Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222716
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2005-09-14
Brief Title:
Managing Medications
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Improving Adherence to Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MM2
Brief Summary:
The primary aim of this study is to compare the effect of an individualized adherence intervention TI and a structured adherence intervention TS to usual care on adherence to antiretroviral therapy in persons infected with HIV PWHIV
Detailed Description:
The primary aim of this study is to compare the effect of an individualized adherence intervention TI and a structured adherence intervention TS to usual care on adherence to antiretroviral therapy in persons infected with HIV PWHIV The secondary aims address the relationship between adherence and quality of life QOL and between adherence and clinical response The exploratory aims focus on examining the effect of self-efficacy on the relationship between the intervention and adherence the effect of adherence on the relationship between self-efficacy and outcomes clinical response and quality of life as well as the effects of symptoms alcohol andor drug use chronic interpersonal problems mood social support optimism perceived burden of medication regimen perceived stigma purpose in life co-morbidity personality literacy and intimate partner abuse on self-efficacy and psychometric analyses of the instruments The sample of 300 plus 51 dropouts PWHIV who are taking antiretroviral therapy and without cognitive dysfunction will be randomly assigned to one of two treatment arms Those individuals who are deemed to be 100 adherers approximately 25-50 will be assigned to the control group but will be followed separately as a natural history substudy and interviewed Data will be collected at baseline post-treatment post-maintenance post-booster and 18 months Electronic event monitors diaries the Self-reported Medication-taking Scale and the ACTG Adherence Follow-up Questionnaire will be used to assess adherence The Digit Vigilance Test will be used to assess the effect of sustained attention on adherence QOL will be measured using the MOS-HIV the Satisfaction with Life Scale and the Perception of Illness Visual Analogue Scale Clinical response will be assessed using viral load CD4 T-cell count AIDS defining conditions and hospitalizations Variables influencing self-efficacy measured with an investigator-developed Self-efficacy Scale will be examined symptoms CRCD Symptom Checklist alcohol andor drug use AUDIT chronic interpersonal problems IIP social support Interpersonal Support Evaluation List optimism Life Orientation Test anxiety Beck Anxiety Inventory and Beck Depression Inventory II perceived burden of regimen visual analog scales perceived stigma Perceived Stigma of HIV Scale purpose in life Purpose in Life Scale co-morbidity CRCD Co-Morbidity Scale personality characteristics NEO-FFI health literacy Test of Functional Health Literacy in Adults knowledge about HIV medication adherence HIV Medication Adherence Knowledge and intimate partner abuse Abuse Assessment Screen A repeated measures model with planned comparisons will be used to test the hypotheses for the primary aim Structural equation modeling will be used to examine the relationships identified in the secondary and exploratory aims PWHIV who adhere to their therapy may live longer require fewer hospitalizations and have an improved QOL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None