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Personalized HIV and STI Testing Tool (PHASTT)

Primary Purpose

Risk Reduction, HIV, Sexually Transmitted Infections (Not HIV or Hepatitis)

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sex Pro mobile Application
Sponsored by
Public Health Foundation Enterprises, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Risk Reduction focused on measuring mHealth, HIV Prevention

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Bridge HIV, San Francisco Department of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Participants in this arm will have access to the Sex Pro mobile app and support for HIV/STI testing and PrEP uptake.

Participants in this arm will be given the local standard of care for HIV/STI testing and PrEP access.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2017
Last Updated
February 18, 2020
Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
National Institute of Mental Health (NIMH), San Francisco Department of Public Health, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03109899
Brief Title
Personalized HIV and STI Testing Tool
Acronym
PHASTT
Official Title
Randomized, Controlled Trial of the Sex Pro Mobile App for Young Black MSM in San Francisco and Oakland, CA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
National Institute of Mental Health (NIMH), San Francisco Department of Public Health, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Reduction, HIV, Sexually Transmitted Infections (Not HIV or Hepatitis)
Keywords
mHealth, HIV Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this arm will have access to the Sex Pro mobile app and support for HIV/STI testing and PrEP uptake.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this arm will be given the local standard of care for HIV/STI testing and PrEP access.
Intervention Type
Behavioral
Intervention Name(s)
Sex Pro mobile Application
Intervention Description
Mobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM.
Primary Outcome Measure Information:
Title
The feasibility and acceptability of Sex Pro to increase HIV/STI testing and PrEP uptake among young Black MSM.
Description
As measured via computer assisted interview (CASI)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.
Description
As measured by CASI
Time Frame
9 months
Title
The rate of STI testing in the Sex Pro mobile application intervention versus control arms.
Description
As measured by CASI
Time Frame
9 months
Title
The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.
Description
As measured by pharmacy confirmation
Time Frame
9 months
Title
Changes in sexual risk behaviors among young Black MSM in the Sex Pro mobile application intervention vs. control arms
Description
As measured via CASI
Time Frame
9 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Coleman, MA
Phone
628-217-7443
Email
kenneth.coleman@sfdph.org
First Name & Middle Initial & Last Name or Official Title & Degree
Hyman Scott, MD, MPH
Phone
628-217-7483
Email
hyman.scott@sfdph.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyman Scott
Organizational Affiliation
Public Health Foundation Enterprises; San Francisco Department of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridge HIV, San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyman Scott, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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