The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictors of Health Service Utilizations Among Key Population in Washington DC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date September 13, 2023
First Posted Date September 21, 2023
Last Update Posted Date September 21, 2023
Estimated Study Start Date September 15, 2023
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2023)		 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors of Health Service Utilizations Among Key Population in Washington DC
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Pre-exposure Prophylaxis
  • HIV
  • Health Behavior
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 13, 2023)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2026
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: DeMarc Hickson, PhD 6786139827 dhickson@uhupil.org
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT06046079
Other Study ID Numbers HOPP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Us Helping Us, People Into Living, Inc.
Original Responsible Party Same as current
Current Study Sponsor Us Helping Us, People Into Living, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Us Helping Us, People Into Living, Inc.
Verification Date September 2023