SNS and PrEP Initiation and Adherence in Black SMM

NCT05499962 | Unknown

• 1 other identifier: 21-USHE-104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim 1. Conduct 18 focus groups among Black gay, bisexual and other sexual minority men (SMM; n=72-90) in the Washington, DC area of different age groups (18-24, 25-34, 35+) and various pre-exposure prophylaxis (PrEP) use profiles (i.e., PrEP naïve, current PrEP users, and discontinued PrEP; two per age-group and PrEP use profile) to understand intervention feasibility, acceptability and appropriateness, how the intervention can address experienced and perceived socio-structural barriers, and increase PrEP initiation and adherence among Black SMM in the Washington, District of Columbia (DC) area. Specific Aim 2. Implement an iterative open-phase pilot of an SNS intervention to increase PrEP initiation among human immunodeficiency virus (HIV)-negative Black SMM, aged 18 years and above, in the Washington, DC area. Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the social networking strategy (SNS) intervention's feasibility and acceptability.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention as measured by Weiner et al., 2017.

  Assess the feasibility of intervention delivery method (i.e., PrEP-using SMM as the Interventionist/Recruiter).

  During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.

• Acceptability of Intervention as measured by Weiner et al., 2017.

  Assess the feasibility of intervention delivery method (i.e., PrEP-using SMM as the Interventionist/Recruiter).

  During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.

Secondary Outcomes (3)

• Recruited Network Members

  Immediately after PrEP-using SMM enroll as an Interventionist (i.e., Recruiter)

• Network members on PrEP

  Immediately after PrEP-using SMM enroll as an Interventionist (i.e., Recruiter)

• Comfortability of the Intervention as measured by an adaptation of Weiner et al., 2017.

  During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.

Study Arms (1)

PrEP-using Black SMM as Recruiters

OTHER

Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the SNS intervention's feasibility and acceptability.

Behavioral: Social Networking Strategies

Interventions

Social Networking Strategies BEHAVIORAL

Assess whether PrEP-using Black SMM can serve as an Interventionist to get their social and sexual network members to uptake and adhere to PrEP

PrEP-using Black SMM as Recruiters

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender Black gay, bisexual and other sexual minority men (SMM)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or above
• Black or African American race
• Cisgender male identity
• Gay, bisexual or a male who has sex with other males
• Residence in the greater Washington, DC area (includes District of Columbia, Prince George's County, MD and Montgomery County, MD)
• Current PrEP use
• Confirmed HIV-negative status.

You may not qualify if:

• Being younger than 18 years of age ;
• Cisgender or transgender female identity
• Males having sex with women exclusively
• Being unable to speak or read English
• Reside outside of the defined greater Washington, DC area
• Being unable or unwilling to provide written informed consent
• Being unable to comply with the requirements of the protocol (e.g. persons with mental health conditions, persons who are intoxicated or incoherent for other reasons)
• Being a member of other vulnerable populations: pregnant women, children or wards of the state.

Sponsors & Collaborators

• Us Helping Us, People Into Living, Inc.: lead

Study Sites (1)

Us Helping Us, People Into Living, Inc.

Washington D.C., District of Columbia, 20010-1646, United States

RECRUITING

Study Officials

• DeMarc A Hickson, PhD

  Executive Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DeMarc A Hickson, PhD

CONTACT

678.613.9827; dhickson@uhupil.org

Adedotun Ogunbajo, PhD

CONTACT

202.446.1100; aogunbajo@uhupil.org

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: Executive Director

Model Details: Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the SNS intervention's feasibility and acceptability.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)