Multifactorial intervention for frail individuals with HIV
Prevalence of Frailty in Individuals With HIV Infection and Age Older Than 60 Years, Factors Associated and 6-month Effectiveness of a Multifactorial Intervention: HIDRA360
This study tests a new program that includes diet tips, exercise, and social activities to see if it helps frail people with HIV feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Hospital Costa del Sol Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Marbella, Málaga) |
| Trial ID | NCT05832164 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a multifactorial intervention designed for frail individuals living with HIV. The intervention includes educational videos on maintaining a Mediterranean diet and implementing an exercise program, alongside a review of polypharmacy and socialization activities. Participants will be assessed for changes in frailty status, adherence to dietary guidelines, mental health indicators, and microbiota diversity before and after the intervention. The study employs a quasi-experimental design without a control group to observe these outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with HIV for at least six months who are experiencing frailty.
Not a fit: Patients with severe comorbidities, such as advanced cirrhosis or end-stage renal failure, are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could improve the health and quality of life for frail individuals with HIV by addressing multiple factors contributing to their condition.
How similar studies have performed: While multifactorial interventions in frail populations have shown promise in other studies, this specific approach targeting frail individuals with HIV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV infection of at least 6 months' duration after initial diagnosis * Ability to sign the informed consent form * Stable residence in our health area Exclusion Criteria: * Barthel Index\<90 * Prognosis of less than one year of life at the discretion of the investigator. * Inability to complete the study (8 months) as judged by the investigator or the patient * Presence of Child stage C cirrhosis, end-stage renal failure (Fge by CKD-EPI\<10 mL/min or dialysis in any form), dementia. * Bone fracture within the last 3 months that interferes with gait or prehensile strength in the judgement of the investigator. * Diagnosis prior to inclusion in the study of diseases requiring the use of chemotherapy, radiotherapy or non-minor surgery. * End of chemotherapy or radiotherapy in the three months prior to study entry * Major surgery in the three months prior to study entry * Current diagnosis of wasting syndrome * Active neoplasm at the time of study entry, except for non-melanoma skin cancer or anal carcinoma in situ
Where this trial is running
Marbella, Málaga
- Hospital Costa del Sol — Marbella, Málaga, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.