Accelerated PrEP Access for Black MSM and TW

May 16, 2022 updated by: University of Chicago

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: PrEP Received
Participants will be provided with a free 30-day supply of PrEP.
Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
30 day supply of 200mg tablets
Other Names:
  • Truvada

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intention to Continue PrEP
Time Frame: Post Intervention (1 month after receiving intervention)
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.
Post Intervention (1 month after receiving intervention)
Intention to Continue PrEP
Time Frame: Post Intervention (4 months after receiving intervention)
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.
Post Intervention (4 months after receiving intervention)
PrEP Adherence
Time Frame: Post Intervention (1 month after receiving intervention)
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.
Post Intervention (1 month after receiving intervention)
PrEP Adherence
Time Frame: Post Intervention (4 months after receiving intervention)
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.
Post Intervention (4 months after receiving intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PrEP Adherence Self-Efficacy
Time Frame: Post Intervention (1 month after receiving intervention)
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).
Post Intervention (1 month after receiving intervention)
PrEP Adherence Self-Efficacy
Time Frame: Post Intervention (4 months after receiving intervention)
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).
Post Intervention (4 months after receiving intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Planned Parenthood Great Plains

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Darnell N Motley, PhD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB19-1154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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