Risk ReductionPHASTTNCT03109899
Personalized HIV and STI Testing Tool
A study testing Sex Pro mobile Application in people with Risk Reduction and HIV, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction, HIV, Sexually Transmitted Infections (Not HIV or Hepatitis)
- What is being tested?
- Sex Pro mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
Hyman Scott, MD, MPH
About this study
Official title: Randomized, Controlled Trial of the Sex Pro Mobile App for Young Black MSM in San Francisco and Oakland, CA
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.
Read the 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.
- Being tested
- Sex Pro mobile Application
- Keywords
- mHealth, HIV Prevention
- Medical subject headings
- Risk Reduction Behavior, Sexually Transmitted Diseases, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sex Pro mobile ApplicationBehavioural
Mobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this arm will have access to the Sex Pro mobile app and support for HIV/STI testing and PrEP uptake. Receives: Behavioral: Sex Pro mobile Application |
| Control | No intervention | Participants in this arm will be given the local standard of care for HIV/STI testing and PrEP access. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9 months
Secondary outcomes (4)
The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.
As measured by CASI
Measured: 9 months
The rate of STI testing in the Sex Pro mobile application intervention versus control arms.
As measured by CASI
Measured: 9 months
The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.
As measured by pharmacy confirmation
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start18 Sep 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), San Francisco Department of Public Health, University of California, San Francisco
- Responsible party
- Principal investigator, Hyman Scott, Public Health Foundation Enterprises, Inc.
- Investigators
- Hyman Scott, Principal investigator, Public Health Foundation Enterprises; San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109899
- Sponsor's protocol ID
- 17-22103
- Other IDs
- 5K23MH104116
- Acronym
- PHASTT
- Status last verified
- Feb 2020
- First submitted
- 29 Mar 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of the Sex Pro Mobile App for Young Black MSM in San Francisco and Oakland, CA
- ClinicalTrials.gov ID
- NCT03109899
- Acronym / sponsor ID
- PHASTT / 17-22103
- Keywords
- mHealth, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), San Francisco Department of Public Health, University of California, San Francisco
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sex Pro mobile ApplicationParticipants in this arm will have access to the Sex Pro mobile app and support for HIV/STI testing and PrEP uptake. |
| Control | No intervention | –Participants in this arm will be given the local standard of care for HIV/STI testing and PrEP access. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sex Pro mobile ApplicationMobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM. | Behavioural | Intervention |
Primary outcome
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)
4 secondary outcomes
The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.
Time frame: 9 months
The rate of STI testing in the Sex Pro mobile application intervention versus control arms.
Time frame: 9 months
The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.
Time frame: 9 months
Changes in sexual risk behaviors among young Black MSM in the Sex Pro mobile application intervention vs. control arms
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyman Scott principal investigator
Public Health Foundation Enterprises; San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sex Pro mobile Application in people with Risk Reduction and HIV, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Coleman, MA (628-217-7443, kenneth.coleman@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility and acceptability of Sex Pro to increase HIV/STI testing and PrEP uptake among young Black MSM. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.