NCT05472051

Brief Summary

In Mali, migration from rural zones is a cultural phenomenon existing since 1970. During the dry season (9 months), an important number of young women leave their villages and migrate towards urban zones to seek for a job. In Bamako, the estimated number of housekeepers is 100 000 coming from rural regions and aged between 11 and 19 years. The current healthcare offer seems to be non-adapted to their particularities. This is a community-based research constructed on the basis of the activities of two NGOs in Mali: ADDAD (association for the defense of the rights of Housekeepers and domestic helpers ) and ARCAD Santé PLUS (the main NGO for healthcare access for HIV, hepatitis, and sexual health services). The research is conducted by the SanteRCom team in the UMR1252 SESSTIM research unit. The main objective of this observational study is to study the knowledge, beliefs, behaviors and practices in terms of health in general, and sexual health in particular; and to assess the acceptability of an offer of community-based prevention and health services provided by ARCAD Santé PLUS integrated in the activities of ADDAD. The integrating of community-based healthcare offer in a familiar and reassuring framework, such as that of ADDAD, should promote access to health services among housekeepers. The research is organized in 3 stages:

  1. 1.Preliminary qualitative survey based on focus group discussions. Allowing the identification of the housekeepers' needs in terms of prevention and healthcare services; and the behavioral particularities of the housekeepers community. It is planned to conduct 7 focus groups including between 42 and 56 housekeepers.
  2. 2.Communication and awareness campaigns in the regions of origin of housekeepers. Campaigns will be constructed on the basis of the results obtained from the preliminary qualitative survey.
  3. 3.Communication and awareness campaigns in Bamako; community-based activities for housekeepers will be organized 3 times per week during 5 months by the NGO ADDAD. Activities will include the community-based offer of prevention and healthcare services provided by the NGO ARCAD Santé PLUS, i.e. the novelty in the ADDAD's activities. A quantitative and qualitative surveys will be conducted over 5 months with participants recruited during the community-based activities. It is expected to enroll at least 1134 housekeepers, and to conduct a maximum of 25 individual interviews with selected housekeepers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
644

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

September 13, 2021

Last Update Submit

March 11, 2024

Conditions

Keywords

HousekeepersYoung girlsMaliAccès to healthcareCommunity-based services

Outcome Measures

Primary Outcomes (5)

  • Acceptability of the community-based offer of healthcare services

    Percentage of housekeepers attending the community-based healthcare services during the ADDAD's activities (among the total number of housekeepers attending the ADDAD's activities)

    18 month after the start of the study

  • Prevalence of infectious diseases among housekeepers attending the community-based healthcare services and accepting screening

    Prevalence of infectious diseases among housekeepers attending the community-based healthcare services and accepting screening: Percentage of HIV positive Percentage of HBV positive Percentage of HCV positive Percentage of TB POSITIVE Percentage of genital infectious diseases

    18 month after the start of the study

  • Pregnancy

    Number of positive pregnancy tests among housekeepers accepting screening

    18 month after the start of the study

  • HBV Vaccin

    Number of housekeepers accepting HBV vaccine among those negative to both HBV and HCV

    18 month after the start of the study

  • Mental health

    Prevalence of mental disorders such as depression, anxiety, insomnia, post-traumatic stress

    18 month after the start of the study

Study Arms (1)

Young girls housekeepers

Malian young girls migrating from rural areas towards Bamako to seek for a job as housekeepers. Include young girls aged at least 12 years.

Other: Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO

Interventions

In the framework of the current activities of the ARCAD Santé PLUS a team formed by a doctor, a nurse and laboratory assistant will provide prevention and medical activities during the community-based activities organized by the housekeepers ADDAD NGO. The medical consultation will propose: * HIV screening, including pre- and post- counseling * Hepatitis B and hepatitis C screening, including pré- and post- counseling. The HBV vaccine will be proposed to housekeepers with negative results to both HBV and HCV testing * Tuberculosis screening will be proposed to housekeepers with symptoms suggesting the possibility of TB * For housekeepers sexually active, the medical team will propose a gynecological test in order to screen for genital infections. Furthermore, a pregnancy test will be proposed. Medicines for current diseases (headache, diarrhea, etc. will be provided by the medical staff).

Young girls housekeepers

Eligibility Criteria

Age12 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsYoung girls working in Bamako as housekeepers (not self-representation)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Young girls working in Bamako as Housekeepers being aged at least 12 years.

You may qualify if:

  • Being a young girl and working in Bamako as housekeeper
  • Speak one of the most current languages : Bambara, Dogon, French
  • Being aged at least 12 years,
  • To provide written consent. For minors (12 to 17 years old) the consent of a member of the ADDAD NGO as the legal responsible.

You may not qualify if:

  • Minor housekeepers refusing the presence and signature of the ADDAD's member
  • Housekeepers whose mental health would be judged (by the doctor) not appropriate to participate
  • Housekeepers not able to understand and/or to sign the written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADDAD

Bamako, Niamakoro, Sièbougouni, Rue 173, Porte 146, Commune VI, Mali

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis BHepatitis CTuberculosisSexually Transmitted DiseasesSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Luis Sagaon Teyssier, PhD

    UMR 1252 SESSTIM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

July 25, 2022

Study Start

February 28, 2022

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations