跳至主要内容
临床试验/NCT04468724
NCT04468724Unknown不适用

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

French National Agency for Research on AIDS and Viral Hepatitis2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
2
主要终点
Change of Forced sex

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change of Forced sex

时间窗: 0, 3 months, 6 months after inclusion

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

Change of transactional sex

时间窗: 0, 3 months, 6 months after inclusion

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

Change of unprotected sex

时间窗: 0, 3 months, 6 months after inclusion

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

次要结局

  • Empowerment - HIV test(0, 3 months, 6 months after inclusion)
  • Empowerment - Social Isolation(0, 3 months, 6 months after inclusion)
  • Empowerment - TASP knowledge(0, 3 months, 6 months after inclusion)
  • Empowerment - access to healthcare structure(0, 3 months, 6 months after inclusion)
  • Empowerment - mental health score(0, 3 months, 6 months after inclusion)
  • Empowerment - HIV risk awareness(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 - self-efficacy(0, 3 months, 6 months after inclusion)

研究者

发起方
French National Agency for Research on AIDS and Viral Hepatitis
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验