<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/NCT04408729</url>
  </required_header>
  <id_info>
    <org_study_id>R34MH122362</org_study_id>
    <nct_id>NCT04408729</nct_id>
  </id_info>
  <brief_title>PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women</brief_title>
  <official_title>&quot;PrEP My Way&quot;: A Novel PrEP Delivery System to Meet the Needs of Young African Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</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 investigators will first develop, tailor, and refine PrEP My Way for use with young women&#xD;
      in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach,&#xD;
      involving up to 15 individual interviews and two focus group discussions (with up to 5 women&#xD;
      each) to optimally design the PrEP My Way kit (with instructional materials) and peer&#xD;
      delivery system (including communication and kit delivery plans). The investigators will then&#xD;
      test the intervention for feasibility, acceptability, and preliminary impact on PrEP&#xD;
      adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to&#xD;
      PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health&#xD;
      services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at&#xD;
      1, 3, and 6 months and ability to use its components per protocol. Acceptability will be&#xD;
      determined through a mixed-methods interview at 6 months. Preliminary impact will be&#xD;
      evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6&#xD;
      months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g.,&#xD;
      empowerment and mental health) will be explored through questionnaires at baseline and 6&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Develop PrEP My Way. Using a client-centered approach, the study team will iteratively&#xD;
           conduct individual interviews and focus group discussions with up to 25 Kenyan women&#xD;
           (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and&#xD;
           peer delivery system (including phone communication and kit delivery plans).&#xD;
&#xD;
        2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP&#xD;
           adherence and program retention. The investigators will randomize 100 Kenyan women (age&#xD;
           16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and&#xD;
           sexual health services) and follow them for 6 months. Feasibility will be assessed by&#xD;
           receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol.&#xD;
           Acceptability will be determined through a mixed-methods interview. Preliminary impact&#xD;
           will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic&#xD;
           attendance at 6 months (retention). Potential influencing and mediating socio-behavioral&#xD;
           factors will be explored with questionnaires at 0 and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">October 26, 2022</completion_date>
  <primary_completion_date type="Actual">October 26, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP Adherence</measure>
    <time_frame>Six months</time_frame>
    <description>PrEP adherence as measured by tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported PrEP adherence</measure>
    <time_frame>Months 1, 3, 6 (intervention arm), Month 6 (control arm)</time_frame>
    <description>PrEP adherence as measured by questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP persistence</measure>
    <time_frame>Over the six month period</time_frame>
    <description>PrEP adherence as measured by pharmacy pick up over the six months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of STI testing</measure>
    <time_frame>Months 1, 3, and 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of pregnancy test and contraception pick up</measure>
    <time_frame>Months 1, 3, and 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost estimate</measure>
    <time_frame>Six months</time_frame>
    <description>The study team will conduct a micro-costing analysis to assess the cost of the intervention in a standard clinic setting from the payer perspective. Cost will be presented as US dollars per intervention and sub-divided into amounts for capital goods, personnel, supplies, overhead, and training.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility of intervention use</measure>
    <time_frame>Six months</time_frame>
    <description>The PrEP My Way intervention will be considered feasible if &gt;70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) achieve a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at &gt;66% (2/3) of visits.</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability of intervention</measure>
    <time_frame>Six months</time_frame>
    <description>The PrEP My Way intervention will be considered acceptable if &gt;70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale as &quot;very good&quot; or higher.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>PrEP My Way intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These participants will continue to receive PrEP at the clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PrEP My Way</intervention_name>
    <description>Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).&#xD;
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.</description>
    <arm_group_label>PrEP My Way intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have&#xD;
             not yet attained the age of legal competency as defined by state law, but who are&#xD;
             entitled to treatment as if they had by virtue of assuming adult responsibilities,&#xD;
             such as self-support, marriage, or procreation) per Kenyan national guidelines [39])&#xD;
             or 16-17 year-olds with parental consent&#xD;
&#xD;
          -  Reported sexual activity within the past 3 months&#xD;
&#xD;
          -  Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1)&#xD;
&#xD;
          -  Residence in the Kisumu region&#xD;
&#xD;
          -  Phone ownership&#xD;
&#xD;
          -  Ability to understand KiSwahili, DhoLuo, and/or English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent (e.g., intoxication, mental disability)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kenya Medical Research Institute</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jessica Haberer, MD</investigator_full_name>
    <investigator_title>Director of Research, Center for Global Health</investigator_title>
  </responsible_party>
  <keyword>prevention</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/NCT04408729
org study id: R34MH122362
nct id: NCT04408729
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will first develop, tailor, and refine PrEP My Way for use with young women
      in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach,
      involving up to 15 individual interviews and two focus group discussions (with up to 5 women
      each) to optimally design the PrEP My Way kit (with instructional materials) and peer
      delivery system (including communication and kit delivery plans). The investigators will then
      test the intervention for feasibility, acceptability, and preliminary impact on PrEP
      adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to
      PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health
      services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at
      1, 3, and 6 months and ability to use its components per protocol. Acceptability will be
      determined through a mixed-methods interview at 6 months. Preliminary impact will be
      evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6
      months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g.,
      empowerment and mental health) will be explored through questionnaires at baseline and 6
      months.
1. Develop PrEP My Way. Using a client-centered approach, the study team will iteratively
           conduct individual interviews and focus group discussions with up to 25 Kenyan women
           (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and
           peer delivery system (including phone communication and kit delivery plans).

        2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP
           adherence and program retention. The investigators will randomize 100 Kenyan women (age
           16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and
           sexual health services) and follow them for 6 months. Feasibility will be assessed by
           receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol.
           Acceptability will be determined through a mixed-methods interview. Preliminary impact
           will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic
           attendance at 6 months (retention). Potential influencing and mediating socio-behavioral
           factors will be explored with questionnaires at 0 and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: PrEP Adherence
time frame: Six months
description: PrEP adherence as measured by tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) testing
measure: Self-reported PrEP adherence
time frame: Months 1, 3, 6 (intervention arm), Month 6 (control arm)
description: PrEP adherence as measured by questionnaires
measure: PrEP persistence
time frame: Over the six month period
description: PrEP adherence as measured by pharmacy pick up over the six months
measure: Rates of STI testing
time frame: Months 1, 3, and 6
measure: Rates of pregnancy test and contraception pick up
time frame: Months 1, 3, and 6
measure: Cost estimate
time frame: Six months
description: The study team will conduct a micro-costing analysis to assess the cost of the intervention in a standard clinic setting from the payer perspective. Cost will be presented as US dollars per intervention and sub-divided into amounts for capital goods, personnel, supplies, overhead, and training.
measure: Feasibility of intervention use
time frame: Six months
description: The PrEP My Way intervention will be considered feasible if >70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) achieve a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at >66% (2/3) of visits.
measure: Acceptability of intervention
time frame: Six months
description: The PrEP My Way intervention will be considered acceptable if >70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale as "very good" or higher.
arm group label: PrEP My Way intervention
arm group type: Experimental
description: PrEP My Way is an intervention that involves peer-delivery of a kit containing PrEP and other sexual health services. Participants will be offered PrEP if HIV-negative per a point-of-care test, pregnancy testing, vaginal swabs for gonorrhea and chlamydia testing, condoms, and/or self-injection medroxyprogesterone, as desired.
arm group label: Control
arm group type: No Intervention
description: These participants will continue to receive PrEP at the clinic.
intervention type: Other
intervention name: PrEP My Way
description: Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.
arm group label: PrEP My Way intervention
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jessica Haberer, MD
investigator title: Director of Research, Center for Global Health
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections