A Pilot Study of PrEP Acceptance Among Young Black MSM (MI-PrEP)
Primary Purpose
HIV Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MI-PrEP
control condition
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infection
Eligibility Criteria
Inclusion Criteria:
- 18 to 29 years of age
- Identification as Black or African American
- Eligible for PrEP
Exclusion Criteria:
- none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MI-PrEP
control
Arm Description
This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP. The control condition is a one-hour, theory-based, one-to-one session that will help YBMSM think more about using condoms consistently and correctly with every sex partner.
This condition will include the provision of free condoms and lubricants - selected from a buffet of condoms and lubricants designed to offer men a broad selection of high quality products that can optimize the "fit and feel" of condoms during sex.
Outcomes
Primary Outcome Measures
Number of Participants Who Decide to Take PrEP
Researchers will evaluate and compare the number of participants who decide to take PrEP in the control condition and MI-PrEP condition.
Secondary Outcome Measures
Full Information
NCT ID
NCT02671591
First Posted
January 26, 2016
Last Updated
March 5, 2018
Sponsor
Richard Crosby
Collaborators
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02671591
Brief Title
A Pilot Study of PrEP Acceptance Among Young Black MSM
Acronym
MI-PrEP
Official Title
A Pilot Study of PrEP Acceptance Among Young Black MSM
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2015 (Actual)
Primary Completion Date
February 1, 2016 (Actual)
Study Completion Date
February 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Crosby
Collaborators
University of Mississippi Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overarching goal of the proposed study is to determine effective outreach methods designed to recruit and improve acceptance of high-risk HIV-negative YBMSM to initiate PrEP and to identify and modify psychosocial and structural predictors of PrEP acceptance. Specifically, the objective of this pilot study is to test the feasibility of a motivational interview-based intervention designed to improve PrEP acceptance among YBMSM.
Detailed Description
The study will occur in conjunction with standard clinical practice, which now includes offering high-risk YBMSM PrEP. If a person accepts this offer the person will be provided the service, but the person will not be asked to participate in the proposed study. Indeed, the study is designed for men who initially refuse this offer. Thus, for those who refuse researchers will offer study enrollment. For those who accept this offer and enroll, researchers will conduct baseline assessment and then randomize to I (intervention) versus C (control). Volunteers will receive the I or C condition immediately.
The intervention condition will be called MI-PrEP. This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP. The control condition is a one-hour, theory-based, one-to-one session that will help YBMSM think more about using condoms consistently and correctly with every sex partner. This is the same program that is currently being tested at Crossroads, known as Focus on the Future. Both conditions (I and C) will include the provision of free condoms and lubricants - selected from a buffet of condoms and lubricants designed to offer men a broad selection of high quality products that can optimize the "fit and feel" of condoms during sex.
After receiving the I or C condition, researchers will collect extensive contact information for the volunteer and explain to the participant that researchers will make contact each week for the next 4 weeks, at which time researchers would like the participant to return to complete a second computer-assisted self-administered survey. Thus, approximately 4 weeks (but no later than six weeks) after study enrollment, the volunteer will return to the clinic for a second assessment. At this time, a second formal offer of PrEP by the clinician will be made (note: participants may accept the initial offer at any time up until this point). For persons accepting the offer of PrEP at this time, researchers will follow standard of care procedures and administer the PrEP. Nonetheless, this person will remain in study until 6 months has elapsed since enrollment occurred. At the conclusion of that 6-month period, blood will be collected to test for PrEP levels plus self-reported adherence measures will be collected and a follow-up computer-assisted self-interview will be given.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MI-PrEP
Arm Type
Experimental
Arm Description
This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP. The control condition is a one-hour, theory-based, one-to-one session that will help YBMSM think more about using condoms consistently and correctly with every sex partner.
Arm Title
control
Arm Type
Active Comparator
Arm Description
This condition will include the provision of free condoms and lubricants - selected from a buffet of condoms and lubricants designed to offer men a broad selection of high quality products that can optimize the "fit and feel" of condoms during sex.
Intervention Type
Behavioral
Intervention Name(s)
MI-PrEP
Intervention Description
This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP and it will help YBMSM think more about using condoms consistently and correctly with every sex partner.
Intervention Type
Behavioral
Intervention Name(s)
control condition
Intervention Description
This is a behavioral program designed to provide men with condoms and lubricants that make sex feel good even though it is fully protected by latex condoms
Primary Outcome Measure Information:
Title
Number of Participants Who Decide to Take PrEP
Description
Researchers will evaluate and compare the number of participants who decide to take PrEP in the control condition and MI-PrEP condition.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 29 years of age
Identification as Black or African American
Eligible for PrEP
Exclusion Criteria:
none
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of PrEP Acceptance Among Young Black MSM
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