Clinical trial NCT03109899: Personalized HIV and STI Testing Tool
Official title: Randomized, Controlled Trial of the Sex Pro Mobile App for Young Black MSM in San Francisco and Oakland, CA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk Reduction
HIV
Sexually Transmitted Infections (Not HIV or Hepatitis)
Keywords: mHealth
HIV Prevention
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: San Francisco Department of Public Health
name: University of California, San Francisco
First posted: 2017-04-12
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The feasibility and acceptability of Sex Pro to increase HIV/STI testing and PrEP uptake among young Black MSM.
timeFrame: 9 months
Secondary outcomes:
measure: The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.
timeFrame: 9 months
measure: The rate of STI testing in the Sex Pro mobile application intervention versus control arms.
timeFrame: 9 months
measure: The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.
timeFrame: 9 months
measure: Changes in sexual risk behaviors among young Black MSM in the Sex Pro mobile application intervention vs. control arms
timeFrame: 9 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
Study officials:
affiliation: Public Health Foundation Enterprises; San Francisco Department of Public Health
name: Hyman Scott
role: PRINCIPAL_INVESTIGATOR
References: