Project WERK (Wellness Encouragement Respect Kinship)

The University of Chicago

Status: Completed

Conditions: HIV Prevention

Treatments: Other: WERK Supportive Contact

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03148171

R34MH111392 (U.S. NIH Grant/Contract)

IRB17-0152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

290 participants in 2 patient groups

Routine PrEP Care

No Intervention group

Description:

Routine PrEP Care at each clinical site.

WERK Supportive Contact

Active Comparator group

Description:

Support contact will provide emotional support and practical support in order to help their friend/family member to stay engaged in PrEP Care.

Treatment:

Other: WERK Supportive Contact