- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07621224
Multimorbidity and Polypharmacy in People With HIV vs. the General Population in the Basque Country
A Comparative Study on the Prevalence of Multimorbidity, Polypharmacy and Potentially Inappropriate Prescriptions Among the General Population and People Living With HIV in the Basque Country
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Advances in antiretroviral treatment for people living with Human Immunodeficiency Virus (HIV) have brought their life expectancy into line with that of the general population. These individuals now have a higher prevalence of multiple co-morbidities and polypharmacy than the general population.
According to the latest report on the AIDS plan, there are 6,273 patients in our region currently receiving antiretroviral treatment. However, the recent corporate care pathway for people with multiple co-morbidities in the Basque Country's public health system does not include patients with HIV. This fact, together with the lack of data on the prevalence of multiple co-morbidities, polypharmacy and potentially inappropriate prescribing among these individuals in our region, motivated the conduct of this study. Its aim is to estimate this prevalence among all people with HIV receiving care in the infectious diseases departments of the hospitals in Araba, Basurto, Galdakao, Cruces and Donostia, and to compare it with a control group without HIV. To this end, we designed a cross-sectional comparative study involving 6,273 people with HIV and a control group drawn from the general population through stratified sampling according to the distribution by age, sex and health centre of the HIV population. The results, obtained by extracting data from electronic health records, will enable us to confirm whether the HIV-positive population has a higher prevalence of multimorbidity, polypharmacy and inappropriate prescribing than the general population. The results obtained from both populations will provide us with the necessary knowledge to update the corporate care pathway and to plan coordinated care for HIV-positive patients with multimorbidity.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- People with HIV aged 18 or over
- Being monitored by the infectious diseases departments of the Araba, Cruces, Basurto and Donostia University Hospitals and the Galdakao-Usansolo Hospital, all part of Osakidetza.
Exclusion Criteria:
- Being under 18 years of age
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
People with HIV
People with HIV aged 18 years or over receiving care in the infectious diseases departments of the hospitals in Araba, Basurto, Galdakao, Cruces and Donostia.
|
No intervention
|
|
General population
General population through stratified sampling according to the distribution by age, sex and health centre of the HIV population
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of multimorbidity in people with HIV in the Basque Country
Time Frame: Enrollment
|
Proportion of people with HIV aged ≥18 years who have ≥2 chronic diseases recorded in their electronic health records.
Automated extraction of active diagnoses coded in the electronic health records.
|
Enrollment
|
|
Prevalence of multimorbidity in the general population in the Basque Country
Time Frame: Enrollment
|
Proportion of people aged ≥18 years who have ≥2 chronic diseases recorded in their electronic health record.
Automated extraction of active diagnoses coded in the electronic health records.
|
Enrollment
|
|
Prevalence of polypharmacy in people with HIV in the Basque Country
Time Frame: Enrollment
|
Proportion of people with HIV aged ≥18 years who have ≥5 prescribed medications and ≥10 medications (excessive polypharmacy) as chronic or on demand treatments, excluding antiretroviral therapy.
Adherence according to the dispensing records.
|
Enrollment
|
|
Prevalence of polypharmacy in the general population in the Basque Country
Time Frame: Enrollment
|
Proportion of people aged ≥18 years who have ≥5 prescribed medications and ≥10 medications (excessive polypharmacy) as chronic or on demand treatments, excluding antiretroviral therapy.
Adherence according to the dispensing records.
|
Enrollment
|
|
Prevalence of potentially inappropriate prescriptions in people with HIV in the Basque Country
Time Frame: Enrollment
|
Proportion of people with HIV aged ≥18 years who present potentially inappropriate prescriptions according to the STOPP/START criteria: duplications, exceeded maximum doses, contraindicated or severe interactions, anticholinergic burden in people over 70 years of age, and exceeded treatment duration.
|
Enrollment
|
|
Prevalence of potentially inappropriate prescriptions in the general population in the Basque Country
Time Frame: Enrollment
|
Proportion of people aged ≥18 years who present potentially inappropriate prescriptions according to the STOPP/START criteria: duplications, exceeded maximum doses, contraindicated or severe interactions, anticholinergic burden in people over 70 years of age, and exceeded treatment duration.
|
Enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 2023111044
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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