Clinical trial NCT04468724: MAKASI Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Paris Greater Area
Official title: MAKASI. An Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Order to Reduce Their Social and Health Vulnerabilities in Paris Greater Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
STI
Keywords: Migrants
Sexual Health
Empowerment
community-based intervention
HIV prevention
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2020-07-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: Migrants from Sub-Saharan Africa are the second group most affected by HIV epidemic in France. Previous study established that part of HIV infections among Sub-Saharan migrants occurred after arrival in France, and that the exposure to sexual risks was linked both to social hardships and structural difficulties experienced during the settlement period in France. Many actors strive for an easier access to healthcare services for migrants, however the mere supply of knowledge and medicalised solutions is not enough to make persons adopt protection or healthcare practices. It seems necessary to work for the individual and community empowerment in order to bring resources to individuals and communities so they can more easily take action in the new and complex context of a host country.

To improve the prevention of sexual risks in this population coming from Sub-Saharan Africa, local charities and researchers join forces in order to propose an interventional research which aims at enabling Sub-Saharan migrants to appropriate prevention and healthcare means, especially in the area of sexual health, to reinforce their autonomy, their capacity and power to take action and to protect their health against the disruption caused by migration and the difficulty in accessing rights and fundamental needs.

The pilot phase of this research has made it possible to build an empowerment intervention which consists of a single individual interview based on the principles of motivational maintenance, articulated with an active orientation towards adequate social or health services, possibly accompanied when necessary. Our hypothesis is that this intervention will strengthen four dimensions of empowerment in sexual health among immigrants:

* Ability to express needs: Ability to talk about sexuality or sexual health to peers or professionals
* sexual health skills: know the different tools of combined prevention, know where to go for screening, gynaecology or sexual health consultation
* self-esteem: knowing your rights, having the material means (housing, administrative situation, financial resources) to refuse a situation of sexual constraint and avoid being exposed to violence, feeling that you can act on your own situation (sense of personal effectiveness)
* awareness of HIV exposure and its determinants: being informed about the epidemiology of HIV, the fact that it is possible to be infected in France, and risk factors

Objectives

To strengthen the sexual health empowerment of immigrants from sub-Saharan Africa and the Caribbean, we propose to act on the four dimensions of sexual empowerment with the following specific objectives:

Ability to express needs:

* Speaking up
* Reduce social isolation

Sexual Health Skills:

* Improve knowledge of health and social resources
* Improve access to screening
* Improve access to sexual health services (Contraception, condoms, Prep)
* Improve ownership of combined prevention

Self-esteem:

* Improve people's autonomy in social processes (housing, paper)
* Improving Mental Health: Reducing Psychological Distress and Suffering
* Improve personal efficiency

Awareness of HIV and STI exposure

• Improve perception of HIV and STI exposure, effectiveness of antiretroviral treatment and preventive strategies.

The research aims to measure the effectiveness of the intervention against all of these indicators, as well as to conduct an evaluation of the processes and efficiency (cost-effectiveness).

Methods:

The intervention is part of the action already carried out by the mobile team of Afrique Avenir, which offers in strategic places of passage (markets, squares, RER stations, etc.) an awareness of sexual health through cultural mediation and a TROD offer. The MAKASI intervention involves identifying immigrants in precarious situations and exposed to HIV in these awareness-raising places, offering them a personalized interview with a health mediator to help them prioritize their needs, and guide them through the health and welfare system.

To assess this complex intervention, we will use an integrated mixed-method approach. A quantitative impact assessment and a qualitative assessment of the processes will be conducted in parallel to establish, by integrating these data, the causal attribution of the effects of the intervention.

Quantitative assessment of impact:

To measure the impact of the intervention, we propose a two-arm diagram: an intervention arm and a control arm. However, for ethical reasons, in order to offer help to all identified people with social or health needs, we will compare an arm where the intervention is immediate, and an arm where it is delayed by 3 months (control arm). The comparison of what happens in the first three months will measure the short-term effect of the intervention, and establish a causal link between the intervention and the observed changes. All people, in both arms, will be followed six months to observe the evolution of the indicators in the medium term. The impact assessment of the intervention will be made possible both by comparison between the immediate intervention arm and the control arms in the first three months, and by comparison before/after the intervention in both arms). Individuals will be randomly allocated to the immediate or delayed intervention arm after an initial interview to identify social and health needs. The goal is to include 1200 people (600 in each arm).

Qualitative assessment of processes and effects:

The qualitative analysis of the processes aims to highlight and analyse the successes, failures and limitations of the intervention, with particular regard to the implementation and its effects. It will also be necessary to produce knowledge on the conditions of reproduction or the extension of the intervention. This analysis will be based on an ethnographic approach to the intervention and the participants' journey, with a work of observation of the different stages and in-depth and repeated semi-directive interviews.

Cost collection will measure the efficiency of the response.

Expected results :

This project will demonstrate the effectiveness and efficiency of an innovative intervention to reduce exposure to sexual health risks among immigrants from sub-Saharan Africa and the Caribbean, and will highlight the conditions of its reproduction or extension. It is closely linked to the initiative towards Paris without AIDS, which develops the collective dimensions of empowerment through different approaches in the communities concerned.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of unprotected sex
timeFrame: 0, 3 months, 6 months after inclusion
measure: Change of transactional sex
timeFrame: 0, 3 months, 6 months after inclusion
measure: Change of Forced sex
timeFrame: 0, 3 months, 6 months after inclusion
Secondary outcomes:
measure: Empowerment - Social Isolation
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - Ability to talk
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - Health insurance
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - HIV test
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - TASP knowledge
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - mental health score
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - self-efficacy
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - HIV risk awareness
timeFrame: 0, 3 months, 6 months after inclusion
measure: Empowerment - access to healthcare structure
timeFrame: 0, 3 months, 6 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Afrique Avenir Mobile Unit
Study officials:
affiliation: French Institute for Sustainable Developement (IRD)
name: Annabel Desgrées du Loû, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.