NCT06046079

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

September 13, 2023

Last Update Submit

March 5, 2025

Conditions

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Black sexual minority men, Latino sexual minority men, Black cisgender women, people who inject drugs, and transgender women

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Us Helping Us, People into Living Inc

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

DeMarc Hickson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

August 25, 2023

Primary Completion

July 3, 2025

Study Completion

January 1, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations