Clinical Trials Directory

Trials / Completed

CompletedNCT03226496

Motivational Interviewing for PrEP Uptake

A Pilot Study Assessing a Single Motivational Interviewing Session to Improve Uptake of PrEP Among Young Black Men Who Have Sex With Men

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Richard Crosby · Academic / Other
Sex
Male
Age
18 Years – 29 Years
Healthy volunteers
Accepted

Summary

The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes.

Detailed description

The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes. In the parent study we had the foresight to include a cross-sectional survey of men's attitudes toward PrEP use as part of their first follow-up assessment. Using that data, we will identify the predictors of readiness to accept PrEP and we will use these findings to inform the design of a brief Motivational Interviewing session (MI-PrEP) that will promote uptake of PrEP. We will enroll 65 YBMSM who have completed the 12-month follow-up assessment from the parent study and 35 YBMSM (same inclusion criteria) from either of two clinics used in the parent study (the Crossroads Clinic or the Open Arms Clinic) who did not participate in the parent study. Using small block randomization, these 100 men will be assigned to the MI-PrEP condition or to the standard of care only control condition. At the conclusion of the enrollment session men will be asked if they would like to schedule an appointment to begin taking PrEP. This same offer will be made again approximately 14 days after the enrollment session. The dependent variables will thus include measures of whether men made/kept an appointment to begin PrEP and, if so, how much time elapsed before doing so and whether they filled the prescription for PrEP. For those who do fill the prescription we will test their blood for levels of tenofovir and emtricitabine after 3 months of time has elapsed. Group differences (Intervention vs. Control) in uptake, time to uptake, and actual use/adherence of PrEP are hypothesized to favor those receiving the MI-PrEP intervention program. If this is the case then an initial body of evidence will exist supporting the potential efficacy of a Motivational Interviewing-based, single session intervention that can be delivered to YBMSM in clinical settings.

Conditions

Interventions

TypeNameDescription
BEHAVIORALmotivational interviewing

Timeline

Start date
2016-01-03
Primary completion
2017-03-30
Completion
2017-03-30
First posted
2017-07-21
Last updated
2017-07-21

Source: ClinicalTrials.gov record NCT03226496. Inclusion in this directory is not an endorsement.