ANRS 12392 Sanu Gundo

NCT04482010 | Unknown

• 1 other identifier: ANRS 12392
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections

Keywords

Linkage-to-care and retention; Community-based research; Informal gold mining zones; Mali

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after HIV diagnosis (M12)

Secondary Outcomes (3)

• Extent of the HIV epidemic in the artisanal gold-mining sites

  At enrolment (M0)

• 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)

• 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)

Other Outcomes (2)

• Material and human resources available for healthcare supply around gold-mining zones

  From enrolment (M0) to 12 months after HIV diagnosis (M12)

• Working conditions of healthcare professionals involved in the classic HIV care

  From enrolment (M0) to 12 months after HIV diagnosis (M12)

Study Arms (2)

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.

Other: Local community-based HIV care

Interventions

Local community-based HIV care OTHER

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.

Community-based HIV care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• UMR 1252 SESSTIM: collaborator
• ARCAD Santé PLUS: collaborator
• SEREFO: collaborator

Study Sites (4)

ARCAD Santé PLUS mobile care unit for community-based HIV care and study follow-up (Kofoulatiè, intervention site)

Kofoulaté, Koulikoro, Mali

RECRUITING

ARCAD Santé PLUS mobile care unit for recruitment of participants (Kofoulatiè, Intervention site)

Kofoulaté, Koulikoro, Mali

RECRUITING

ARCAD Santé PLUS mobile care unit for recruitment of participants (Diassa, control site)

Diassa, Sikasso, Mali

RECRUITING

Referral health center (CSRéf) Kolondieba, classic HIV care

Kolondiéba, Sikasso, Mali

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Luis Sagaon Teyssier, PhD

  UMR1252 SESSTIM (INSERM, IRD, Aix Marseille Université)

  PRINCIPAL INVESTIGATOR

• Bintou Dembélé Keïta, MD

  ARCAD Santé PLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Sagaon Teyssier, PhD

CONTACT

+223 94 00 45 63; luis.sagaon-teyssier@inserm.fr

Aliou Kamissoko, MD

CONTACT

+223 93 00 94 53; kamissokoaliou8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 22, 2020
• Study Start: November 29, 2020
• Primary Completion: March 28, 2022
• Study Completion: December 28, 2022
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

MA (4)