Clinical trial NCT03308097: A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
Official title: A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: PrEP
Uptake
MSM
Black
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2017-10-12
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of PrEP Services Appointments Attended-Full Sample
timeFrame: 16 weeks
measure: Number of PrEP Services Appointments Attended- Restricted Sample
timeFrame: 16 weeks
measure: Number of Participants Who Received a PrEP Prescription-Full Sample
timeFrame: 16 weeks
measure: Number of Participants Who Received a PrEP Prescription-Restricted Sample
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in PrEP Knowledge-Full Sample
timeFrame: Baseline, 16 weeks
measure: Change in PrEP Knowledge-Restricted Sample
timeFrame: Baseline, 16 weeks
measure: Change in Social Motivational Readiness for PrEP Care-Full Sample
timeFrame: Baseline, 16 weeks
measure: Change in Social Motivational Readiness for PrEP Care-Restricted Sample
timeFrame: Baseline, 16 weeks
measure: Change in PrEP Self-efficacy-Full Sample
timeFrame: Baseline, 16 weeks
measure: Change in PrEP Self-efficacy-Restricted Sample
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Rhode Island Hospital
name: Larry K. Brown, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Laura Whiteley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: Leandro Mena, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.