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

Study Overview
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: PrEP Mobile Messaging Intervention
* Behavioral: Enhanced Standard of Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP Mobile Messaging Intervention<br>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<br>* See group description<br>|
| Active Comparator: Enhanced Standard of Care<br>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<br>* See group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PrEP Knowledge-Full Sample | Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge. | Baseline, 16 weeks | 
| Change in PrEP Knowledge-Restricted Sample | Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment. | Baseline, 16 weeks | 
| Change in Social Motivational Readiness for PrEP Care-Full Sample | Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation. | Baseline, 16 weeks | 
| Change in Social Motivational Readiness for PrEP Care-Restricted Sample | Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment. | Baseline, 16 weeks | 
| Change in PrEP Self-efficacy-Full Sample | Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy. | Baseline, 16 weeks | 
| Change in PrEP Self-efficacy-Restricted Sample | Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy. Restricted sample is those who did not receive a PrEP prescription the same day as enrollment. | Baseline, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Uptake, MSM, Black