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Predictors of Health Service Utilizations Among Key Population in Washington DC

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ClinicalTrials.gov Identifier: NCT06046079
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Us Helping Us, People Into Living, Inc.

Study Description
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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
Pre-exposure Prophylaxis HIV Health Behavior

Study Design
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Study Type : Observational
Estimated 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
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : March 31, 2026
Groups and Cohorts
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Outcome Measures
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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. [ Time Frame: Over 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046079


Contacts
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Contact: DeMarc Hickson, PhD 6786139827 dhickson@uhupil.org

Sponsors and Collaborators
Us Helping Us, People Into Living, Inc.
More Information
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Responsible Party: Us Helping Us, People Into Living, Inc.
ClinicalTrials.gov Identifier: NCT06046079    
Other Study ID Numbers: HOPP1
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No