Project WERK (Wellness Encouragement Respect Kinship)

NCT03148171 | Completed DMC

• 2 other identifiers: IRB17-0152R34MH111392
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention

Keywords

Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care

Outcome Measures

Primary Outcomes (1)

• Retention in PrEP Care

  Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data

  12-month

Secondary Outcomes (2)

• HIV testing and STI testing

  12 months

• Closeness and social support

  12 months

Study Arms (2)

Routine PrEP Care

NO INTERVENTION

Routine PrEP Care at each clinical site.

WERK Supportive Contact

ACTIVE COMPARATOR

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

Interventions

WERK Supportive Contact OTHER

Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.

WERK Supportive Contact

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• years of age or older;
• English speaking; and
• Owns a cell phone that is not shared with other persons.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Howard Brown Health Center: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Chicago Center for HIV Elimination

Chicago, Illinois, 60615, United States

Location

Study Officials

• Alida Bouris, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: October 9, 2017
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)