Motivational Interviewing to Increase PrEP Uptake (MI-PrEP) (MI-PrEP)

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

Study Overview

• Status: Completed
• Conditions: Risk Factor
• Intervention / Treatment: Behavioral: Experimental Intervention (MI-PrEP); Behavioral: Enhanced Treatment as Usual (E-TAU)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI-PrEP; Participants in this arm will receive the manualized two-session intervention entitled "Motivational Interviewing to Increase PrEP Uptake"	Behavioral: Experimental Intervention (MI-PrEP); 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.; Other Names: Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)
Active Comparator: Enhanced Treatment as Usual (E-TAU); Participants in this arm will receive two sessions which entail psychoeducation on PrEP.	Behavioral: Enhanced Treatment as Usual (E-TAU); Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Up to 6 weeks
Change in PrEP uptake	PrEP uptake will be verified by the participants' providers.	Baseline, Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): November 11, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Women; PrEP; African American; HIV Prevention; Black; At risk for HIV
• Other Study ID Numbers: 20180516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No