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Withdrawn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
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
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.
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
NCT ID
NCT04329442
First Posted
March 26, 2020
Last Updated
May 16, 2022
Sponsor
University of Chicago
Collaborators
Planned Parenthood Great Plains
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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