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Personalized HIV and STI Testing Tool (PHASTT)

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ClinicalTrials.gov Identifier: NCT03109899
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
San Francisco Department of Public Health
University of California, San Francisco
Information provided by (Responsible Party):
Hyman Scott, Public Health Foundation Enterprises, Inc.

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 Not Applicable

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  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. The feasibility and acceptability of Sex Pro to increase HIV/STI testing and PrEP uptake among young Black MSM. [ Time Frame: 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. [ Time Frame: 9 months ]
    As measured by CASI

  2. The rate of STI testing in the Sex Pro mobile application intervention versus control arms. [ Time Frame: 9 months ]
    As measured by CASI

  3. The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms. [ Time Frame: 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 [ Time Frame: 9 months ]
    As measured via CASI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109899


Contacts
Contact: Kenneth Coleman, MA 415-437-7443 kenneth.coleman@sfdph.org
Contact: Hyman Scott, MD, MPH 415-437-7483 hyman.scott@sfdph.org

Locations
United States, California
Bridge HIV, San Francisco Department of Public Health Not yet recruiting
San Francisco, California, United States, 94102
Principal Investigator: Hyman Scott, MD, MPH         
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

Responsible Party: Hyman Scott, Medical Director, Clinical Research, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03109899     History of Changes
Other Study ID Numbers: 17-22103
5K23MH104116 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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, Public Health Foundation Enterprises, Inc.:
mHealth
HIV Prevention

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female