Clinical trial NCT03148171: Project WERK (Wellness Encouragement Respect Kinship)
Official title: Project WERK (Wellness Encouragement Respect Kinship): Network Support to Engage and Retain Younger Black MSM in PrEP Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Howard Brown Health Center
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: National Institute of Mental Health (NIMH)
First posted: 2017-05-10
Enrollment: 290
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Retention in PrEP Care
timeFrame: 12-month
Secondary outcomes:
measure: HIV testing and STI testing
timeFrame: 12 months
measure: Closeness and social support
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Center for HIV Elimination
state: Illinois
Study officials:
affiliation: University of Chicago
name: Alida Bouris, PhD
role: PRINCIPAL_INVESTIGATOR
References: