Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EON-MEM
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.
Cognitive Rehabilitation
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.
Compensatory Cognitive Training
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.
Cognitive Rehabilitation
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.
Psychoeducation
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.
No interventions assigned to this group
Interventions
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Cognitive Rehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Kimberly Smith
Posstdoctoral Scientist
Principal Investigators
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Kimberly Smith, PsyD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Berger 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.
Chang 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.
Chang 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.
Chesney 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.
Chesney 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.
Contardo 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.
Crum 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.
Fogarty 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.
Gonzalez 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.
Goujard 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.
Hinkin 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.
Hinkin 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.
Kumar 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.
Lovejoy 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.
Malta M, Magnanini MM, Strathdee SA, Bastos FI. Adherence to antiretroviral therapy among HIV-infected drug users: a meta-analysis. AIDS Behav. 2010 Aug;14(4):731-47. doi: 10.1007/s10461-008-9489-7. Epub 2008 Nov 20.
Mugavero MJ, Lin HY, Willig JH, Westfall AO, Ulett KB, Routman JS, Abroms S, Raper JL, Saag MS, Allison JJ. Missed visits and mortality among patients establishing initial outpatient HIV treatment. Clin Infect Dis. 2009 Jan 15;48(2):248-56. doi: 10.1086/595705.
Mugavero M, Ostermann J, Whetten K, Leserman J, Swartz M, Stangl D, Thielman N. Barriers to antiretroviral adherence: the importance of depression, abuse, and other traumatic events. AIDS Patient Care STDS. 2006 Jun;20(6):418-28. doi: 10.1089/apc.2006.20.418.
Nicastri E, Leone S, Angeletti C, Palmisano L, Sarmati L, Chiesi A, Geraci A, Vella S, Narciso P, Corpolongo A, Andreoni M. Sex issues in HIV-1-infected persons during highly active antiretroviral therapy: a systematic review. J Antimicrob Chemother. 2007 Oct;60(4):724-32. doi: 10.1093/jac/dkm302. Epub 2007 Aug 21.
Nieuwkerk PT, Oort FJ. Self-reported adherence to antiretroviral therapy for HIV-1 infection and virologic treatment response: a meta-analysis. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):445-8. doi: 10.1097/01.qai.0000147522.34369.12.
Oh DL, Sarafian F, Silvestre A, Brown T, Jacobson L, Badri S, Detels R. Evaluation of adherence and factors affecting adherence to combination antiretroviral therapy among White, Hispanic, and Black men in the MACS Cohort. J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):290-3. doi: 10.1097/QAI.0b013e3181ab6d48.
Paasche-Orlow MK, Cheng DM, Palepu A, Meli S, Faber V, Samet JH. Health literacy, antiretroviral adherence, and HIV-RNA suppression: a longitudinal perspective. J Gen Intern Med. 2006 Aug;21(8):835-40. doi: 10.1111/j.1525-1497.2006.00527.x.
Power R, Koopman C, Volk J, Israelski DM, Stone L, Chesney MA, Spiegel D. Social support, substance use, and denial in relationship to antiretroviral treatment adherence among HIV-infected persons. AIDS Patient Care STDS. 2003 May;17(5):245-52. doi: 10.1089/108729103321655890.
Reynolds NR, Testa MA, Marc LG, Chesney MA, Neidig JL, Smith SR, Vella S, Robbins GK; Protocol Teams of ACTG 384, ACTG 731 and A5031s. Factors influencing medication adherence beliefs and self-efficacy in persons naive to antiretroviral therapy: a multicenter, cross-sectional study. AIDS Behav. 2004 Jun;8(2):141-50. doi: 10.1023/B:AIBE.0000030245.52406.bb.
Reynolds NR, Sun J, Nagaraja HN, Gifford AL, Wu AW, Chesney MA. Optimizing measurement of self-reported adherence with the ACTG Adherence Questionnaire: a cross-protocol analysis. J Acquir Immune Defic Syndr. 2007 Dec 1;46(4):402-9. doi: 10.1097/qai.0b013e318158a44f.
Safren SA, Otto MW, Worth JL, Salomon E, Johnson W, Mayer K, Boswell S. Two strategies to increase adherence to HIV antiretroviral medication: life-steps and medication monitoring. Behav Res Ther. 2001 Oct;39(10):1151-62. doi: 10.1016/s0005-7967(00)00091-7.
Santos CP, Felipe YX, Braga PE, Ramos D, Lima RO, Segurado AC. Self-perception of body changes in persons living with HIV/AIDS: prevalence and associated factors. AIDS. 2005 Oct;19 Suppl 4:S14-21. doi: 10.1097/01.aids.0000191485.92285.c7.
Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
Simoni JM, Kurth AE, Pearson CR, Pantalone DW, Merrill JO, Frick PA. Self-report measures of antiretroviral therapy adherence: A review with recommendations for HIV research and clinical management. AIDS Behav. 2006 May;10(3):227-45. doi: 10.1007/s10461-006-9078-6.
Turner BJ. Adherence to antiretroviral therapy by human immunodeficiency virus-infected patients. J Infect Dis. 2002 May 15;185 Suppl 2:S143-51. doi: 10.1086/340197.
van Servellen G, Carpio F, Lopez M, Garcia-Teague L, Herrera G, Monterrosa F, Gomez R, Lombardi E. Program to enhance health literacy and treatment adherence in low-income HIV-infected Latino men and women. AIDS Patient Care STDS. 2003 Nov;17(11):581-94. doi: 10.1089/108729103322555971.
Wagner GJ. Predictors of antiretroviral adherence as measured by self-report, electronic monitoring, and medication diaries. AIDS Patient Care STDS. 2002 Dec;16(12):599-608. doi: 10.1089/108729102761882134.
Woods SP, Moore DJ, Weber E, Grant I. Cognitive neuropsychology of HIV-associated neurocognitive disorders. Neuropsychol Rev. 2009 Jun;19(2):152-68. doi: 10.1007/s11065-009-9102-5. Epub 2009 May 22.
Reekie J, Mocroft A, Sambatakou H, Machala L, Chiesi A, van Lunzen J, Clumeck N, Kirk O, Gazzard B, Lundgren JD; EuroSIDA Study Group. Does less frequent routine monitoring of patients on a stable, fully suppressed cART regimen lead to an increased risk of treatment failure? AIDS. 2008 Nov 12;22(17):2381-90. doi: 10.1097/QAD.0b013e328317a6eb.
Lazo M, Gange SJ, Wilson TE, Anastos K, Ostrow DG, Witt MD, Jacobson LP. Patterns and predictors of changes in adherence to highly active antiretroviral therapy: longitudinal study of men and women. Clin Infect Dis. 2007 Nov 15;45(10):1377-85. doi: 10.1086/522762. Epub 2007 Oct 11.
Pellowski JA, Kalichman SC. Health behavior predictors of medication adherence among low health literacy people living with HIV/AIDS. J Health Psychol. 2016 Sep;21(9):1981-91. doi: 10.1177/1359105315569617. Epub 2015 Feb 20.
Pellowski JA, Kalichman SC, White D, Amaral CM, Hoyt G, Kalichman MO. Real-time medication adherence monitoring intervention: test of concept in people living with HIV infection. J Assoc Nurses AIDS Care. 2014 Nov-Dec;25(6):646-51. doi: 10.1016/j.jana.2014.06.002. Epub 2014 Jul 16. No abstract available.
Pellowski JA, Kalichman SC, Grebler T. Optimal Treatment Adherence Counseling Outcomes for People Living with HIV and Limited Health Literacy. Behav Med. 2016;42(1):39-47. doi: 10.1080/08964289.2014.963006. Epub 2014 Dec 13.
Kalichman S, Pellowski J, Chen Y. Requesting help to understand medical information among people living with HIV and poor health literacy. AIDS Patient Care STDS. 2013 Jun;27(6):326-32. doi: 10.1089/apc.2013.0056. Epub 2013 May 23.
Pellowski JA, Kalichman SC, Matthews KA, Adler N. A pandemic of the poor: social disadvantage and the U.S. HIV epidemic. Am Psychol. 2013 May-Jun;68(4):197-209. doi: 10.1037/a0032694.
Kalichman SC, Pellowski J, Kalichman MO, Cherry C, Detorio M, Caliendo AM, Schinazi RF. Food insufficiency and medication adherence among people living with HIV/AIDS in urban and peri-urban settings. Prev Sci. 2011 Sep;12(3):324-32. doi: 10.1007/s11121-011-0222-9.
Claborn KR, Meier E, Miller MB, Leffingwell TR. A systematic review of treatment fatigue among HIV-infected patients prescribed antiretroviral therapy. Psychol Health Med. 2015;20(3):255-65. doi: 10.1080/13548506.2014.945601. Epub 2014 Aug 11.
Marrazzo JM, del Rio C, Holtgrave DR, Cohen MS, Kalichman SC, Mayer KH, Montaner JS, Wheeler DP, Grant RM, Grinsztejn B, Kumarasamy N, Shoptaw S, Walensky RP, Dabis F, Sugarman J, Benson CA; International Antiviral Society-USA Panel. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society-USA Panel. JAMA. 2014 Jul 23-30;312(4):390-409. doi: 10.1001/jama.2014.7999.
Kalichman SC, Cherry C, Kalichman MO, Amaral C, White D, Grebler T, Eaton LA, Cruess D, Detorio MA, Caliendo AM, Schinazi RF. Randomized clinical trial of HIV treatment adherence counseling interventions for people living with HIV and limited health literacy. J Acquir Immune Defic Syndr. 2013 May 1;63(1):42-50. doi: 10.1097/QAI.0b013e318286ce49.
Other Identifiers
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Pro00033072
Identifier Type: -
Identifier Source: org_study_id
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