Since the advent of antiretroviral therapy, a substantial number of HIV+ adults enjoy stable health and an extended lifespan. However, despite the financial and social benefits of employment, studies show that 45 to 62% are unemployed, not all by choice. Barriers are both structural (e.g. the "golden handcuffs" of needs-based benefits) and personal. In view of the widespread prevalence of fatigue in the HIV population, we conducted clinical trials to treat fatigue with modafinil or armodafinil for 7 years However, we observed that alleviation of fatigue by itself did not enable most patients to find work on their own despite their stated intention to do so. We are now completing a pilot feasibility (R 34) study in which we adapted and refined a stepped program treating fatigue with armodafinil;once fatigue improves, we provide a manualized intervention using the behavioral activation model (Behavioral Activation Program for Energy and Productivity: BA-PEP) to promote achievement of personal goals of employment (paid or volunteer, part-time or more) and/or vocational training. Several patients received supportive counseling to test its acceptability and feasibility as a control arm. Among 44 patients whose energy improved and who received BA-PEP counseling, 63% found work, compared to 28% of patients in earlier fatigue treatment trials of modafinil and armodafinil alone. These findings encourage us to formally assess BA- PEP efficacy. We propose to conduct a randomized clinical trial comparing BA-PEP with supportive counseling, to be conducted in both in our research clinic and a community clinic site, for 100 patients presenting with clinically significant fatigue whose energy has improved with armodafinil, as well as 40 HIV+ patients without significant fatigue at baseline. All participants are HIV+ adults whose health is stable, without current substance use or untreated major depression, and who wish to return to work or vocational training but who have not done so on their own. In addition to testing the efficacy of an intervention easily adapted to other settings with implementation data to support its dissemination to community-based settings, our findings may contribute toward modification of current government policy placing strict limits on earned income to retain needs based benefits.

Public Health Relevance

Employment rates are low in the HIV community, despite the wishes of many people with HIV/AIDS to work. Addressing this problem is considered a critical piece of the coordinated response to HIV/AIDS in President Obama's National HIV/AIDS Strategy for the United States (2010). A common barrier to work is fatigue, widespread among people with HIV/AIDS even when health is stable. Our randomized trial will evaluate a combination of medication (armodafinil) and a behavioral intervention (vs. supportive counseling) for HIV+ adults who want to return to work/vocational training but whose fatigue interferes with their doing so, as well as a sample of otherwise comparable patients without significant fatigue who would like to work but have not succeeded on their own.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
1R01MH102161-01A1
Application #
8731484
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Stoff, David M
Project Start
2014-04-01
Project End
2018-02-28
Budget Start
2014-04-01
Budget End
2015-02-28
Support Year
1
Fiscal Year
2014
Total Cost
$533,281
Indirect Cost
$195,154
Name
New York State Psychiatric Institute
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032