Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

Risk Factor Clinical Trial

— MI-PrEP  

Official title:

Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592719
• Other study ID #: 20180516
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 11, 2019

Study information

• Verified date: December 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Risk Factor

Intervention

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.
• Enhanced Treatment as Usual (E-TAU)
Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in PrEP uptake	PrEP uptake will be verified by the participants' providers.	Baseline, Up to 6 weeks
Secondary	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
Secondary	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