Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
The use of a mobile unit to reach vulnerable HIV-infected people with poor access to the health care system and starting/restarting on the same day ("simplified same day test and treat strategy") is feasible, effective and safe and will allow these people to have a rapid access to ART and long-term follow-up and health care for HIV.
At the screening visit the patient will sign the informed consent form, revise the clinical history and ensure compliance with criteria. A history of drug abuse, complete physical examination, pregnancy test, rapid hepatitis C test, questionnaires and social situation will be collected from the patient.
At the basal visit the patients enrolled in the study will collect lab test (blood count, biochemistry, coagulation, serology, inmunology and virology), vital signs and directed physical examination, concomitant medication and adverse events.
After the basal visit the patient will be followed up on visits week 4, 12, 24, 48 and last visit 50 as follow up safety visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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...)
研究组 & 干预措施
Patients received BIKTARVY (BIC/FTC/TAF)
The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service.
The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing.
The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months.
干预措施: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] (Drug)
结局指标
主要结局
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.
时间窗: 24-48 weeks
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.
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.
时间窗: 24-48 weeks
Proportion of subjects making visits at weeks 24 and 48.
次要结局
- To assess the implementation and feasibility of the intervention(24-48 weeks)
- To Assess the Implementation and Feasibility of the Intervention(Baseline, week 4, week 12, week 24 and week 48)