Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

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

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

Conditions
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Risk Factor

Intervention / Treatment
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* Behavioral: Experimental Intervention (MI-PrEP)
* Behavioral: Enhanced Treatment as Usual (E-TAU)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, PrEP, Black, African American, Women, Motivational Interviewing, At risk for HIV