HIV PreventionWERKNCT03148171
Project WERK (Wellness Encouragement Respect Kinship)
A study testing WERK Supportive Contact in people with HIV Prevention, run by University of Chicago at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- WERK Supportive Contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Center for HIV Elimination
Chicago, Illinois, 60615
About this study
Official title: Project WERK (Wellness Encouragement Respect Kinship): Network Support to Engage and Retain Younger Black MSM in PrEP Care
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.
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- WERK Supportive Contact
- Keywords
- Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WERK Supportive ContactOther
Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.
| Study group | Role | What they receive |
|---|---|---|
| Routine PrEP Care | No intervention | Routine PrEP Care at each clinical site. |
| WERK Supportive Contact | Active comparator | Support contact will provide emotional support and practical support in order to help their friend/family member to stay engaged in PrEP Care. Receives: Other: WERK Supportive Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in PrEP Care
Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data
Measured: 12-month
Secondary outcomes (2)
HIV testing and STI testing
HIV serostatus and STI testing as determined by EMR data
Measured: 12 months
Closeness and social support
Closeness and social support measures based on self-report
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start9 Oct 2017
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Howard Brown Health Center, Ann & Robert H Lurie Children's Hospital of Chicago, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Alida Bouris, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148171
- Sponsor's protocol ID
- IRB17-0152
- Other IDs
- R34MH111392
- Acronym
- WERK
- Status last verified
- May 2024
- First submitted
- 8 May 2017
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project WERK (Wellness Encouragement Respect Kinship): Network Support to Engage and Retain Younger Black MSM in PrEP Care
- ClinicalTrials.gov ID
- NCT03148171
- Acronym / sponsor ID
- WERK / IRB17-0152
- Conditions
- HIV Prevention
- Keywords
- Pre-Exposure Prophylaxis (PrEP); Retention in PrEP Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Howard Brown Health Center, Ann & Robert H Lurie Children's Hospital of Chicago, National Institute of Mental Health (NIMH)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine PrEP Care | No intervention | –Routine PrEP Care at each clinical site. |
| WERK Supportive Contact | Active comparator | Other: WERK Supportive ContactSupport contact will provide emotional support and practical support in order to help their friend/family member to stay engaged in PrEP Care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WERK Supportive ContactProvide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care. | Other | WERK Supportive Contact |
Primary outcome
Retention in PrEP Care
Time frame: 12-month
Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data
2 secondary outcomes
HIV testing and STI testing
Time frame: 12 months
Closeness and social support
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alida Bouris, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WERK Supportive Contact in people with HIV Prevention, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in PrEP Care (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.