Personalized HIV and STI Testing Tool (PHASTT)

Randomized, Controlled Trial of the Sex Pro Mobile App for Young Black MSM in San Francisco and Oakland, CA

The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use among young Black men who have sex with men (MSM), and testing a novel mobile app to increase HIV/STI testing and PrEP uptake.

Study Overview

• Status: Unknown
• Conditions: HIV; Risk Reduction; Sexually Transmitted Infections (Not HIV or Hepatitis)
• Intervention / Treatment: Behavioral: Sex Pro mobile Application

Detailed Description

The Sex Pro mobile application (app) being tested facilitates home HIV-testing, home sexually transmitted infection (STI) test self-collection, and pre-exposure prophylaxis (PrEP) uptake. The app integrates a personalized HIV risk assessment with home HIV and STI testing options for young, Black MSM.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyman Scott, MD, MPH; Phone Number: 628-217-7483; Email: hyman.scott@sfdph.org

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • Recruiting
      • Bridge HIV, San Francisco Department of Public Health
      • Principal Investigator: Hyman Scott, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 27 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Self-identify as Black.
• Self-report being HIV negative.
• Report anal sex with at two or more male sex partners in the prior 12 months.
• Own an iOS or Android mobile phone.
• Willing and able to give written informed consent to participate in all activities outlined by the protocol.

Exclusion Criteria:

• Inadequate contact information for follow-up
• In a mutually monogamous sexual relationship for the past 12 months
• Currently taking PrEP
• Does not have reliable access to the internet
• Does not live, work or play in the San Francisco Bay Area
• Currently enrolled in another HIV intervention study
• Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product
• Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in this arm will have access to the Sex Pro mobile app and support for HIV/STI testing and PrEP uptake.	Behavioral: Sex Pro mobile Application; Mobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM.
No Intervention: Control; Participants in this arm will be given the local standard of care for HIV/STI testing and PrEP access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility and acceptability of Sex Pro to increase HIV/STI testing and PrEP uptake among young Black MSM.	As measured via computer assisted interview (CASI)	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.	As measured by CASI	9 months
The rate of STI testing in the Sex Pro mobile application intervention versus control arms.	As measured by CASI	9 months
The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.	As measured by pharmacy confirmation	9 months
Changes in sexual risk behaviors among young Black MSM in the Sex Pro mobile application intervention vs. control arms	As measured via CASI	9 months

Collaborators and Investigators

• Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: National Institute of Mental Health (NIMH); University of California, San Francisco; San Francisco Department of Public Health
• Investigators: Principal Investigator: Hyman Scott, Public Health Foundation Enterprises; San Francisco Department of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: mHealth; HIV Prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 17-22103; 5K23MH104116 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No