NCT04166851

Brief Summary

The aim of this study is to examine the utility of neuroimaging technique to evaluate pre-exposure prophylaxis (PrEP) promotion messages for men who have sex with men (MSM) at risk of HIV in Baltimore.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

October 23, 2019

Results QC Date

September 26, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

Pre-exposure prophylaxisHealth PromotionHIV/AIDS primary preventionmen who have sex with menNeuroimaging

Outcome Measures

Primary Outcomes (1)

  • Change of Willingness to Take PrEP

    Questions on willingness to take PrEP. Participants will be asked, "Suppose that PrEP is at least 90% effective in preventing HIV when taken daily. How likely would you be to take PrEP if it were available for free?" with responses ranging from "Extremely unlikely-1," "Somewhat unlikely-2," "Somewhat likely-3," "Extremely likely-4." The mean of the changes between baseline and after participants reviewed the messages was calculated.

    baseline, 30 days post baseline

Study Arms (2)

Open contest messages

EXPERIMENTAL

Participants will view the top PrEP-promotion messages developed via an open contest.

Behavioral: PrEP campaign messages developed via open contest

Social marketing messages

ACTIVE COMPARATOR

Participants will view the PrEP-promotion messages developed via social marketing.

Behavioral: PrEP campaign messages developed via social marketing approach

Interventions

PrEP campaign messages will be developed via an open contest in Baltimore.

Open contest messages

PrEP campaign messages developed with a traditional social marketing approach.

Social marketing messages

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Biological male sex at birth
  • Sexually active with men in the past 6 months
  • Never taken PrEP
  • HIV negative
  • Reside in Baltimore City or surrounding counties
  • Meet one of the criteria for being an appropriate PrEP candidate (i.e. in a relationship with a partner not known to be HIV-negative; are in a nonmonogamous relationship; have had any condomless anal sex with a casual male partner regardless of status in the prior 6 months; or had a positive sexual transmitted infection (STI) diagnosis within the prior 6 months).

You may not qualify if:

  • \- Participated in open contest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHomosexuality

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Results Point of Contact

Title
Cui Yang
Organization
Rutgers School of Public Health

Study Officials

  • Cui Yang, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

November 18, 2019

Study Start

November 15, 2019

Primary Completion

October 1, 2023

Study Completion

October 30, 2023

Last Updated

October 22, 2024

Results First Posted

October 22, 2024

Record last verified: 2024-09

Locations