Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
Phase: NA
Conditions: HIV Infection, Fatigue
Sponsor: New York State Psychiatric Institute

IRB # 6911 
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Return to Work Randomized Controlled Trial:  
Counseling After Fatigue Treatment in HIV/AIDS 
 
 
 
Consent form – 11/17/2017 
ClinicalTrials.Gov ID:  NCT 02140775 
 

IRB # 6911 
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11.17.17  
Questions about study: 
Call Dr. J. Rabkin 646 774 8075 
 
CONSENT FORM A 
 
RETURN TO WORK STUDY: MODAFINIL AND COUNSELING 
 
Purpose of Study 
You have been asked to participate in a study of MODAFINIL (Provigil) for HIV+ men and women 
who wish to return to work but find that fatigue prevents them from doing so. The study has two 
parts. First, you will be treated for 4 weeks with modafinil , and, if your energy improves, 
medication will be continued for another 12 weeks. You will also have 8 counseling sessions 
(behavioral activation or supportive counseling) to help you succeed in finding work or training. 
Modafinil is approved by the Food and Drug Administration (FDA) for treatment of daytime 
sleepiness related to serious conditions called narcolepsy and obstructive sleep apnea, and for 
work-shift related sleep disorders. The aim of the study is to see whether counseling plus 
modafinil are helpful in overcoming fatigue and achieving vocational goals for adults with 
HIV/AIDS. The study is supported by the National Institute of Mental Health (NIMH). 
 
Voluntary Participation 
Participation in this research study is voluntary. If you decide not to participate, or if you decide to 
stop participating, you will not lose any benefits to which you are otherwise entitled. A decision not 
to participate will not affect your treatment at New York State Psychiatric Institute.  You will be 
notified of significant new findings that may relate to your willingness to Continue to participate in 
this project. 
 
Alternative Treatments For Fatigue 
Modafinil  is available by prescription outside of the study, although it is not approved for 
treatment of fatigue. . Alternative treatments for fatigue include psychostimulants such as 
methylphenidate, dextroamphetamine, or steroids such as oxandrolone or testosterone (for men). 
Antidepressant treatment may also help with fatigue, which may be related to depression among 
other factors. 
 
Alternative Programs Providing Assistance with Employment 
New York City has 17 career centers that provide job placement services and career guidance. 
Community agencies such as Housing Works and GMHC also offer job promotion services. 
 
Study Procedures 
Before you begin, you will have had a comprehensive laboratory work-up which includes  blood 
chemistries, thyroid tests, immune tests (T cell count), and hormone blood levels. You also will 
have had a physical examination (or you will get a letter from your health care provider saying you 
had one within the past 3 months). You will be asked to give permission for the study doctor to 
call your physician regarding your study participation if clinically indicated.  
 
The clinical trial lasts 4 weeks. During this time, you will see the study psychiatrist weekly and 
take study medication every day. Please return any unused medication at the next study visit. 
During this time, you cannot start taking other medicines to increase energy. After 4 weeks, you 
and the doctor will decide together if your fatigue has been significantly reduced. 
 

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An additional 12 weeks of modafinil treatment is offered if you found it helpful and you participate 
in the counseling program. After that, you will be given a prescription, and thereafter your own 
doctor will be responsible for providing subsequent treatment. 
 
At the first visit, you will meet with the study psychiatrist, review the nature of the study including 
risks and benefits, sign the consent form and start medication. You will be asked to return weekly 
for 4 weeks. After four weeks on modafinil, if you continue, visits will be scheduled every 2 weeks, 
or monthly. Study visits with the doctor will last about a half hour. You will take your medication by 
mouth once a day when you get up in the morning, unless otherwise instructed by your doctor. 
The starting dose is 100 mg/day, which may be increased slowly up to 200 mg/day in the absence 
of clinical effect and dose-limiting side effects. 
 
After 2 weeks: 
After 2 weeks of modafinil, you will meet with a study psychologist to identify specific work-related 
goals as well as other goals you seek to attain in the next 3 or 4 months. At this visit you will be 
assigned to one of the two forms of counseling, and at the Week 3 visit, meet with your counselor 
for the first counseling session. Initiation of counseling will be deferred if you have not responded 
to modafinil by Week 3. If you have not benefited from modafinil by Week 4, counseling will not be 
offered and your study participation will end. 
 
Goal-Directed Counseling: Behavioral Activation Counseling (“BA”) or Supportive Counseling 
(“SC”) 
There will be 8 counseling sessions, scheduled every other week from Week 4 on, to work on 
steps to accomplish your goals. Since we do not know which method is more helpful, we are 
comparing these two forms of counseling. BA is more focused on specific actions to promote each 
person's vocational goals. Supportive counseling focuses on emotional aspects of reaching such 
goals. You will be randomly assigned (as in the flip of a coin) to one or the other. 
 
The counseling sessions will coincide with study visits for medication. The sessions each will be 
about an hour initially, but may be shorter over time depending on your needs regarding work or 
training. The counseling will include homework assignments between visits with the object of 
increasing goal-directed activities. 
 
The sessions will be audiotaped, with no identifying information, to permit a clinical supervisor to 
monitor the counselor’s work to be sure he or she is following the study guidelines.  Audiotaping is 
a study requirement. If you do not agree to audiotaping, you cannot participate in the study. 
 
One and three months after the final counseling session, you will be asked to return to see how 
you are doing, to repeat some of the questionnaires you filled out earlier, and evaluate goals.  In 
the future, you may be contacted about participating in other studies, but you are under no 
obligation to do so. 
 
When both medication visits and counseling occur in the same week, we will schedule them 
consecutively on the same day in our clinic  unless you prefer a different schedule. 
 
Study Measures and Tests 
You will be asked to fill out brief rating scales at 4-week intervals during the study, in order to 
detect any changes that may occur in your energy level, mood, alertness, and goals. 
 
At one or more of the regularly scheduled study visits, you will be asked for a urine sample for a 
toxicology (drug) screen. 

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Pulse and blood pressure will be measured at every study visit for the first 4 weeks, and then 
every 4 weeks thereafter. 
 
 
Women of childbearing age: You should use barrier methods of protection, not hormonal patches 
or oral contraceptives during the study if you are sexually active, to avoid pregnancy.  This is 
important because of the possibility that modafinil may reduce the effectiveness of oral 
contraceptives or patches. 
 
If you are depressed before entering this study, please initial one of the following as appropriate: 
 
“ I have been told that I have depression which currently is not being treated. I have also been told 
that fatigue is one of the symptoms of depression, and that treatment for depression may help 
with my fatigue. However, at this time I do not wish to be treated with an antidepressant, and 
instead wish to participate in the modafinil study.” 
(Initials)_______ 
 
If you are already taking an antidepressant but are still depressed: “I have been told that I have 
symptoms of depression which are currently being treated with a dose of antidepressant that has 
not eliminated my symptoms. I understand that the study doctor can raise this dose for 2-4 weeks 
to see if this helps with my fatigue, before I enter the modafinil study. If I still have significant 
fatigue, then I can enter the modafinil study at that time. However, I do not want this option, but 
instead choose to participate in the modafinil study without this delay.” (Initials)_______ 
 
Risks and Benefits 
Risks. The most common side effect of modafinil is headache. Other side effects, reported by 
patients in our previous studies include increased irritability, and, uncommonly, dizziness, dry 
mouth, or anxiety.  Although not observed in clinical trials, post-marketing cases of serious rash, 
including Stevens-Johnson Syndrome and other hypersensitivity reactions, have been reported 
among patients taking modafinil. In some cases this required hospitalization. While skin conditions 
or other hypersensitivity reactions connected to modafinil or armodafinil are extremely rare, we 
are bringing this information to your attention and request that you immediately stop taking the 
study medication if you develop a rash of unknown origin, or swelling of the face, eyes, 
lips, tongue or larynx and/or difficulty breathing or swallowing. We ask that you call your 
doctor and also notify us if this occurs. 
 
The effects of modafinil on HIV viral load and the immune system are currently unknown. Also, 
drug interactions between modafinil and the antiviral medications or other HIV-related medications 
you may be taking are currently unknown; no data are available. One drug can sometimes 
increase or decrease the amount of the other drug in the blood, but the clinical significance of 
such changes, if any, are also currently unknown. We have treated about 300 HIV+ people with 
modafinil or armodafinil. For these patients, all of whom took either medication for at least 4 
weeks and up to 26 weeks, on average there were no changes in CD4 cell counts or viral load 
over the period of observation. 
 
There may be as yet unknown side effects from the combination of antidepressants and modafinil. 
However, to date we have treated over 100 study participants with modafinil or armodafinil who 
were also taking an antidepressant, and no adverse events were reported by them or observed by 
us. In 7 published studies where modafinil was used in combination with an antidepressant, there 
were similarly no reports of drug interactions.  Nevertheless, it is a possibility. 

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Other risks include the possibility of elevated blood pressure (hypertension), and the possibility 
that your fatigue may worsen during the study. In addition, if you are depressed, your depressive 
symptoms also may worsen during the study.  The risk of blood tests is the possibility of slight 
discomfort at the site of needle entry or a small bruise. 
 
There also have been rare reports of worsened mental state in patients taking modafinil  including 
psychosis (hallucinations, irrational thoughts), aggression, and thoughts of suicide. If you begin to 
feel worse mentally or emotionally, please let us know right away. 
 
During counseling, you may become distressed or anxious about some of the topics that may 
come up. You can discontinue the conversation or the session if you wish to do so. Violation of 
confidentiality is another risk, although as we explain below, we take great precautions to protect 
your personal information. 
 
Benefits. Participants may or may not benefit from study participation. In our clinical trials of 
modafinil and armodafinil, we found that most participants experienced reduced daytime 
sleepiness, and increases in energy, alertness and mood. However, only a minority of patients 
who said they wanted to return to work or school once their energy was restored were successful 
in doing so.  We are conducting this study to see whether modafinil in combination with behavioral 
activation or supportive counseling is helpful to participants who seek these goals.. If counseling 
is not effective in promoting return to work, other programs meant to promote employment will be 
recommended. If modafinil is not helpful, alternative treatments for fatigue such as 
methylphenidate will be offered for up to 2 months as clinically indicated after the initial 4-week 
trial. 
 
Benefits to other people: This study may help in identifying an effective strategy for HIV+ adults 
ho want to return to work. This would provide useful information for other people and their doctors 
in the future. Note on availability and cost of medication:  Insurance programs may not provide 
coverage after the end of your study participation. 
 
Confidentiality 
All information including results of laboratory tests will be treated confidentially. To help us protect 
your privacy, this research is covered by a Certificate of Confidentiality issued by the National 
Institutes of Health. With this certificate, researchers cannot be forced to release any research 
data in which you are identified, even under a court order or subpoena, without your written 
consent.  The researchers will use the Certificate to resist any demands for information that would 
identify you, except as explained below. 
 
The Certificate does not prevent the researchers from reporting suspected or known neglect or 
sexual or physical abuse of a child, or threatened violence to self or others. Such information will 
be reported to appropriate authorities. 
 
You should understand that a Certificate of Confidentiality does not prevent you or a member of 
your family from voluntarily releasing information about yourself or your involvement in this 
research. If an insurer, employer, or other person obtains your written consent to receive research 
information, then the researchers may not use the Certificate to withhold this information.  
 
Records will be available to research staff, and Federal, State and Institutional regulatory 
personnel (who may review records as part of routine audits). 
 

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A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. law. This web site will not include information that can identify you. At most, the web site will 
include a summary of results. You can search this web site at any time.  
 
Your records will be labeled only with a pseudonym if you so request. All records will be kept in 
the investigators' offices and research records will be coded only by number.  
 
Compensation 
You will be paid $20 in cash for assessments at Weeks 4, 8, 12 and 16. For the follow-up visit one 
month after the last counseling session, you will be paid $40, and for the final follow-up you will be 
paid $50. In addition, at each visit you will be offered $6 (or whatever the fare is on public 
transportation at the time) to cover travel costs. Excluding carfare, the total compensation for all 
visits is $170. 
 
In Case of Injury 
Federal regulations require that we inform participants about our institution's policy with regard to 
compensation and payment for treatment of research-related injuries. 
 
If you believe you have sustained an injury as a result of participating in a research study, you 
may contact the Principal Investigator, Dr. Judith Rabkin, at 646 774 8075 so that you can review 
the matter and identify the medical resources that may be available to you.  
 
In case of injury, New York State Psychiatric Institute will provide short term emergency medical 
treatment, which has been determined to be necessary by the New York State Psychiatric 
Institute's doctors, and which is within the capability of New York State Psychiatric Institute's 
capacity to provide. In addition, we will provide assistance in arranging follow-up care in such 
instances.  
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not provide 
compensation or payment for treatment of research related injuries. However, you should be 
aware that you do not give up your legal right to seek such compensation through the courts by 
participating in this research. 
 
Questions 
Your study doctor is available to answer questions about the study at any time. He can be 
reached during the day at (646) 774-8082.  Dr. Judith Rabkin, principal investigator,  can be 
reached during the day at (646) 774 8075.. 
 
If you have any questions about your rights as a research participant, want to provide feedback, 
or have a complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a 
committee that protects the rights of human subjects in research studies.) You may call the IRB 
Administrative Director at (646) 774 7155 during regular office hours. 
 
The study doctor can withdraw you from the study at any time without your consent for reasons 
such as improving your health, your failure to follow study requirements, worsening depression, or 
the occurrence of unusual or serious side effects. If you are depressed at the beginning of the 
study and your depression gets worse during the initial 4-week trial, you may ask to end the study 
and be treated for depression. If both the first and second urine toxicology screen test positive for 
substances you have not reported to the study doctor, you will be withdrawn from the study at that 
time. 
 

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You will be notified of significant new findings about modafinil that may relate to your willingness 
to participate. 
 
 
Documentation of Consent 
"I voluntarily agree to participate in the study described above.  
 
 
NAME__________________________________ 
 
SIGNATURE _____________________________ DATE _________________ 
 
 
 
I have discussed the proposed research with this patient including the risks, benefits, and  
alternatives (including non-participation). The participant has had the opportunity to ask questions, 
and in my opinion is capable of freely consenting to participate in this research. 
 
 
NAME__________________________________ 
 
SIGNATURE ______________________________ DATE _________________ 
                                Study Physician