Assessing Differential Adherence to Medications and Quality of Life Among People Living With HIV and Comorbidities

NCT03387397 | Completed

• 1 other identifier: 17-0063
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to utilize quantitative and qualitative methodology to better understand the impact of multiple drug use (polypharmacy) on medication adherence as well as the driving forces behind differential adherence in people living with HIV (PLWH) with comorbidities. Since the clinical relevance of differential adherence to antiretroviral therapy (ART) medication has already been demonstrated and associated with virologic failure and a more rapid progression to AIDS and death, it is imperative to understand the driving forces behind differential adherence (selective drug taking) and its impact on treatment outcomes in PLWH with comorbidities. To this end, the investigators propose utilizing self-report adherence data and abstracted medical record data including pharmacy refills to assess medication adherence among PLWH with comorbidities. The information gained regarding patients' clinical outcomes as well as patients' reported treatment adherence, quality of life, beliefs about medications, and treatment satisfaction will provide the investigators with a comprehensive picture of what constitutes successful HIV treatment among those PLWH managing multiple medications. This is particularly important as non-successful treatment may result in low patient satisfaction, breach of patient-provider trust and reduced medication adherence.

Conditions

HIV Infection Primary

Keywords

Co-morbidities

Outcome Measures

Primary Outcomes (1)

• Self-reported adherence to antiretroviral therapy (ART)

  To measure medication adherence to ART the investigators will use the validated AIDS Clinical Trials Group (ACTG) Adherence Questionnaire. This assessment is considered one of the "gold-standard" ART self-reported adherence questionnaires. The questionnaire assesses the number of doses missed per medication per day over a recall period of the previous four days. Mean number of doses missed is calculated for all ART medications over the four days. A higher mean, indicates more doses missed.

  baseline and 6 months

Secondary Outcomes (11)

• Quality of Life (QoL)

  Change from baseline QoL at six months

• Patients' illness-specific symptoms and medication-specific side effects

  Change from patients' baseline illness-specific symptoms and medication-specific side effects at six months

• Patients' beliefs about medication's

  Change from patients' baseline beliefs about medication's at six months

• Patients' illness perception's

  Change from patients' baseline illness perception's at six months

• Patients' pill burden perceptions

  Baseline

Other Outcomes (1)

• Qualitative Measures for Focus Group

  End of enrollment period ( 6 months)

Study Arms (2)

Lower Medications (LM) cohort

Patients will be assigned to the Lower Medications (LM) cohort group (N=85) if they received a drug regimen of less than five different medications/day during the study period.

Higher Medications (HM) cohort

Patients will be assigned to the Higher Medications (HM) cohort group (N=85) if they received a drug regimen of more than 5 different chronic medications/day during the study period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with HIV who have at least one comorbidity and are taking medications for both conditions for at least 6 months

You may qualify if:

• All patients must:
• be HIV infected
• be English speaking
• be 18 years or older
• have at least one comorbidity requiring, at least, one additional chronic medication (defined as a medication that the person needs to be taking for at least six months).
• Receiving care at North Shore University Hospital Center for AIDS Research and Treatment

You may not qualify if:

• Evidence of cognitive impairment that limits the ability to complete the intervention
• Terminally ill patients will be also excluded.

Sponsors & Collaborators

• Northwell Health: lead
• Gilead Sciences: collaborator

Study Sites (1)

North Shore University Hospital Division of Infectious Diseases/ Center for AIDS Research and Treatment

Manhasset, New York, 11030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

HIV-1 RNA viral load and CD4

Study Officials

• Frances R Wallach, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 2, 2018
• Study Start: December 12, 2017
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

US (1)