Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

N/ACompletedNCT03592719

University of Miami50 enrolled

Overview

The purpose of this study is to test a counseling program for Black women at high risk for HIV

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Risk Factor

Interventions

Experimental Intervention (MI-PrEP)BEHAVIORAL

The experimental intervention will consist of two sessions. The first session will involve psycho-education on PrEP and Motivational Interviewing to explore ambivalence about PrEP uptake. The second session will involve Motivational Interviewing and case management to explore barriers to accessing PrEP.

Enhanced Treatment as Usual (E-TAU)BEHAVIORAL

Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-negative * Identify as Black and/or African American * Age 18 or older * Cis-gender 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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Change in Motivation for PrEP

Motivation to use PrEP will be measured with the Contemplation Ladder and the Readiness Ruler, which assess intention to use PrEP and the perceived importance of using PrEP. The Contemplation Ladder and the Readiness Ruler each have a total score range from 0 to 10. Higher scores on the Contemplation Ladder indicate higher levels of contemplation or consideration about PrEP use. Higher scores on the Readiness Ruler indicate higher perceived importance of starting PrEP.

Time frame: Baseline, Up to 6 weeks

Change in PrEP uptake

PrEP uptake will be verified by the participants' providers.

Time frame: Baseline, Up to 6 weeks

Secondary Outcomes

Change in Knowledge of PrEP

Knowledge of PrEP will be measured using a PrEP fact sheet, with basic information about PrEP. The PrEP Fact Sheet has a total score range of 0 to 12, with higher scores indicating higher levels of PrEP knowledge.

Time frame: Baseline, Up to 6 weeks

Change in Barriers for PrEP

Perceived barriers to PrEP uptake/usage will be measured by an adapted version of the Barriers to Care Scale, in which participants are asked about factors that make it difficult to receive PrEP related services. The Barriers to Care scale has a total score range of 7 to 28, with higher scores indicating increased difficulty regarding barriers to PrEP uptake.

Time frame: Baseline, Up to 6 weeks

Data from ClinicalTrials.gov

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