<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/NCT03019770</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000185</org_study_id>
    <secondary_id>K23MH098795</secondary_id>
    <nct_id>NCT03019770</nct_id>
  </id_info>
  <brief_title>Optimizing HIV PrEP Through Shared Decision Making</brief_title>
  <official_title>Optimizing HIV Pre-Exposure Prophylaxis Through Shared Decision Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Fenway Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</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>
      The purpose of this study is to test a clinical Decision Aid that will help patients and&#xD;
      providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision&#xD;
      Aid will be tested in both clinical and non-clinical settings with 80 patient-provider dyads.&#xD;
      The investigators hypothesize that the use of the Decision Aid will reduce patient decisional&#xD;
      conflict. The investigators predict that it will increase patient and provider knowledge of&#xD;
      and intent to initiate PrEP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess if a clinical Decision Aid (DA) that integrates a&#xD;
      decision-support tool for patients and a risk-prediction tool for providers can facilitate&#xD;
      shared decision making (SDM) and reduce decisional conflict regarding pre-exposure&#xD;
      prophylaxis (PrEP) use. The patient tool was developed through an iterative process using the&#xD;
      Ottawa Decision Support Framework (ODSF). The provider tool is a validated model that uses&#xD;
      patient-reported data to estimate HIV risk for individual men who have sex with men (MSM).&#xD;
      The DA includes information on the harms associated with HIV, a list of treatment options,&#xD;
      which includes doing nothing, a patient's individualized risk of acquiring HIV, positive and&#xD;
      negative features of PrEP, exercises to clarify patient values, and interactive exercises to&#xD;
      help patients weight the risks and benefits of PrEP use. The Health Communications Core at&#xD;
      the Dana-Farber Cancer Center, a Core that receives NIH funding to provide web-design&#xD;
      services to Harvard-affiliated investigators, is building a web-based version of the Decision&#xD;
      Aid under the investigator's direction, as the investigators have learned from qualitative&#xD;
      research that patients and providers would prefer a web-based version. Presentation of the&#xD;
      DA's content will be done in a manner to enhance comprehension and minimize bias.&#xD;
&#xD;
      The DA will be tested with 20 patient-provider dyads to determine acceptability, and then an&#xD;
      additional 60 provider-dyad visits will be conducted. The study will involve Boston-area MSM&#xD;
      and primary care providers at Beth Israel Deaconess Medical Center (BIDMC) and Fenway Health.&#xD;
      The investigators believe it will be important to capture the perspectives of clinicians at&#xD;
      Fenway (which specializes in the care of sexual and gender minorities), BIDMC (a large,&#xD;
      academic medical center), as well as those who practice at other clinical sites in the&#xD;
      community who may be less knowledgeable about and experienced with PrEP.&#xD;
&#xD;
      To pilot test the DA, MSM-provider dyads will be scheduled for a simulated 20 minute clinic&#xD;
      visit at BIDMC or Fenway Health. Providers will complete a verbal consent procedure prior to&#xD;
      the visit. Providers will be emailed the Decision Aid for review, as well as a pre-study&#xD;
      questionnaire to complete on their own time.MSM will arrive 60 minutes before the visit. At&#xD;
      this time, the MSM participant will complete an informed consent procedure followed by a&#xD;
      brief demographic and behavioral survey. The survey will be administered using either pen and&#xD;
      paper or a web-based format. This survey will be reviewed by a study staff member to confirm&#xD;
      eligibility. MSM Participants will then have the opportunity to view the DA before meeting&#xD;
      with providers. Using a computer or touch screen tablet, both the participant and provider&#xD;
      will complete the DA, which will be online, and enter the patient-reported data that are&#xD;
      needed for the risk-prediction tool. The website will not store any answers to the questions&#xD;
      in the DA. The questions that are used to obtain these sensitive data will be presented in a&#xD;
      culturally-sensitive manner. Both MSM participant and provider will be able to explore the DA&#xD;
      website, which will include information about HIV, PrEP and next steps for providers that are&#xD;
      interested in prescribing PrEP. After the visit, MSM and providers will complete&#xD;
      acceptability surveys and brief exit interviews with a member of the study staff.&#xD;
      Acceptability will be pre-specified as &gt;70% of participants and providers indicating that the&#xD;
      DA is acceptable for use. Based on the surveys and feedback, the investigators will refine&#xD;
      the DA, website content, and visit process in preparation for testing with an additional 60&#xD;
      dyads. If the MSM participant is interested in learning more about the study, staff will&#xD;
      provide instructions to access information about PrEP on the Fenway Institute's website. If a&#xD;
      participant would also like to speak to a healthcare professional about obtaining a&#xD;
      prescription for PrEP, the study staff will recommend scheduling a visit with a provider at&#xD;
      Fenway Health or the BIDMC Infectious Disease clinic.&#xD;
&#xD;
      Once acceptability has been established, and additional 60 MSM-provider dyads will be&#xD;
      scheduled either for a simulated or in-clinic 20 minute visit at BIDMC or Fenway Health,&#xD;
      depending on availability of providers during clinic hours. These visits will follow the same&#xD;
      protocol as the pilot testing visits, with possible adjustments made based on pilot testing&#xD;
      feedback. In addition to the initial study visit, there will be a 3 month follow up survey&#xD;
      provided to MSM participants. This survey will be available online through RedCap, and the&#xD;
      link to complete the survey will be emailed to MSM participants. Alternatively, participants&#xD;
      can complete these surveys in person or by phone according to their preferences.&#xD;
&#xD;
      Assuming a standard deviation of 12 for both pre- and post-DA primary outcome measures of&#xD;
      Decisional Conflict Scale scores, a null hypothesis of no difference in pairs pre- and&#xD;
      post-DA, a 2-sided significance level of 0.05, and correlation of 0.23 between pre- and&#xD;
      post-DA scores, and adjusting sample size for non-parametric test (using worst case of 86.5%&#xD;
      efficiency) in case of non-normal data, a sample size of 60 MSM (each with a pair of&#xD;
      evaluations pre- and post-DA) will provide approximately 80% power to detect a difference&#xD;
      between pre- and post-DA scores of 6 (~1/2 SD).&#xD;
&#xD;
      Acceptability surveys will be analyzed with descriptive statistics to determine the&#xD;
      percentage of participants who find the DA to be acceptable. The paired t-test (or Wilcoxon&#xD;
      Signed Rank test if data are non-normal) will be used to determine if there are changes in&#xD;
      the following measures pre- and post-use of the DA: (1) MSM Decisional Conflict Scale scores;&#xD;
      (2) MSM and provider knowledge; (3) intentions to initiate PrEP; (4) decisional regret; and&#xD;
      (5) sexual risk behaviors. The proportion of MSM reporting HIV or sexually transmitted&#xD;
      disease testing in the 3 months prior to use of the DA will be compared to the proportion who&#xD;
      report testing in the 3 months after use of the DA using a paired (1-sample) exact test of&#xD;
      rate/proportion against the null value of 0. Kruskal-Wallis tests (multi-group extension to&#xD;
      Wilcoxon Rank Sum Test) will be used to determine if the distribution of post-DA Decisional&#xD;
      Conflict Scale scores differs between/among groups defined by level of adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Decisional Conflict Scale</measure>
    <time_frame>30 minutes prior to intervention, 5 minutes after intervention, 3 months after intervention</time_frame>
    <description>Decisional conflict will be measured for patients before and immediately after reviewing the Decision Aid, as well as 3 months later.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knowledge</measure>
    <time_frame>30 minutes prior to intervention, 5 minutes after intervention, 3 months after intervention</time_frame>
    <description>Both patients and providers will be tested on their knowledge of PrEP before and after reviewing the Decision Aid. Patients will also be tested on knowledge 3 months after reviewing the Decision Aid.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Acceptability of Decision Aid</measure>
    <time_frame>5 minutes after intervention</time_frame>
    <description>Acceptability of and intent to use Decision Aid among patients and providers.</description>
  </other_outcome>
  <other_outcome>
    <measure>Shared Decision Making Questionnaire</measure>
    <time_frame>5 minutes after intervention</time_frame>
    <description>A questionnaire to assess perceptions about the degree to which shared decision making between the patient and provider occurred during the visit.</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of PrEP since intervention</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>Questions that will determine if a patient has used PrEP or attempted to obtain a prescription for PrEP since the intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Communication Questions</measure>
    <time_frame>5 minutes after intervention</time_frame>
    <description>Patient perceptions of provider communication during clinic visits as well as questions to assess the quality of interactions with the provider during the visit.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intentions to use PrEP</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>A question to determine if a patient would like to obtain a prescription for PrEP, if they have not used PrEP since the intervention.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Pre-Exposure Prophylaxis</condition>
  <arm_group>
    <arm_group_label>PrEP Decision Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in the study will go through the Decision Aid with a provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PrEP Decision Aid</intervention_name>
    <description>All participants will participate in a simulated or actual clinical visit with a healthcare provider. During this visit, they will review the Decision Aid which will give them an HIV risk score and ask questions about their values. The goal of these visits will be to make an informed decision about whether or not to begin using PrEP.</description>
    <arm_group_label>PrEP Decision Aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Patients:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Male at birth&#xD;
&#xD;
          -  HIV-uninfected&#xD;
&#xD;
          -  Have sex with men&#xD;
&#xD;
          -  Have never been prescribed HIV pre-exposure prophylaxis&#xD;
&#xD;
        Inclusion Criteria for Providers:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Healthcare clinicians who provide clinical care to any HIV-uninfected MSM at BIDMC,&#xD;
             Fenway Health, or other practices&#xD;
&#xD;
          -  Licensed to prescribe medications (Medical Doctor, Doctor of Osteopathy, Physician&#xD;
             Assistant, or Nurse Practitioner).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients or providers who are unable to provide informed consent due to severe mental&#xD;
             or physical illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Krakower, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fenway Institute</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>
  <link>
    <url>https://fenwayhealth.org/</url>
    <description>The Fenway Institute website</description>
  </link>
  <reference>
    <citation>O'Connor AM. Ottawa Decision Support Framework to Address Decisional Conflict. Available at: http://www.ohri.ca/decisionaid.</citation>
  </reference>
  <reference>
    <citation>Menza TW, Hughes JP, Celum CL, Golden MR. Prediction of HIV acquisition among men who have sex with men. Sex Transm Dis. 2009 Sep;36(9):547-55. doi: 10.1097/OLQ.0b013e3181a9cc41.</citation>
    <PMID>19707108</PMID>
  </reference>
  <reference>
    <citation>Smith DK, Pals SL, Herbst JH, Shinde S, Carey JW. Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):421-7. doi: 10.1097/QAI.0b013e318256b2f6.</citation>
    <PMID>22487585</PMID>
  </reference>
  <reference>
    <citation>Schneider J, Kaplan SH, Greenfield S, Li W, Wilson IB. Better physician-patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. J Gen Intern Med. 2004 Nov;19(11):1096-103. doi: 10.1111/j.1525-1497.2004.30418.x.</citation>
    <PMID>15566438</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Douglas Krakower</investigator_full_name>
    <investigator_title>Staff Physician, Division of Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>Pre-Exposure Prophylaxis</keyword>
  <keyword>HIV</keyword>
  <keyword>Decision Aid</keyword>
  <keyword>Shared Decision Making</keyword>
  <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/NCT03019770
org study id: 2015P000185
secondary id: K23MH098795
nct id: NCT03019770
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test a clinical Decision Aid that will help patients and
      providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision
      Aid will be tested in both clinical and non-clinical settings with 80 patient-provider dyads.
      The investigators hypothesize that the use of the Decision Aid will reduce patient decisional
      conflict. The investigators predict that it will increase patient and provider knowledge of
      and intent to initiate PrEP.
The purpose of this study is to assess if a clinical Decision Aid (DA) that integrates a
      decision-support tool for patients and a risk-prediction tool for providers can facilitate
      shared decision making (SDM) and reduce decisional conflict regarding pre-exposure
      prophylaxis (PrEP) use. The patient tool was developed through an iterative process using the
      Ottawa Decision Support Framework (ODSF). The provider tool is a validated model that uses
      patient-reported data to estimate HIV risk for individual men who have sex with men (MSM).
      The DA includes information on the harms associated with HIV, a list of treatment options,
      which includes doing nothing, a patient's individualized risk of acquiring HIV, positive and
      negative features of PrEP, exercises to clarify patient values, and interactive exercises to
      help patients weight the risks and benefits of PrEP use. The Health Communications Core at
      the Dana-Farber Cancer Center, a Core that receives NIH funding to provide web-design
      services to Harvard-affiliated investigators, is building a web-based version of the Decision
      Aid under the investigator's direction, as the investigators have learned from qualitative
      research that patients and providers would prefer a web-based version. Presentation of the
      DA's content will be done in a manner to enhance comprehension and minimize bias.

      The DA will be tested with 20 patient-provider dyads to determine acceptability, and then an
      additional 60 provider-dyad visits will be conducted. The study will involve Boston-area MSM
      and primary care providers at Beth Israel Deaconess Medical Center (BIDMC) and Fenway Health.
      The investigators believe it will be important to capture the perspectives of clinicians at
      Fenway (which specializes in the care of sexual and gender minorities), BIDMC (a large,
      academic medical center), as well as those who practice at other clinical sites in the
      community who may be less knowledgeable about and experienced with PrEP.

      To pilot test the DA, MSM-provider dyads will be scheduled for a simulated 20 minute clinic
      visit at BIDMC or Fenway Health. Providers will complete a verbal consent procedure prior to
      the visit. Providers will be emailed the Decision Aid for review, as well as a pre-study
      questionnaire to complete on their own time.MSM will arrive 60 minutes before the visit. At
      this time, the MSM participant will complete an informed consent procedure followed by a
      brief demographic and behavioral survey. The survey will be administered using either pen and
      paper or a web-based format. This survey will be reviewed by a study staff member to confirm
      eligibility. MSM Participants will then have the opportunity to view the DA before meeting
      with providers. Using a computer or touch screen tablet, both the participant and provider
      will complete the DA, which will be online, and enter the patient-reported data that are
      needed for the risk-prediction tool. The website will not store any answers to the questions
      in the DA. The questions that are used to obtain these sensitive data will be presented in a
      culturally-sensitive manner. Both MSM participant and provider will be able to explore the DA
      website, which will include information about HIV, PrEP and next steps for providers that are
      interested in prescribing PrEP. After the visit, MSM and providers will complete
      acceptability surveys and brief exit interviews with a member of the study staff.
      Acceptability will be pre-specified as >70% of participants and providers indicating that the
      DA is acceptable for use. Based on the surveys and feedback, the investigators will refine
      the DA, website content, and visit process in preparation for testing with an additional 60
      dyads. If the MSM participant is interested in learning more about the study, staff will
      provide instructions to access information about PrEP on the Fenway Institute's website. If a
      participant would also like to speak to a healthcare professional about obtaining a
      prescription for PrEP, the study staff will recommend scheduling a visit with a provider at
      Fenway Health or the BIDMC Infectious Disease clinic.

      Once acceptability has been established, and additional 60 MSM-provider dyads will be
      scheduled either for a simulated or in-clinic 20 minute visit at BIDMC or Fenway Health,
      depending on availability of providers during clinic hours. These visits will follow the same
      protocol as the pilot testing visits, with possible adjustments made based on pilot testing
      feedback. In addition to the initial study visit, there will be a 3 month follow up survey
      provided to MSM participants. This survey will be available online through RedCap, and the
      link to complete the survey will be emailed to MSM participants. Alternatively, participants
      can complete these surveys in person or by phone according to their preferences.

      Assuming a standard deviation of 12 for both pre- and post-DA primary outcome measures of
      Decisional Conflict Scale scores, a null hypothesis of no difference in pairs pre- and
      post-DA, a 2-sided significance level of 0.05, and correlation of 0.23 between pre- and
      post-DA scores, and adjusting sample size for non-parametric test (using worst case of 86.5%
      efficiency) in case of non-normal data, a sample size of 60 MSM (each with a pair of
      evaluations pre- and post-DA) will provide approximately 80% power to detect a difference
      between pre- and post-DA scores of 6 (~1/2 SD).

      Acceptability surveys will be analyzed with descriptive statistics to determine the
      percentage of participants who find the DA to be acceptable. The paired t-test (or Wilcoxon
      Signed Rank test if data are non-normal) will be used to determine if there are changes in
      the following measures pre- and post-use of the DA: (1) MSM Decisional Conflict Scale scores;
      (2) MSM and provider knowledge; (3) intentions to initiate PrEP; (4) decisional regret; and
      (5) sexual risk behaviors. The proportion of MSM reporting HIV or sexually transmitted
      disease testing in the 3 months prior to use of the DA will be compared to the proportion who
      report testing in the 3 months after use of the DA using a paired (1-sample) exact test of
      rate/proportion against the null value of 0. Kruskal-Wallis tests (multi-group extension to
      Wilcoxon Rank Sum Test) will be used to determine if the distribution of post-DA Decisional
      Conflict Scale scores differs between/among groups defined by level of adherence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Decisional Conflict Scale
time frame: 30 minutes prior to intervention, 5 minutes after intervention, 3 months after intervention
description: Decisional conflict will be measured for patients before and immediately after reviewing the Decision Aid, as well as 3 months later.
measure: Change in Knowledge
time frame: 30 minutes prior to intervention, 5 minutes after intervention, 3 months after intervention
description: Both patients and providers will be tested on their knowledge of PrEP before and after reviewing the Decision Aid. Patients will also be tested on knowledge 3 months after reviewing the Decision Aid.
measure: Acceptability of Decision Aid
time frame: 5 minutes after intervention
description: Acceptability of and intent to use Decision Aid among patients and providers.
measure: Shared Decision Making Questionnaire
time frame: 5 minutes after intervention
description: A questionnaire to assess perceptions about the degree to which shared decision making between the patient and provider occurred during the visit.
measure: Use of PrEP since intervention
time frame: 3 months after intervention
description: Questions that will determine if a patient has used PrEP or attempted to obtain a prescription for PrEP since the intervention.
measure: Quality of Communication Questions
time frame: 5 minutes after intervention
description: Patient perceptions of provider communication during clinic visits as well as questions to assess the quality of interactions with the provider during the visit.
measure: Intentions to use PrEP
time frame: 3 months after intervention
description: A question to determine if a patient would like to obtain a prescription for PrEP, if they have not used PrEP since the intervention.
arm group label: PrEP Decision Aid
arm group type: Experimental
description: All participants in the study will go through the Decision Aid with a provider.
intervention type: Behavioral
intervention name: PrEP Decision Aid
description: All participants will participate in a simulated or actual clinical visit with a healthcare provider. During this visit, they will review the Decision Aid which will give them an HIV risk score and ask questions about their values. The goal of these visits will be to make an informed decision about whether or not to begin using PrEP.
arm group label: PrEP Decision Aid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Douglas Krakower, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
facility: 
country: United States
url: https://fenwayhealth.org/
description: The Fenway Institute website
citation: O'Connor AM. Ottawa Decision Support Framework to Address Decisional Conflict. Available at: http://www.ohri.ca/decisionaid.
citation: Menza TW, Hughes JP, Celum CL, Golden MR. Prediction of HIV acquisition among men who have sex with men. Sex Transm Dis. 2009 Sep;36(9):547-55. doi: 10.1097/OLQ.0b013e3181a9cc41.
PMID: 19707108
citation: Smith DK, Pals SL, Herbst JH, Shinde S, Carey JW. Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):421-7. doi: 10.1097/QAI.0b013e318256b2f6.
PMID: 22487585
citation: Schneider J, Kaplan SH, Greenfield S, Li W, Wilson IB. Better physician-patient relationships are associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. J Gen Intern Med. 2004 Nov;19(11):1096-103. doi: 10.1111/j.1525-1497.2004.30418.x.
PMID: 15566438
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Douglas Krakower
investigator title: Staff Physician, Division of Infectious Diseases
sharing ipd: No