Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US

NCT04832477 | Active Not Recruiting

• 1 other identifier: H20-0117
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research aims to assess the multiple forms and paths of stigma and substance use as they relate to pre-exposure prophylaxis (PrEP) use for HIV prevention. How stigma and an evolving public health landscape impact PrEP use among Black sexual minorit men who use substances is unknown. The current application focuses on addressing critical and novel questions to improving the essential building blocks of biomedical prevention approaches by providing crucial information for enhancing interventions to lower HIV prevalence among substance using Black sexual minority men.

Conditions

HIV Seropositivity; Substance Use; STI; Stigma, Social

Outcome Measures

Primary Outcomes (1)

• PrEP Use

  TFV-DP (Tenofovir Diphosphate) biological testing for PrEP pill taking will be assessed. TFV-DP measured at \>700 fmol will be interpreted as having taken ≥4 doses/week, and TFV-DP measured at \>700 fmol over two consecutive time points will be interpreted as persistence to taking PrEP. The lower scale limit is 0 and upper scale limit is approximately around 2500. Higher values indicate greater medication adherence to PrEP pills.

  12 months

Secondary Outcomes (1)

• PrEP stigma

  12 months

Study Arms (1)

Stigma Counseling for PrEP Access

OTHER

Behavioral counseling

Behavioral: Stigma counseling for PrEP use

Interventions

Stigma counseling for PrEP use BEHAVIORAL

This counseling consists of a single-session (45 minute) delivered by trained peer counselors. The primary aims and relevant content areas for counseling are: (1) Assessing and discussing factors known to be drivers of emotional barriers to accessing health care. This counseling aim has two main sub-components: (a) participants will be asked about their prior experiences with accessing health care and their concerns regarding future access, and (b) the counseling will focus on creating personal agency around needing to prioritize one's health. (2) Evaluating concerns around discussing PrEP with health care providers. The counseling combines motivational interviewing with medical decisional balance, which focuses on points to consider when evaluating PrEP. (3) Promoting resiliency beliefs and positive adaptation. For this objective the counselor works with the participant to establish PrEP use goals and problem-solving strategies.

Stigma Counseling for PrEP Access

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men (based on male sex assignment at birth)
• Age 18 or older
• Identify as Black, African-American, Afro-Brazilian, Afro-Carribean, or African diaspora,
• Report condomless anal sex with man in past six months
• Test HIV negative
• Report recent (\<3 months) substance use
• Positive drug toxicology for substance use

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

SHARE Project

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

HIV Seropositivity; Substance-Related Disorders; Sexually Transmitted Diseases; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Lisa A Eaton, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 5, 2021
• Study Start: September 15, 2021
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)