HIV (Human Immunodeficiency Virus)NCT07621224
Multimorbidity and Polypharmacy in People With HIV vs. the General Population in the Basque Country
An observational study of HIV (Human Immunodeficiency Virus), run by Biogipuzkoa Health Research Institute.
Trial summary
People living with HIV now have a life expectancy similar to that of the general population, thanks to major advances in antiretroviral treatment. As they live longer, many of them experience multiple health conditions at the same time and take several medications, often more than people without HIV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- How many people
- 12,546 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with HIV aged 18 or over who are 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. Five HIV-negative controls will be selected for each person with HIV. Stratified random sampling will be carried out by age, sex and referral hospital, according to the composition of the HIV population.
Who may be able to join
- 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.
Who cannot join
- Being under 18 years of age
About this study
Official title: 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
People living with HIV now have a life expectancy similar to that of the general population, thanks to major advances in antiretroviral treatment. As they live longer, many of them experience multiple health conditions at the same time and take several medications, often more than people without HIV. In our region, 6,273 people are currently receiving antiretroviral therapy. However, the new care pathway designed for patients with multiple chronic conditions in the Basque Country's public health system does not include people with HIV. At the same time, we lack local data on how common multimorbidity, polypharmacy, and potentially inappropriate prescribing are among this group. These gaps motivated our study. Our goal is to estimate how frequent these issues are among all people with HIV who receive care in the infectious disease departments of the hospitals in Araba, Basurto, Galdakao, Cruces, and Donostia, and to compare them with a similar group of people without HIV. To do this, we designed a cross-sectional study including the 6,273 people with HIV and a control group from the general population, selected to match them by age, sex, and health centre. By analysing data from electronic health records, we aim to determine whether people with HIV have higher rates of multimorbidity, polypharmacy, and inappropriate prescribing than the general population. The findings from both groups will help us update the care pathway and improve coordinated care for HIV-positive patients with multiple health conditions.
Read the 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.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- No intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention | |
| General population | General population through stratified sampling according to the distribution by age, sex and health centre of the HIV population Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of multimorbidity in people with HIV in the Basque Country
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.
Measured: Enrollment
Prevalence of multimorbidity in the general population in the Basque Country
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.
Measured: Enrollment
Prevalence of polypharmacy in people with HIV in the Basque Country
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.
Measured: Enrollment
Prevalence of polypharmacy in the general population in the Basque Country
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.
Measured: Enrollment
Prevalence of potentially inappropriate prescriptions in people with HIV in the Basque Country
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.
Measured: Enrollment
Prevalence of potentially inappropriate prescriptions in the general population in the Basque Country
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.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12,546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621224
- Sponsor's protocol ID
- 2023111044
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07621224
- Acronym / sponsor ID
- 2023111044
- Conditions
- HIV (Human Immunodeficiency Virus)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,546 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People living with HIV now have a life expectancy similar to that of the general population, thanks to major advances in antiretroviral treatment. As they live longer, many of them experience multiple health conditions at the same time and take several medications, often more than people without HIV. In our region, 6,273 people are currently receiving antiretroviral therapy. However, the new care pathway designed for patients with multiple chronic conditions in the Basque Country's public health system does not include people with HIV. At the same time, we lack local data on how common multimorbidity, polypharmacy, and potentially inappropriate prescribing are among this group. These gaps motivated our study. Our goal is to estimate how frequent these issues are among all people with HIV who receive care in the infectious disease departments of the hospitals in Araba, Basurto, Galdakao, Cruces, and Donostia, and to compare them with a similar group of people without HIV. To do this, we designed a cross-sectional study including the 6,273 people with HIV and a control group from the general population, selected to match them by age, sex, and health centre. By analysing data from electronic health records, we aim to determine whether people with HIV have higher rates of multimorbidity, polypharmacy, and inappropriate prescribing than the general population. The findings from both groups will help us update the care pathway and improve coordinated care for HIV-positive patients with multiple health conditions.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with HIV | – | Other: No interventionPeople with HIV aged 18 years or over receiving care in the infectious diseases departments of the hospitals in Araba, Basurto, Galdakao, Cruces and Donostia. |
| General population | – | Other: No interventionGeneral population through stratified sampling according to the distribution by age, sex and health centre of the HIV population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with HIV aged 18 or over who are 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. Five HIV-negative controls will be selected for each person with HIV. Stratified random sampling will be carried out by age, sex and referral hospital, according to the composition of the HIV population.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Being under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | General population, People with HIV |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV (Human Immunodeficiency Virus), run by Biogipuzkoa Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of multimorbidity in people with HIV in the Basque Country (time frame: Enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.