<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/NCT03818984</url>
  </required_header>
  <id_info>
    <org_study_id>2013P002693</org_study_id>
    <nct_id>NCT03818984</nct_id>
  </id_info>
  <brief_title>Helping Men Have Healthy Babies</brief_title>
  <official_title>Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize&#xD;
      sexual HIV transmission risks while allowing for conception. The study will evaluate a safer&#xD;
      conception intervention that leverages men's motivations to have healthy babies in order to&#xD;
      promote serostatus disclosure and early ART initiation. The intervention is based on the&#xD;
      investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and&#xD;
      structural factors that affect periconception risk behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate and test a safer conception intervention that leverages men's&#xD;
      motivations to have healthy babies in order to promote serostatus disclosure and early ART&#xD;
      initiation. The intervention is based on a Safer Conception Conceptual Framework, which&#xD;
      considers individual, dyadic, and structural factors that affect periconception risk&#xD;
      behavior.&#xD;
&#xD;
      The researchers will conduct an open pilot to refine the intervention. The study will enroll&#xD;
      men who want to have children with uninfected or unknown status female partners. Men will&#xD;
      participate in three study sessions offering motivational interviewing and problem solving to&#xD;
      help men develop a plan to have a healthy baby. The counseling will explore safer conception&#xD;
      options including safe disclosure, delaying conception attempts until on ART with viral&#xD;
      suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary&#xD;
      outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability,&#xD;
      feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and&#xD;
      testing uptake, and limiting unprotected sex to peak fertility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2015</start_date>
  <completion_date type="Actual">October 25, 2017</completion_date>
  <primary_completion_date type="Actual">October 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Men will be offered 3 safer conception counseling sessions plus 2 booster sessions</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV RNA Suppression</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of men achieving HIV-RNA suppression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uptake of ART</measure>
    <time_frame>12 weeks</time_frame>
    <description>The proportion of men who initiate or continue ART</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of HIV-serostatus disclosure</measure>
    <time_frame>12 weeks</time_frame>
    <description>The proportion of men who report disclosure of HIV serostatus to pregnancy partner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of timing condomless sex to peak fertility</measure>
    <time_frame>12 weeks</time_frame>
    <description>Through SMS surveys to assess weekly sexual behavior the study will evaluate the proportion of men who attempt to limit condomless sex to peak fertility</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>HIV Prevention</condition>
  <arm_group>
    <arm_group_label>Safer Conception Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men will participate in 3 counseling sessions with a lay counselor. In the first session, the counselor will share information on the various safer conception strategies and help the participant think about developing a healthy plan. In the following 2 sessions, the counselor and the participant will work together to develop a healthy baby plan using motivational interviewing and problem solving. In the 2 booster sessions, the counselor and the participant will check in to evaluate the success of the plan and make changes as necessary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safer Conception for Men with At Risk Partners</intervention_name>
    <description>CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.</description>
    <arm_group_label>Safer Conception Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Identifies as male&#xD;
&#xD;
          -  Not on ART, or initiated ART within the past 3 months&#xD;
&#xD;
          -  HIV-positive and status known for at least 1 (one) month,&#xD;
&#xD;
          -  in care/patient at iThembalabantu clinic&#xD;
&#xD;
          -  want to have a child in the next year,&#xD;
&#xD;
          -  with a stable sexual pregnancy partner for at least 6 months,&#xD;
&#xD;
          -  their pregnancy partner should be HIV-uninfected or HIV-status unknown,&#xD;
&#xD;
          -  their pregnancy partner should not be known to be currently pregnant,&#xD;
&#xD;
          -  have their own/ a mobile phone&#xD;
&#xD;
          -  be fluent in either English or isiZulu and,&#xD;
&#xD;
          -  able to participate in informed consent process&#xD;
&#xD;
          -  not sterilized or known to be infertile&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>April 15, 2020</last_update_submitted>
  <last_update_submitted_qc>April 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Lynn T Matthews</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>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT03818984
org study id: 2013P002693
nct id: NCT03818984
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize
      sexual HIV transmission risks while allowing for conception. The study will evaluate a safer
      conception intervention that leverages men's motivations to have healthy babies in order to
      promote serostatus disclosure and early ART initiation. The intervention is based on the
      investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and
      structural factors that affect periconception risk behavior.
The study will evaluate and test a safer conception intervention that leverages men's
      motivations to have healthy babies in order to promote serostatus disclosure and early ART
      initiation. The intervention is based on a Safer Conception Conceptual Framework, which
      considers individual, dyadic, and structural factors that affect periconception risk
      behavior.

      The researchers will conduct an open pilot to refine the intervention. The study will enroll
      men who want to have children with uninfected or unknown status female partners. Men will
      participate in three study sessions offering motivational interviewing and problem solving to
      help men develop a plan to have a healthy baby. The counseling will explore safer conception
      options including safe disclosure, delaying conception attempts until on ART with viral
      suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary
      outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability,
      feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and
      testing uptake, and limiting unprotected sex to peak fertility.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Men will be offered 3 safer conception counseling sessions plus 2 booster sessions
primary purpose: Prevention
masking: None (Open Label)
measure: HIV RNA Suppression
time frame: 12 weeks
description: Proportion of men achieving HIV-RNA suppression
measure: Uptake of ART
time frame: 12 weeks
description: The proportion of men who initiate or continue ART
measure: Uptake of HIV-serostatus disclosure
time frame: 12 weeks
description: The proportion of men who report disclosure of HIV serostatus to pregnancy partner
measure: Use of timing condomless sex to peak fertility
time frame: 12 weeks
description: Through SMS surveys to assess weekly sexual behavior the study will evaluate the proportion of men who attempt to limit condomless sex to peak fertility
arm group label: Safer Conception Intervention
arm group type: Experimental
description: Men will participate in 3 counseling sessions with a lay counselor. In the first session, the counselor will share information on the various safer conception strategies and help the participant think about developing a healthy plan. In the following 2 sessions, the counselor and the participant will work together to develop a healthy baby plan using motivational interviewing and problem solving. In the 2 booster sessions, the counselor and the participant will check in to evaluate the success of the plan and make changes as necessary.
intervention type: Behavioral
intervention name: Safer Conception for Men with At Risk Partners
description: CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.
arm group label: Safer Conception Intervention
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Lynn T Matthews
investigator title: Principal Investigator
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections