Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат ACCESS+ strategy Epclusa 400/100 Oral Tablet
  The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing (rapid diagnostic test and GeneXpert), (2) same-day on-site pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg once daily for 12 weeks), (3) minimal clinical and biological monitoring, and (4) management of patients in non-specialist services by trained general medical doctors and counselors (community health workers, nurses or social workers).
• Препарат ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet
  The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing (rapid diagnostic test and GeneXpert), (2) same-day on-site pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100mg) once daily for 12 weeks, (3) minimal clinical and biological monitoring, and (4) management of patients in non-specialist services by trained general medical doctors and counselors (community health workers, nurses or social workers).
• Препарат Standard Strategy Vosevi 400/100/100 Oral Tablet
  In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists who will initiate pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.
• Препарат Standard Strategy Epclusa 400/100 Oral Tablet
  In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists who will initiate pan-genotypic DAA treatment initiation (sofosbuvir 400 mg/velpatasvir 100 mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.

Первичные конечные точки

• Effectiveness of ACCESS+ strategy [Срок оценки: 12 weeks after the end of treatment]

Вторичные конечные точки (10)

• HCV cascade (HCV RNA Test) of care between both strategies [Срок оценки: 12 weeks after end of treatment]
• HCV Cascade (HCV RNA positive) of care between both strategies [Срок оценки: 12 weeks after end of treatment]
• HCV Cascade (communication of HCV RNA Status) of care between the two strategies [Срок оценки: 12 weeks after end of treatment]
• HCV Cascade (start of treatment) of care between the two strategies [Срок оценки: 12 weeks after end of treatment]
• HCV Cascade (treatment completed) of care between the two strategies [Срок оценки: 12 weeks after the end of treatment]
• HCV Cascade (patients cured) of care between the two strategies [Срок оценки: 12 weeks after the end of treatment]
• Patient-reported outcomes between both strategies [Срок оценки: 12 weeks after end of treatment]
• Patient-reported outcomes (quality of life) between both strategies [Срок оценки: 12 weeks after end of treatment]
• Patient-reported outcomes (fatigue) between both strategies [Срок оценки: 12 weeks after end of treatment]
• Cost-effectiveness of the ACCESS+ strategy [Срок оценки: 12 weeks after end of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07098481 · ANRS 0388s ACCESS+

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗