NCT03109899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

March 29, 2017

Last Update Submit

February 18, 2020

Conditions

Risk ReductionHIVSexually Transmitted Infections (Not HIV or Hepatitis)

Keywords

mHealthHIV Prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The rate of HIV testing in the Sex Pro mobile application intervention versus control arms.

    9 months

  • The rate of STI testing in the Sex Pro mobile application intervention versus control arms.

    9 months

  • The rate of PrEP uptake in the Sex Pro mobile application intervention versus control arms.

    9 months

  • Changes in sexual risk behaviors among young Black MSM in the Sex Pro mobile application intervention vs. control arms

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Sex Pro mobile ApplicationBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction BehaviorSexually Transmitted DiseasesHepatitis

Condition Hierarchy (Ancestors)

BehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Hyman Scott

    Public Health Foundation Enterprises; San Francisco Department of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Coleman, MA

CONTACT

628-217-7443kenneth.coleman@sfdph.org

Hyman Scott, MD, MPH

CONTACT

628-217-7483hyman.scott@sfdph.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Clinical Research

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 12, 2017

Study Start

September 18, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)