PHASTT: Personalized HIV and STI Testing Tool

• Sponsor: Public Health Foundation Enterprises, Inc. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03109899
• Collaborator: National Institute of Mental Health (NIMH) (NIH), San Francisco Department of Public Health (Other), University of California, San Francisco (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Risk Reduction; HIV; Sexually Transmitted Infections (Not HIV or Hepatitis)	Behavioral: Sex Pro mobile Application	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized, Controlled Trial of the Sex Pro Mobile App for Young Black MSM in San Francisco and Oakland, CA
• Actual Study Start Date: Sep 18, 2019
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Jan 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The feasibility and acceptability of Sex Pro to increase HIV/STI testing and PrEP uptake among young Black MSM. [9 months]

   As measured via computer assisted interview (CASI)

Secondary Outcome Measures

1. The rate of HIV testing in the Sex Pro mobile application intervention versus control arms. [9 months]

   As measured by CASI

2. The rate of STI testing in the Sex Pro mobile application intervention versus control arms. [9 months]

   As measured by CASI

3. The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms. [9 months]

   As measured by pharmacy confirmation

4. Changes in sexual risk behaviors among young Black MSM in the Sex Pro mobile application intervention vs. control arms [9 months]

   As measured via CASI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bridge HIV, San Francisco Department of Public Health	San Francisco	California	United States	94102

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Hyman Scott, Public Health Foundation Enterprises; San Francisco Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyman Scott, Medical Director, Clinical Research, Public Health Foundation Enterprises, Inc.
• ClinicalTrials.gov Identifier: NCT03109899
• Other Study ID Numbers: 17-22103; 5K23MH104116
• First Posted: Apr 12, 2017
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hyman Scott, Medical Director, Clinical Research, Public Health Foundation Enterprises, Inc.: mHealth; HIV Prevention
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

No Results Posted as of Feb 20, 2020