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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03148171
Other study ID # IRB17-0152
Secondary ID R34MH111392
Status Completed
Phase N/A
First received
Last updated
Start date October 9, 2017
Est. completion date June 15, 2020

Study information

Verified date May 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 290
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
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.

Study Design


Related Conditions & MeSH terms


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
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