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Completed

NCT Number: NCT03148171

Project WERK (Wellness Encouragement Respect Kinship)

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chicago Center for HIV Elimination

Chicago, Illinois, 60615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WERK Supportive Contact

Other

Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.

Primary outcomes

  1. Retention in PrEP Care

    Time frame: 12-month

    Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Howard Brown Health Center
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: WERK

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 10, 2017
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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