HIV InfectionsSANU GUNDONCT04482010
ANRS 12392 Sanu Gundo
A study testing Local community-based HIV care in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 4 sites in Mali.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Local community-based HIV care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 4 sitesMali
- Study dates
- 29 Nov 2020to 28 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Mali4 sites, 4 recruiting
- Recruiting
ARCAD Santé PLUS mobile care unit for recruitment of participants (Diassa, control site)
Diassa, Sikasso
To be recruited To be recruited, MD
Fodié Diallo, MD
- Recruiting
ARCAD Santé PLUS mobile care unit for community-based HIV care and study follow-up (Kofoulatiè, intervention site)
Kofoulaté, Koulikoro
Zoumana Diarra, MD, +223 79 26 51 89, zoumanadiarra72@gmail.com
- Recruiting
ARCAD Santé PLUS mobile care unit for recruitment of participants (Kofoulatiè, Intervention site)
Kofoulaté, Koulikoro
Zoumana Diarra, MD, +223 79 26 51 89, zoumanadiarra72@gmail.com
Zoumana Diarra, MD
- Recruiting
Referral health center (CSRéf) Kolondieba, classic HIV care
Kolondiéba, Sikasso
Mamoutou Diarra, MD, +223 76 33 58 56
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Local community-based HIV care
- Keywords
- Linkage-to-care and retention, Community-based research, Informal gold mining zones, Mali
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local community-based HIV careOther
Compared to the classic HIV care, community-based HIV care includes:
- Individual interviews with a psychosocial agent;
- Support groups conducted by psychosocial agents;
- Culinary workshops gathering PLWHIV and healthcare professionals;
- Home visits by a community worker;
- Emergency relief based on a funding for patients with urgent needs
As in the classic HIV care, ARCAD Santé PLUS provides consultations with doctors, prescriptions and delivery of antiretroviral (ARV) treatment every 3 months, biological analyses for enrolment, and follow-up every 6 months. In addition, psychosocial agents from ARCAD Santé PLUS propose workshops on education and support for adherence to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Classic HIV care | No intervention | Participants diangosed HIV positive at the time of the community-based activities conducted by ARCAD Santé PLUS. They will be referred to the referral centers (CSRéf) for the classic HIV care in the Malian public health system. |
| Community-based HIV care | Other | Participants diagnosed HIV positive at the time of the community-based activities by ARCAD Santé PLUS. They will receive community-based HIV care by the NGO at the gold-mining site. Receives: Other: Local community-based HIV care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lost to follow-up rate 12 months after the HIV diagnosis
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.
Measured: 12 months after HIV diagnosis (M12)
Secondary outcomes (3)
Extent of the HIV epidemic in the artisanal gold-mining sites
This outcome provides the prevalence of the HIV epidemic among people living/working in the artisanal gold-mining sites:
number of HIV positive tests as percentage of the total number of people living/working in the sites
Measured: At enrolment (M0)
Comparing linkage-to-care and retention between classic and community-based HIV care
For linkage-to-care:
Percentage of people living with HIV starting a treatment 1 month and 3 months after diagnosis
Percentage of people living with HIV with available blood tests (CD4 count, Viral load, etc) at the beginning of ARV treatment
For retention in care:
% of people living with HIV present for HIV care visits at 3, 6, 9 and 12 months after diagnosis
Measured: 1 month after HIV diagnosis (M1) and 12 months after HIV diagnosis (M12)
Comparing the impact of classic and community-based HIV care on virological succes, behavioral and psychosocial outcomes
CD4 count and viral load at the time of diagnosis (M0) and its evolution 6 and 12 months later (M6 and M12)
Self-perception of health status, sexual behavior indicators at M1 and evolution at M12: number of partners, number of sexual intercourses, etc.
Measured: From enrolment (M0) to 12 months after HIV diagnosis (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start29 Nov 2020
- Primary completion28 Mar 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- UMR 1252 SESSTIM, ARCAD Santé PLUS, SEREFO
- Responsible party
- Sponsor
- Investigators
- Luis Sagaon Teyssier, PhD, Principal investigator, UMR1252 SESSTIM (INSERM, IRD, Aix Marseille Université)Bintou Dembélé Keïta, MD, Principal investigator, ARCAD Santé PLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482010
- Sponsor's protocol ID
- ANRS 12392
- Acronym
- SANU GUNDO
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04482010
- Acronym / sponsor ID
- SANU GUNDO / ANRS 12392
- Conditions
- HIV Infections
- Keywords
- Linkage-to-care and retention, Community-based research, Informal gold mining zones, Mali
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- UMR 1252 SESSTIM, ARCAD Santé PLUS, SEREFO
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 28 Mar 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Classic HIV care | No intervention | –Participants diangosed HIV positive at the time of the community-based activities conducted by ARCAD Santé PLUS. They will be referred to the referral centers (CSRéf) for the classic HIV care in the Malian public health system. |
| Community-based HIV care | Other | Other: Local community-based HIV careParticipants diagnosed HIV positive at the time of the community-based activities by ARCAD Santé PLUS. They will receive community-based HIV care by the NGO at the gold-mining site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local community-based HIV careCompared to the classic HIV care, community-based HIV care includes: * Individual interviews with a psychosocial agent; * Support groups conducted by psychosocial agents; * Culinary workshops gathering PLWHIV and healthcare professionals; * Home visits by a community worker; * Emergency relief based on a funding for patients with urgent needs As in the classic HIV care, ARCAD Santé PLUS provides consultations with doctors, prescriptions and delivery of antiretroviral (ARV) treatment every 3 months, biological analyses for enrolment, and follow-up every 6 months. In addition, psychosocial agents from ARCAD Santé PLUS propose workshops on education and support for adherence to treatment. | Other | Community-based HIV care |
Primary outcome
Lost to follow-up rate 12 months after the HIV diagnosis
Time frame: 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.
3 secondary outcomes
Extent of the HIV epidemic in the artisanal gold-mining sites
Time frame: At enrolment (M0)
Comparing linkage-to-care and retention between classic and community-based HIV care
Time frame: 1 month after HIV diagnosis (M1) and 12 months after HIV diagnosis (M12)
Comparing the impact of classic and community-based HIV care on virological succes, behavioral and psychosocial outcomes
Time frame: From enrolment (M0) to 12 months after HIV diagnosis (M12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Sagaon Teyssier, PhD principal investigator
UMR1252 SESSTIM (INSERM, IRD, Aix Marseille Université)
Bintou Dembélé Keïta, MD principal investigator
ARCAD Santé PLUS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local community-based HIV care in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 4 sites in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Sagaon Teyssier, PhD (+223 94 00 45 63, luis.sagaon-teyssier@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lost to follow-up rate 12 months after the HIV diagnosis (time frame: 12 months after HIV diagnosis (M12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.