Clinical trial NCT04482010: ANRS 12392 Sanu Gundo
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: Linkage-to-care and retention
Community-based research
Informal gold mining zones
Mali
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: UMR 1252 SESSTIM
name: ARCAD Santé PLUS
name: SEREFO
First posted: 2020-07-22
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ARCAD Santé PLUS NGO will offer community-based activities of HIV prevention and screening during 5 months. 8833 people will be tested for HIV in the two artisanal gold-mining sites. Thus, 265 HIV-positive individuals will be enrolled:

* Control group: 129 (Diassa), 30% of attrition and 5% of discordant HIV screening and confirmatory tests;
* Intervention group: 136 (Kofoulatiè), 30% of attrition; 5% of people accepting the study but refusing the community-based HIV care; and 5% of discordant HIV screening and enrolment tests.

This is the minimum number required to verify the primary endpoint of the study. The intervention consists in the provision of community-based healthcare services for HIV provided by ARCAD Santé PLUS's members in the Kofoulatiè site. People in the Diassa site (control group) will be referred to the public healthcare centers for classic HIV care. A quantitative survey with follow-up at M1, M3, M6, M9 and M12 after HIV diagnosis.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

A quantitative survey will be conducted with the administration of questionnaires at different point-times during the follow-up for HIV care: M1 (first contact with the healthcare system and linkage-to-care), M3 (linkage-to-care and initiation of ARV treatment), M6, M9 and M12 (medical follow-up and retention in care). Blood samples will be collected using Dried Blood Spot testing (DBS) at enrolment, M6 and M12. Furthermore, data will be collected about the characteristics of the healthcare centers around the artisanal gold mining sites (i.e. healthcare supply) and the costs of community-based HIV care.

The results will overcome the lack of epidemiological data about HIV in the informal gold mining zones, about the way in which PLWH are linked-to-care, and about the extent of the PLWH loss to follow-up. The results will also allow both testing the feasibility of the implementation of proximity community-based services for HIV care in the informal gold mining zones, and evaluating their contribution to retention of PLWH in care. The success of this project could allow extending the proposed strategy to other informal gold mining zones in Mali.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lost to follow-up rate 12 months after the HIV diagnosis
timeFrame: 12 months after HIV diagnosis (M12)
Secondary outcomes:
measure: Extent of the HIV epidemic in the artisanal gold-mining sites
timeFrame: At enrolment (M0)
measure: Comparing linkage-to-care and retention between classic and community-based HIV care
timeFrame: 1 month after HIV diagnosis (M1) and 12 months after HIV diagnosis (M12)
measure: Comparing the impact of classic and community-based HIV care on virological succes, behavioral and psychosocial outcomes
timeFrame: From enrolment (M0) to 12 months after HIV diagnosis (M12)
Other outcomes:
measure: Material and human resources available for healthcare supply around gold-mining zones
timeFrame: From enrolment (M0) to 12 months after HIV diagnosis (M12)
measure: Working conditions of healthcare professionals involved in the classic HIV care
timeFrame: From enrolment (M0) to 12 months after HIV diagnosis (M12)
Locations:
city: Kofoulaté
country: Mali
facility: ARCAD Santé PLUS mobile care unit for community-based HIV care and study follow-up (Kofoulatiè, intervention site)
state: Koulikoro
city: Kofoulaté
country: Mali
facility: ARCAD Santé PLUS mobile care unit for recruitment of participants (Kofoulatiè, Intervention site)
state: Koulikoro
city: Diassa
country: Mali
facility: ARCAD Santé PLUS mobile care unit for recruitment of participants (Diassa, control site)
state: Sikasso
city: Kolondieba
country: Mali
facility: Referral health center (CSRéf) Kolondieba, classic HIV care
state: Sikasso
Study officials:
affiliation: UMR1252 SESSTIM (INSERM, IRD, Aix Marseille Université)
name: Luis Sagaon Teyssier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ARCAD Santé PLUS
name: Bintou Dembélé Keïta, MD
role: PRINCIPAL_INVESTIGATOR
References: