<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/NCT03235518</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR0256</org_study_id>
    <secondary_id>R01MH110051</secondary_id>
    <nct_id>NCT03235518</nct_id>
  </id_info>
  <brief_title>A Combination HIV Prevention Strategy for Young Women at Risk for HIV</brief_title>
  <acronym>IPrEP</acronym>
  <official_title>A Combination HIV Prevention Strategy for Young Women at Risk for HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</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>Columbia University</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>
      The purpose of this study is to conduct formative research to inform the design and&#xD;
      implementation of combination prevention interventions, including pre-exposure prophylaxis&#xD;
      (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention&#xD;
      strategies for female sex workers and their male clients in Kenya.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite remarkable advances in the global HIV response with 17 million persons, out of nearly&#xD;
      37 million living with HIV, who have initiated antiretroviral therapy (ART) in low- and&#xD;
      middle-income countries (LMIC) as of end of 2015, there were an estimated 5,700 new HIV&#xD;
      infections each day and a total of 2.1 million new HIV infections in 2015, of which 66% were&#xD;
      in sub-Saharan Africa (SSA). Key populations within the generalized HIV epidemics in SSA,&#xD;
      including female sex workers (FSW), have received insufficient attention, with data&#xD;
      indicating that they are at disproportionate risk with limited access to prevention and&#xD;
      treatment services. Globally, new infections among key populations and their sexual partners&#xD;
      accounted for 36% of all new HIV infections in 2015. HIV prevalence among FSW is 29.3%&#xD;
      worldwide. While reliable HIV prevalence estimates are lacking, younger FSW &lt;25 years may be&#xD;
      at significantly greater risk due to the confluence of biological, behavioral and structural&#xD;
      risk factors.6 Mathematical modeling suggests that the proportion of new HIV infections&#xD;
      attributable to sex work is likely to increase over time.&#xD;
&#xD;
      In settings where key populations contribute substantially to HIV burden, as in Kenya,&#xD;
      effective integrated prevention strategies are urgently needed for populations such as FSW&#xD;
      and can have a substantial impact on reducing new HIV infections.&#xD;
&#xD;
      In 2012, HIV prevalence among Kenyan 15-64 year olds was 5.6%, with 1,192,000 people living&#xD;
      with HIV, but was markedly higher (15.1%) in the region of Kenya, formerly named Nyanza&#xD;
      Province. HIV prevalence is 14.1% among FSW and 7.6% among male clients of sex workers (MC).&#xD;
      FSW contribute significantly to new HIV infections in Kenya,14 with modelled estimates&#xD;
      showing that 1 in 3 new HIV infections can be attributed to key populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2017</start_date>
  <completion_date type="Actual">April 4, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of FSW participants who would be willing to participate in HIV prevention research</measure>
    <time_frame>6 months</time_frame>
    <description>To inform prevention interventions for FSW, we will assess the percentage of FSW willing to participate in HIV prevention research or a PrEP study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of MC participants who would be willing to participate in HIV prevention research</measure>
    <time_frame>6 months</time_frame>
    <description>To inform prevention interventions, we will assess the percentage of MC willing to participate in HIV prevention research</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">329</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Structure Interviews with FSW</arm_group_label>
    <description>Structured interviews with 200 purposively sampled FSW will be conducted. These interviews will be conducted prior to focus group discussion (FGD) and in-depth qualitative interview (IDI) with FSW. Structured interviews will take approximately 45-60 minutes to complete and will be administered privately in Kiswahili, Dholuo or English by trained female research staff. Quantitative interviews will be administered to conduct an assessment of FSW sociodemographics, sexual behaviour patterns and HIV-related knowledge, attitudes and practices regarding HIV prevention and other factors that might affect initiation and adherence to PrEP use, ability to use PrEP covertly, HIV testing history, mobility patterns, social networks, pregnancy intentions, ability to use condoms consistently with clients, and regular partners, and interpersonal violence from clients, regular partners and the police.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Focus Group Discussions with FSW</arm_group_label>
    <description>Three to five FGDs of up to 10 FSW per group will be conducted. These FGD will take place prior to FSW IDI. FSW who participated in FGDs will be ineligible for participation in the IDI. All group discussions will last approximately 1.5 to 2 hours and be conducted in Kiswahili, Dholuo or English. Each group discussion will be facilitated by trained female research staff and held in a private space at a pre-specified location. The themes that will be explored in the FGDs include: FSW social networks, participation in PrEP studies, barriers and facilitators to PrEP use and use of resource transfers for PrEP adherence. In addition, participants will complete a brief demographic survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Depth Qualitative Interviews with FSW</arm_group_label>
    <description>30 IDI will be conducted with FSW. FSW who participated in FGDs will be ineligible for participation in the IDI. All in-depth interviews will be conducted by trained female research staff using a semi-structured interview guide. All interviews will be held in a private space at a pre-specified location within the community. The topics that will be discussed in the IDI with FSW include demographics, social support, dynamics of sex work, HIV prevention methods (including condom use), perception of HIV risk and development of PrEP intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Depth Qualitative Interviews with MC</arm_group_label>
    <description>30 IDI will be conducted with MC. All IDI will last approximately 60-90 minutes and be conducted in Kiswahili, Dholuo, or English. Each interview will be conducted by a trained male research staff using semi-structured interview guide. All interviews will be held in a private space at a pre-specified location. Topics include demographics, relationships with FSW, HIV prevention methods (including use of condoms), perception of HIV risk and development of PrEP intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Depth Qualitative Interviews with HCPs</arm_group_label>
    <description>30 IDI will be conducted with health care provider (HCP). All IDI will last approximately 60-90 minutes and be conducted in English. Each interview will be conducted by trained research staff using a semi-structured interview guide. Interviews will be held in a private space at the health facility where they work or another venue preferred by the HCP. Topics include demographics, health care needs of FSW and sources of care, HIV prevention needs of FSW, PrEP for FSW and training needs for HCP.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Female sex workers, male clients of female sex workers, and health care providers will be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        FSW. Inclusion criteria for the structured interviews, FGDs and IDI are identical.&#xD;
&#xD;
          -  Report being female or transgender women born make who have sex with men&#xD;
&#xD;
          -  Report being HIV-negative or unknown status&#xD;
&#xD;
          -  Report being between 18-24 years of age&#xD;
&#xD;
          -  Report residing or working in study community&#xD;
&#xD;
          -  Reports exchange sex for goods, money, flavors or other services in past 3 months&#xD;
&#xD;
          -  Willing to allow audio-recording of FGDs or IDI&#xD;
&#xD;
          -  Able to complete study procedures in English, Kiswahili or Dhuluo&#xD;
&#xD;
        Male Clients&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Report being &gt;=18 years of age&#xD;
&#xD;
          -  Report exchanging goods, money, favors or other services for sex in past 3 months&#xD;
&#xD;
          -  Willing to allow audio-recording of IDI&#xD;
&#xD;
          -  Able to complete study procedures in English, Kiswahili or Dhuluo&#xD;
&#xD;
        Health Care Providers&#xD;
&#xD;
          -  Currently working as nurse or clinical officer at a clinic or other facility likely to&#xD;
             offer PrEP&#xD;
&#xD;
          -  Report being &gt;= 18 years of age&#xD;
&#xD;
          -  Willing to allow audio-recording of IDI&#xD;
&#xD;
          -  Able to complete study procedures in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who do not meet the inclusion criteria&#xD;
&#xD;
          -  Individuals who in the opinion of the investigators would interfere with adherence to&#xD;
             study study requirements&#xD;
&#xD;
          -  FSW participating in FGD are not eligible for participation in IDI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Wafaa M. El-Sadr, MD, MPH, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kisumu, Kenya</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 5, 2022</last_update_submitted>
  <last_update_submitted_qc>January 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV Prevention</keyword>
  <keyword>Female sex workers</keyword>
  <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/NCT03235518
org study id: AAAR0256
secondary id: R01MH110051
nct id: NCT03235518
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to conduct formative research to inform the design and
      implementation of combination prevention interventions, including pre-exposure prophylaxis
      (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention
      strategies for female sex workers and their male clients in Kenya.
Despite remarkable advances in the global HIV response with 17 million persons, out of nearly
      37 million living with HIV, who have initiated antiretroviral therapy (ART) in low- and
      middle-income countries (LMIC) as of end of 2015, there were an estimated 5,700 new HIV
      infections each day and a total of 2.1 million new HIV infections in 2015, of which 66% were
      in sub-Saharan Africa (SSA). Key populations within the generalized HIV epidemics in SSA,
      including female sex workers (FSW), have received insufficient attention, with data
      indicating that they are at disproportionate risk with limited access to prevention and
      treatment services. Globally, new infections among key populations and their sexual partners
      accounted for 36% of all new HIV infections in 2015. HIV prevalence among FSW is 29.3%
      worldwide. While reliable HIV prevalence estimates are lacking, younger FSW <25 years may be
      at significantly greater risk due to the confluence of biological, behavioral and structural
      risk factors.6 Mathematical modeling suggests that the proportion of new HIV infections
      attributable to sex work is likely to increase over time.

      In settings where key populations contribute substantially to HIV burden, as in Kenya,
      effective integrated prevention strategies are urgently needed for populations such as FSW
      and can have a substantial impact on reducing new HIV infections.

      In 2012, HIV prevalence among Kenyan 15-64 year olds was 5.6%, with 1,192,000 people living
      with HIV, but was markedly higher (15.1%) in the region of Kenya, formerly named Nyanza
      Province. HIV prevalence is 14.1% among FSW and 7.6% among male clients of sex workers (MC).
      FSW contribute significantly to new HIV infections in Kenya,14 with modelled estimates
      showing that 1 in 3 new HIV infections can be attributed to key populations.
observational model: Other
time perspective: Cross-Sectional
measure: Percentage of FSW participants who would be willing to participate in HIV prevention research
time frame: 6 months
description: To inform prevention interventions for FSW, we will assess the percentage of FSW willing to participate in HIV prevention research or a PrEP study
measure: Percentage of MC participants who would be willing to participate in HIV prevention research
time frame: 6 months
description: To inform prevention interventions, we will assess the percentage of MC willing to participate in HIV prevention research
arm group label: Structure Interviews with FSW
description: Structured interviews with 200 purposively sampled FSW will be conducted. These interviews will be conducted prior to focus group discussion (FGD) and in-depth qualitative interview (IDI) with FSW. Structured interviews will take approximately 45-60 minutes to complete and will be administered privately in Kiswahili, Dholuo or English by trained female research staff. Quantitative interviews will be administered to conduct an assessment of FSW sociodemographics, sexual behaviour patterns and HIV-related knowledge, attitudes and practices regarding HIV prevention and other factors that might affect initiation and adherence to PrEP use, ability to use PrEP covertly, HIV testing history, mobility patterns, social networks, pregnancy intentions, ability to use condoms consistently with clients, and regular partners, and interpersonal violence from clients, regular partners and the police.
arm group label: Focus Group Discussions with FSW
description: Three to five FGDs of up to 10 FSW per group will be conducted. These FGD will take place prior to FSW IDI. FSW who participated in FGDs will be ineligible for participation in the IDI. All group discussions will last approximately 1.5 to 2 hours and be conducted in Kiswahili, Dholuo or English. Each group discussion will be facilitated by trained female research staff and held in a private space at a pre-specified location. The themes that will be explored in the FGDs include: FSW social networks, participation in PrEP studies, barriers and facilitators to PrEP use and use of resource transfers for PrEP adherence. In addition, participants will complete a brief demographic survey.
arm group label: In-Depth Qualitative Interviews with FSW
description: 30 IDI will be conducted with FSW. FSW who participated in FGDs will be ineligible for participation in the IDI. All in-depth interviews will be conducted by trained female research staff using a semi-structured interview guide. All interviews will be held in a private space at a pre-specified location within the community. The topics that will be discussed in the IDI with FSW include demographics, social support, dynamics of sex work, HIV prevention methods (including condom use), perception of HIV risk and development of PrEP intervention.
arm group label: In-Depth Qualitative Interviews with MC
description: 30 IDI will be conducted with MC. All IDI will last approximately 60-90 minutes and be conducted in Kiswahili, Dholuo, or English. Each interview will be conducted by a trained male research staff using semi-structured interview guide. All interviews will be held in a private space at a pre-specified location. Topics include demographics, relationships with FSW, HIV prevention methods (including use of condoms), perception of HIV risk and development of PrEP intervention.
arm group label: In-Depth Qualitative Interviews with HCPs
description: 30 IDI will be conducted with health care provider (HCP). All IDI will last approximately 60-90 minutes and be conducted in English. Each interview will be conducted by trained research staff using a semi-structured interview guide. Interviews will be held in a private space at the health facility where they work or another venue preferred by the HCP. Topics include demographics, health care needs of FSW and sources of care, HIV prevention needs of FSW, PrEP for FSW and training needs for HCP.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Wafaa M. El-Sadr, MD, MPH, MPA
role: Principal Investigator
affiliation: Columbia University
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections