MAKASI Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Paris Greater Area

NCT04468724 | Unknown

• 1 other identifier: ANRS 14056
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Immigrants from Sub-Saharan Africa are the second group most affected by HIV in France. Part of these HIV infections occurred after arrival in France, in relation to social hardships. Immigrants coming from the non-French Caribbean islands face similar difficulties. Many actors strive for an easier access to healthcare services for immigrants; however the mere supply of knowledge and medicalised solutions is not enough to make persons adopt prevention behaviours. It seems necessary to act upon empowerment to bring resources to individuals and communities in order to improve their autonomy and action capacity. Civil Society Organisations and researchers join forces in the MAKASI interventional research which aims at reinforcing immigrants' empowerment in sexual health in order to reduce their exposure to sexual risks. Objectives : The MAKASI intervention consists in a unique Empowerment interview based on the principles of motivational interviewing, using an Active Referral system to social or sanitary services relevant to the person's needs. Our hypothesis is that this intervention is going to reinforce four dimensions of empowerment in sexual health among immigrants: the capacity to express their needs, competencies in sexual, self-esteem, awareness of exposure to HIV and STIs. The proposed research aims at measuring the efficacy of the intervention on these four dimensions, and at evaluating its processes and efficiency (cost-efficacy). Methods: The intervention is delivered within the mobile units of Afrique Avenir in the public spaces where African and Caribbean populations live and work. The evaluation uses integrated mixed-method approach, combining a quantitative evaluation of impact and a qualitative research on processes. The measure of impact will be done by comparing indicators on the four dimensions of empowerment in sexual health and indicators of exposure to sexual risks, between an arm where the intervention is immediate and an arm where the intervention is differed by 3 months (control arm). The qualitative evaluation of the intervention processes will be based upon an ethnographic approach of the intervention and the participants' experience. Perspectives: This project will demonstrate the efficacy and the efficiency of an innovative intervention aiming at reducing Sub-Saharan and Caribbean immigrants' exposure to risks in sexual health.

Conditions

HIV/AIDS; STI

Keywords

Migrants; Sexual Health; Empowerment; community-based intervention; HIV prevention

Outcome Measures

Primary Outcomes (3)

• Change of unprotected sex

  Declare unprotected sex at least once during the last three months (percent)

  0, 3 months, 6 months after inclusion

• Change of transactional sex

  Declare Transactional sex at least once during the last three months (percent)

  0, 3 months, 6 months after inclusion

• Change of Forced sex

  Declare having forced to have sex at least once during the last three months (percent)

  0, 3 months, 6 months after inclusion

Secondary Outcomes (9)

• Empowerment - Social Isolation

  0, 3 months, 6 months after inclusion

• Empowerment - Ability to talk

  0, 3 months, 6 months after inclusion

• Empowerment - Health insurance

  0, 3 months, 6 months after inclusion

• Empowerment - HIV test

  0, 3 months, 6 months after inclusion

• Empowerment - TASP knowledge

  0, 3 months, 6 months after inclusion

Study Arms (2)

IMMEDIATE

EXPERIMENTAL

People who are included in the Immediate Arm receive the Makasi intervention right away or in a six-week time if they are not available on the spot

Behavioral: MAKASI

DIFFERED

OTHER

People who are included in the Differed Arm receive the Makasi intervention three months after inclusion

Behavioral: MAKASI

Interventions

MAKASI BEHAVIORAL

The Makasi intervention consists in a unique Empowerment interview, based on motivational interviewing techniques. Is is made of three components: * Listening and building trust * Active referral to structures that answers sanitary and social needs * Sexual Health Prevention Materials used are: referral letters, bilingual health guides, adapted maps of the the neighborhoods with useful addresses. The Makasi intervention is proposed and delivered in an outreach setting: health mediators propose information on general health and rapid HIV and HCV testing. They screen the people attending and propose Makasi to eligible persons.

DIFFERED; IMMEDIATE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged at least 18
• HIV negative
• Born in sub-Saharan Africa or the non-French Carribean
• At least one of the eight vulnerability criteria: no stable house, no job, food deprivation, no papers, feeling isolated, not knowing where to go to to the doctor, no health insurance, experiencing violence

You may not qualify if:

• Does not speak French or English
• Persons whose rapid HIV or HCV test is reactive
• Persons who are not able to give an informed consent: bad mental health, persons who are on drugs

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Agence Regionale de Sante d'Ile de France: collaborator

Study Sites (1)

Afrique Avenir Mobile Unit

Paris, 75003, France

RECRUITING

Related Publications (4)

• Gosselin A, Carillon S, Coulibaly K, Ridde V, Taeron C, Kohou V, Zoumenou I, Mbiribindi R, Derche N, Desgrees du Lou A; MAKASI Study Group. Participatory development and pilot testing of the Makasi intervention: a community-based outreach intervention to improve sub-Saharan and Caribbean immigrants' empowerment in sexual health. BMC Public Health. 2019 Dec 5;19(1):1646. doi: 10.1186/s12889-019-7943-2.

  PMID: 31805909 BACKGROUND

• Coulibaly K, Gosselin A, Derche N, Mbiribindi R, Desgrees du Lou A; MAKASI Study Group. Association between HIV risk perception, knowledge of biomedical prevention and sexual behaviour among sub-Saharan African immigrants living in a precarious situation in France. Sex Transm Infect. 2025 Jul 17;101(5):294-300. doi: 10.1136/sextrans-2024-056392.

  PMID: 39884844 DERIVED

• Goncalves Tasca B, Bousmah MA, Coulibaly K, Gosselin A, Ravalihasy A, Desgrees du Lou A, Melchior M; Makasi Study Group. Depression and loneliness among Sub-Saharan immigrants living in the greater Paris area: results from the MAKASI empowerment stepped wedge cluster randomised controlled trial. Soc Psychiatry Psychiatr Epidemiol. 2024 Nov;59(11):2049-2061. doi: 10.1007/s00127-024-02665-7. Epub 2024 Apr 7.

  PMID: 38584200 DERIVED

• Coulibaly K, Bousmah MA, Ravalihasy A, Taeron C, Mbiribindi R, Senne JN, Gubert F, Gosselin A, Desgrees du Lou A; MAKASI Study Group. Bridging the knowledge gap of biomedical HIV prevention tools among sub-saharan african immigrants in France. Results from an empowerment-based intervention. SSM Popul Health. 2023 Jul 23;23:101468. doi: 10.1016/j.ssmph.2023.101468. eCollection 2023 Sep.

  PMID: 37560089 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Empowerment

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Annabel Desgrées du Loû, PhD

  French Institute for Sustainable Developement (IRD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabel Desgrées du Loû, PhD

CONTACT

+33 1 76 53 34 53; annabel.desgrees@ird.fr

Anne Gosselin, PhD

CONTACT

anne.gosselin@icmigrations.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: In order to measure the impact of the intervention, we propose a two-arm essay: an intervention arm and a control arm. However, for ethical reasons, it was impossible not to offer help to all the screened persons who were in need of help for social or health reasons. That is why we will compare an arm where the intervention is immediate with an arm where the intervention is differed by three months (control arm). The comparison about what happens in the three first months will allow us to measure the impact of the intervention at three months. All participants will have a follow up of six months after the intervention. The participants will be randomly allocated to the immediate arm or the differed arm (please see below).

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 13, 2020
• Study Start: February 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)