Personalized HIV and STI Testing Tool

HIV Clinical Trial

— PHASTT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03109899
• Other study ID #: 17-22103
• Secondary ID: 5K23MH104116
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: January 2021

Study information

• Verified date: February 2020
• Source: Public Health Foundation Enterprises, Inc.
• Contact: Kenneth Coleman, MA
• Phone: 628-217-7443
• Email: kenneth.coleman[@]sfdph.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Risk Reduction
• Sexually Transmitted Diseases
• Sexually Transmitted Infections (Not HIV or Hepatitis)

Intervention

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.

Locations

Country	Name	City	State
United States	Bridge HIV, San Francisco Department of Public Health	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Public Health Foundation Enterprises, Inc.	National Institute of Mental Health (NIMH), San Francisco Department of Public Health, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.	As measured by CASI	9 months
Secondary	The rate of STI testing in the Sex Pro mobile application intervention versus control arms.	As measured by CASI	9 months
Secondary	The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.	As measured by pharmacy confirmation	9 months
Secondary	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