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Multicomponent Intervention for PrEP Initiation

N/A
Waitlist Available
Led By Derek Dangerfield II, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reporting being HIV-negative or status unknown
Not currently taking Truvada or Descovy as pre-exposure prophylaxis (PrEP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial is designed to increase uptake of PrEP, a preventative medication for HIV, among black sexual minority men in the US, who have been shown to have high rates of HIV infection. The intervention will use a mobile app to record sexual risk behaviors, which will be reviewed with a peer change agent. The hope is that this will increase HIV risk perceptions and lead to more men taking PrEP.

Who is the study for?
This trial is for Black, cis-gender men who have sex with men, are at least 18 years old, and own a smartphone. They should not be currently on PrEP medications like Truvada or Descovy, must consider themselves HIV-negative or of unknown status, and have had anal intercourse with a male partner in the past year.Check my eligibility
What is being tested?
The study tests a multi-component strategy using an app called PrEPme and peer discussions to increase HIV risk awareness and encourage starting PrEP among Black sexual minority men. Participants will log their sexual activities in the app and review them with trained peers to evaluate risks and discuss potential PrEP use.See study design
What are the potential side effects?
Since this intervention involves education, technology use, and peer discussion rather than medication or medical procedures, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am either not HIV-positive or unsure of my HIV status.
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I am not currently using Truvada or Descovy for HIV prevention.
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I identify as a cisgender man.
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I have had anal sex with one or more men in the last year.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HIV risk perception as assessed by the Perceived Risk of HIV Scale
Secondary outcome measures
Proportion of participants who express interest in PrEP initiation

Trial Design

1Treatment groups
Experimental Treatment
Group I: BSMMExperimental Treatment1 Intervention
Intervention arm will include motivational interview-consistent discussion with a peer change agent and use of a mobile application to record and review sexual risk behaviors with participants.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,239 Previous Clinical Trials
14,816,368 Total Patients Enrolled
George Washington UniversityLead Sponsor
241 Previous Clinical Trials
453,217 Total Patients Enrolled
1 Trials studying Pre-Exposure Prophylaxis
57 Patients Enrolled for Pre-Exposure Prophylaxis
Derek Dangerfield II, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Multi-component intervention strategy Clinical Trial Eligibility Overview. Trial Name: NCT04533386 — N/A
Pre-Exposure Prophylaxis Research Study Groups: BSMM
Pre-Exposure Prophylaxis Clinical Trial 2023: Multi-component intervention strategy Highlights & Side Effects. Trial Name: NCT04533386 — N/A
Multi-component intervention strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04533386 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can join this research endeavor?

"Affirmative, clinicaltrials.gov confirms that this investigation is actively seeking to enrol participants. It was initially posted on the 1st of September 2020 and last updated on the 20th of September 2022 with a requirement for 80 volunteers across one medical site."

Answered by AI

Is enrollment to this experiment currently open for participants?

"Per clinicaltrials.gov, this research is presently looking for volunteers to take part in the trial. The opening date of the study was September 1st 2020 and it has been updated most recently on September 20th 2022."

Answered by AI
Recent research and studies
~5 spots leftby Jun 2024