Managing Medications

HIV Infections Clinical Trial

— MM2  

Official title:

Improving Adherence to Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222716
• Other study ID #: 2R01NR004749
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: June 22, 2017
• Start date: January 2004
• Est. completion date: December 2009

Study information

• Verified date: June 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Problem solving counseling
Telephone nurse counseling behavioral intervention focused on problem solving.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence as measured by electronic event monitors	MEMS data using AARDEX medication monitoring caps, percent daily dose correct.	12 weeks
Secondary	Morisky Medication Adherence Scaler	9 item Morisky self report measure on medication adherence	12 weeks