Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

NCT ID: NCT03592719

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-11-11

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

Detailed Description

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Conditions

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Risk Factor

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MI-PrEP

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

Group Type EXPERIMENTAL

Experimental Intervention (MI-PrEP)

Intervention Type 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.

Enhanced Treatment as Usual (E-TAU)

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

Group Type ACTIVE_COMPARATOR

Enhanced Treatment as Usual (E-TAU)

Intervention Type BEHAVIORAL

Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.

Interventions

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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.

Intervention Type BEHAVIORAL

Enhanced Treatment as Usual (E-TAU)

Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.

Intervention Type BEHAVIORAL

Other Intervention Names

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Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Sannisha K Dale

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sannisha K Dale, PhD, EdM

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20180516

Identifier Type: -

Identifier Source: org_study_id