- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046079
Predictors of Health Service Utilizations Among Key Population in Washington DC
March 5, 2025 updated by: Us Helping Us, People Into Living, Inc.
A Mixed Methods Study of the Association Between LAI PrEP Initiation and Adherence, and Utilization of Health and Social Support Services Among Key Populations in Washington DC
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: DeMarc Hickson, PhD
- Phone Number: 6786139827
- Email: dhickson@uhupil.org
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Recruiting
- Us Helping Us, People into Living Inc
-
Contact:
- DeMarc Hickson, PhD
- Email: dhickson@uhupil.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Black sexual minority men, Latino sexual minority men, Black cisgender women, people who inject drugs, and transgender women
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Over 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2023
Primary Completion (Estimated)
July 3, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
September 13, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 5, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- HOPP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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