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Completed

NCT Number: NCT03592719

Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

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

Completed

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Key information

Conditions

Risk Factor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Motivational Interviewing to Increase PrEP Uptake (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.

Primary outcomes

  1. Change in Motivation for PrEP

    Time frame: 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.

  2. Change in PrEP uptake

    Time frame: Baseline, Up to 6 weeks

    PrEP uptake will be verified by the participants' providers.

Secondary outcomes

  1. Change in Knowledge of PrEP

    Time frame: 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.

  2. Change in Barriers for PrEP

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: MI-PrEP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2018
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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