NCT02671591

Brief Summary

The overarching goal of the proposed study is to determine effective outreach methods designed to recruit and improve acceptance of high-risk HIV-negative YBMSM to initiate PrEP and to identify and modify psychosocial and structural predictors of PrEP acceptance. Specifically, the objective of this pilot study is to test the feasibility of a motivational interview-based intervention designed to improve PrEP acceptance among YBMSM.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

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 5, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

January 26, 2016

Last Update Submit

March 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Decide to Take PrEP

    Researchers will evaluate and compare the number of participants who decide to take PrEP in the control condition and MI-PrEP condition.

    6 months

Study Arms (2)

MI-PrEP

EXPERIMENTAL

This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP. The control condition is a one-hour, theory-based, one-to-one session that will help YBMSM think more about using condoms consistently and correctly with every sex partner.

Behavioral: MI-PrEP

control

ACTIVE COMPARATOR

This condition will include the provision of free condoms and lubricants - selected from a buffet of condoms and lubricants designed to offer men a broad selection of high quality products that can optimize the "fit and feel" of condoms during sex.

Behavioral: control condition

Interventions

MI-PrEPBEHAVIORAL

This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP and it will help YBMSM think more about using condoms consistently and correctly with every sex partner.

MI-PrEP

This is a behavioral program designed to provide men with condoms and lubricants that make sex feel good even though it is fully protected by latex condoms

control

Eligibility Criteria

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

You may qualify if:

  • to 29 years of age
  • Identification as Black or African American
  • Eligible for PrEP

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

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
Professor

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

January 5, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share