Managing Medications - Full Text View

Purpose

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).

Condition	Intervention
HIV Infections	Behavioral: Problem solving counseling


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Improving Adherence to Antiretroviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Medication adherence as measured by electronic event monitors [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medication diaries, Self-reported Medication-taking Scale, and the ACTG Adherence Follow-up Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Estimated Enrollment:	300
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Structured Structured nurse counseling behavioral intervention focused on problem solving.	Behavioral: Problem solving counseling Telephone nurse counseling behavioral intervention focused on problem solving.
Experimental: Individualized Individualized nurse counseling behavioral intervention focused on problem solving.	Behavioral: Problem solving counseling Telephone nurse counseling behavioral intervention focused on problem solving.
No Intervention: Usual Care Control arm	Behavioral: Problem solving counseling Telephone nurse counseling behavioral intervention focused on problem solving.

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 and/or 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 and/or 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be able to give informed consent,
be 18 years or older,
be taking antiretroviral therapy,
be able to speak and understand English,
have a telephone or access to a telephone,
and be living in a private residence or apartment in the community as opposed to a personal care/nursing home.

Exclusion Criteria:

significant cognitive impairment,
blind
motor impairment of their upper extremities
if another person in their household was or is currently enrolled in the study
the HDS that we will use to screen for cognitive impairment cannot be used with individuals who have these physical problems
Those with a hearing impairment who do not have a modified telephone to enhance their hearing will be excluded since they are unable to participate in the telephone delivered interventions or data collection.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222716

Locations


United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

University of Pittsburgh

National Institute of Nursing Research (NINR)

Investigators


Principal Investigator:	Judith A Erlen, PHD	University of Pittsburgh
Study Director:	Lisa K Tamres, MS	University of Pittsburgh School of Nursing

More Information


Responsible Party:	Judith Erlen, PhD, RN, FAAN, University of Pittsburgh School of Nursing
ClinicalTrials.gov Identifier:	NCT00222716 History of Changes
Other Study ID Numbers:	2R01NR004749
Study First Received:	September 14, 2005
Last Updated:	March 26, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:


Treatment adherence HIV Self-efficacy Treatment Experienced

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016