NCT06046079 · Us Helping Us, People Into Living, Inc.
Predictors of Health Service Utilizations Among Key Population in Washington DC
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 10, 2025 · Source of record for eligibility and locations