Human Immunodeficiency VirusNCT02392884
HIV Medication Adherence in Underserved Populations
A study testing Cognitive Rehabilitation in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome
- What is being tested?
- Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, age 18 and older.
- Able and willing to provide written informed consent.
- Diagnosed as HIV-seropositive by licensed enzyme-linked immunoabsorbent assay (ELISA) or HIV-seropositive by Western blot (WB).
- Diagnosed as HIV seropositive within the last two years.
- Willing and able to provide adequate information for locator purposes.
Who cannot join
- Under the age of 18.
- Have ever sustained a traumatic brain injury.
- Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process, or otherwise contraindicate participation in the study.
- Have a learning disability where they cannot read or write pass the third grade level.
- Have an active substance dependence diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Kimberly L Smith, PsyD, 310-248-6782, kimberly.smith2@cshs.org
Enrique Lopez, PsyD, 310-423-4555, Enrique.Lopez2@cshs.org
About this study
Official title: A Cognitive Rehabilitation Program to Promote Treatment Adherence for Individuals Who Are HIV Positive With Mild Neurocognitive Difficulties
The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.
Read the detailed description
Although antiretroviral therapy (ART) has proven extremely effective in the treatment of HIV and AIDS, the ability to effectively combat the disease is inconsequential when individuals do not take their medication as prescribed and do not attend their scheduled medical appointments. Non-adherence to effective ART and medical visits is widespread in the United States, especially among ethnic minorities. A recent study indicated that patients who miss a medical appointment in the first year of an HIV diagnosis show over twice the mortality rate of patients who attended all visits. This study is developed to investigate the relationship between HIV Associated Neurocognitive Disorder (HAND) and adherence to HIV treatment among traditionally marginalized populations. Participants will be administered a brief neuropsychiatric screener. Participants will be randomly enrolled one of two cognitive rehabilitation programs so they may learn compensatory cognitive strategies to remain treatment adherent, or they will be receive psychoeducation concerning the importance of taking their medications and regularly attending medical appointments. Participants will be tracked and followed-up with regarding their treatment adherence in regular intervals over the course of 6 months.
- Being tested
- Cognitive Rehabilitation
- Keywords
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Cognitive Rehabilitation, Minority Health, Vulnerable Populations, Underserved, Patients, Medication Adherence, Medication Compliance, Medication Non-compliance, Medication Persistence, Medication Non-Adherence
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
Provide cognitive techniques and teach compensatory strategies that subjects can use to help them remember to attend appointments, take their medications regularly, increase attention (conversational and task) and concentration, increase cognitive flexibility, develop better problem-solving skills.
| Study group | Role | What they receive |
|---|---|---|
| EON-MEM | Active comparator | Intervention: Cognitive Rehabilitation and compensatory strategies will be taught to subjects to help them remember routes, viral load count, CD4 count, faces of providers and managing their schedules. Over the course of 5 visits, subjects will receive this intervention. Receives: Behavioral: Cognitive Rehabilitation |
| Compensatory Cognitive Training | Active comparator | Cognitive Rehabilitation and physical reminders, such as calendars, smart phones, self-notes and other methods to help subjects remember to attend all medical appointments and take their HIV medication. Subject will be exposed to 5 sessions of this particular training. Receives: Behavioral: Cognitive Rehabilitation |
| Psychoeducation | No intervention | The psychoeducation group, which aims to teach subjects the importance of taking medications and attending all doctor's appointment for HIV treatment. If you subjects are assigned to this group, they will be followed and receive the care generally followed for individuals with this condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medication Adherence in 6 Months (adherence score)
Patients may experience an increase in treatment adherence. High scores indicate increased levels of adherence, while low scores reflect difficulties with treatment adherence.
Measured: 1,2, 3, 6 months
Secondary outcomes (1)
Change in Self Efficacy in 6 Months (subjective self-control score)
Subjects may experience an increase in subjective self-control over their HIV treatment. High scores indicate high levels of perceived control over their treatment, while lower scores reflect a reduced amount of perceived self-efficacy over their treatment.
Measured: 1, 2, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Smith, Cedars-Sinai Medical Center
- Investigators
- Kimberly Smith, PsyD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392884
- Sponsor's protocol ID
- Pro00033072
- Status last verified
- Mar 2015
- First submitted
- 10 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barclay TR, Hinkin CH, Castellon SA, Mason KI, Reinhard MJ, Marion SD, Levine AJ, Durvasula RS. Age-associated predictors of medication adherence in HIV-positive adults: health beliefs, self-efficacy, and neurocognitive status. Health Psychol. 2007 Jan;26(1):40-9. doi: 10.1037/0278-6133.26.1.40.
PubMed 17209696Berger BE, Ferrans CE, Lashley FR. Measuring stigma in people with HIV: psychometric assessment of the HIV stigma scale. Res Nurs Health. 2001 Dec;24(6):518-29. doi: 10.1002/nur.10011.
PubMed 11746080Chang L, Ernst T, Leonido-Yee M, Speck O. Perfusion MRI detects rCBF abnormalities in early stages of HIV-cognitive motor complex. Neurology. 2000 Jan 25;54(2):389-96. doi: 10.1212/wnl.54.2.389.
PubMed 10668700Chang L, Ernst T, Witt MD, Ames N, Gaiefsky M, Miller E. Relationships among brain metabolites, cognitive function, and viral loads in antiretroviral-naive HIV patients. Neuroimage. 2002 Nov;17(3):1638-48. doi: 10.1006/nimg.2002.1254.
PubMed 12414302Chesney MA. The elusive gold standard. Future perspectives for HIV adherence assessment and intervention. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S149-55. doi: 10.1097/01.qai.0000243112.91293.26.
PubMed 17133199Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. doi: 10.1080/09540120050042891.
PubMed 10928201Contardo C, Black AC, Beauvais J, Dieckhaus K, Rosen MI. Relationship of prospective memory to neuropsychological function and antiretroviral adherence. Arch Clin Neuropsychol. 2009 Sep;24(6):547-54. doi: 10.1093/arclin/acp046. Epub 2009 Jul 31.
PubMed 19648150Crum NF, Riffenburgh RH, Wegner S, Agan BK, Tasker SA, Spooner KM, Armstrong AW, Fraser S, Wallace MR; Triservice AIDS Clinical Consortium. Comparisons of causes of death and mortality rates among HIV-infected persons: analysis of the pre-, early, and late HAART (highly active antiretroviral therapy) eras. J Acquir Immune Defic Syndr. 2006 Feb 1;41(2):194-200. doi: 10.1097/01.qai.0000179459.31562.16.
PubMed 16394852Fogarty L, Roter D, Larson S, Burke J, Gillespie J, Levy R. Patient adherence to HIV medication regimens: a review of published and abstract reports. Patient Educ Couns. 2002 Feb;46(2):93-108. doi: 10.1016/s0738-3991(01)00219-1.
PubMed 11867239Gonzalez JS, Hendriksen ES, Collins EM, Duran RE, Safren SA. Latinos and HIV/AIDS: examining factors related to disparity and identifying opportunities for psychosocial intervention research. AIDS Behav. 2009 Jun;13(3):582-602. doi: 10.1007/s10461-008-9402-4. Epub 2008 May 23.
PubMed 18498050Goujard C, Bernard N, Sohier N, Peyramond D, Lancon F, Chwalow J, Arnould B, Delfraissy JF. Impact of a patient education program on adherence to HIV medication: a randomized clinical trial. J Acquir Immune Defic Syndr. 2003 Oct 1;34(2):191-4. doi: 10.1097/00126334-200310010-00009.
PubMed 14526208Hinkin CH, Hardy DJ, Mason KI, Castellon SA, Lam MN, Stefaniak M, Zolnikov B. Verbal and spatial working memory performance among HIV-infected adults. J Int Neuropsychol Soc. 2002 May;8(4):532-8. doi: 10.1017/s1355617702814278.
PubMed 12030306Hinkin CH, Hardy DJ, Mason KI, Castellon SA, Durvasula RS, Lam MN, Stefaniak M. Medication adherence in HIV-infected adults: effect of patient age, cognitive status, and substance abuse. AIDS. 2004 Jan 1;18 Suppl 1(Suppl 1):S19-25. doi: 10.1097/00002030-200418001-00004.
PubMed 15075494Kumar V, Encinosa W. Effects of antidepressant treatment on antiretroviral regimen adherence among depressed HIV-infected patients. Psychiatr Q. 2009 Sep;80(3):131-41. doi: 10.1007/s11126-009-9100-z. Epub 2009 Apr 22.
PubMed 19387832Lovejoy TI, Suhr JA. The relationship between neuropsychological functioning and HAART adherence in HIV-positive adults: a systematic review. J Behav Med. 2009 Oct;32(5):389-405. doi: 10.1007/s10865-009-9212-9. Epub 2009 Mar 17.
PubMed 19291386
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Rehabilitation Program to Promote Treatment Adherence for Individuals Who Are HIV Positive With Mild Neurocognitive Difficulties
- ClinicalTrials.gov ID
- NCT02392884
- Acronym / sponsor ID
- Pro00033072
- Keywords
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Cognitive Rehabilitation, Minority Health, Vulnerable Populations, Underserved, Patients, Medication Adherence, Medication Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- 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 purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.
Detailed description
Although antiretroviral therapy (ART) has proven extremely effective in the treatment of HIV and AIDS, the ability to effectively combat the disease is inconsequential when individuals do not take their medication as prescribed and do not attend their scheduled medical appointments. Non-adherence to effective ART and medical visits is widespread in the United States, especially among ethnic minorities. A recent study indicated that patients who miss a medical appointment in the first year of an HIV diagnosis show over twice the mortality rate of patients who attended all visits. This study is developed to investigate the relationship between HIV Associated Neurocognitive Disorder (HAND) and adherence to HIV treatment among traditionally marginalized populations. Participants will be administered a brief neuropsychiatric screener. Participants will be randomly enrolled one of two cognitive rehabilitation programs so they may learn compensatory cognitive strategies to remain treatment adherent, or they will be receive psychoeducation concerning the importance of taking their medications and regularly attending medical appointments. Participants will be tracked and followed-up with regarding their treatment adherence in regular intervals over the course of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EON-MEM | Active comparator | Behavioral: Cognitive RehabilitationIntervention: Cognitive Rehabilitation and compensatory strategies will be taught to subjects to help them remember routes, viral load count, CD4 count, faces of providers and managing their schedules. Over the course of 5 visits, subjects will receive this intervention. |
| Compensatory Cognitive Training | Active comparator | Behavioral: Cognitive RehabilitationCognitive Rehabilitation and physical reminders, such as calendars, smart phones, self-notes and other methods to help subjects remember to attend all medical appointments and take their HIV medication. Subject will be exposed to 5 sessions of this particular training. |
| Psychoeducation | No intervention | –The psychoeducation group, which aims to teach subjects the importance of taking medications and attending all doctor's appointment for HIV treatment. If you subjects are assigned to this group, they will be followed and receive the care generally followed for individuals with this condition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult, age 18 and older.
- Able and willing to provide written informed consent.
- Diagnosed as HIV-seropositive by licensed enzyme-linked immunoabsorbent assay (ELISA) or HIV-seropositive by Western blot (WB).
- Diagnosed as HIV seropositive within the last two years.
- Willing and able to provide adequate information for locator purposes.
Key exclusion criteria (5 listed)
- Under the age of 18.
- Have ever sustained a traumatic brain injury.
- Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process, or otherwise contraindicate participation in the study.
- Have a learning disability where they cannot read or write pass the third grade level.
- Have an active substance dependence diagnosis.
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 |
|---|---|---|
| Cognitive RehabilitationProvide cognitive techniques and teach compensatory strategies that subjects can use to help them remember to attend appointments, take their medications regularly, increase attention (conversational and task) and concentration, increase cognitive flexibility, develop better problem-solving skills. | Behavioural | Compensatory Cognitive Training, EON-MEM |
Primary outcome
Change in Medication Adherence in 6 Months (adherence score)
Time frame: 1,2, 3, 6 months
Patients may experience an increase in treatment adherence. High scores indicate increased levels of adherence, while low scores reflect difficulties with treatment adherence.
1 secondary outcome
Change in Self Efficacy in 6 Months (subjective self-control score)
Time frame: 1, 2, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 17209696Barclay TR, Hinkin CH, Castellon SA, Mason KI, Reinhard MJ, Marion SD, Levine AJ, Durvasula RS. Age-associated predictors of medication adherence in HIV-positive adults: health beliefs, self-efficacy, and neurocognitive status. Health Psychol. 2007 Jan;26(1):40-9. doi: 10.1037/0278-6133.26.1.40.
- Background: PubMed 11746080Berger BE, Ferrans CE, Lashley FR. Measuring stigma in people with HIV: psychometric assessment of the HIV stigma scale. Res Nurs Health. 2001 Dec;24(6):518-29. doi: 10.1002/nur.10011.
- Background: PubMed 10668700Chang L, Ernst T, Leonido-Yee M, Speck O. Perfusion MRI detects rCBF abnormalities in early stages of HIV-cognitive motor complex. Neurology. 2000 Jan 25;54(2):389-96. doi: 10.1212/wnl.54.2.389.
- Background: PubMed 12414302Chang L, Ernst T, Witt MD, Ames N, Gaiefsky M, Miller E. Relationships among brain metabolites, cognitive function, and viral loads in antiretroviral-naive HIV patients. Neuroimage. 2002 Nov;17(3):1638-48. doi: 10.1006/nimg.2002.1254.
- Background: PubMed 17133199Chesney MA. The elusive gold standard. Future perspectives for HIV adherence assessment and intervention. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S149-55. doi: 10.1097/01.qai.0000243112.91293.26.
- Background: PubMed 10928201Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. doi: 10.1080/09540120050042891.
- Background: PubMed 19648150Contardo C, Black AC, Beauvais J, Dieckhaus K, Rosen MI. Relationship of prospective memory to neuropsychological function and antiretroviral adherence. Arch Clin Neuropsychol. 2009 Sep;24(6):547-54. doi: 10.1093/arclin/acp046. Epub 2009 Jul 31.
- Background: PubMed 16394852Crum NF, Riffenburgh RH, Wegner S, Agan BK, Tasker SA, Spooner KM, Armstrong AW, Fraser S, Wallace MR; Triservice AIDS Clinical Consortium. Comparisons of causes of death and mortality rates among HIV-infected persons: analysis of the pre-, early, and late HAART (highly active antiretroviral therapy) eras. J Acquir Immune Defic Syndr. 2006 Feb 1;41(2):194-200. doi: 10.1097/01.qai.0000179459.31562.16.
- Background: PubMed 11867239Fogarty L, Roter D, Larson S, Burke J, Gillespie J, Levy R. Patient adherence to HIV medication regimens: a review of published and abstract reports. Patient Educ Couns. 2002 Feb;46(2):93-108. doi: 10.1016/s0738-3991(01)00219-1.
- Background: PubMed 18498050Gonzalez JS, Hendriksen ES, Collins EM, Duran RE, Safren SA. Latinos and HIV/AIDS: examining factors related to disparity and identifying opportunities for psychosocial intervention research. AIDS Behav. 2009 Jun;13(3):582-602. doi: 10.1007/s10461-008-9402-4. Epub 2008 May 23.
- Background: PubMed 14526208Goujard C, Bernard N, Sohier N, Peyramond D, Lancon F, Chwalow J, Arnould B, Delfraissy JF. Impact of a patient education program on adherence to HIV medication: a randomized clinical trial. J Acquir Immune Defic Syndr. 2003 Oct 1;34(2):191-4. doi: 10.1097/00126334-200310010-00009.
- Background: PubMed 12030306Hinkin CH, Hardy DJ, Mason KI, Castellon SA, Lam MN, Stefaniak M, Zolnikov B. Verbal and spatial working memory performance among HIV-infected adults. J Int Neuropsychol Soc. 2002 May;8(4):532-8. doi: 10.1017/s1355617702814278.
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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.
Kimberly Smith, PsyD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Cedars-Sinai Medical Center 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly L Smith, PsyD (310-248-7682, kimberly.smith2@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence in 6 Months (adherence score) (time frame: 1,2, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392884, which also lists 44 linked publications.
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 19 Mar 2015.