Clinical trial NCT00222716: Managing Medications
Official title: Improving Adherence to Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment adherence
HIV
Self-efficacy
Treatment Experienced
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-09-22
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: Medication adherence as measured by electronic event monitors
timeFrame: 12 weeks
Secondary outcomes:
measure: Morisky Medication Adherence Scaler
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Judith A Erlen, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh School of Nursing
name: Lisa K Tamres, MS
role: STUDY_DIRECTOR
References:
citation: Butler KR, Harrell FR, Rahim-Williams B, Robinson JM, Zhang X, Gyamfi A, Erlen JA, Henderson WA. Symptoms and Comorbidities Differ Based on Race and Weight Status in Persons with HIV in the Northern United States: a Cross-Sectional Study. J Racial Ethn Health Disparities. 2023 Apr;10(2):826-833. doi: 10.1007/s40615-022-01271-0. Epub 2022 Mar 10.