Accelerated PrEP Access for Black MSM and TW

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04329442
• Other study ID #: IRB19-1154
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Drug:
• Emtricitabine / Tenofovir Disoproxil Oral Tablet
30 day supply of 200mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Planned Parenthood Great Plains

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post Intervention (1 month after receiving intervention)
Primary	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.	Post Intervention (4 months after receiving intervention)
Primary	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.	Post Intervention (1 month after receiving intervention)
Primary	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.	Post Intervention (4 months after receiving intervention)
Secondary	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).	Post Intervention (1 month after receiving intervention)
Secondary	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).	Post Intervention (4 months after receiving intervention)