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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308097
Recruitment Status : Active, not recruiting
First Posted : October 12, 2017
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
University of Mississippi Medical Center
Information provided by (Responsible Party):
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Hiv Behavioral: PrEP Mobile Messaging Intervention Behavioral: Enhanced Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: PrEP Mobile Messaging Intervention
See group description

Active Comparator: 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.
Behavioral: Enhanced Standard of Care
See group description




Primary Outcome Measures :
  1. Attendance at a PrEP Services Appointment [ Time Frame: 16 weeks ]
    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.


Secondary Outcome Measures :
  1. HIV knowledge [ Time Frame: Baseline, 4 weeks, 16 weeks ]
    Participants complete the HIV knowledge scale and STI Knowledge Questionnaire.

  2. STI Knowledge [ Time Frame: Baseline, 4 weeks, 16 weeks ]
    Participants complete STI Knowledge Questionnaire.

  3. PrEP knowledge [ Time Frame: Baseline, 4 weeks, 16 weeks ]
    Participants complete the PrEP Knowledge Questionnaire.

  4. Personal readiness for PrEP care [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    Participants complete the Rollnick's Readiness Ruler (used to assess motivation for engaging in PrEP care).

  5. Social motivational readiness for PrEP care [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    Participants complete the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use).

  6. PrEP & appointment self-efficacy [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    Participants complete a scale that assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments.

  7. PrEP Self-efficacy [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    Participants complete the IMB PrEP Behavioral Skills Scale to assess information, motivation, perception of behavioral ability to perform the necessary PrEP skills.

  8. Recent sexual behavior [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    Participants complete the Risk Behavior Assessment to assess types of sexual behavior (i.e., anal, oral, vaginal) in the past three months.

  9. Recent substance use [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    Participants complete the Risk Behavior Assessment to assess substance use in the past three months.

  10. Receipt of a PrEP Prescription [ Time Frame: 16 weeks ]
    Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study only open to self-identifying male participants.
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308097


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
Rhode Island Hospital
University of Mississippi Medical Center
Investigators
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Principal Investigator: Larry K. Brown, M.D. Rhode Island Hospital
Principal Investigator: Laura Whiteley, M.D. Rhode Island Hospital
Study Director: Leandro Mena, M.D. University of Mississippi Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03308097    
Other Study ID Numbers: R34MH111342 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhode Island Hospital:
PrEP
Uptake
MSM
Black