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Accelerated PrEP Access for Black MSM and TW

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04329442
Enrollment
0
Registered
2020-04-01
Start date
2020-04-01
Completion date
2021-07-31
Last updated
2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

PrEP, HIV Prevention, Young Men Who Have Sex with Men, Young Transgender Women

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.

Interventions

30 day supply of 200mg tablets

Sponsors

Planned Parenthood Great Plains
CollaboratorOTHER
University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A single-arm longitudinal pre/post study

Eligibility

Sex/Gender
MALE
Age
18 Years to 24 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Intention to Continue PrEPPost 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.
PrEP AdherencePost 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.

Secondary

MeasureTime frameDescription
PrEP Adherence Self-EfficacyPost 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026