Recruiting

Observational Study

Sponsor:

Us Helping Us, People Into Living, Inc.

Code:

NCT06046079

Conditions

Pre-exposure Prophylaxis

HIV

Health Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The primary objective of the proposed study is to investigate how PrEP use might result in an increase in the utilization of health and social services offered at a local community-based organization. Our primary hypothesis is that the investigators will observe higher utilization of sexual health (STI screenings), psychosocial health (psychotherapy, and substance use treatment) and other social services (emergency cash assistance, food pantry, transportation assistance, clothing,and housing resources) among PrEP users (LAI-PrEP or daily oral) compared to participants who are PrEP naïve over the 12-month follow-up period.

Conditions

Pre-exposure Prophylaxis

HIV

Health Behavior

Study ID

NCT06046079

Start date

Aug 25, 2023

Status verified date

Mar, 2025

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Jul 3, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • age of 18 years or above;
  • confirmed HIV-negative status;
  • residence in the Washington, DC metropolitan area;
  • one of the following PrEP profiles (PrEP naïve \[no history of any PrEP use in the past\] currently on daily oral PrEP or receiving LAI-PrEP).

Exclusion Criteria:

  • being younger than18 years of age
  • being unable to speak and/or read English
  • a reported residence outside of the defined Washington, DC metropolitan area
  • being unable or unwilling to provide written informed consent
  • being unable to comply with the requirements of the protocol (i.e. persons with mental health conditions, persons who are intoxicated or incoherent for other reasons)
  • evidence of suspected hepatoxicity

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The rate of service utilization (sexual health, psychosocial health & other social services) over 12 months as a function of demographic characteristics, mental health, and substance use behavior. [ Time Frame: Over 12 months ]

Central Contacts and Locations

Central contacts

DeMarc Hickson, PhD

6786139827dhickson@uhupil.org

Locations

Us Helping Us, People into Living Inc

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

DeMarc Hickson, PhD

dhickson@uhupil.org

More Information

Sponsor

Us Helping Us, People Into Living, Inc.

Last update posted

Mar 10, 2025

Last verified

Mar, 2025

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 2025-03-10.