NCT03308097

Brief Summary

This study will develop and test an interactive mobile messaging intervention to improve engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors for Black men who have sex with men living in the Southern U.S. The mobile messaging intervention will include interactive text messaging and free, publicly available links to websites and YouTube videos. During the intervention participants will gain information about their health, improve motivation for engagement in PrEP related care, and build skills for healthy behaviors. Participants will also receive intervention materials to help decrease frequent barriers to care. If the intervention is found to be effective, it can be tested in a larger study and then disseminated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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

October 2, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

October 2, 2017

Results QC Date

January 18, 2021

Last Update Submit

February 15, 2021

Conditions

Hiv

Keywords

PrEPUptakeMSMBlack

Outcome Measures

Primary Outcomes (4)

  • Number of PrEP Services Appointments Attended-Full Sample

    With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.

    16 weeks

  • Number of PrEP Services Appointments Attended- Restricted Sample

    With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care. Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.

    16 weeks

  • Number of Participants Who Received a PrEP Prescription-Full Sample

    Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.

    16 weeks

  • Number of Participants Who Received a PrEP Prescription-Restricted Sample

    Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.

    16 weeks

Secondary Outcomes (6)

  • Change in PrEP Knowledge-Full Sample

    Baseline, 16 weeks

  • Change in PrEP Knowledge-Restricted Sample

    Baseline, 16 weeks

  • Change in Social Motivational Readiness for PrEP Care-Full Sample

    Baseline, 16 weeks

  • Change in Social Motivational Readiness for PrEP Care-Restricted Sample

    Baseline, 16 weeks

  • Change in PrEP Self-efficacy-Full Sample

    Baseline, 16 weeks

  • +1 more secondary outcomes

Study Arms (2)

PrEP Mobile Messaging Intervention

EXPERIMENTAL

Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.

Behavioral: PrEP Mobile Messaging Intervention

Enhanced Standard of Care

ACTIVE COMPARATOR

As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.

Behavioral: Enhanced Standard of Care

Interventions

PrEP Mobile Messaging InterventionBEHAVIORAL

See group description

PrEP Mobile Messaging Intervention
Enhanced Standard of CareBEHAVIORAL

See group description

Enhanced Standard of Care

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsStudy only open to self-identifying male participants.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking
  • Black MSM
  • Eligible for PrEP
  • Visit STI/HIV testing clinics at University of Mississippi Medical Center
  • Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

You may not qualify if:

  • \- Involved in another PrEP or HIV prevention related study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

  • Rouffiac AE, Whiteley L, Brown L, Mena L, Craker L, Healy M, Haubrick K. A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 20;9(2):e15781. doi: 10.2196/15781.

    PMID: 32130196DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Larry K. Brown, MD
Organization
Rhode Island Hospital
lkbrown@lifespan.org
(401) 793 - 8808

Study Officials

  • Larry K. Brown, M.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

  • Laura Whiteley, M.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

  • Leandro Mena, M.D.

    University of Mississippi Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 12, 2017

Study Start

November 20, 2018

Primary Completion

August 12, 2020

Study Completion

August 12, 2020

Last Updated

February 21, 2021

Results First Posted

February 21, 2021

Record last verified: 2020-01

Locations

US(1)