Project WERK (Wellness Encouragement Respect Kinship) (WERK)

Project WERK (Wellness Encouragement Respect Kinship): Network Support to Engage and Retain Younger Black MSM in PrEP Care

The Project WERK intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM). The intervention has been developed with input from clients and their support network members, case managers, social workers, primary care providers. The goal of the intervention is to improve retention in PrEP care for young Black MSM.

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Other: WERK Supportive Contact

Detailed Description

Project WERK will recruit, consent and randomize 160 men, with 80 men randomized to each arm of the study. Men randomized to the control condition will receive standard PrEP care at each clinical site. Men randomized to the experimental condition will receive standard PrEP care and also will be asked to recruit a supportive contact from their social network. The support contact will then be engaged in a brief intervention designed to support their friend/family member around PrEP Care. Men and support contacts in the WERK intervention also will receive booster sessions via telephone and text. All participants will complete surveys at baseline and at three and twelve months post intervention.

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60615
      • Chicago Center for HIV Elimination

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

Index subjects:

• Self-identify as African American/Black;
• Assigned male sex at birth;
• Any same gender anal or oral sex in the past 2 years;
• English speaking;
• Have at least one support contact in their network;
• Own a cell phone not shared with other persons;
• Between the ages of 18-35 years old; and
• Have had fewer than 3 PrEP clinical visits in the past 12 months.

Support Contact:

• Index participant has agreed to including the support contact
• Willing to attend face to face and telephone mini-booster sessions;
• 18 years of age or older;
• English speaking; and
• Owns a cell phone that is not shared with other persons.

Exclusion Criteria

Index Subject:

• Unable to provide informed consent;
• Plan to move out of the area within the next 12 months;
• Are not willing to attend intervention sessions; or
• Not willing to return for assessments.

For index participants without a support contact, we will refer them to an appropriate support group for PrEP.

Support Contact:

• Romantic partner of index participant;
• Unable to provide informed consent;
• Plan to move out of the area within the next 12 months;
• Are not willing to attend intervention sessions; or
• Not willing to return for assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine PrEP Care; Routine PrEP Care at each clinical site.
Active Comparator: WERK Supportive Contact; Support contact will provide emotional support and practical support in order to help their friend/family member to stay engaged in PrEP Care.	Other: WERK Supportive Contact; Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in PrEP Care	Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV testing and STI testing	HIV serostatus and STI testing as determined by EMR data	12 months
Closeness and social support	Closeness and social support measures based on self-report	12 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Mental Health (NIMH); Ann & Robert H Lurie Children's Hospital of Chicago; Howard Brown Health Center
• Investigators: Principal Investigator: Alida Bouris, PhD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care
• Other Study ID Numbers: IRB17-0152; R34MH111392 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes