<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/NCT02263391</url>
  </required_header>
  <id_info>
    <org_study_id>3878</org_study_id>
    <secondary_id>1R21AA022596-01</secondary_id>
    <nct_id>NCT02263391</nct_id>
  </id_info>
  <brief_title>HIV Risk and Prevention in Women</brief_title>
  <official_title>Collaborative Biosocial Research on HIV Risk and Prevention in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Russian Foundation for Basic Research (RFBR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint Petersburg State University, Russia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study gathers information about HIV testing utilization and influences on HIV testing&#xD;
      decisions among young, general population Russian women at-risk of HIV exposure. The study&#xD;
      compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in&#xD;
      vs. opt-out) and conducts one of the first randomized experimental comparisons of these&#xD;
      strategies. The overarching goal is to gain knowledge that can be used to increase&#xD;
      utilization of HIV testing among at-risk young women and offer gender-specific strategies for&#xD;
      improving prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study uses an adaptive design. That is, the procedures and phases of the study&#xD;
      experienced by a participant depend to some extent on their responses to earlier phases.&#xD;
      Ultimately, this design yields a number of practice relevant pathways and endpoints, each of&#xD;
      which has a testing rate associated with it.&#xD;
&#xD;
      Phase-I is initial screening for risk status, collecting background data, and ascertaining&#xD;
      whether there has been recent independent HIV testing. If there has been independent testing,&#xD;
      information about the independent testing is collected and the participant's involvement is&#xD;
      complete.&#xD;
&#xD;
      Those who are not independent testers enter Phase-II. Phase II will include: randomization to&#xD;
      opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or&#xD;
      non-acceptance; participating in a focus group in which participants who have not accepted&#xD;
      HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their&#xD;
      health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then&#xD;
      (5) after the focus group is complete, privately offer another testing opportunity to&#xD;
      non-accepters, under the same opt-in or opt-out strategy to which they previously were&#xD;
      randomized. The design was selected in order simultaneously answer a number of questions that&#xD;
      we believe will be important for engineering a testing and prevention strategy suitable for&#xD;
      testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey);&#xD;
      (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data&#xD;
      about reasons for decisions in the women's own words (focus group); and (4) identify any&#xD;
      incremental benefit related to peer discussion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who accepted a rapid health screening/HIV test</measure>
    <time_frame>At first visit, an expected average of 1 hour</time_frame>
    <description>Women's decision to take/not take a health screening test/HIV test is recorded. If a woman chooses to be tested, she will be asked a few questions to assess her reasons for being tested. She will be provided with the results of the testing. If a woman's test is positive for HIV (or other health risks in the bundled opt-out condition), counseling with a trained study nurse, physician or psychologist will be available on-site and a referral for additional testing, counseling, and appropriate medical care will be provided.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who accepted the health screening/HIV test after a focus group</measure>
    <time_frame>After completing a focus group discussion, an expected average of 4 weeks</time_frame>
    <description>participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief survey to assess reasons for being tested</measure>
    <time_frame>At first visit, an expected average of 1 hour</time_frame>
    <description>Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Opt-in testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Common barriers to HIV screening testing will be removed as much as possible (i.e., providing rapid testing, results shortly available, testing on-site, confidentiality). The research assistant will say: &quot;There is voluntary HIV testing available to all study participants if you wish to do it. It is free, private, it is only a finger stick, and you will learn your HIV results in just minutes.&quot; Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opt-out testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be informed that a routine health test bundle is available on a voluntary basis to study participants, and the participant may elect to decline all or any individual part of the testing. The assistant will say: &quot;We are offering a voluntary panel of routine health screening test today for study participants. It includes blood sugar, cholesterol, and HIV. We recommend all of them for everyone, but you can choose to decline any or all of them. This is free, private, it is only a finger stick, and you will learn your results for all the tests in just minutes.&quot; Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Opt-in or Opt-out testing</intervention_name>
    <description>Study participants will be offered a health screening onsite.</description>
    <arm_group_label>Opt-in testing</arm_group_label>
    <arm_group_label>Opt-out testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focus Group</intervention_name>
    <description>Study participants will be invited to participate in a focus group discussion.</description>
    <arm_group_label>Opt-in testing</arm_group_label>
    <arm_group_label>Opt-out testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participant's sexual risk behaviors (i.e., a) two or more partners in the last 12&#xD;
             months, or her partner's HIV risk (e.g., HIV positive, no HIV testing and a diagnosis&#xD;
             of sexually transmitted diseases in last 12 months, multiple partners, blood&#xD;
             transmission, male partners, served in prison, or drug use) and no or inconsistent&#xD;
             condom use in the last 3 months, and no HIV testing in the last 12 months, or b) any&#xD;
             sexually-transmitted disease and no HIV testing in the last 12 months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not speak Russian, are currently pregnant, have a condition that might preclude a&#xD;
             finger-stick procedure, or have tested HIV positive in the past.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatiana Balachova, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alla Shaboltas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Facility: St. Petersburg State University St. Peterburg, Russian Federation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State University</name>
      <address>
        <city>St. Peterburg</city>
        <zip>199034</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Balachova TN, Batluk JV, Bryant KJ, Shaboltas AV. International collaboration in HIV prevention research: evidence from a research seminar in Russia. AIDS Res Hum Retroviruses. 2015 Feb;31(2):163-72. doi: 10.1089/AID.2014.0078. Epub 2014 Dec 31.</citation>
    <PMID>25430518</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transmission</keyword>
  <keyword>prevention</keyword>
  <keyword>women</keyword>
  <keyword>childbearing age</keyword>
  <keyword>HIV testing</keyword>
  <keyword>testing strategy</keyword>
  <!-- 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/NCT02263391
org study id: 3878
secondary id: 1R21AA022596-01
nct id: NCT02263391
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study gathers information about HIV testing utilization and influences on HIV testing
      decisions among young, general population Russian women at-risk of HIV exposure. The study
      compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in
      vs. opt-out) and conducts one of the first randomized experimental comparisons of these
      strategies. The overarching goal is to gain knowledge that can be used to increase
      utilization of HIV testing among at-risk young women and offer gender-specific strategies for
      improving prevention.
The study uses an adaptive design. That is, the procedures and phases of the study
      experienced by a participant depend to some extent on their responses to earlier phases.
      Ultimately, this design yields a number of practice relevant pathways and endpoints, each of
      which has a testing rate associated with it.

      Phase-I is initial screening for risk status, collecting background data, and ascertaining
      whether there has been recent independent HIV testing. If there has been independent testing,
      information about the independent testing is collected and the participant's involvement is
      complete.

      Those who are not independent testers enter Phase-II. Phase II will include: randomization to
      opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or
      non-acceptance; participating in a focus group in which participants who have not accepted
      HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their
      health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then
      (5) after the focus group is complete, privately offer another testing opportunity to
      non-accepters, under the same opt-in or opt-out strategy to which they previously were
      randomized. The design was selected in order simultaneously answer a number of questions that
      we believe will be important for engineering a testing and prevention strategy suitable for
      testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey);
      (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data
      about reasons for decisions in the women's own words (focus group); and (4) identify any
      incremental benefit related to peer discussion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of participants who accepted a rapid health screening/HIV test
time frame: At first visit, an expected average of 1 hour
description: Women's decision to take/not take a health screening test/HIV test is recorded. If a woman chooses to be tested, she will be asked a few questions to assess her reasons for being tested. She will be provided with the results of the testing. If a woman's test is positive for HIV (or other health risks in the bundled opt-out condition), counseling with a trained study nurse, physician or psychologist will be available on-site and a referral for additional testing, counseling, and appropriate medical care will be provided.
measure: Number of participants who accepted the health screening/HIV test after a focus group
time frame: After completing a focus group discussion, an expected average of 4 weeks
description: participating in a focus group in which participants who have not accepted HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then (5) after the focus group is complete, privately offer another testing opportunity to non-accepters, under the same opt-in or opt-out strategy to which they previously were randomized.
measure: Brief survey to assess reasons for being tested
time frame: At first visit, an expected average of 1 hour
description: Participants who accepted a rapid health screening/HIV test are asked about reasons for taking the test at this time.
arm group label: Opt-in testing
arm group type: Experimental
description: Common barriers to HIV screening testing will be removed as much as possible (i.e., providing rapid testing, results shortly available, testing on-site, confidentiality). The research assistant will say: "There is voluntary HIV testing available to all study participants if you wish to do it. It is free, private, it is only a finger stick, and you will learn your HIV results in just minutes." Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group.
arm group label: Opt-out testing
arm group type: Experimental
description: Participants will be informed that a routine health test bundle is available on a voluntary basis to study participants, and the participant may elect to decline all or any individual part of the testing. The assistant will say: "We are offering a voluntary panel of routine health screening test today for study participants. It includes blood sugar, cholesterol, and HIV. We recommend all of them for everyone, but you can choose to decline any or all of them. This is free, private, it is only a finger stick, and you will learn your results for all the tests in just minutes." Participants will be scheduled for a two-hour appointment to complete the written consent procedure, enroll in the study, and participate in the study activities, testing and a focus group.
intervention type: Behavioral
intervention name: Opt-in or Opt-out testing
description: Study participants will be offered a health screening onsite.
arm group label: Opt-in testing
arm group label: Opt-out testing
intervention type: Behavioral
intervention name: Focus Group
description: Study participants will be invited to participate in a focus group discussion.
arm group label: Opt-in testing
arm group label: Opt-out testing
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Tatiana Balachova, PhD
role: Principal Investigator
affiliation: University of Oklahoma
last name: Alla Shaboltas, PhD
role: Principal Investigator
affiliation: Facility: St. Petersburg State University St. Peterburg, Russian Federation
facility: 
facility: 
country: Russian Federation
country: United States
citation: Balachova TN, Batluk JV, Bryant KJ, Shaboltas AV. International collaboration in HIV prevention research: evidence from a research seminar in Russia. AIDS Res Hum Retroviruses. 2015 Feb;31(2):163-72. doi: 10.1089/AID.2014.0078. Epub 2014 Dec 31.
PMID: 25430518
responsible party type: Sponsor