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

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

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Us Helping Us, People into Living Inc
        • Contact:

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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