HIV Infections Clinical Trial
— SIMPLIFIEDOfficial title:
Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population.
Verified date | July 2023 |
Source | Fundacion SEIMC-GESIDA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Implementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2024 |
Est. primary completion date | December 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Vulnerable person =18 years - Understand and sign the informed consent form - Confirmed HIV infection - Not receiving ART or on ART with a PVL > copies/ml Exclusion Criteria: - Unable to provide contact details - History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine - Taking antiretroviral treatment for less than 1 month - Pregnancy or breastfeeding at the time of screening or gestational desires during the study period. - Suspected or diagnosed of active opportinistic disease - History of severe liver disease (Child- Pugh C) or history of descompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice) - History of kidney disease CKP-EPI< 30ml/min - Have any condition that, as per investigator criteria, makes the patient not candidate to be included (active disease, social situation, intoxication...) |
Country | Name | City | State |
---|---|---|---|
Spain | H. Infanta Leonor | Madrid |
Lead Sponsor | Collaborator |
---|---|
Fundacion SEIMC-GESIDA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To find out whether the implementation of a model of access and retention in care for HIV among vulnerable people using a mobile screening unit and a same-day diagnosis and treatment initiation strategy is effective and safety. | Proportion of subjects agreeing to participate in the study, proportion of subjects starting ART after inclusion, median time from the study inclusion to ART starting, proportion of subjects with HIV-1 RNA <50 copies/mL at 24 weeks after inclusion, absolute values and changes from baseline in CD4+ cell count and CD4:CD8 at 24 weeks and proportion of subjects making visits at weeks 24 and 48 will be the endponts to measure the effectiveness of the strategy. The effectiveness threshold defined is: >80% of enrolled subjects have plasma HIV-1 RNA <50 copies/mL at 24 weeks post-inclusion and who are on follow-up and on ART at remain on follow-up and on ART at week 48. Incidence and severity of adverse events (clinical and laboratory) up to 24 weeks, incidence of adverse events leading to discontinuation of treatment up to week 24 and incidence of genotypic resistance mutations in participants with virological failure will be the endpoints to measure the safety of the strategy. |
24-48 weeks | |
Secondary | To assess the implementation and feasibility of the intervention | The evaluation of acceptability, comfort, suitability, usefulness, appropriateness, quality, perceived benefit and satisfaction with the perceived benefit and satisfaction of the intervention at the baseline visit and at the week 24 visit. These parameters will be collected using a scale of 0 to 5 and will be used to measure and assess the implementation of the strategy. In addittion to assess the implementation of this project it will be used the endpoints referred to above (Evaluate the effectiveness of the strategy and evaluate the security of the strategy). The time frame for evaluate the effectivebes of the strategy and evaluate the security of the strategy are betwen 24 and 48 weeks. |
24-48 weeks |
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