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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
Richard Crosby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    January 26, 2016
    Last Updated
    March 5, 2018
    Sponsor
    Richard Crosby
    Collaborators
    University of Mississippi Medical Center
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    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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