Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

Not Applicable

Completed

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

• Registration Number: NCT03592719
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2018-10-01
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI-PrEP	Experimental Intervention (MI-PrEP)	Participants in this arm will receive the manualized two-session intervention entitled "Motivational Interviewing to Increase PrEP Uptake"
Enhanced Treatment as Usual (E-TAU)	Enhanced Treatment as Usual (E-TAU)	Participants in this arm will receive two sessions which entail psychoeducation on PrEP.

Primary Outcome Measures

Name	Time	Method
Change in Motivation for PrEP	Baseline, Up to 6 weeks	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.
Change in PrEP uptake	Baseline, Up to 6 weeks	PrEP uptake will be verified by the participants' providers.

Secondary Outcome Measures

Name	Time	Method
Change in Barriers for PrEP	Baseline, Up to 6 weeks	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.
Change in Knowledge of PrEP	Baseline, Up to 6 weeks	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States