<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/NCT03810170</url>
  </required_header>
  <id_info>
    <org_study_id>R44AG034707</org_study_id>
    <nct_id>NCT03810170</nct_id>
  </id_info>
  <brief_title>Prevention of HIV/AIDS and STDs in Women Over Fifty</brief_title>
  <official_title>Prevention of HIV/AIDS and STDs in Women Over Fifty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Environment and Health Group, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Environment and Health Group, Inc.</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>
      In response to the increasing rates of HIV/STD infections among women over the age of 50,&#xD;
      especially minority women, and in the attempt to reduce HIV/STD risks for over ten million&#xD;
      older adult American women who are impacted by gray divorce and at risk for unsafe sex, the&#xD;
      investigators will create, test, and commercialize a novel positive psychology-based&#xD;
      &quot;SmartWeb&quot; intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among&#xD;
      culturally-diverse older divorced or separated women who are dating. This large end-user&#xD;
      market for the proposed HIV/STD risk reduction intervention will greatly facilitate&#xD;
      commercialization through advertisements, marketing research based on data mining, and in&#xD;
      collaboration with manufacturers of condoms, and other large companies offering health&#xD;
      products and services to older women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older adult women (age 50+) account for almost a third of the U.S. HIV/AIDS population, and&#xD;
      infection rates among this group are increasing. The overall goal of the proposed Phase II&#xD;
      application is to develop a culturally-sensitive, gender-specific, and age-appropriate HIV&#xD;
      prevention intervention for older women, especially African American and Latino women who are&#xD;
      at disproportionally high risk for HIV/STD infection. The target population is the growing&#xD;
      number of divorced/separated older women for whom interventions have not been developed and,&#xD;
      due to cohort and social contextual factors, are likely unaware that they are at risk, and&#xD;
      more likely than single (never married) women to forgo condom use. Building on Phase I and&#xD;
      ARRA study results, the Phase II objectives are to create, test, and commercialize a positive&#xD;
      psychology-based &quot;SmartWeb&quot; intervention to promote wellbeing and safe sex practices among&#xD;
      culturally diverse older divorced or separated women who are dating or planning on dating.&#xD;
      Specific Phase II Aims are: 1) Create the SmartWeb intervention; 2) Evaluate its&#xD;
      effectiveness in a randomized controlled trial (RCT) of divorced/separated women over 50; and&#xD;
      3) Prepare marketing and commercialization plans for the SmartWeb intervention.&#xD;
&#xD;
      Consistent with Phase I objectives, i.e., developing content to address Stages 1-3 of the&#xD;
      M-AARM theoretical model, the proposed Phase II includes new components to address M-AARM&#xD;
      Stages 4-5. The Phase II is also responsive to Phase I evaluation findings, including the&#xD;
      desire for mobile access, membership; video interviews with experts in women's health,&#xD;
      positive aging, HIV/STD prevention in culturally diverse communities, safe sex negotiation&#xD;
      strategies, and gray divorce; online community, and positive psychology- based self-efficacy&#xD;
      and affect-boosting emails, as well as expanded versions of Phase I components to reinforce&#xD;
      stages 1-3 of the M-ARRM theoretical model.&#xD;
&#xD;
      The investigators are supported in these efforts through partnerships in both Boston, MA and&#xD;
      Columbia SC, the sites for the randomized controlled trial. Participating partners include&#xD;
      those providing commercialization support (Global Protection Corp, USC Columbia Incubator, SC&#xD;
      Launch, Moker CPCA), recruitment and marketing support in Boston (New England Association of&#xD;
      HIV over 50, Massachusetts Department of Public Health Statewide Consumer Advisory Board on&#xD;
      HIV/AIDS, Brigham &amp; Women's Hospital Women's Health Center) and in Columbia (South Carolina&#xD;
      Lieutenant Governor's Office on Aging, South Carolina HIV/AIDS Council, AID Upstate in South&#xD;
      Carolina, Lowcountry AIDS Services, United Way Association of South Carolina, South Carolina&#xD;
      Primary Care Association, Columbia Housing Authority in South Carolina, Palmetto AIDS Life&#xD;
      Support Services), and content and technology development and support (University of South&#xD;
      Carolina College of Social Work and Department of Computer Science and Engineering, South&#xD;
      Carolina HIV/AIDS Council)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2009</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intention to engage in safe sex questionnaire</measure>
    <time_frame>90 days</time_frame>
    <description>A three-item intention to engage in safe sex practices instrument. Participants will answer 3 questions, validated for this population (Fisher et al., 1998; Mausbach et al., 2009), regarding their intentions to use protection during sex over the next two months (e.g., &quot;I intend to always use condoms during vaginal sex with all of my partners during the next two months&quot;) Responses are on a 5-point Likert scale, 1 = &quot;Very Untrue&quot; and 5 = &quot;Very True&quot;. The score ranges from 3 to 15. The higher score indicate better intention to engage in safe sex.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safe sex self-efficacy questionnaire</measure>
    <time_frame>90 days</time_frame>
    <description>8-item Self-efficacy for Sexual Discussion Scale. Responses are on a 4-point scale, 1='disagree' and 4='agree'. The first two questions should be reversed when coding. Sum up the final score and the higher the score is indicate the higher self-efficacy for sexual discussion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV transmission knowledge questionnaire</measure>
    <time_frame>90 days</time_frame>
    <description>There are two questionnaires in this outcome: a 13-item modified HIV Sexual Transmission and Prevention Knowledge and a 15-item HIV/AIDS Knowledge and Attitudes Survey. Each correct answer get one point. The final score is the sum up of all the questions. Range from 0-28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceived sexual/HIV risk questionnaire</measure>
    <time_frame>90 days</time_frame>
    <description>38-item Perceived Sexual Risks Scale. The self-assessment allows participants to evaluate the degree to which they may be at risk for engaging in behavior that exposes themselves to HIV. For each of the 38 items, participants choose from 'agree', 'undecided', or 'disagree' that best characterizes their option. Begin by giving scoring eighty points. Subtract one point for every undecided response. Subtract two points every time that participants disagreed with odd-numbered items or with item number 38. Subtract two points every time participants agreed with even-numbered items 2 through 36. Higher scores are more likely to engage in risky sexual activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>positive affect questionnaire</measure>
    <time_frame>90 days</time_frame>
    <description>4-item scale General Happiness Scale. A 4-item scale designed to measure subjective happiness. Each of item is completed by choosing one of 7 options that finish a given sentence fragment. Compute the mean across responses to all four questions; item #4 is reverse coded. The higher score indicate higher subjective happiness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">331</enrollment>
  <condition>Hiv</condition>
  <condition>Sexually Transmitted Diseases</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control group receives 2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention group receives safe sex and HIV/STD prevention education via a website, and weekly emails on with positive psychology-based happiness and resilience boosting activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>safe sex and HIV/STD prevention education via a website</intervention_name>
    <description>website providing positive psychology-based advice and education for women over the age of 50 who are divorced. embedded in site is safe sex education.</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>written materials on safe sex</intervention_name>
    <description>2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  divorced or separated women&#xD;
&#xD;
          -  50 years of age and older&#xD;
&#xD;
          -  who are dating or thinking of dating in the near future&#xD;
&#xD;
          -  HIV negative&#xD;
&#xD;
          -  access to internet via computer or smartphone&#xD;
&#xD;
          -  English primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently married&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  participating in another research study or clinical trial&#xD;
&#xD;
          -  do not own home computer with internet access or smartphone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Environment and Health Group</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Environment and Health Group, Inc.</investigator_affiliation>
    <investigator_full_name>Patricia Weitzman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
  </condition_browse>
  <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/NCT03810170
org study id: R44AG034707
nct id: NCT03810170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In response to the increasing rates of HIV/STD infections among women over the age of 50,
      especially minority women, and in the attempt to reduce HIV/STD risks for over ten million
      older adult American women who are impacted by gray divorce and at risk for unsafe sex, the
      investigators will create, test, and commercialize a novel positive psychology-based
      "SmartWeb" intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among
      culturally-diverse older divorced or separated women who are dating. This large end-user
      market for the proposed HIV/STD risk reduction intervention will greatly facilitate
      commercialization through advertisements, marketing research based on data mining, and in
      collaboration with manufacturers of condoms, and other large companies offering health
      products and services to older women.
Older adult women (age 50+) account for almost a third of the U.S. HIV/AIDS population, and
      infection rates among this group are increasing. The overall goal of the proposed Phase II
      application is to develop a culturally-sensitive, gender-specific, and age-appropriate HIV
      prevention intervention for older women, especially African American and Latino women who are
      at disproportionally high risk for HIV/STD infection. The target population is the growing
      number of divorced/separated older women for whom interventions have not been developed and,
      due to cohort and social contextual factors, are likely unaware that they are at risk, and
      more likely than single (never married) women to forgo condom use. Building on Phase I and
      ARRA study results, the Phase II objectives are to create, test, and commercialize a positive
      psychology-based "SmartWeb" intervention to promote wellbeing and safe sex practices among
      culturally diverse older divorced or separated women who are dating or planning on dating.
      Specific Phase II Aims are: 1) Create the SmartWeb intervention; 2) Evaluate its
      effectiveness in a randomized controlled trial (RCT) of divorced/separated women over 50; and
      3) Prepare marketing and commercialization plans for the SmartWeb intervention.

      Consistent with Phase I objectives, i.e., developing content to address Stages 1-3 of the
      M-AARM theoretical model, the proposed Phase II includes new components to address M-AARM
      Stages 4-5. The Phase II is also responsive to Phase I evaluation findings, including the
      desire for mobile access, membership; video interviews with experts in women's health,
      positive aging, HIV/STD prevention in culturally diverse communities, safe sex negotiation
      strategies, and gray divorce; online community, and positive psychology- based self-efficacy
      and affect-boosting emails, as well as expanded versions of Phase I components to reinforce
      stages 1-3 of the M-ARRM theoretical model.

      The investigators are supported in these efforts through partnerships in both Boston, MA and
      Columbia SC, the sites for the randomized controlled trial. Participating partners include
      those providing commercialization support (Global Protection Corp, USC Columbia Incubator, SC
      Launch, Moker CPCA), recruitment and marketing support in Boston (New England Association of
      HIV over 50, Massachusetts Department of Public Health Statewide Consumer Advisory Board on
      HIV/AIDS, Brigham & Women's Hospital Women's Health Center) and in Columbia (South Carolina
      Lieutenant Governor's Office on Aging, South Carolina HIV/AIDS Council, AID Upstate in South
      Carolina, Lowcountry AIDS Services, United Way Association of South Carolina, South Carolina
      Primary Care Association, Columbia Housing Authority in South Carolina, Palmetto AIDS Life
      Support Services), and content and technology development and support (University of South
      Carolina College of Social Work and Department of Computer Science and Engineering, South
      Carolina HIV/AIDS Council)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Prevention
masking: None (Open Label)
measure: intention to engage in safe sex questionnaire
time frame: 90 days
description: A three-item intention to engage in safe sex practices instrument. Participants will answer 3 questions, validated for this population (Fisher et al., 1998; Mausbach et al., 2009), regarding their intentions to use protection during sex over the next two months (e.g., "I intend to always use condoms during vaginal sex with all of my partners during the next two months") Responses are on a 5-point Likert scale, 1 = "Very Untrue" and 5 = "Very True". The score ranges from 3 to 15. The higher score indicate better intention to engage in safe sex.
measure: safe sex self-efficacy questionnaire
time frame: 90 days
description: 8-item Self-efficacy for Sexual Discussion Scale. Responses are on a 4-point scale, 1='disagree' and 4='agree'. The first two questions should be reversed when coding. Sum up the final score and the higher the score is indicate the higher self-efficacy for sexual discussion.
measure: HIV transmission knowledge questionnaire
time frame: 90 days
description: There are two questionnaires in this outcome: a 13-item modified HIV Sexual Transmission and Prevention Knowledge and a 15-item HIV/AIDS Knowledge and Attitudes Survey. Each correct answer get one point. The final score is the sum up of all the questions. Range from 0-28.
measure: perceived sexual/HIV risk questionnaire
time frame: 90 days
description: 38-item Perceived Sexual Risks Scale. The self-assessment allows participants to evaluate the degree to which they may be at risk for engaging in behavior that exposes themselves to HIV. For each of the 38 items, participants choose from 'agree', 'undecided', or 'disagree' that best characterizes their option. Begin by giving scoring eighty points. Subtract one point for every undecided response. Subtract two points every time that participants disagreed with odd-numbered items or with item number 38. Subtract two points every time participants agreed with even-numbered items 2 through 36. Higher scores are more likely to engage in risky sexual activities.
measure: positive affect questionnaire
time frame: 90 days
description: 4-item scale General Happiness Scale. A 4-item scale designed to measure subjective happiness. Each of item is completed by choosing one of 7 options that finish a given sentence fragment. Compute the mean across responses to all four questions; item #4 is reverse coded. The higher score indicate higher subjective happiness.
arm group label: control
arm group type: Active Comparator
description: control group receives 2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics
arm group label: intervention
arm group type: Experimental
description: intervention group receives safe sex and HIV/STD prevention education via a website, and weekly emails on with positive psychology-based happiness and resilience boosting activities
intervention type: Behavioral
intervention name: safe sex and HIV/STD prevention education via a website
description: website providing positive psychology-based advice and education for women over the age of 50 who are divorced. embedded in site is safe sex education.
arm group label: intervention
intervention type: Other
intervention name: written materials on safe sex
description: 2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics
arm group label: control
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Environment and Health Group, Inc.
investigator full name: Patricia Weitzman
investigator title: Principal Investigator
mesh term: Sexually Transmitted Diseases
sharing ipd: No