Pre-exposure ProphylaxisNCT06046079
Predictors of Health Service Utilizations Among Key Population in Washington DC
An observational study of Pre-exposure Prophylaxis and HIV, run by Us Helping Us, People Into Living, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-exposure Prophylaxis, HIV, Health Behavior
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Black sexual minority men, Latino sexual minority men, Black cisgender women, people who inject drugs, and transgender women
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Us Helping Us, People into Living Inc
Washington D.C., District of Columbia, 20010
DeMarc Hickson, PhD, dhickson@uhupil.org
About this study
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
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.
- Conditions
- Pre-exposure Prophylaxis, HIV, Health Behavior
- Medical subject headings
- Health Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Aug 2023
- Primary completion3 Jul 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Us Helping Us, People Into Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046079
- Sponsor's protocol ID
- HOPP1
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06046079
- Acronym / sponsor ID
- HOPP1
- Conditions
- Pre-exposure Prophylaxis, HIV, Health Behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Us Helping Us, People Into Living, Inc.University, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 3 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Black sexual minority men, Latino sexual minority men, Black cisgender women, people who inject drugs, and transgender women
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-exposure Prophylaxis and HIV, run by Us Helping Us, People Into Living, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DeMarc Hickson, PhD (6786139827, dhickson@uhupil.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.