Project WERK (Wellness Encouragement Respect Kinship)

HIV Prevention Clinical Trial

— WERK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03148171
• Other study ID #: IRB17-0152
• Secondary ID: R34MH111392
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: November 2021

Study information

• Verified date: November 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: November 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Other:
• WERK Supportive Contact
Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.

Locations

Country	Name	City	State
United States	Chicago Center for HIV Elimination	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Chicago	Ann & Robert H Lurie Children's Hospital of Chicago, Howard Brown Health Center, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in PrEP Care	Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data	12-month
Secondary	HIV testing and STI testing	HIV serostatus and STI testing as determined by EMR data	12 months
Secondary	Closeness and social support	Closeness and social support measures based on self-report	12 months