Project WERK (Wellness Encouragement Respect Kinship)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Prevention

Intervention / Treatment
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* Other: WERK Supportive Contact


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine PrEP Care<br>Routine PrEP Care at each clinical site. | |
| Active Comparator: WERK Supportive Contact<br>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<br>* Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care