A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM

NCT ID: NCT03308097

Last Updated: 2021-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2020-08-12

Brief Summary

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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.

Detailed Description

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The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs) living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be texted interactive links to publicly available, online content about PrEP and HIV prevention. Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The material used in the intervention will be consistent with the Information Motivation Behavior (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A small randomized controlled study among 66 new participants in the clinics will examine the preliminary efficacy of the intervention compared to enhanced standard of care on attendance at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile Messaging Intervention will show greater attendance at a PrEP Services Appointment and decreased HIV risk behavior at 4 and 16 weeks.

Conditions

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Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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PrEP Mobile Messaging Intervention

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.

Group Type EXPERIMENTAL

PrEP Mobile Messaging Intervention

Intervention Type BEHAVIORAL

See group description

Enhanced Standard of Care

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.

Group Type ACTIVE_COMPARATOR

Enhanced Standard of Care

Intervention Type BEHAVIORAL

See group description

Interventions

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PrEP Mobile Messaging Intervention

See group description

Intervention Type BEHAVIORAL

Enhanced Standard of Care

See group description

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- Involved in another PrEP or HIV prevention related study
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larry K. Brown, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Laura Whiteley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Leandro Mena, M.D.

Role: STUDY_DIRECTOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32130196 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R34MH111342

Identifier Type: NIH

Identifier Source: org_study_id

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