ATN 151 Work-to-Prevent: Employment as HIV Prevention (W2P)

November 6, 2020 updated by: University of North Carolina, Chapel Hill

Work-to-Prevent: Employment as HIV Prevention for Young Men Who Have Sex With Men (YMSM) and Young Transgender Women (YTW)

The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Work2Prevent will advance the science by adapting, tailoring, and pilot-testing a novel social and structural-level HIV intervention for YMSM and YTW of color ages16-24 aimed at increasing economic stability (i.e., employment) through youth empowerment and asset development, and decreasing HIV risk behaviors (i.e., sex work) associated with social and economic marginalization.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Phase 2 Inclusion Criteria:

  1. Being male or assigned male at birth (YTW)
  2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
  3. Identifies as African American/Black or Hispanic/Latino
  4. 16-24 years old
  5. English-speaking (primary)
  6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
  7. Is able to attend a 4-session employment program

Phase 2 Exclusion Criteria:

  1. Individuals identifying as non-Hispanic White
  2. Individuals not assigned male at birth
  3. Individuals with a known HIV positive-status at time of consent

Phase 3 Inclusion Criteria:

  1. Being male or assigned male at birth (YTW)
  2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
  3. Identifies as African American/Black or Hispanic/Latino
  4. 16-24 years old
  5. English-speaking (primary)
  6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
  7. Is able to attend a 4-session employment program
  8. Did not participate in Phase 2

Phase 3 Exclusion Criteria:

  1. Individuals identifying as non-Hispanic White
  2. Individuals not assigned male at birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Employment Intervention
An employment intervention (iFOUR) that has been adapted from previous piloting work of focus groups, key informant interviews and a community advisory board.
Behavioral: Employment Intervention
Participants will complete 4 workshop sessions in groups of 6-12. The workshop curriculum was based on the pre-existing iFOUR program, and tailored based on feedback from a Community Advisory Board (CAB), Focus Groups, and In Depth Interviews.
Other Names:
  • iFOUR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Information Systems Success Model Score
Time Frame: Post-Intervention (up to 2 weeks after completion of intervention)
The Information Systems Success Model (ISSM) will be used to assess for intervention acceptability and satisfaction. The 21-item scale measures four sub-domains: information quality, handbook quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-5 scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". Responses are averaged within each sub-domain to produce four sub-domain scores. The four sub-domain scores are then averaged to produce an overall ISSM score (1-5; higher scores indicate higher acceptability/satisfaction).
Post-Intervention (up to 2 weeks after completion of intervention)
Number of Participants Completing Two or More Workshop Sessions
Time Frame: Post-Intervention (up to 2 weeks after completion of intervention)
Workshop completion will be used to assess for intervention feasibility, as the workshop sessions are the intervention. Workshop completion will be defined as having attended at least two of the four workshop sessions and will be measured by tracking participant attendance.
Post-Intervention (up to 2 weeks after completion of intervention)
Change From Baseline in Job Seeking Self-Efficacy Scale Score
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Job seeking self-efficacy is defined as one's perceived ability and confidence to perform job search and application activities. The 12-item Job Seeking Self-Efficacy (JSS) scale uses response values on a 1-10 score, with 1 being "Not at All Confident" and 10 being "Very Confident". Responses are averaged to yield a total score, with higher scores indicating higher self-efficacy. Change in JSS will be calculated by subtracting the JSS score at baseline (T1) from the JSS score at the 8-month follow-up (T3) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy).
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Protean Career Attitudes Scale Score
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Protean career attitudes (PCAs) are defined as having self-direction in the pursuit of success in one's work. PCAs have previously been found to be associated with positive career satisfaction and self-perceived success. The validated 7-item scale measures two sub-domains: self-directed attitudes and values-driven attitudes. Every item is scored on a 1-5 scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". Responses are averaged within each sub-domain to produce two sub-domain scores, which are then averaged as well to produce an overall PCA score. Change in PCA score will be calculated by subtracting the score at baseline (T1) from the score at the 8-month follow-up (T3) (-4 to +4; negative change indicates decreased PCAs, while positive change indicates increased PCAs).
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Self-Reported Hours Worked Per Week
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Employment status will be assessed using self-reported average number of hours worked each week. Change in hours worked per week will be calculated by subtracting the baseline (T1) value from the follow-up (T3) value (negative change indicates fewer hours worked per week, while positive change indicates more hours work per week).
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Self-Reported Sexual Risk Behaviors
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Sexual risk behaviors will be measured using 6 yes/no items assessing for engagement in the following behaviors during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3:

  1. condomless anal intercourse (CAI) with male partner of unknown HIV status
  2. anal intercourse with 3 or more males
  3. sex with male partner with a Sexually Transmitted Infection (STI)
  4. CAI with HIV+ male partner
  5. anal intercourse with condom failure
  6. transactional sex work involvement

Responses will be averaged at each assessment. Change in sexual risk behaviors will be calculated by subtracting the average at baseline from the average at the 8-month follow-up (range: -1 to +1; negative change indicates fewer sexual risk behaviors, while positive change indicates more sexual risk behaviors).
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Oral Chlamydia Test Result
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Chlamydia infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. The number of positive test results at baseline and follow-up will be calculated.
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Anal Chlamydia Test Result
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Chlamydia infection will be assessed at baseline and follow up using an anal sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Urine Chlamydia Test Result
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Chlamydia infection will be assessed at baseline and follow up using a urine sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Oral Gonorrhea Test Result
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Gonorrhea infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Anal Gonorrhea Test Result
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Gonorrhea infection will be assessed at baseline and follow-up using an anal sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Change From Baseline in Urine Gonorrhea Test Result
Time Frame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Gonorrhea infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Reactive HIV Result or Reported New HIV+ Status
Time Frame: Follow-Up (8 months for Phase 2, 3 months for Phase 3)
HIV infection will be assessed at follow-up using reactive HIV testing. Test results yield: Reactive or Non-reactive. Participants who reported HIV+ status will not be tested. A reactive HIV result will be defined as those with a "Reactive" result. Reported new HIV+ status is defined as those who report positive HIV status at follow-up and who were tested for HIV, with a non-reactive result, at baseline.
Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brandon Hill, PhD, University of Chicago
  • Study Director: Lisa Strader, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATN 151
  • 5U24HD089880-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.

IPD Sharing Time Frame

Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.

IPD Sharing Access Criteria

Please see DASH guidelines for access criteria.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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