Recruiting

SNS & PrEP

Sponsor:

Us Helping Us, People Into Living, Inc.

Code:

NCT05499962

Conditions

HIV

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Social Networking Strategies

Study Details

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

Study ID

NCT05499962

Start date

Mar 1, 2022

Status verified date

Sep, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: PrEP-using Black SMM as Recruiters

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.

Interventions

Social Networking Strategies

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

Primary outcome measure

  • Feasibility of Intervention as measured by Weiner et al., 2017. [ Time Frame: 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. [ Time Frame: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot. ]

Central Contacts and Locations

Central contacts

DeMarc A Hickson, PhD

678.613.9827dhickson@uhupil.org

Adedotun Ogunbajo, PhD

202.446.1100aogunbajo@uhupil.org

Locations

Us Helping Us, People Into Living, Inc.

Recruiting

Washington, District of Columbia, United States, 20010-1646

Contacts

Dianne Murphy

202-446-1100dmurphy@uhupil.org

Alexa Euceda, MPH

202.446.1100aeuceda@uhupil.org

Principal Investigator:

DeMarc A Hickson, PhD

More Information

Sponsor

Us Helping Us, People Into Living, Inc.

Last update posted

Sep 15, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Us Helping Us, People Into Living, Inc. on 2023-09-15.