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

Hiv Clinical Trial

— MobilePrEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308097
• Other study ID #: R34MH111342
• Status: Completed
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: August 12, 2020

Study information

• Verified date: January 2020
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• PrEP Mobile Messaging Intervention
See group description
• Enhanced Standard of Care
See group description

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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