HIV Infections2DM2KNCT05472051
Health and Migration Trajectories of Housekeepers in Bamako
An observational study of HIV Infections and Hepatitis B, run by ANRS, Emerging Infectious Diseases at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- HIV Infections, Hepatitis B, Hepatitis C
- What is being tested?
- Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO
- Type of treatment
- Vaccines
- How many people
- 644 participants
- Where
- 1 siteMali
- Study dates
- 28 Feb 2022to 22 Jun 2023
- Phase
- Observational
- 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Young girls working in Bamako as Housekeepers being aged at least 12 years.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health and Migration Trajectories of Housekeepers in Bamako: Situation and Acceptability of a Community-based Offer of Sexual Health Services
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.
Read more
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:
- 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.
- 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.
- 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.
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C, Tuberculosis, STIs, Sex Behavior
- Being tested
- Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO
- Keywords
- Housekeepers, Young girls, Mali, Accès to healthcare, Community-based services
- Medical subject headings
- HIV Infections, Hepatitis B, Hepatitis C, Tuberculosis, Sexually Transmitted Diseases, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGOOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 18 month after the start of the study
Pregnancy
Number of positive pregnancy tests among housekeepers accepting screening
Measured: 18 month after the start of the study
HBV Vaccin
Number of housekeepers accepting HBV vaccine among those negative to both HBV and HCV
Measured: 18 month after the start of the study
Mental health
Prevalence of mental disorders such as depression, anxiety, insomnia, post-traumatic stress
Measured: 18 month after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start28 Feb 2022
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
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.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Luis Sagaon Teyssier, PhD, Principal investigator, UMR 1252 SESSTIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472051
- Sponsor's protocol ID
- ANRS 0005s
- Acronym
- 2DM2K
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2021
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Migration Trajectories of Housekeepers in Bamako: Situation and Acceptability of a Community-based Offer of Sexual Health Services
- ClinicalTrials.gov ID
- NCT05472051
- Acronym / sponsor ID
- 2DM2K / ANRS 0005s
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C, Tuberculosis, STIs, Sex Behavior
- Keywords
- Housekeepers, Young girls, Mali, Accès to healthcare, Community-based services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 25 Jul 2022 (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.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young girls housekeepers | – | Other: Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGOMalian young girls migrating from rural areas towards Bamako to seek for a job as housekeepers. Include young girls aged at least 12 years. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young girls working in Bamako as Housekeepers being aged at least 12 years.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGOIn 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). | Other | Young girls housekeepers |
Primary outcome
Acceptability of the community-based offer of healthcare services
Time frame: 18 month after the start of the study
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)
Prevalence of infectious diseases among housekeepers attending the community-based healthcare services and accepting screening
Time frame: 18 month after the start of the study
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
Pregnancy
Time frame: 18 month after the start of the study
Number of positive pregnancy tests among housekeepers accepting screening
HBV Vaccin
Time frame: 18 month after the start of the study
Number of housekeepers accepting HBV vaccine among those negative to both HBV and HCV
Mental health
Time frame: 18 month after the start of the study
Prevalence of mental disorders such as depression, anxiety, insomnia, post-traumatic stress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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
UMR 1252 SESSTIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis B, run by ANRS, Emerging Infectious Diseases at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the community-based offer of healthcare services (time frame: 18 month after the start of the study). The study lists 5 primary outcomes in all. 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 12 Mar 2024.