Promoting Employment in Persons Living With HIV/AIDS
Primary Purpose
Unemployment, HIV
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
activity contracting
contingency management for activity completion
Sponsored by
About this trial
This is an interventional treatment trial for Unemployment focused on measuring contingency management
Eligibility Criteria
Inclusion Criteria:
- HIV positive
- aged 18+ years
- not working in the formal economy
Exclusion Criteria:
- have a condition that may hinder study participation
Sites / Locations
- United Labor AgencyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Job activity contracting
Reinforcement for completing activities
Arm Description
Standard services plus job activity contracting
Standard services plus job activity contracting plus reinforcement for completing job-related activities
Outcomes
Primary Outcome Measures
job attainment
self-report of job attainment: yes/no
proportion of days worked for pay
self-report of number of days worked
Secondary Outcome Measures
Full Information
NCT ID
NCT03959826
First Posted
May 17, 2019
Last Updated
September 11, 2023
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03959826
Brief Title
Promoting Employment in Persons Living With HIV/AIDS
Official Title
Promoting Employment in Persons Living With HIV/AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Many persons living with HIV/AIDS (PLWHA) are unemployed, with estimates indicating rates as high as 60%. This study will examine the efficacy of reinforcing job-acquisition activities for improving employment outcomes in PLWHA who desire to return to the workforce in part- or full-time capacity. In total, this study will randomly assign 144 unemployed PLWHA to one of two interventions. All participants will receive usual unemployment services with an emphasis on specific issues related to HIV/AIDS, plus encouragement for completing activities geared toward employment readiness and acquisition. The enhanced intervention will involve that same treatment plus chances to win prizes for engaging in job-related activities each week. Participants will receive study treatments for 16 weeks and complete follow-up evaluations throughout 18 months. The hypothesis is that participants reinforced for completing job-related activities will transition to employment at higher and faster rates and work more often than those who are not reinforced for job-related activities.
Detailed Description
Many persons living with HIV/AIDS (PLWHA) are unemployed, with estimates indicating rates as high as 60%. This study will examine the efficacy of reinforcing job-acquisition activities for improving employment outcomes in PLWHA who desire to return to the workforce in part- or full-time capacity. In total, this study will randomly assign 144 unemployed PLWHA to one of two interventions. All participants will receive usual unemployment services with an emphasis on specific issues related to HIV/AIDS, plus encouragement for completing activities geared toward employment readiness and acquisition. The enhanced intervention will involve that same treatment plus chances to win prizes for engaging in job-related activities each week. Participants will receive study treatments for 16 weeks and complete follow-up evaluations throughout 18 months. Structured evaluations will assess employment outcomes, quality of life indices, physical and cognitive functioning, psychological symptoms, viral loads, and drug use and risk behaviors. The hypothesis is that participants reinforced for completing job-related activities will transition to employment at higher and faster rates and work more often than those who are not reinforced for job-related activities. The investigators also expect the reinforcement intervention will increase quality of life, reduce depressive symptoms, and improve medical outcomes. Compared to the standard care condition, it may also maintain or improve cognitive functioning and medication adherence and reduce risk behaviors that spread infectious diseases. The investigators will evaluate moderators and mediators of key employment and health outcomes, with an emphasis on exploring the extent to which work conditions (temporary, under the table, physically or emotionally demanding jobs etc.) impact psychosocial and physical health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unemployment, HIV
Keywords
contingency management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Job activity contracting
Arm Type
Active Comparator
Arm Description
Standard services plus job activity contracting
Arm Title
Reinforcement for completing activities
Arm Type
Experimental
Arm Description
Standard services plus job activity contracting plus reinforcement for completing job-related activities
Intervention Type
Behavioral
Intervention Name(s)
activity contracting
Intervention Description
Participants will complete job-related activity contracts each week with the goal of obtaining employment.
Intervention Type
Behavioral
Intervention Name(s)
contingency management for activity completion
Intervention Description
Participants will earn chances to win prizes for completing specific job-related activities.
Primary Outcome Measure Information:
Title
job attainment
Description
self-report of job attainment: yes/no
Time Frame
18 months
Title
proportion of days worked for pay
Description
self-report of number of days worked
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV positive
aged 18+ years
not working in the formal economy
Exclusion Criteria:
have a condition that may hinder study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Fetter
Phone
860-679-4556
Email
fetter@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Rash, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Labor Agency
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Fetter
Phone
860-679-4556
Email
fetter@uchc.edu
12. IPD Sharing Statement
Learn more about this trial
Promoting Employment in Persons Living With HIV/AIDS
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