Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/3/2019
Start Date:October 1, 2018
End Date:December 2020
Contact:Sannisha K Dale, PhD, EdM
Email:sdale@med.miami.edu
Phone:305-243-3288

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This project is funded by a Provost Award for Dr. Sannisha Dale from the University of Miami.
An open pilot trial and a pilot randomized control trial of a brief two-session counseling
intervention to increase PrEP uptake among Black women at risk for HIV utilizing Motivational
Interviewing will be conducted. Outcomes include knowledge of and motivation to use PrEP,
PrEP uptake, and perceived barriers to PrEP usage.

Compared to women of other racial/ethnic groups Black women in the U.S. bear a
disproportionate burden of the HIV epidemic in terms of numbers of new diagnoses and
morbidity/mortality once infected. However, the advent of PrEP (Pre-exposure prophylaxis) may
help curb the epidemic in all communities including those most impacted. PrEP is an
antiretroviral pill (e.g. Truvada) that if taken once per day by an HIV negative individual
protects that person from acquiring HIV from an HIV positive sexual partner. However, the
uptake among Black women at risk for HIV remains low. Motivational Interviewing (MI) is a
counseling style with a strong evidence base showing success in brief interventions with
diverse samples to increase intention to quit among tobacco users, decrease alcohol
consumption among drinkers, and increase medication adherence among individuals with chronic
illnesses. This study will develop and pilot a brief two-session counseling intervention
(MI-PrEP) that combines psychoeducation on PrEP, MI techniques, and case management (e.g.
helping with access to insurance or medication programs for low-income patients) in a
culturally-informed manner to promote PrEP uptake among Black women at high risk for HIV.

An open pilot trial (n=10) will be conducted to examine the feasibility of all study
procedures and participant acceptability of the resulting intervention. A two-arm pilot
randomized control trial (RCT) (n=40) will compare an intervention group (n=20) to a control
group (n=20) based on motivation to use PrEP and PrEP uptake (primary outcomes) and knowledge
of PrEP and perceived barriers to PrEP uptake/usage (secondary outcomes). Participants' study
visits will last for 6 weeks (baseline [consent and self-report measures], 2 weekly sessions,
and 6 week follow up [self-report measures]).

Inclusion Criteria:

- HIV-negative

- Identify as Black and/or African American

- Age 18 or older

- Female

- English speaking

- Is capable of completing and fully understanding the informed consent process and the
study procedures and

- Meets the Center for Disease Control's indications for PrEP use (17): (a) any sex with
opposite sex partners in the past 6 months and (b) not in a monogamous partnership
with a recently tested HIV-negative partner or (c) any injection of drugs not
prescribed by a clinician in the past 6 months AND (d) at least one of the following:
(i) infrequently uses condoms in sex with one/more partners of unknown HIV status (ii)
in a sexual relationship with an HIV-positive partner or (iii) any sharing of
injection/drug preparation equipment in past 6 months.

Exclusion Criteria:

- Not capable of completing/fully understanding the consent process and the study
procedures.
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Sannisha Dale, PhD, EdM
Phone: 305-243-6714
University of Miami A private research university with more than 15,000 students from around the...
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mi
from
Miami, FL
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