Assessing the Feasibility and Preliminary Impact of a mHealth App on Reducing STI Risk in Black MSM PrEP Users

NCT05395754 | Completed

• 1 other identifier: 2268
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

The study will recruit 120 Black men who have sex with men (BMSM) from the local area, New Orleans. The main purpose of this research study is to test the effect of a new smartphone application, "PCheck," on reducing the incidence of STIs, compared to routine care through the LSU-Crescent Care Sexual Health/PrEP Clinic.

Conditions

STI; Sexually Transmitted Diseases; Pre-exposure Prophylaxis

Keywords

BMSM; STI; Sexually Transmitted Infection; Mobile health; PrEP; pre-exposure prophylaxis; MSM

Outcome Measures

Primary Outcomes (1)

• STI incidence

  New diagnosis of syphilis, gonorrhea, chlamydia, or hepatitis C per 100 person-years. Number of new HIV diagnoses.

  24 months

Secondary Outcomes (2)

• Social Support

  24 months

• Social Isolation

  24 months

Study Arms (2)

PCheck

EXPERIMENTAL

Participants allocated to the intervention arm will receive the intervention (use of the PCheck app) for 12 months of follow-up. Participants will be encouraged to use the app as much as they wish throughout the study and will be informed that there will be no set expectation for how frequently they must use the app, although they will be encouraged to use it regularly to "thoroughly test it". The app will send notification reminders to "check in" (in other words, use the daily check-in feature to track their mood, stress, and behaviors related to STI-prevention over time). The notification settings can be adjusted in phone settings by the participant. To encourage peer support and a sense of community, users can interact with community members anonymously through a message board, monitored by research staff. Participants in the intervention will continue routine PrEP care and STI testing through the clinic.

Device: App Intervention

Routine Care

NO INTERVENTION

Participants in the routine care arm will continue routine PrEP care and STI testing through the clinic.

Interventions

App Intervention DEVICE

Use of the PCheck app, an app encouraging STI prevention behaviors.

PCheck

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cisgender man who has sex with cisgender men (MSM) including gay, bisexual, or other MSM
• Age 18-35 years
• Black race or multi-racial including Black race
• Prescribed, administered or otherwise taking PrEP via routine care or PrEP clinical trial
• Smartphone possession

You may not qualify if:

• Unable to read and write
• Not fluent in English

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• University of Virginia: collaborator

Study Sites (2)

CrescentCare PrEP Clinic

New Orleans, Louisiana, 70119, United States

Location

LSU-CrescentCare Sexual Health Center

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meredith Clement, MD

  LSUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)