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Accelerated PrEP Access for Black MSM and TW

Primary Purpose

HIV/AIDS

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emtricitabine / Tenofovir Disoproxil Oral Tablet
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring PrEP, HIV Prevention, Young Men Who Have Sex with Men, Young Transgender Women

Eligibility Criteria

18 Years - 24 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. ages 18-24;
  2. assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer;
  3. identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American;
  4. not currently taking PrEP or attending a visit to initiate PrEP;
  5. self-report being HIV-negative;
  6. reporting one of the following HIV risks in the last 6 months (Hosek, Rudy et al. 2015, Hosek, Rudy et al. 2017): a. condomless anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status; b. anal intercourse with 3 or more male sex partners; c. exchange of money, gifts, shelter, or drugs for anal sex with a male partner; d. sex with a male partner and has had a sexually transmitted infection; e. sexual partner of an HIV-infected male with whom condoms were not consistently used; f. anal intercourse where the condom broke or slipped off

Exclusion Criteria:

  • We are excluding those individuals who were assigned female at birth (female birth certificate) and/or cis-gender women (those assigned female at birth and identify as women) from the all phases of this study as this study is intended to explore the HIV prevention behaviors of B/AA young men who have sex with men and young transgender women (assigned male at birth) as these two groups represent the highest risk groups for HIV infection in the US, yet only a small percentage are aware or currently use PrEP for HIV prevention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PrEP Received

    Arm Description

    Participants will be provided with a free 30-day supply of PrEP.

    Outcomes

    Primary Outcome Measures

    Intention to Continue PrEP
    Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
    Intention to Continue PrEP
    Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
    PrEP Adherence
    PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
    PrEP Adherence
    PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.

    Secondary Outcome Measures

    PrEP Adherence Self-Efficacy
    PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007).
    PrEP Adherence Self-Efficacy
    PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007).

    Full Information

    First Posted
    March 26, 2020
    Last Updated
    May 16, 2022
    Sponsor
    University of Chicago
    Collaborators
    Planned Parenthood Great Plains
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04329442
    Brief Title
    Accelerated PrEP Access for Black MSM and TW
    Official Title
    Point of Care PrEP Delivery for Young Black/African American Men Who Have Sex With Men and Young Transgender Women at High Risk for HIV Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-19 caused substantial barriers to recruitment.
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    July 31, 2021 (Anticipated)
    Study Completion Date
    July 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Chicago
    Collaborators
    Planned Parenthood Great Plains

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts.
    Detailed Description
    The study team will provide a free 30-day supply of HIV pre-exposure prophylaxis (PrEP) to young Black MSM and TW identified as PrEP-eligible and interested in taking PrEP to reduce their risk of HIV acquisition. This intervention is intended to assist youth at high risk for HIV acquisition in successfully initiating PrEP use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS
    Keywords
    PrEP, HIV Prevention, Young Men Who Have Sex with Men, Young Transgender Women

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A single-arm longitudinal pre/post study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PrEP Received
    Arm Type
    Experimental
    Arm Description
    Participants will be provided with a free 30-day supply of PrEP.
    Intervention Type
    Drug
    Intervention Name(s)
    Emtricitabine / Tenofovir Disoproxil Oral Tablet
    Other Intervention Name(s)
    Truvada
    Intervention Description
    30 day supply of 200mg tablets
    Primary Outcome Measure Information:
    Title
    Intention to Continue PrEP
    Description
    Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
    Time Frame
    Post Intervention (1 month after receiving intervention)
    Title
    Intention to Continue PrEP
    Description
    Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.
    Time Frame
    Post Intervention (4 months after receiving intervention)
    Title
    PrEP Adherence
    Description
    PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
    Time Frame
    Post Intervention (1 month after receiving intervention)
    Title
    PrEP Adherence
    Description
    PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.
    Time Frame
    Post Intervention (4 months after receiving intervention)
    Secondary Outcome Measure Information:
    Title
    PrEP Adherence Self-Efficacy
    Description
    PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007).
    Time Frame
    Post Intervention (1 month after receiving intervention)
    Title
    PrEP Adherence Self-Efficacy
    Description
    PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007).
    Time Frame
    Post Intervention (4 months after receiving intervention)

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    The study is open to cisgender men who have sex with men and transgender women.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ages 18-24; assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer; identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American; not currently taking PrEP or attending a visit to initiate PrEP; self-report being HIV-negative; reporting one of the following HIV risks in the last 6 months (Hosek, Rudy et al. 2015, Hosek, Rudy et al. 2017): a. condomless anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status; b. anal intercourse with 3 or more male sex partners; c. exchange of money, gifts, shelter, or drugs for anal sex with a male partner; d. sex with a male partner and has had a sexually transmitted infection; e. sexual partner of an HIV-infected male with whom condoms were not consistently used; f. anal intercourse where the condom broke or slipped off Exclusion Criteria: We are excluding those individuals who were assigned female at birth (female birth certificate) and/or cis-gender women (those assigned female at birth and identify as women) from the all phases of this study as this study is intended to explore the HIV prevention behaviors of B/AA young men who have sex with men and young transgender women (assigned male at birth) as these two groups represent the highest risk groups for HIV infection in the US, yet only a small percentage are aware or currently use PrEP for HIV prevention.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Darnell N Motley, PhD
    Organizational Affiliation
    University of Chicago
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Accelerated PrEP Access for Black MSM and TW

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