Personalized HIV and STI Testing Tool

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Sex Pro mobile Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Mobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM.<br>|
| No Intervention: Control<br>Participants in this arm will be given the local standard of care for HIV/STI testing and PrEP access. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of HIV testing in the Sex Pro mobile application intervention versus control arms. | As measured by CASI | 9 months | 
| The rate of STI testing in the Sex Pro mobile application intervention versus control arms. | As measured by CASI | 9 months | 
| The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms. | As measured by pharmacy confirmation | 9 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, HIV Prevention