Identifying people at risk or infected with HIV and HCV
Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to Identify People At Risk or Already Infected with HIV and HCV
This study is testing a new way to find people at risk for HIV and hepatitis C by using a self-questionnaire and quick blood tests in health centers to see if it helps identify more cases than the usual methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240000 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06528626 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce hidden and new infections of HIV and HCV by implementing a self-questionnaire and rapid serological tests in health centers. It utilizes a stepped-wedge cluster randomized trial design across eight community health centers in Madrid. Participants will be assessed using standard care methods alongside the new tools to evaluate their effectiveness in identifying at-risk individuals and improving screening rates. The study will compare the outcomes of the intervention group with those receiving standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14-65 who are in the health area and consent to participate.
Not a fit: Patients who have already been included in the study or do not sign the consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the identification and treatment of individuals at risk for HIV and HCV, leading to better health outcomes.
How similar studies have performed: Other studies have shown success in using similar screening tools and rapid testing approaches for infectious diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 14-65 years in the health area or who are captured for inclusion by health personnel. They give their consent to participate. Exclusion Criteria: * Having already been included in the study, not signing the consent.
Where this trial is running
Madrid, Madrid
- Maria J. Vivancos-Gallego — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Maria J. Vivancos-Gallego, MD, PhD
- Email: mariajesus.vivancos@salud.madrid.org
- Phone: +34913368672
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.