HIV Infection Clinical Trial
Official title:
A Pilot Study of PrEP Acceptance Among Young Black MSM
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.
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.
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