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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06046079
Other study ID # HOPP1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 15, 2023
Est. completion date March 31, 2026

Study information

Verified date September 2023
Source Us Helping Us, People Into Living, Inc.
Contact DeMarc Hickson, PhD
Phone 6786139827
Email dhickson@uhupil.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 31, 2026
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Us Helping Us, People Into Living, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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