<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/NCT03284541</url>
  </required_header>
  <id_info>
    <org_study_id>DP2DA042417</org_study_id>
    <nct_id>NCT03284541</nct_id>
  </id_info>
  <brief_title>Online HIV Prevention for Young Male Couples</brief_title>
  <acronym>2GETHER</acronym>
  <official_title>A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</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>
      Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in&#xD;
      which rates of new HIV infections are on the rise. There has been a relative dearth of&#xD;
      research dedicated to understanding these health disparities between gay/bisexual and&#xD;
      heterosexual youth, and even less has focused on identifying factors that might promote&#xD;
      resilience against negative health outcomes. Understanding both risk factors and processes of&#xD;
      resilience is critical in developing efficacious interventions to improve health in this&#xD;
      population.&#xD;
&#xD;
      Through a grant from the National Institutes of Health, the investigators completed formative&#xD;
      research with young male couples. Qualitative interviews identified preferences for&#xD;
      couples-based intervention format and content. While coupled YMSM expressed some interest in&#xD;
      HIV prevention, they were most interested in building relationship skills. Coupled YMSM&#xD;
      preferred group-based interventions in order to meet and learn from other couples but had&#xD;
      concerns about discussing personal topics in groups. Quantitative analyses found that the&#xD;
      rate of condomless sex in couples increased from adolescence to young adulthood. Further, the&#xD;
      influence of older partners, partner violence, and drinking before sex were strongest in&#xD;
      emerging adulthood. Informed by these, the investigators developed 2GETHER, which aims to&#xD;
      reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a&#xD;
      four session program. The first two sessions are group sessions aimed at skills building, and&#xD;
      the second two sessions are individualized couple sessions aimed at skills implementation.&#xD;
      Modules address communication skills, coping with stress (both general and sexual&#xD;
      minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within&#xD;
      the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in&#xD;
      couples regardless of HIV status; couples learn to use behavioral and biomedical approaches&#xD;
      to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and&#xD;
      transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis&#xD;
      on the health of the couple.&#xD;
&#xD;
      The investigators completed a pilot trial of 2GETHER with funding from Northwestern&#xD;
      University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility,&#xD;
      acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized&#xD;
      pre-/post-test design because the goal was to evaluate feasibility, acceptability and&#xD;
      preliminary effects in a large number of diverse couples to inform a future efficacy RCT.&#xD;
      Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial&#xD;
      recruited a diverse sample of couples in less than one year and each program module receive&#xD;
      high ratings of acceptability during post-sessions evaluation and an exit interview. At the&#xD;
      2-week post-test, the investigators observed significant decreases in HIV risk behavior,&#xD;
      improvements in motivation to reduce HIV risk, and improvements in relationship investment.&#xD;
&#xD;
      The current study will conduct a randomized controlled trial (RCT) to test the efficacy of&#xD;
      2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that&#xD;
      aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be&#xD;
      implemented online; both the experimental and control condition will be administered via&#xD;
      video-conferencing technology to couples across the United States. The investigators will&#xD;
      conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive&#xD;
      the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on&#xD;
      the HIV status of individuals in the dyad. Couples in which both members are HIV-negative&#xD;
      will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol.&#xD;
      Couples in which both members are HIV-positive will receive the single session Life-Steps&#xD;
      medication adherence protocol. Couples with discordant HIV statuses will receive both&#xD;
      interventions jointly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2018</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <phase>Phase 2</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>Couples are randomized into an experimental condition or control (existing public health practice).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Condomless anal sex</measure>
    <time_frame>12-months</time_frame>
    <description>change in number of condomless anal sex acts with serodiscordant or unknown status partners</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of Sexually Transmitted Infections</measure>
    <time_frame>12-months</time_frame>
    <description>the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV Testing</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>frequency of HIV testing among HIV-negative or unknown status participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV Viral Load</measure>
    <time_frame>Baseline, 12-months</time_frame>
    <description>change in serum viral load among HIV-positive participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol and Drug Use Problems</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>change in problems associated with alcohol, marijuana and other illicit drug use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Satisfaction</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>change in relationship satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communication Skills</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>change in communication skills with romantic partners</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Antiretroviral Medication Adherence</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>change in ART medication adherence among HIV-positive participants</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre-Exposure Prophylaxis</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>initiation of pre-exposure prophylaxis among HIV-negative or unknown status participants</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre-Exposure Prophylaxis Adherence</measure>
    <time_frame>Baseline, 3-, 6-, 9-, 12-months</time_frame>
    <description>change in pre-exposure prophylaxis adherence among participants have have initiated pre-exposure prophylaxis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Hiv</condition>
  <condition>Chlamydia</condition>
  <condition>Gonorrhea</condition>
  <arm_group>
    <arm_group_label>2GETHER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 individualized couple session) administered over the course of 1 month (1 session per week). Group sessions focus on developing skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing Public Health Practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control condition consists of the single-session Couples-Based HIV Counseling and Testing protocol for HIV-negative couples, the single-session Life-Steps medication adherence protocol for HIV-positive couples, or both intervention delivered jointly to serodiscordant couples</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>2GETHER</intervention_name>
    <description>Communication skills, coping skills, problem-solving, acceptance, HIV prevention</description>
    <arm_group_label>2GETHER</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Existing Public Health Practice</intervention_name>
    <description>HIV testing, medication adherence, HIV risk reduction</description>
    <arm_group_label>Existing Public Health Practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both members of the couple assigned male at birth and currently identify as male&#xD;
&#xD;
          -  Both members of the couples at least 18 years of age; at least one between the ages of&#xD;
             18-29 years&#xD;
&#xD;
          -  Both members of the couple identify one another as primary partners&#xD;
&#xD;
          -  Couple has had oral or anal sex with one another in the past 3 months&#xD;
&#xD;
          -  At least one member of the couple reports condomless anal sex with a serodiscordant or&#xD;
             unknown status partner during the past 3 months&#xD;
&#xD;
          -  At least one member of the couple reports an episode of binge-drinking or illicit drug&#xD;
             use during the last 30 days&#xD;
&#xD;
          -  Both members of the couple read and speak English at 8th grade level or better&#xD;
&#xD;
          -  Both members have Internet access&#xD;
&#xD;
          -  Both members audio recording of intervention sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe intimate partner violence during the past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Both members of the dyad must be assigned male at birth and currently identify as male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael E Newcomb, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jim Carey, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ricky Hill, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University-Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34.</citation>
    <PMID>19417579</PMID>
  </reference>
  <reference>
    <citation>Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. &quot;Is this normal? Is this not normal? There's no set example&quot;: Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2.</citation>
    <PMID>25678895</PMID>
  </reference>
  <reference>
    <citation>Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7.</citation>
    <PMID>24980246</PMID>
  </reference>
  <reference>
    <citation>Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x.</citation>
    <PMID>22283386</PMID>
  </reference>
  <reference>
    <citation>Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0.</citation>
    <PMID>28083833</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Michael E. Newcomb</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gonorrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03284541/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03284541
org study id: DP2DA042417
nct id: NCT03284541
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in
      which rates of new HIV infections are on the rise. There has been a relative dearth of
      research dedicated to understanding these health disparities between gay/bisexual and
      heterosexual youth, and even less has focused on identifying factors that might promote
      resilience against negative health outcomes. Understanding both risk factors and processes of
      resilience is critical in developing efficacious interventions to improve health in this
      population.

      Through a grant from the National Institutes of Health, the investigators completed formative
      research with young male couples. Qualitative interviews identified preferences for
      couples-based intervention format and content. While coupled YMSM expressed some interest in
      HIV prevention, they were most interested in building relationship skills. Coupled YMSM
      preferred group-based interventions in order to meet and learn from other couples but had
      concerns about discussing personal topics in groups. Quantitative analyses found that the
      rate of condomless sex in couples increased from adolescence to young adulthood. Further, the
      influence of older partners, partner violence, and drinking before sex were strongest in
      emerging adulthood. Informed by these, the investigators developed 2GETHER, which aims to
      reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a
      four session program. The first two sessions are group sessions aimed at skills building, and
      the second two sessions are individualized couple sessions aimed at skills implementation.
      Modules address communication skills, coping with stress (both general and sexual
      minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within
      the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in
      couples regardless of HIV status; couples learn to use behavioral and biomedical approaches
      to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and
      transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis
      on the health of the couple.

      The investigators completed a pilot trial of 2GETHER with funding from Northwestern
      University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility,
      acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized
      pre-/post-test design because the goal was to evaluate feasibility, acceptability and
      preliminary effects in a large number of diverse couples to inform a future efficacy RCT.
      Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial
      recruited a diverse sample of couples in less than one year and each program module receive
      high ratings of acceptability during post-sessions evaluation and an exit interview. At the
      2-week post-test, the investigators observed significant decreases in HIV risk behavior,
      improvements in motivation to reduce HIV risk, and improvements in relationship investment.

      The current study will conduct a randomized controlled trial (RCT) to test the efficacy of
      2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that
      aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be
      implemented online; both the experimental and control condition will be administered via
      video-conferencing technology to couples across the United States. The investigators will
      conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive
      the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on
      the HIV status of individuals in the dyad. Couples in which both members are HIV-negative
      will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol.
      Couples in which both members are HIV-positive will receive the single session Life-Steps
      medication adherence protocol. Couples with discordant HIV statuses will receive both
      interventions jointly.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Couples are randomized into an experimental condition or control (existing public health practice).
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Condomless anal sex
time frame: 12-months
description: change in number of condomless anal sex acts with serodiscordant or unknown status partners
measure: Occurrence of Sexually Transmitted Infections
time frame: 12-months
description: the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months
measure: HIV Testing
time frame: Baseline, 3-, 6-, 9-, 12-months
description: frequency of HIV testing among HIV-negative or unknown status participants
measure: HIV Viral Load
time frame: Baseline, 12-months
description: change in serum viral load among HIV-positive participants
measure: Alcohol and Drug Use Problems
time frame: Baseline, 3-, 6-, 9-, 12-months
description: change in problems associated with alcohol, marijuana and other illicit drug use
measure: Relationship Satisfaction
time frame: Baseline, 3-, 6-, 9-, 12-months
description: change in relationship satisfaction
measure: Communication Skills
time frame: Baseline, 3-, 6-, 9-, 12-months
description: change in communication skills with romantic partners
measure: Antiretroviral Medication Adherence
time frame: Baseline, 3-, 6-, 9-, 12-months
description: change in ART medication adherence among HIV-positive participants
measure: Pre-Exposure Prophylaxis
time frame: Baseline, 3-, 6-, 9-, 12-months
description: initiation of pre-exposure prophylaxis among HIV-negative or unknown status participants
measure: Pre-Exposure Prophylaxis Adherence
time frame: Baseline, 3-, 6-, 9-, 12-months
description: change in pre-exposure prophylaxis adherence among participants have have initiated pre-exposure prophylaxis
arm group label: 2GETHER
arm group type: Experimental
description: 2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 individualized couple session) administered over the course of 1 month (1 session per week). Group sessions focus on developing skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.
arm group label: Existing Public Health Practice
arm group type: Active Comparator
description: The control condition consists of the single-session Couples-Based HIV Counseling and Testing protocol for HIV-negative couples, the single-session Life-Steps medication adherence protocol for HIV-positive couples, or both intervention delivered jointly to serodiscordant couples
intervention type: Behavioral
intervention name: 2GETHER
description: Communication skills, coping skills, problem-solving, acceptance, HIV prevention
arm group label: 2GETHER
intervention type: Behavioral
intervention name: Existing Public Health Practice
description: HIV testing, medication adherence, HIV risk reduction
arm group label: Existing Public Health Practice
criteria: 
gender: Male
gender based: Yes
gender description: Both members of the dyad must be assigned male at birth and currently identify as male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael E Newcomb, Ph.D.
role: Principal Investigator
affiliation: Northwestern University
last name: Jim Carey, MPH
role: Study Director
affiliation: Northwestern University
last name: Ricky Hill, Ph.D.
role: Study Director
affiliation: Northwestern University
facility: 
country: United States
citation: Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34.
PMID: 19417579
citation: Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. "Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2.
PMID: 25678895
citation: Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7.
PMID: 24980246
citation: Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x.
PMID: 22283386
citation: Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0.
PMID: 28083833
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Michael E. Newcomb
investigator title: Assistant Professor
mesh term: Gonorrhea
sharing ipd: Undecided
provided document: 