<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/NCT01688167</url>
  </required_header>
  <id_info>
    <org_study_id>20110290</org_study_id>
    <secondary_id>R01MH095539</secondary_id>
    <nct_id>NCT01688167</nct_id>
  </id_info>
  <brief_title>Increasing Availability and Acceptability of Circumcision in Zambia</brief_title>
  <official_title>Increasing Availability and Acceptability of Circumcision in Zambia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study proposes to balance supply and demand of male circumcision through a systematic&#xD;
      scale-up of coordinated biomedical surgical and behavioral counseling services. The study&#xD;
      will compare the combined biobehavioral sexual risk reduction intervention to the standard of&#xD;
      care, which focuses exclusively on the provision of circumcision services alone, with the&#xD;
      goal of optimizing both local and national HIV prevention efforts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in likelihood of undergoing male circumcision across the study using stages of change model</measure>
    <time_frame>Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up</time_frame>
    <description>Readiness to undergo male circumcision will be assessed using the stages of change model (pre-contemplation, contemplation, preparation, action, maintenance). Intervention and attention control conditions will be compared at baseline, immediately following intervention, and 6 and 12 months post-intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uptake of male circumcision</measure>
    <time_frame>From the date of study enrollment to the date male circumcision is performed or study completion.</time_frame>
    <description>To determine if participants in the sexual risk reduction/MC promotion intervention (experimental condition) will be more likely to shift to the &quot;Action&quot; stage (undergo circumcision), in comparison with participants having identical MC services available plus usual care (attention control condition).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Male and female condom use post male circumcision</measure>
    <time_frame>3 months after undergoing male circumcision</time_frame>
    <description>To determine whether MC will significantly affect the maintenance of safer sexual practices (&quot;risk compensation&quot;) in the experimental group as compared to the attention control group</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1468</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental condition clinics offer the MC and sexual risk reduction intervention: four group counseling sessions focused on male circumcision and sexual risk reduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Male participants in the standard of care control condition CHCs will receive counseling per the VCT protocol guidelines. Participants will attend four video-based time-equivalent &quot;attention-control&quot; group sessions on endemic disease prevention strategies (e.g., TB, malaria, cholera, waterborne diseases). Female partners will be invited to participate in a similar four session program devoted to endemic disease risk reduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>3 CHC sites will be randomly assigned as &quot;observation only;&quot; only aggregated clinic VCT and circumcision data will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MC and sexual risk reduction</intervention_name>
    <description>Four group counselling sessions focused on male circumcision and sexual risk reduction</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV negative&#xD;
&#xD;
          -  Uncircumcised male&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  Able to understand and sign informed consent in English, Bemba, or Nyanja&#xD;
&#xD;
          -  Have not requested male circumcision services at the time of or following VCT&#xD;
&#xD;
          -  Female partners of enrolled males are invited to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men seeking circumcision services are not eligible for this study&#xD;
&#xD;
          -  Men with genital abnormalities requiring MC, e.g. balanitis (inflammation of the&#xD;
             preputial skin), posthitis (inflammation of the glans penis; common in patients with&#xD;
             diabetes), phimosis (scarring of the distal margins of the foreskin) resulting from&#xD;
             chronic balanitis, paraphimosis (the inability to pull the retracted foreskin back&#xD;
             over the glans) or diseases of the foreskin, including localized carcinoma are not&#xD;
             eligible for this study&#xD;
&#xD;
          -  Men with congenital or acquired penile abnormalities that require the preputial skin&#xD;
             for generative repair, such as hypospadias (urethra exits from underside of penis) are&#xD;
             not eligible to participate&#xD;
&#xD;
          -  Participants unable to provide informed consent will not be eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen M Weiss, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Zambia Teaching Hospital</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <reference>
    <citation>Weiss SM, Zulu R, Jones DL, Redding CA, Cook R, Chitalu N. The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial. Lancet HIV. 2015 May;2(5):e181-9. doi: 10.1016/S2352-3018(15)00042-9.</citation>
    <PMID>26120594</PMID>
  </reference>
  <reference>
    <citation>Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.</citation>
    <PMID>24294330</PMID>
  </reference>
  <reference>
    <citation>Jones D, Weiss S, Chitalu N. HIV Prevention in Resource Limited Settings: A Case Study of Challenges and Opportunities for Implementation. Int J Behav Med. 2015 Jun;22(3):384-92. doi: 10.1007/s12529-014-9397-3.</citation>
    <PMID>24604206</PMID>
  </reference>
  <reference>
    <citation>Cook R, Jones D, Redding CA, Zulu R, Chitalu N, Weiss SM. Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project. AIDS Behav. 2016 Nov;20(11):2503-2513. doi: 10.1007/s10461-015-1079-x.</citation>
    <PMID>25931242</PMID>
  </reference>
  <reference>
    <citation>Redding CA, Jones D, Zulu R, Chitalu N, Cook R, Weiss SM. Stages of Change for Voluntary Medical Male Circumcision and Sexual Risk Behavior in Uncircumcised Zambian Men: The Spear and Shield Project. Int J Behav Med. 2015 Dec;22(6):799-806. doi: 10.1007/s12529-015-9485-z.</citation>
    <PMID>25896876</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>June 22, 2022</last_update_submitted>
  <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Stephen Weiss</investigator_full_name>
    <investigator_title>Research Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Male circumcision</keyword>
  <keyword>Sexual risk reduction</keyword>
  <keyword>Stages of change</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/NCT01688167
org study id: 20110290
secondary id: R01MH095539
nct id: NCT01688167
lead sponsor: 
collaborator: 
has dmc: No
This study proposes to balance supply and demand of male circumcision through a systematic
      scale-up of coordinated biomedical surgical and behavioral counseling services. The study
      will compare the combined biobehavioral sexual risk reduction intervention to the standard of
      care, which focuses exclusively on the provision of circumcision services alone, with the
      goal of optimizing both local and national HIV prevention efforts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Change in likelihood of undergoing male circumcision across the study using stages of change model
time frame: Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up
description: Readiness to undergo male circumcision will be assessed using the stages of change model (pre-contemplation, contemplation, preparation, action, maintenance). Intervention and attention control conditions will be compared at baseline, immediately following intervention, and 6 and 12 months post-intervention.
measure: Uptake of male circumcision
time frame: From the date of study enrollment to the date male circumcision is performed or study completion.
description: To determine if participants in the sexual risk reduction/MC promotion intervention (experimental condition) will be more likely to shift to the "Action" stage (undergo circumcision), in comparison with participants having identical MC services available plus usual care (attention control condition).
measure: Male and female condom use post male circumcision
time frame: 3 months after undergoing male circumcision
description: To determine whether MC will significantly affect the maintenance of safer sexual practices ("risk compensation") in the experimental group as compared to the attention control group
arm group label: Intervention
arm group type: Experimental
description: Experimental condition clinics offer the MC and sexual risk reduction intervention: four group counseling sessions focused on male circumcision and sexual risk reduction.
arm group label: Standard of Care
arm group type: No Intervention
description: Male participants in the standard of care control condition CHCs will receive counseling per the VCT protocol guidelines. Participants will attend four video-based time-equivalent "attention-control" group sessions on endemic disease prevention strategies (e.g., TB, malaria, cholera, waterborne diseases). Female partners will be invited to participate in a similar four session program devoted to endemic disease risk reduction.
arm group label: Observational
arm group type: No Intervention
description: 3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected.
intervention type: Behavioral
intervention name: MC and sexual risk reduction
description: Four group counselling sessions focused on male circumcision and sexual risk reduction
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen M Weiss, PhD
role: Study Chair
affiliation: University of Miami
facility: 
country: Zambia
citation: Weiss SM, Zulu R, Jones DL, Redding CA, Cook R, Chitalu N. The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial. Lancet HIV. 2015 May;2(5):e181-9. doi: 10.1016/S2352-3018(15)00042-9.
PMID: 26120594
citation: Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.
PMID: 24294330
citation: Jones D, Weiss S, Chitalu N. HIV Prevention in Resource Limited Settings: A Case Study of Challenges and Opportunities for Implementation. Int J Behav Med. 2015 Jun;22(3):384-92. doi: 10.1007/s12529-014-9397-3.
PMID: 24604206
citation: Cook R, Jones D, Redding CA, Zulu R, Chitalu N, Weiss SM. Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project. AIDS Behav. 2016 Nov;20(11):2503-2513. doi: 10.1007/s10461-015-1079-x.
PMID: 25931242
citation: Redding CA, Jones D, Zulu R, Chitalu N, Cook R, Weiss SM. Stages of Change for Voluntary Medical Male Circumcision and Sexual Risk Behavior in Uncircumcised Zambian Men: The Spear and Shield Project. Int J Behav Med. 2015 Dec;22(6):799-806. doi: 10.1007/s12529-015-9485-z.
PMID: 25896876
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Stephen Weiss
investigator title: Research Professor