Sanu Gundo (jòli sègèsègèli - furakèli - jàntoli): Survey on the Feasibility of the Community-based HIV Care, and Its Impact on Access and Retention in Care in Artisanal Gold Mining Zones in Mali
试验速览
- 阶段
- 不适用
- 入组人数
- 265
- 试验地点
- 4
- 主要终点
- Lost to follow-up rate 12 months after the HIV diagnosis
研究概览
简要总结
Sanu Gundo ANRS 12392 is a non-randomized and non-comparative intervention trial in Mali.
The main objective of the project is to study the feasibility of the community-based HIV care in the context of the artisanal gold mining zones and to evaluate its contribution to the linkage-to-care of PLWHIV with the health system and their retention in care, as well as its effect on their health status.
详细描述
Convergence of key-populations in the informal gold mining zones suggests the important exposure to HIV contamination of people living in these zones. The pilot project Sanu Gundo showed a prevalence of 8% in the site of Kokoyo, much higher than the 1.1% national prevalence. The large rates of HIV patients lost to followup underline the difficulties experienced by the health system. Introducing a community-based HIV care offer in proximity to people in the informal gold mining zones could contribute to the improvement not only of access to HIV prevention and testing, but also to the access and retention in care.
Sanu Gundo ANRS 12392 is a non-randomized and non-comparative intervention trial. Community-based activities conducted by ARCAD Santé PLUS (during 5 months) including HIV testing will contribute to the construction of both a control and intervention groups. These groups will be formed by people tested positive to HIV during the community-based activities conducted by ARCAD Santé PLUS in two artisanal gold mining sites.
The control group will include 129 participants positive to HIV in Diassa (Sikasso region), and the intervention group will include 136 participants positive to HIV in Kofoulatiè (Koulikoro region).
The intervention consists local community-based activities for HIV care provided by ARCAD Santé PLUS for people living in Kofoulatiè (intervention group), whereas people living in Diassa (control group) will be referred to the Referral Health Centers (CSRéf) as recommended by the national guidelines.
The total number of 265 participants diagnosed positive to HIV enrolled in the study corresponds (at least) to the HIV prevalence of 3% observed during the first two months of participants enrolment (November 2020 to January 2021). Accounting for survey attrition, refusal of the community-based HIV care and non-inclusion criteria, it is expected that 172 participants (86 per group) will be followed-up during the whole duration of the study. This corresponds to the number of participants required to verify the primary endpoint of the study: a better retention rate in healthcare 12 months after of HIV diagnosis for people receiving community-based care by ARCAD Santé PLUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants in the control group (HIV positive people at the artisanal gold-mining site in Diassa) will not be aware of the existence of the community-based HIV care services provided by ARCAD Santé PLUS at the Kofoulatiè artisanal gold-mining site.
The distance between these sites is around 400km. However they share similar characteristics in terms of geographical localisation, size and healthcare supply.
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
- •To live and/or to work in the sites of Kofoulatiè or Diassa (Mali)
- •To be diagnosed positive to HIV by ARCAD Santé PLUS (screening and enrolment tests positive)
- •To be 18 years or older
- •To speak one of the most common languages (Bambara, French or English) and to be able of providing informed consent
- •In addition, to be included in the intervention group, people living with HIV in the Kofoulatiè site must accept the community-based HIV care provided by ARCAD Santé PLUS
排除标准
- •Women pregnant at the time of the HIV screening test by ARCAD Santé PLUS, or needing ultrasound to confirm pregnancy
- •People with discordant screening and enrolment tests
- •People inebriated or under the influence of drugs at enrolment
- •Adults not able to understand and/or to provide informed consent
结局指标
主要结局
Lost to follow-up rate 12 months after the HIV diagnosis
时间窗: 12 months after HIV diagnosis (M12)
It was defined on the basis of existing data: 1) lost to follow-up rate in HIV care at the national level in Mali (32% in 2019); 2) lost to follow-up rate in the HIV care of ARCAD Santé PLUS in urban areas (12% in 2019). The primary endpoint is : the lost to follow-up rate in the community-based HIV care 12 months after diagnosis is (at least) 20 percentage points lower than the lost to follow-up rate in the classic HIV care.
次要结局
- Comparing the impact of classic and community-based HIV care on virological succes, behavioral and psychosocial outcomes(From enrolment (M0) to 12 months after HIV diagnosis (M12))
- Comparing linkage-to-care and retention between classic and community-based HIV care(1 month after HIV diagnosis (M1) and 12 months after HIV diagnosis (M12))
- Extent of the HIV epidemic in the artisanal gold-mining sites(At enrolment (M0))