NCT03226496

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

July 20, 2017

Last Update Submit

July 20, 2017

Conditions

the Intervention Condition is a Brief Motivational Interviewing Session

Outcome Measures

Primary Outcomes (1)

  • Obtains first prescription for PrEP

    first prescription will be determined by self report

    3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group receives a brief motivational interviewing session about PrEP

Behavioral: motivational interviewing

Control Group

NO INTERVENTION

This group receives standard of care clinic based counseling about PrEP

Interventions

motivational interviewingBEHAVIORAL
Intervention Group

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • self-identify as being Black/African American and they must be 18 to 29 years of age. In addition, these men must answer yes to the following screening question: "have you had anal sex with a male in the past 6 months?" Also, to be eligible all men (including those having completed the 12-month follow-up assessment in the parent study) must have an HIV-negative test result in the past 30 days.

You may not qualify if:

  • already taking PrEP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor PI

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 21, 2017

Study Start

January 3, 2016

Primary Completion

March 30, 2017

Study Completion

March 30, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07