Personalized HIV and STI Testing Tool

NCT ID: NCT03109899

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

Sex Pro mobile Application

Intervention Type BEHAVIORAL

Mobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Public Health Foundation Enterprises, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hyman Scott

Medical Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyman Scott

Role: PRINCIPAL_INVESTIGATOR

Public Health Foundation Enterprises; San Francisco Department of Public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kenneth Coleman, MA

Role: CONTACT

628-217-7443

Hyman Scott, MD, MPH

Role: CONTACT

628-217-7483

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5K23MH104116

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-22103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PrEP iT! Mobile App Intervention
NCT04509076 COMPLETED NA
Peer-driven Intervention on PrEP
NCT05161663 COMPLETED NA