<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/NCT04499781</url>
  </required_header>
  <id_info>
    <org_study_id>20-01135</org_study_id>
    <nct_id>NCT04499781</nct_id>
  </id_info>
  <brief_title>Adherence Connection for Counseling, Education, and Support (ACCESS) II</brief_title>
  <acronym>ACCESS</acronym>
  <official_title>Adherence Connection for Counseling, Education, and Support (ACCESS) II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jacobi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of the proposed clinical trial, Adherence Connection for Counseling,&#xD;
      Education, and Support (ACCESS)-II, is to test the efficacy of ACCESS-II on antiretroviral&#xD;
      treatment (ART) adherence and HIV-viral load in Black and Hispanic HIV-infected (HIV+)&#xD;
      adolescents and young adults (AYA), ages 18-29 years (N=120) using a longitudinal (12 and 24&#xD;
      week outcomes), two-group, randomized control trial (RCT). Participants in the intervention&#xD;
      condition will use videoconferencing to connect synchronously with trained HIV+ peer health&#xD;
      coaches who will deliver eight weekly, 60-minute cognitive behavioral/motivational sessions&#xD;
      for improved ART adherence. Participants in the control will connect asynchronously to a&#xD;
      web-based HIV ART adherence education condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve these aims, a longitudinal (12 and 24- week study outcomes), two-group, randomized&#xD;
      control trial (RCT) is proposed in a sample population of 120 perinatally and behaviorally,&#xD;
      HIV-infected youth (ages 18-29 years). Participants in the intervention condition will use&#xD;
      videoconferencing to connect synchronously with trained HIV+ peer health coaches who will&#xD;
      deliver eight weekly, 60-minute cognitive behavioral47-50 motivational18 sessions for&#xD;
      improved ART adherence. Participants in the control will connect asynchronously to a&#xD;
      web-based HIV ART adherence education condition.&#xD;
&#xD;
      Study participants will access the intervention and control conditions outside of the&#xD;
      clinical setting using study funded smart phones. Self-reported adherence and viral load&#xD;
      (extracted from the medical records) of study participants will be measured, and uploaded to&#xD;
      RedCAP. ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological&#xD;
      distress, and substance use will be measured using survey measures. Statistical analyses will&#xD;
      be computed to assess the potential impact of ACCESS on adherence and HIV viral suppression,&#xD;
      and will also be computed to assess changes in ART knowledge, adherence self-efficacy, HIV&#xD;
      stigma, social support, psychological distress, and substance use among participants in both&#xD;
      the intervention and control conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 14, 2022</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <intervention_model_description>The ACCESS II RCT uses a two group, parallel, longitudinal study design. Participants will be randomized to the ACCESS synchronous peer intervention or the asynchronous web-based HIV ART adherence control. Block randomization will be used; the randomization scheme will be developed by the biostatistician and implemented in Research Electronic Data Capture (REDCap) to ensure that assignment to treatment condition is evenly distributed within each site.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported ART adherence</measure>
    <time_frame>3 Days</time_frame>
    <description>3-day self-report of ART adherence will be collected to describe subjective adherence behavior. Investigators will compute an average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum HIV RNA quantitative viral load</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data will be extracted from the medical records of participants at baseline (pre-intervention), and 12 and 24-weeks. In cases where a visit does not include a biological assessment of HIV viral load, we will use the most recent assessment in the medical record (within two-weeks of the visit)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence self-efficacy</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Assessed with the HIV Medication Taking Self-Efficacy Scale. This 27-item survey measure, including sub-scales, uses a 10-point Likert scale (0=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knowledge about ART</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Assessed with the HIV Treatment Knowledge Scale: This 21-item instrument uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance (scores range from 0-21; higher scores = increased knowledge).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HIV stigma</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Assessed with the HIV Stigma Scale. 40 item questionnaire. Items are scored as follows: strongly disagree = 1 disagree = 2 agree = 3 strongly agree = 4. The range of possible scores depends on the number of items in the scale. For the total HIV Stigma Scale, scores can range from 40 to 160 [1 x 40 items to 4 x 40 items]. For the personalized stigma subscale, scores can range from 18 to 72. For the disclosure subscale, scores can range from 10 to 40. For the negative self-image subscale, scores can range from 13 to 52. For the public attitudes subscale, scores can range from 20 to 80.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Depression will be measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). Depression is scored as mild, moderate, moderately severe, and severe using composite scores of 5, 10, 15, and 20, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Generalized anxiety disorder (GAD) will be assessed with the Generalized Anxiety Disorder - 7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Scores &gt; 10 indicate a probable case of GAD, with scores &gt; 15 considered to be severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological Distress</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Post-traumatic stress disorder (PTSD) will be measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. Total scores range from 0 to 4 with a score of 3 or greater indicating probable or positive screen for PTSD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social support and isolation</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Assessed with the Adolescent Trials Network (ATN) iTech short measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship scales. The ATN short measure is a 20-item tool which uses a 5-point Likert scale with total possible composite scores of 25 to 125; higher scores suggest increased social support and decreased isolation. This measure assesses five domains of social support: emotional, informational, instrumental, companionship, and isolation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Substance use</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Substance use will be assessed with a modified ATN designed for use in clinical settings. The measure will assess use of tobacco, alcohol, marijuana and other drugs (i.e., cocaine or crack, amphetamine type stimulants, inhalants, sedatives, hallucinogens and opioids). The modified measure will assess substance use frequency, substance use related problems (i.e., health, social, financial), interference with functional status, concern from others regarding substance use, and failure to cut down on substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction and Ease of Use of web-based platform</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Client Satisfaction and Ease of Use of the web-based platform will be assessed using a modified Client Satisfaction Questionnaire and Perceived Ease of Use Scale. The measure will be used to assess the participant's satisfaction with the support and education received from the eight sessions in the web-based platform, along with the overall ease of use in operating and functioning the web-based platform.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>HIV-infected youth: Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years).&#xD;
Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV-infected youth: control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years).&#xD;
Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACCESS II mHealth Intervention</intervention_name>
    <description>Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.</description>
    <arm_group_label>HIV-infected youth: Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACCESS II control condition</intervention_name>
    <description>Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.</description>
    <arm_group_label>HIV-infected youth: control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for participation in this study are:&#xD;
&#xD;
          -  HIV seropositive status (perinatally and behaviorally infected youth)&#xD;
&#xD;
          -  Ages 18-29 years&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Currently being prescribed an antiretroviral treatment regimen&#xD;
&#xD;
          -  Evidence of virologic failure or (detectable quantitative HIV serum viral load&gt;200&#xD;
             copies/ml)&#xD;
&#xD;
          -  No neuro-cognitive deficits which would impede participation in videoconferencing&#xD;
             sessions or completion of study measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann-Margaret Navarra, PhD, CPNP-PC</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Meyers College of Nursing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ann-Margaret Navarra, PhD, CPNP-PC</last_name>
    <phone>212-998-9009</phone>
    <email>amd363@nyu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lloyd Goldsamt, PhD</last_name>
    <phone>212-998-5315</phone>
    <email>lloydgoldsamt@nyu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jacobi Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Rosenberg, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to amd363@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to amd363@nyu.edu</ipd_access_criteria>
  </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/NCT04499781
org study id: 20-01135
nct id: NCT04499781
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the proposed clinical trial, Adherence Connection for Counseling,
      Education, and Support (ACCESS)-II, is to test the efficacy of ACCESS-II on antiretroviral
      treatment (ART) adherence and HIV-viral load in Black and Hispanic HIV-infected (HIV+)
      adolescents and young adults (AYA), ages 18-29 years (N=120) using a longitudinal (12 and 24
      week outcomes), two-group, randomized control trial (RCT). Participants in the intervention
      condition will use videoconferencing to connect synchronously with trained HIV+ peer health
      coaches who will deliver eight weekly, 60-minute cognitive behavioral/motivational sessions
      for improved ART adherence. Participants in the control will connect asynchronously to a
      web-based HIV ART adherence education condition.
To achieve these aims, a longitudinal (12 and 24- week study outcomes), two-group, randomized
      control trial (RCT) is proposed in a sample population of 120 perinatally and behaviorally,
      HIV-infected youth (ages 18-29 years). Participants in the intervention condition will use
      videoconferencing to connect synchronously with trained HIV+ peer health coaches who will
      deliver eight weekly, 60-minute cognitive behavioral47-50 motivational18 sessions for
      improved ART adherence. Participants in the control will connect asynchronously to a
      web-based HIV ART adherence education condition.

      Study participants will access the intervention and control conditions outside of the
      clinical setting using study funded smart phones. Self-reported adherence and viral load
      (extracted from the medical records) of study participants will be measured, and uploaded to
      RedCAP. ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological
      distress, and substance use will be measured using survey measures. Statistical analyses will
      be computed to assess the potential impact of ACCESS on adherence and HIV viral suppression,
      and will also be computed to assess changes in ART knowledge, adherence self-efficacy, HIV
      stigma, social support, psychological distress, and substance use among participants in both
      the intervention and control conditions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The ACCESS II RCT uses a two group, parallel, longitudinal study design. Participants will be randomized to the ACCESS synchronous peer intervention or the asynchronous web-based HIV ART adherence control. Block randomization will be used; the randomization scheme will be developed by the biostatistician and implemented in Research Electronic Data Capture (REDCap) to ensure that assignment to treatment condition is evenly distributed within each site.
primary purpose: Other
masking: None (Open Label)
measure: Self-reported ART adherence
time frame: 3 Days
description: 3-day self-report of ART adherence will be collected to describe subjective adherence behavior. Investigators will compute an average missed dose calculation: # of doses missed divided by total number of prescribed doses over the past 3 days. (scores range from 0 to 100%; higher scores = better adherence )
measure: Change in serum HIV RNA quantitative viral load
time frame: Baseline, 12 weeks, 24 weeks
description: Measured to eliminate the potential for social desirability bias associated with self-reported adherence. Viral load data will be extracted from the medical records of participants at baseline (pre-intervention), and 12 and 24-weeks. In cases where a visit does not include a biological assessment of HIV viral load, we will use the most recent assessment in the medical record (within two-weeks of the visit)
measure: Adherence self-efficacy
time frame: Baseline, 12 weeks, 24 weeks
description: Assessed with the HIV Medication Taking Self-Efficacy Scale. This 27-item survey measure, including sub-scales, uses a 10-point Likert scale (0=not confident; 10=completely confident) to assess HIV-medication taking self-efficacy belief and outcome expectancy. Higher scores indicate higher levels of self-efficacy.
measure: Change in Knowledge about ART
time frame: Baseline, 12 weeks, 24 weeks
description: Assessed with the HIV Treatment Knowledge Scale: This 21-item instrument uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance (scores range from 0-21; higher scores = increased knowledge).
measure: Change in HIV stigma
time frame: Baseline, 12 weeks, 24 weeks
description: Assessed with the HIV Stigma Scale. 40 item questionnaire. Items are scored as follows: strongly disagree = 1 disagree = 2 agree = 3 strongly agree = 4. The range of possible scores depends on the number of items in the scale. For the total HIV Stigma Scale, scores can range from 40 to 160 [1 x 40 items to 4 x 40 items]. For the personalized stigma subscale, scores can range from 18 to 72. For the disclosure subscale, scores can range from 10 to 40. For the negative self-image subscale, scores can range from 13 to 52. For the public attitudes subscale, scores can range from 20 to 80.
measure: Change in Depression
time frame: Baseline, 12 weeks, 24 weeks
description: Depression will be measured with the Patient Health Questionnaire (PHQ-9). The PHQ-9 includes 9 items from the DSM-IV criteria for depression with scores on a 4-point Likert scale (0=not at all, 3=nearly every day). Depression is scored as mild, moderate, moderately severe, and severe using composite scores of 5, 10, 15, and 20, respectively.
measure: Change in Anxiety
time frame: Baseline, 12 weeks, 24 weeks
description: Generalized anxiety disorder (GAD) will be assessed with the Generalized Anxiety Disorder - 7 (GAD-7). The measure includes 7 items about symptoms in the past two weeks. Scores > 10 indicate a probable case of GAD, with scores > 15 considered to be severe.
measure: Change in Psychological Distress
time frame: Baseline, 12 weeks, 24 weeks
description: Post-traumatic stress disorder (PTSD) will be measured with the Primary Care-PTSD Screen-5 (PC-PTSD). The PC-PTSD is a brief measure using four-items to screen for symptoms of PTSD (re-experiencing, numbness, hyperarousal and avoidance behaviors) in primary care or ambulatory settings. Total scores range from 0 to 4 with a score of 3 or greater indicating probable or positive screen for PTSD.
measure: Change in Social support and isolation
time frame: Baseline, 12 weeks, 24 weeks
description: Assessed with the Adolescent Trials Network (ATN) iTech short measure of the Patient-Reported Outcomes Measure Information System (PROMIS) Social Relationship scales. The ATN short measure is a 20-item tool which uses a 5-point Likert scale with total possible composite scores of 25 to 125; higher scores suggest increased social support and decreased isolation. This measure assesses five domains of social support: emotional, informational, instrumental, companionship, and isolation.
measure: Change in Substance use
time frame: Baseline, 12 weeks, 24 weeks
description: Substance use will be assessed with a modified ATN designed for use in clinical settings. The measure will assess use of tobacco, alcohol, marijuana and other drugs (i.e., cocaine or crack, amphetamine type stimulants, inhalants, sedatives, hallucinogens and opioids). The modified measure will assess substance use frequency, substance use related problems (i.e., health, social, financial), interference with functional status, concern from others regarding substance use, and failure to cut down on substance use.
measure: Client Satisfaction and Ease of Use of web-based platform
time frame: Baseline, 12 weeks, 24 weeks
description: Client Satisfaction and Ease of Use of the web-based platform will be assessed using a modified Client Satisfaction Questionnaire and Perceived Ease of Use Scale. The measure will be used to assess the participant's satisfaction with the support and education received from the eight sessions in the web-based platform, along with the overall ease of use in operating and functioning the web-based platform.
arm group label: HIV-infected youth: Intervention
arm group type: Experimental
description: Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years).
Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.
arm group label: HIV-infected youth: control
arm group type: Active Comparator
description: Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years).
Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.
intervention type: Behavioral
intervention name: ACCESS II mHealth Intervention
description: Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
arm group label: HIV-infected youth: Intervention
intervention type: Behavioral
intervention name: ACCESS II control condition
description: Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
arm group label: HIV-infected youth: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: No
last name: Ann-Margaret Navarra, PhD, CPNP-PC
role: Principal Investigator
affiliation: NYU Meyers College of Nursing
last name: Ann-Margaret Navarra, PhD, CPNP-PC
phone: 212-998-9009
email: amd363@nyu.edu
last name: Lloyd Goldsamt, PhD
phone: 212-998-5315
email: lloydgoldsamt@nyu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to amd363@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
ipd access criteria: Requests may be directed to amd363@nyu.edu