -  HIV-uninfected by self-report&#xD;
&#xD;
          -  Assigned male sex at birth&#xD;
&#xD;
          -  self-identify as a man who has sex with men or a trans woman who has sex with men&#xD;
&#xD;
          -  able to understand English&#xD;
&#xD;
        Self-reported HIV risk is defined as meeting at least one of the following criteria:&#xD;
&#xD;
          -  At least one episode of unprotected anal intercourse with an HIV-positive partner with&#xD;
             a penis or a partner with a penis of unknown HIV status during the last 6 months;&#xD;
&#xD;
          -  Anal intercourse with 3 or more partners with a penis during the last 6 months;&#xD;
&#xD;
          -  Exchange of money, gifts, shelter or drugs for anal sex with a partner with a penis&#xD;
             during the last 6 months;&#xD;
&#xD;
          -  Sex with a partner with a penis and has had an STI(sexually transmitted infection)&#xD;
             during the last 6 months;&#xD;
&#xD;
          -  Sexual partner of an HIV-positive person with a penis with whom condoms were not&#xD;
             consistently used in the last 6 months; or&#xD;
&#xD;
          -  At least one episode of anal intercourse where the condom broke or slipped off during&#xD;
             the last 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in another PrEP adherence study*&#xD;
&#xD;
          -  Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine&#xD;
             product.*&#xD;
&#xD;
          -  Enrollment in earlier phase of Life Steps for PrEP for Youth*&#xD;
&#xD;
          -  Unable to give informed consent/assent due to severe mental or physical&#xD;
             illness/substance intoxication at baseline visit&#xD;
&#xD;
          -  Has severe cognitive limitation that would limit their ability to comprehend the&#xD;
             informed consent or assent&#xD;
&#xD;
          -  Presence of an active (i.e. untreated) and interfering psychiatric disorder (e.g.,&#xD;
             bipolar disorder, schizophrenia, substance abuse)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ken A Mayer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Fenway Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christina Psaros, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard Medical School and Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PRISM Health</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fenway Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fenway Community Health</investigator_affiliation>
    <investigator_full_name>Kenneth H. Mayer, MD</investigator_full_name>
    <investigator_title>Medical Research Director, Co-Chair TFI</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03805451
org study id: ATN 158
nct id: NCT03805451
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a formative study, designed to provide information required to tailor Life-Steps for
      Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence
      intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with
      men (YMSM) and young transgender women who have sex with men (YTWSM).

      Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention
      based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the
      intervention to focus on the greatest challenges that they perceive in maintaining optimal
      adherence to PrEP.
Aim 1:

      To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and
      appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have
      sex with men (TWSM). The investigators will conduct in-depth qualitative interviews with up
      to 20 HIV-uninfected, at risk YMSM/TWSM at Fenway Health, an Adolescent Trials Network (ATN)
      clinical center. The investigators will also conduct in-depth, individual qualitative
      interviews with up to 10 key informants, including PrEP providers and staff at
      community-based organizations that work with YMSM/TWSM. Through these interviews, perceived
      facilitators and barriers to initiating and adhering to PrEP will be identified, and
      potential strategies to optimize adherence to PrEP for YMSM/TWSM. The investigators will
      explore youth perspectives on the use of nurses to deliver health messages and weekly text
      messages. YMSM/TWSM will be recruited at various points in the PrEP continuum of care,
      including those have opted not to initiate PrEP despite recommendations from clinicians,
      those who are using PrEP who report high levels of adherence and those who report adherence
      challenges through clinician referrals and direct recruitment in clinic waiting areas.
      Interviews will last approximately 60 minutes and will be digitally-recorded. Recordings will
      be transcribed and analyzed rapidly to inform the design of the youth-tailored Life-Steps for
      PrEP for YMSM/TWSM that we will test in Aim 2.

      Aim 2:

      To conduct a 2-arm pilot randomized control trial (RCT) to assess feasibility and
      acceptability of the Life-Steps for PrEP for youth intervention and preliminary efficacy of
      the intervention to improve PrEP adherence and retention in PrEP care compared to the
      standard of PrEP care at three different clinical sites. Investigators will enroll 50
      YMSM/TWSM in the RCT (randomized 1:1 to the 2 arms) across the 3 sites. The primary efficacy
      outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in
      PrEP care-as measured by attendance at quarterly clinic appointments-at 3 and 6 months post
      baseline. Secondary outcomes include changes in sexual behaviors, retention in prevention
      services, and acceptability of the interventions which will be assessed at each major visit.
      Investigators will also conduct a brief, 15-minute semi-structured exit interview with
      participants in the Life-Steps for PrEP for youth intervention arm to provide an opportunity
      for more in-depth (open-ended) feedback on intervention satisfaction and acceptability. These
      data will be used to finalize the intervention manual to enhance participant acceptability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation
time frame: Blood sample collected at 3 month visit post baseline
description: Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
measure: Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation
time frame: blood sample collected at 6 month visit post baseline
description: Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
measure: Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services
time frame: Records will be abstracted at the end of the study period for each participant to determine if they attended a clinic appointment at 3 and 6 months post baseline
description: Attendance at quarterly clinic appointments obtained through medical record abstraction
measure: LifeSteps for PrEP for Youth Intervention Acceptability
time frame: Measured at each study visit (3 and 6 months post baseline)
description: To measure acceptability, participants will be asked to self-report the degree to which they find the intervention appropriate and useful using Likert-type agreement scales.
measure: LifeSteps for PrEP for Youth Intervention Satisfaction
time frame: Measured at each study visit (3 and 6 months post baseline)
description: Satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily scored and administered measurement designed to measure client satisfaction with services.
The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment, or outcome, it does elicit the client's perspective on the value of services received. The CSQ-8 seems to operate about the same across all ethnic groups.
The CSQ-8 is scored by summing the item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.
Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207. Instrument reproduced with permission of C. Clifford Attkisson. Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.
measure: Adapt Life-Steps for PrEP to be appropriate for at-risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM)
time frame: one time qualitative interviews will be conducted
description: Study Investigators will conduct qualitative interviews with up to 20 HIV-uninfected YMSM/TWSM at Fenway Health and with up to 10 key informants, including PrEP providers and staff at community-based organizations that work with YMSM/TWSM. Interviews will be transcribed and analyzed using content analysis to identify changes that should be made to the Life-Steps intervention.
arm group label: Life Steps for PrEP for Youth
arm group type: Experimental
description: Life Steps for PrEP for Youth was derived from our prior PrEP work supported by the National Institute of Mental Health and will be tailored for YMSM/TWSM based on the findings from 20 qualitative interviews with YMSM and TWSM and 10 qualitative interviews with key informants. It will likely consist of four weekly sessions at the time of PrEP initiation and two booster sessions, which occur two and three months after PrEP initiation. Overall, the core components of the intervention will focus on medication adherence, sexual behavior, and problem solving barriers to adherence, using motivational interviewing when needed.
arm group label: Standard of Care
arm group type: No Intervention
description: After being prescribed PrEP, participants will receive standard-of-care adherence support for PrEP. They will have blood collected for medication adherence measures and will complete computer assisted behavioral surveys during study visits. Participants in this arm will also be followed for 6 months.
intervention type: Behavioral
intervention name: Life Steps for PrEP for Youth
description: Life-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis.
arm group label: Life Steps for PrEP for Youth
criteria: 
gender: Male
minimum age: 16 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ken A Mayer, MD
role: Principal Investigator
affiliation: The Fenway Institute
last name: Christina Psaros, Ph.D.
role: Principal Investigator
affiliation: Harvard Medical School and Massachusetts General Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Fenway Community Health
investigator full name: Kenneth H. Mayer, MD
investigator title: Medical Research Director, Co-Chair TFI
sharing ipd: No