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Project WERK (Wellness Encouragement Respect Kinship) (WERK)

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ClinicalTrials.gov Identifier: NCT03148171
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : October 18, 2018
Sponsor:
Collaborators:
Howard Brown Health Center
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
HIV Prevention Other: WERK Supportive Contact Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project WERK (Wellness Encouragement Respect Kinship): Network Support to Engage and Retain Younger Black MSM in PrEP Care
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Routine PrEP Care
Routine PrEP Care at each clinical site.
Active Comparator: WERK Supportive Contact
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
Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.




Primary Outcome Measures :
  1. Retention in PrEP Care [ Time Frame: 12-month ]
    Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data


Secondary Outcome Measures :
  1. HIV testing and STI testing [ Time Frame: 12 months ]
    HIV serostatus and STI testing as determined by EMR data

  2. Closeness and social support [ Time Frame: 12 months ]
    Closeness and social support measures based on self-report



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148171


Contacts
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Contact: Alida Bouris, PhD 773-834-4304 abouris@uchicago.edu
Contact: Olivia Blocker, MSW 773-834-0331 oblocker@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
Chicago Center for HIV Elimination Recruiting
Chicago, Illinois, United States, 60615
Contact: Alida Bouris, PhD    773-834-4304    abouris@uchicago.edu   
Contact: Olivia Blocker, MSW    7738340331    oblocker@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Howard Brown Health Center
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Alida Bouris, PhD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03148171     History of Changes
Other Study ID Numbers: IRB17-0152
R34MH111392 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Chicago:
Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care