Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 576
- 主要终点
- Effectiveness of ACCESS+ strategy
研究概览
简要总结
Hepatitis C is a common and potentially serious disease. However, there are treatments that can cure it. That's why it's so important to detect the hepatitis C virus (HCV) and treat those affected. Today, many hepatitis C sufferers in Cameroon (and elsewhere) remain untreated.
The aim of this research is therefore to evaluate a simplified screening and treatment strategy (developed specifically for the Cameroonian context) in comparison with a standard strategy (based on usual care), in order to improve access to hepatitis C treatment in Cameroon. If the results of this research are positive, this strategy could be recommended to health authorities in Cameroon and other comparable countries.
详细描述
A two-arm, cluster-randomized, controlled trial will be conducted in blood banks and HIV clinics (the clusters) in the two largest cities in Cameroon (Yaoundé and Douala).
Persons aged 21 years or older, anti-HCV positive, and living in the study area will be eligible. The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing, (2) same-day on-site pan-genotypic DAA treatment initiation, (3) minimal clinical and biological monitoring, and (4) management by trained general medical doctors and counselors (community health workers, nurses or social workers) in non-specialist services. In contrast, in the standard strategy, the process for screening and treatment initiation will take longer, and anti-HCV positive participants will be managed by gastroenterologists and will have a closer follow-up.
Biological and clinical data (using standardized case report forms), socioeconomic data (using standardized questionnaires), and qualitative data (using interviews and focus groups) will be collected. A total of 576 anti-HCV positive participants (288 per arm) will be recruited in 16 facilities (8 blood banks and 8 HIV clinics) after testing approximately 32,000 blood donors and 8,400 patients living with HIV. The total duration of the trial will be 36 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons of both genders aged 21 years or older
- •Anti-HCV positive;
- •Living in the study area
- •Agreeing to participate in the trial and signing the informed consent form.
排除标准
- •Participationin a previous study on HCV treatment
- •Previous sofosbuvir treatment
- •HBsAg positive or indeterminate;
- •Pregnancy test positive ;
- •Life-threatening condition ;
- •Impairment of the person making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them.
研究组 & 干预措施
ACCESS+ Strategy
ACCESS+ strategy will rely on four components:
- same-day on-site rapid anti-HCV and HCV RNA testing,
- same-day on-site pan-genotypic DAA treatment initiation,
- minimal clinical and biological monitoring, and
- management by trained general medical doctors and counselors (community health workers, nurses or social workers) in non-specialist services.
干预措施: ACCESS+ strategy Epclusa 400/100 Oral Tablet (Drug)
ACCESS+ Strategy
ACCESS+ strategy will rely on four components:
- same-day on-site rapid anti-HCV and HCV RNA testing,
- same-day on-site pan-genotypic DAA treatment initiation,
- minimal clinical and biological monitoring, and
- management by trained general medical doctors and counselors (community health workers, nurses or social workers) in non-specialist services.
干预措施: ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet (Drug)
Standard Strategy
In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.
干预措施: Standard Strategy Vosevi 400/100/100 Oral Tablet (Drug)
Standard Strategy
In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.
干预措施: Standard Strategy Epclusa 400/100 Oral Tablet (Drug)
结局指标
主要结局
Effectiveness of ACCESS+ strategy
时间窗: 12 weeks after the end of treatment
% of anti-HCV positive patients at enrolment who were correctly managed (classified as follows): Success if either one of the following statement is reached 'baseline HCV RNA negative and informed of this result' or 'baseline HCV RNA positive, treated and HCV RNA negative 24 weeks after start of treatment' Failure in the other situations including 'baseline HCV RNA not tested', 'baseline HCV RNA negative but not informed of this result', 'baseline HCV RNA positive and untreated', 'baseline HCV RNA positive, treated and HCV RNA positive or not tested 24 weeks after start of treatment', and 'missing data'
次要结局
- HCV Cascade (communication of HCV RNA Status) of care between the two strategies(12 weeks after end of treatment)
- HCV cascade (HCV RNA Test) of care between both strategies(12 weeks after end of treatment)
- HCV Cascade (HCV RNA positive) of care between both strategies(12 weeks after end of treatment)
- HCV Cascade (start of treatment) of care between the two strategies(12 weeks after end of treatment)
- HCV Cascade (treatment completed) of care between the two strategies(12 weeks after the end of treatment)
- HCV Cascade (patients cured) of care between the two strategies(12 weeks after the end of treatment)
- Patient-reported outcomes (fatigue) between both strategies(12 weeks after end of treatment)
- Patient-reported outcomes between both strategies(12 weeks after end of treatment)
- Patient-reported outcomes (quality of life) between both strategies(12 weeks after end of treatment)
- Cost-effectiveness of the ACCESS+ strategy(12 weeks after end of treatment)