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Predictors of Health Service Utilizations Among Key Population in Washington DC

Sponsor
Us Helping Us, People Into Living, Inc. (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06046079
Collaborator
(none)
100
Enrollment
30.5
Anticipated Duration (Months)

Study Details

Study Description

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 we 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Anticipated Study Start Date :
    Sep 15, 2023
    Anticipated Primary Completion Date :
    Jul 31, 2025
    Anticipated Study Completion Date :
    Mar 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Over 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Us Helping Us, People Into Living, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Us Helping Us, People Into Living, Inc.
    ClinicalTrials.gov Identifier:
    NCT06046079
    Other Study ID Numbers:
    • HOPP1
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 21, 2023