Accelerated PrEP Access for Black MSM and TW

NCT04329442 | Withdrawn

• 1 other identifier: IRB19-1154
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV/AIDS

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• PrEP Adherence Self-Efficacy

  Post Intervention (1 month after receiving intervention)

• PrEP Adherence Self-Efficacy

  Post Intervention (4 months after receiving intervention)

Study Arms (1)

PrEP Received

EXPERIMENTAL

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

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet DRUG

30 day supply of 200mg tablets

Also known as: Truvada

PrEP Received

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: The study is open to cisgender men who have sex with men and transgender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Planned Parenthood Great Plains: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Darnell N Motley, PhD

  University of Chicago

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm longitudinal pre/post study

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 1, 2020
• Study Start: April 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05