NCT03493555

Brief Summary

The specific aims of this study are:

  1. 1.To explore perceived facilitators and barriers to initiating and adhering to HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) among at-risk YOUNG MEN WHO HAVE SEX WITH MEN (YMSM).
  2. 2.To assess the acceptability and feasibility of a culturally-tailored peer navigator program to optimize adherence to PrEP among YMSM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

February 8, 2018

Last Update Submit

June 25, 2019

Conditions

Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Peer Navigation for PrEP Acceptability and Feasibility

    For the primary outcome, the investigators will conduct qualitative interviews (using an IRB-approved semi-structured interview guide) at 3 and 6 months post-enrollment. Additionally, a question about acceptability of the intervention will be asked at 3 and 6 months post-enrollment. An affirmative response rate of 70% or higher will indicate acceptability of the intervention.

    up to 6 months post-enrollment

Secondary Outcomes (1)

  • PrEP Adherence Through DBS

    up to 6 months post-enrollment

Study Arms (1)

Intervention Development

EXPERIMENTAL

Peer Health Navigator for PrEP

Behavioral: Peer Health Navigator for PrEP

Interventions

Peer Health Navigator for PrEPBEHAVIORAL

Peer health systems navigator to improve adherence to PrEP

Intervention Development

Eligibility Criteria

Age15 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 15-24
  • Self-identify as men who have sex with men
  • Self-identify as sexually active
  • Able to understand English

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Douglas Krakower, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

February 8, 2018

First Posted

April 10, 2018

Study Start

May 4, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

US(1)