A Pilot Study of PrEP Acceptance Among Young Black MSM
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

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.
    

Intervention name(s): MI-PrEP; control condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention