<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/NCT03278990</url>
  </required_header>
  <id_info>
    <org_study_id>IN-US-276-4221</org_study_id>
    <nct_id>NCT03278990</nct_id>
  </id_info>
  <brief_title>Scalable Interventions to Increase PrEP Adherence: Value Affirmation and Future Selves</brief_title>
  <acronym>SIIPA</acronym>
  <official_title>A Test of Scalable Behavioral Interventions to Increase PrEP Adherence for At-Risk HIV- Individuals: Value Affirmation and Future Selves</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stuart Fisk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Allies for Health + Wellbeing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Inclusion Health, Allegheny General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Metro Community Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</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>
      Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where&#xD;
      individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada).&#xD;
      PrEP has been proven medically effective and could help to reduce the rate of new HIV&#xD;
      incidence in the United States, but in five large, randomized and controlled studies, many&#xD;
      prospective PrEP patients chose not to take PrEP, and those that did often did not adhere to&#xD;
      it consistently. How do we increase PrEP uptake and adherence amongst those most at risk for&#xD;
      HIV? Also, will taking PrEP increase or decrease high-risk individual sexual behavior and HIV&#xD;
      incidence? Here, the investigators propose a parallel group randomized, controlled clinical&#xD;
      trial to test the effectiveness of a behavioral intervention designed to buffer individuals&#xD;
      against stigma-related feelings, and to increase their connection to their selves twenty&#xD;
      years in the future. The primary objective of the study is to increase PrEP adherence, as&#xD;
      measured by the concentration of tenofovir diphosphate (TFV-DP) in dried blood spot samples&#xD;
      (DBS). The secondary objectives are to decrease the incidence of STIs and increase safe&#xD;
      sexual practices, as measured by clinic diagnoses and self-reported practices at 3, 6, 9 and&#xD;
      12 months.&#xD;
&#xD;
      This 12-month outpatient study will take place at four PrEP clinics in Pittsburgh and will&#xD;
      enroll 170 subjects across 4 sites, with an expectation of retaining 80%, or 135 subjects.&#xD;
      Eligibility includes male and female adults, ages 18-65, who are at risk of contracting HIV.&#xD;
      Efforts will be made to recruit 33% of subjects from each of the following strata: 1) young,&#xD;
      minority LGBT adults age 18-30 years of age; 2) Caucasian adults (MSM and heterosexual&#xD;
      females) age 18-65 years of age; and 3) IDU adults, age 18-65, of any ethnic background.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where&#xD;
      individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada).&#xD;
      The CDC currently recommends PrEP as a method of HIV prevention in high-risk individuals&#xD;
      based on compelling efficacy data from large international studies in diverse populations,&#xD;
      but the issue of adherence and its relationship to clinical efficacy is still being defined.&#xD;
      In five large, randomized and controlled studies, many prospective PrEP patients chose not to&#xD;
      take PrEP, and those that did often did not adhere to it consistently (Landovitz &amp; Coates,&#xD;
      2014). Experts remain unable to answer several high-stakes questions: How do we increase PrEP&#xD;
      uptake and adherence amongst those most at risk for HIV, and will starting PrEP increase or&#xD;
      decrease high-risk individual sexual behavior and HIV incidence? (Landovitz &amp; Coates, 2014).&#xD;
      In sum, the biggest challenge to reducing new HIV incidence in the U.S. is behavioral, not&#xD;
      medical.&#xD;
&#xD;
      Here, the investigators propose a randomized, controlled clinical study to test the&#xD;
      effectiveness of a &quot;future selves-value affirmation&quot; behavioral intervention on PrEP uptake&#xD;
      and adherence. The intervention is designed to address the challenges of stigma and &quot;present&#xD;
      bias&quot; - the individual propensity to place the gains of the moment ahead of future gains- as&#xD;
      it relates to adherence.&#xD;
&#xD;
      &quot;Present bias&quot; and the suboptimal decisions it produces derive from a limited ability to&#xD;
      imagine one's self in the future, and lead to a patient's preference for smaller, immediate&#xD;
      rewards (e.g., escaping side effects of a medication, safeguarding one's situation from loved&#xD;
      ones) over larger, delayed ones (e.g., not contracting HIV, longer life expectancy, better&#xD;
      health). Research has shown that vivid, concrete, and detailed images of one's future self&#xD;
      enhance a person's ability to envision and emotionally engage the future consequences of&#xD;
      present-day decisions. For instance, creating positive images of one's future self has been&#xD;
      shown to stem delinquent behavior for up to a year (van Gelder, 2013).&#xD;
&#xD;
      To address stigma, the investigators draw on another literature in psychology which has now&#xD;
      established that short value affirmation exercises are able to enhance learning, performance,&#xD;
      control and commitment outcomes, and to do so most effectively with populations facing stigma&#xD;
      in the domain of interest (Vohs &amp; Smeichel, 2009; Creswell et al., 2013; Creswell &amp; Lindsay,&#xD;
      2014), especially within the domain of health behavior change (Ehret &amp; Sherman, 2014; Harris,&#xD;
      2011; Reed &amp; Aspinwall, 1998; Nustad, 2011; Cohen and Sherman, 2014; Epton et al., 2015).&#xD;
      Affirmation exercises can be as simple as writing or talking for 5 minutes about a value one&#xD;
      holds dear. Indeed, one such 5-minute exercise at the beginning of a new program or project&#xD;
      can lead to profoundly powerful long-term outcomes across very different settings. For&#xD;
      example, one intervention led to a .41 point grade increase for minority students in college&#xD;
      over the course of one and two years (Cohen et al, 2009), increased decision making skills&#xD;
      and use of public service information by homeless shelter participants in Seattle (Hall et&#xD;
      al., 2014), and enabled smokers to more readily accept threatening smoking risk information&#xD;
      (Epton et al., 2015). This study will combine value affirmation and future selves approaches.&#xD;
&#xD;
      The first study objective is to evaluate the effect of the &quot;future-selves / value&#xD;
      affirmation&quot; intervention on PrEP adherence, as measured by tenofovir levels in dried blood&#xD;
      spots and categorized via the 5-level ordinal measure for Engagement with PrEP (used in the&#xD;
      iPrEx Open-Label Extension). The secondary study objectives are to evaluate the effect of the&#xD;
      &quot;future-selves / value affirmation&quot; intervention on HIV and STI contraction at 3, 6, 9, and&#xD;
      12 months, and to evaluate the effect of the &quot;future-selves / value affirmation&quot; intervention&#xD;
      on sexual risk behaviors, as self-reported numbers of anal/vaginal sex partners and episodes&#xD;
      of condomless receptive anal and vaginal sex at 3, 6, 9 and 12 months.&#xD;
&#xD;
      This is a parallel group randomized trial with 2 arms-a control arm with allocation ratio of&#xD;
      50%, and an intervention arm (future self-value affirmation) with an allocation ratio of 50%.&#xD;
      At each clinic visit, participants will engage in a 10-minute writing (or oral, for those&#xD;
      with literacy challenges) exercises. Participants in the intervention arm will be given a&#xD;
      list of values, asked to select one that has been particularly important to them at critical&#xD;
      times in their life, then asked to write about why that value is important to them. Next,&#xD;
      those same participants will write a letter to themselves twenty (20) years in the future.&#xD;
      Participants in the control arm will first write for 5 minutes about why two values that are&#xD;
      least important to them may be important to someone else, and next write a letter to&#xD;
      themselves two weeks in the future.&#xD;
&#xD;
      The study includes 170 subjects enrolled across 4 sites in Pittsburgh, with an expectation of&#xD;
      retaining 80%, or 135 subjects. Each subject's participation will last for 12 months.The&#xD;
      entire study is expected to last for 18 months. The investigators will evaluate&#xD;
      concentrations of tenofovir diphosphate (TFV-DP) in dried blood spot samples at baseline and&#xD;
      then quarterly visits; they will also perform quarterly evaluations of self-reported numbers&#xD;
      of anal/vaginal sex partners and episodes of condomless receptive anal and vaginal sex with&#xD;
      and without condoms; incidence of STI and HIV acquisition.&#xD;
&#xD;
      The investigators will employ a mixed ANOVA to look at intervention effects on adherence-as&#xD;
      well as STI incidence, and safe sex practices-across time intervals. They will also estimate&#xD;
      mixed regression models for the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Did not meet recruitment goals&#xD;
  </why_stopped>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a parallel group randomized trial with 2 arms-a control arm with allocation ratio of 50%, and an intervention arm (future self-value affirmation) with an allocation ratio of 50%.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Participants are randomly assigned to treatment or control exercises involving writing for 5 minutes. Participants do not know there is another writing condition. Care providers do not see the written content provided by the participant. Neither the participants nor the care provider will know which condition the participant is in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP Adherence</measure>
    <time_frame>quarterly, for one year</time_frame>
    <description>Tenofovir concentrations in dried blood spots</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV contraction</measure>
    <time_frame>quarterly, for one year</time_frame>
    <description>Diagnosis of HIV throughout the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Risk Behavior 1: Partners</measure>
    <time_frame>quarterly, for one year</time_frame>
    <description>Number of Partners in anal or vaginal sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual risk behavior 2: Condomless sex</measure>
    <time_frame>quarterly, for one year</time_frame>
    <description>number of condomless vaginal or anal sex occurrences</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STI contraction</measure>
    <time_frame>quarterly, for one year</time_frame>
    <description>Diagnosis of an STI throughout the study period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>HIV Prevention</condition>
  <arm_group>
    <arm_group_label>Future Self - Value Affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a behavioral intervention whereby participants write (Value Affirmation and Future Selves Combination) for 5 minutes about 1-2 values that are important to them, as well as about a time in their life when they were particularly important. Next, for five minutes, they write a letter to themselves in 20 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In this sham comparator, participants will also write (Control Writing Exercise) --similar to the intervention above. However, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Value Affirmation and Future Selves Combination</intervention_name>
    <description>Following the questionnaire, participants will complete a 10- to 15-minute writing exercise. In the control condition, they will be given a list of values, select two that are least important to them, then write about why those values might be important to others. Next, they will write a short letter to themselves in 2 weeks. In the treatment condition, they will be given a list of values, select two that are important to them, then write for about why those values are important to them and how they have played a role in their life. They will then write a short letter to themselves twenty years in the future.</description>
    <arm_group_label>Future Self - Value Affirmation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control writing exercise</intervention_name>
    <description>In this sham comparator, participants will also write, however, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. HIV- men and women, age 18 and higher, who are seeking PrEP and deemed appropriate per&#xD;
             local site investigator following the CDC risk indication guidelines for PrEP.&#xD;
&#xD;
          2. Must fit into one of the study's CDC-identified risk strata: a) IDUs and/or b)&#xD;
             Caucasian LGBTQ or Minority LGBTQ&#xD;
&#xD;
          3. Must be able to read and write English for themselves.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Same as that for PrEP initiation, e.g., existing HIV+ diagnosis or contra-indications,&#xD;
             creatinine GFR &lt; 60.&#xD;
&#xD;
          2. Current or previous use of PrEP.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nichole Ben Itzhak, PhD</last_name>
    <role>Study Director</role>
    <affiliation>BI Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Inclusion Health, Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</investigator_affiliation>
    <investigator_full_name>Stuart Fisk</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>PrEP</keyword>
  <keyword>Prevention</keyword>
  <keyword>Value Affirmation</keyword>
  <keyword>Future Selves</keyword>
  <keyword>Behavioral Intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only de-identified information will be shared regarding STI/HIV diagnosis.</ipd_description>
  </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/NCT03278990
org study id: IN-US-276-4221
nct id: NCT03278990
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where
      individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada).
      PrEP has been proven medically effective and could help to reduce the rate of new HIV
      incidence in the United States, but in five large, randomized and controlled studies, many
      prospective PrEP patients chose not to take PrEP, and those that did often did not adhere to
      it consistently. How do we increase PrEP uptake and adherence amongst those most at risk for
      HIV? Also, will taking PrEP increase or decrease high-risk individual sexual behavior and HIV
      incidence? Here, the investigators propose a parallel group randomized, controlled clinical
      trial to test the effectiveness of a behavioral intervention designed to buffer individuals
      against stigma-related feelings, and to increase their connection to their selves twenty
      years in the future. The primary objective of the study is to increase PrEP adherence, as
      measured by the concentration of tenofovir diphosphate (TFV-DP) in dried blood spot samples
      (DBS). The secondary objectives are to decrease the incidence of STIs and increase safe
      sexual practices, as measured by clinic diagnoses and self-reported practices at 3, 6, 9 and
      12 months.

      This 12-month outpatient study will take place at four PrEP clinics in Pittsburgh and will
      enroll 170 subjects across 4 sites, with an expectation of retaining 80%, or 135 subjects.
      Eligibility includes male and female adults, ages 18-65, who are at risk of contracting HIV.
      Efforts will be made to recruit 33% of subjects from each of the following strata: 1) young,
      minority LGBT adults age 18-30 years of age; 2) Caucasian adults (MSM and heterosexual
      females) age 18-65 years of age; and 3) IDU adults, age 18-65, of any ethnic background.
Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where
      individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada).
      The CDC currently recommends PrEP as a method of HIV prevention in high-risk individuals
      based on compelling efficacy data from large international studies in diverse populations,
      but the issue of adherence and its relationship to clinical efficacy is still being defined.
      In five large, randomized and controlled studies, many prospective PrEP patients chose not to
      take PrEP, and those that did often did not adhere to it consistently (Landovitz & Coates,
      2014). Experts remain unable to answer several high-stakes questions: How do we increase PrEP
      uptake and adherence amongst those most at risk for HIV, and will starting PrEP increase or
      decrease high-risk individual sexual behavior and HIV incidence? (Landovitz & Coates, 2014).
      In sum, the biggest challenge to reducing new HIV incidence in the U.S. is behavioral, not
      medical.

      Here, the investigators propose a randomized, controlled clinical study to test the
      effectiveness of a "future selves-value affirmation" behavioral intervention on PrEP uptake
      and adherence. The intervention is designed to address the challenges of stigma and "present
      bias" - the individual propensity to place the gains of the moment ahead of future gains- as
      it relates to adherence.

      "Present bias" and the suboptimal decisions it produces derive from a limited ability to
      imagine one's self in the future, and lead to a patient's preference for smaller, immediate
      rewards (e.g., escaping side effects of a medication, safeguarding one's situation from loved
      ones) over larger, delayed ones (e.g., not contracting HIV, longer life expectancy, better
      health). Research has shown that vivid, concrete, and detailed images of one's future self
      enhance a person's ability to envision and emotionally engage the future consequences of
      present-day decisions. For instance, creating positive images of one's future self has been
      shown to stem delinquent behavior for up to a year (van Gelder, 2013).

      To address stigma, the investigators draw on another literature in psychology which has now
      established that short value affirmation exercises are able to enhance learning, performance,
      control and commitment outcomes, and to do so most effectively with populations facing stigma
      in the domain of interest (Vohs & Smeichel, 2009; Creswell et al., 2013; Creswell & Lindsay,
      2014), especially within the domain of health behavior change (Ehret & Sherman, 2014; Harris,
      2011; Reed & Aspinwall, 1998; Nustad, 2011; Cohen and Sherman, 2014; Epton et al., 2015).
      Affirmation exercises can be as simple as writing or talking for 5 minutes about a value one
      holds dear. Indeed, one such 5-minute exercise at the beginning of a new program or project
      can lead to profoundly powerful long-term outcomes across very different settings. For
      example, one intervention led to a .41 point grade increase for minority students in college
      over the course of one and two years (Cohen et al, 2009), increased decision making skills
      and use of public service information by homeless shelter participants in Seattle (Hall et
      al., 2014), and enabled smokers to more readily accept threatening smoking risk information
      (Epton et al., 2015). This study will combine value affirmation and future selves approaches.

      The first study objective is to evaluate the effect of the "future-selves / value
      affirmation" intervention on PrEP adherence, as measured by tenofovir levels in dried blood
      spots and categorized via the 5-level ordinal measure for Engagement with PrEP (used in the
      iPrEx Open-Label Extension). The secondary study objectives are to evaluate the effect of the
      "future-selves / value affirmation" intervention on HIV and STI contraction at 3, 6, 9, and
      12 months, and to evaluate the effect of the "future-selves / value affirmation" intervention
      on sexual risk behaviors, as self-reported numbers of anal/vaginal sex partners and episodes
      of condomless receptive anal and vaginal sex at 3, 6, 9 and 12 months.

      This is a parallel group randomized trial with 2 arms-a control arm with allocation ratio of
      50%, and an intervention arm (future self-value affirmation) with an allocation ratio of 50%.
      At each clinic visit, participants will engage in a 10-minute writing (or oral, for those
      with literacy challenges) exercises. Participants in the intervention arm will be given a
      list of values, asked to select one that has been particularly important to them at critical
      times in their life, then asked to write about why that value is important to them. Next,
      those same participants will write a letter to themselves twenty (20) years in the future.
      Participants in the control arm will first write for 5 minutes about why two values that are
      least important to them may be important to someone else, and next write a letter to
      themselves two weeks in the future.

      The study includes 170 subjects enrolled across 4 sites in Pittsburgh, with an expectation of
      retaining 80%, or 135 subjects. Each subject's participation will last for 12 months.The
      entire study is expected to last for 18 months. The investigators will evaluate
      concentrations of tenofovir diphosphate (TFV-DP) in dried blood spot samples at baseline and
      then quarterly visits; they will also perform quarterly evaluations of self-reported numbers
      of anal/vaginal sex partners and episodes of condomless receptive anal and vaginal sex with
      and without condoms; incidence of STI and HIV acquisition.

      The investigators will employ a mixed ANOVA to look at intervention effects on adherence-as
      well as STI incidence, and safe sex practices-across time intervals. They will also estimate
      mixed regression models for the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a parallel group randomized trial with 2 arms-a control arm with allocation ratio of 50%, and an intervention arm (future self-value affirmation) with an allocation ratio of 50%.
primary purpose: Prevention
masking: Double (Participant, Care Provider)
masking description: Participants are randomly assigned to treatment or control exercises involving writing for 5 minutes. Participants do not know there is another writing condition. Care providers do not see the written content provided by the participant. Neither the participants nor the care provider will know which condition the participant is in.
measure: PrEP Adherence
time frame: quarterly, for one year
description: Tenofovir concentrations in dried blood spots
measure: HIV contraction
time frame: quarterly, for one year
description: Diagnosis of HIV throughout the study period
measure: Sexual Risk Behavior 1: Partners
time frame: quarterly, for one year
description: Number of Partners in anal or vaginal sex
measure: Sexual risk behavior 2: Condomless sex
time frame: quarterly, for one year
description: number of condomless vaginal or anal sex occurrences
measure: STI contraction
time frame: quarterly, for one year
description: Diagnosis of an STI throughout the study period
arm group label: Future Self - Value Affirmation
arm group type: Experimental
description: This is a behavioral intervention whereby participants write (Value Affirmation and Future Selves Combination) for 5 minutes about 1-2 values that are important to them, as well as about a time in their life when they were particularly important. Next, for five minutes, they write a letter to themselves in 20 years.
arm group label: Control
arm group type: Sham Comparator
description: In this sham comparator, participants will also write (Control Writing Exercise) --similar to the intervention above. However, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.
intervention type: Behavioral
intervention name: Value Affirmation and Future Selves Combination
description: Following the questionnaire, participants will complete a 10- to 15-minute writing exercise. In the control condition, they will be given a list of values, select two that are least important to them, then write about why those values might be important to others. Next, they will write a short letter to themselves in 2 weeks. In the treatment condition, they will be given a list of values, select two that are important to them, then write for about why those values are important to them and how they have played a role in their life. They will then write a short letter to themselves twenty years in the future.
arm group label: Future Self - Value Affirmation
intervention type: Behavioral
intervention name: Control writing exercise
description: In this sham comparator, participants will also write, however, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nichole Ben Itzhak, PhD
role: Study Director
affiliation: BI Development
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
investigator full name: Stuart Fisk
investigator title: Sponsor-Investigator
sharing ipd: No
ipd description: Only de-identified information will be shared regarding STI/HIV diagnosis.