Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

NCT03592719 | Completed

• 1 other identifier: 20180516
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Risk Factor

Keywords

HIV Prevention; PrEP; Black; African American; Women; Motivational Interviewing; At risk for HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Knowledge of PrEP

  Baseline, Up to 6 weeks

• Change in Barriers for PrEP

  Baseline, Up to 6 weeks

Study Arms (2)

MI-PrEP

EXPERIMENTAL

Participants in this arm will receive the manualized two-session intervention entitled "Motivational Interviewing to Increase PrEP Uptake"

Behavioral: Experimental Intervention (MI-PrEP)

Enhanced Treatment as Usual (E-TAU)

ACTIVE COMPARATOR

Participants in this arm will receive two sessions which entail psychoeducation on PrEP.

Behavioral: Enhanced Treatment as Usual (E-TAU)

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.

Also known as: Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

MI-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.

Enhanced Treatment as Usual (E-TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not capable of completing/fully understanding the consent process and the study procedures.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Sannisha K Dale, PhD, EdM

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: October 1, 2018
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)