NCT07621224

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,546

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 27, 2026

Last Update Submit

June 10, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Enrollment

Study Arms (2)

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.

Other: No intervention

General population

General population through stratified sampling according to the distribution by age, sex and health centre of the HIV population

Other: No intervention

Interventions

No intervention

General populationPeople with HIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Being under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06