Condition category
Not Applicable
Date applied
15/02/2019
Date assigned
17/06/2019
Last edited
17/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Homelessness and housing instability in the migrants’ host countries are central features of the experience of migration to the European Union (EU). In the Paris region many migrant individuals and families are housed by the generic housing system for the homeless, in emergency housing facilities including social hotels. Across the EU, migrant women encounter obstacles in accessing healthcare services. However, little is known on the health and access to healthcare services for migrant women in emergency housing in France, especially on sexual and reproductive health.

The DSAFHIR project aimed to better describe the risks faced by migrant and refugee women in situations of administrative and social vulnerability, to analyze the barriers to access healthcare and specifically sexual healthcare, and to test the implementation of specific outreach health-promoting interventions.

Who can participate?
Migrant women aged 18 years or more housed in one of the fifteen surveyed hotels were invited to participate to the survey and to the subsequent health interventions.

What does the study involve?
The study involved a primary survey administered in the hotels where participants were housed. The survey investigated participants’ background, migration path, living conditions since arrival in France, general health status, reproductive health history, access to healthcare and utilization of healthcare services in France and life-long experience of violence. After the survey and when they consented, participants were allocated to one of three health-promoting interventions, based on the hotel where they lived. In the first intervention (control intervention), participants only received written information on local available service providers. The second intervention was individual health counselling: community health workers spent six weeks in the hotels and offered one-on-one sexual health promotion and prevention counselling. The third intervention was group health counselling: community health workers facilitated group sessions focused on sexual health issues and made space for the participants to come up with topics of concern. The general objectives of both interventions were to bring information on sexual health and local service providers to participants, to break the social isolation of hotel residents by bringing women together, and to foster the circulation of information among women residents on health-promotion topics and access to service providers.

Our hypothesis was that such outreach interventions involving community health workers coming to the places where participants lived would have more impact on health care access than only giving written information on where to find service providers. To test this hypothesis, we needed to measure healthcare access and utilization of participants after the interventions took place. Eight months after the initial survey, we reached out to the participants and administered a second survey to those willing to participate. In this second survey, we asked participants about their access and utilization of healthcare services since the last survey, and we asked their opinion on the health-promoting interventions and what could be done to improve them.

What are the possible benefits and risks of participating?
Participants were given a 25-euro voucher to compensate for their time after completing the initial survey, and after completing the second survey. They didn’t receive any compensation for joining in the health-promoting interventions. Participants were informed from the start that participating or not participating in the survey would by no means impact their housing situation, either positively or negatively.

Where is the study run from?
The study research center was the CRIDUP (Institute of Demography research center) at University Paris 1 Pantheon Sorbonne. The study (surveys and interventions) were run at the fifteen hotels where participants were housed. To protect the anonymity of the respondents, hotels name and addresses can not be disclosed.

When is the study starting and how long is it expected to run for?
The start date of the study was 01/09/2016 and it ended on 14/03/2018.

Who is funding the study?
The main funder was Agence Nationale de la Recherche, French National Agency for Research (ANR). Secondary funders were Fondation Sanofi Espoir, Fondation Macif and HRA Pharma.

Who is the main contact?
Dr Armelle Andro
Armelle.andro@univ-paris1.fr

Trial website

https://dsafhir.hypotheses.org/

Contact information

Type

Public

Primary contact

Ms Lorraine Poncet

ORCID ID

Contact details

IDUP - Université Paris 1 Pantheon Sorbonne
90 rue de Tolbiac
Paris
75013
France
(+33) 01 44 07 86 52
lorraine.poncet@univ-paris1.fr

Type

Scientific

Additional contact

Dr Armelle Andro

ORCID ID

Contact details

IDUP - Université Paris 1 Pantheon Sorbonne
90 rue de Tolbiac
Paris
75013
France
(+33) 01 44 07 86 52
armelle.andro@univ-paris1.fr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ANR-16-FASI-0004-01

Study information

Scientific title

The impact of sexual health counselling outreach interventions on primary care access and utilization for migrant women housed in emergency housing hotels – DSAFHIR research project

Acronym

DSAFHIR

Study hypothesis

Primary care access and utilization can be improved with health-promoting outreach interventions, taking place where migrant women are housed. Furthermore, such interventions have more impact on access to care than distribution of written information concerning available local health care providers and services.

Ethics approval

Approved 30/03/2017, Committee for the Protection of Individuals West N°6 (Centre hospitalier universitaire Cavale Blanche – Avenue Tanguy Prigent – 29609 Brest Cedex; 02 98 34 25 80; cpp.ouest6@chu-brest.fr), ref: 2016-A02005-46.

Study design

Interventional, multi-centre, non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Healthcare access and utilisation

Intervention

The interventions took place after an initial survey administered in the hotels where participants were housed. When they consented, participants were allocated to one of three health-promoting interventions: individual health counselling, group health counselling or written information on local healthcare providers and services (control intervention).

Each hotel was allocated to one intervention, therefore all the participants residing in one hotel were offered to participate in the intervention implemented in this hotel.

Individual health counselling: In this intervention, community health workers reached out to participants and offered one-on-one sexual health promotion and prevention counselling. The community health workers were present in three hotels for six weeks, had one or several counselling sessions with available participants. They could help participants make appointments with service providers, and occasionally accompany participants to a specific appointment. The goals were to bring information on sexual health and local service providers to participants, allow an in-depth exchange on these topics with participants individually, and help to untangle problematic situations.

Group health counselling: In this intervention, group health counselling sessions were organized in three hotels. Volunteers from the Family Planning Association facilitated the groups and invited all resident participants to join. The group sessions focused on sexual health issues and made space for participants to come up with topics of concern. The goals were to bring information on sexual health and local service providers to participants, to break the social isolation of hotel residents by bringing women together, and to foster the circulation of information among women residents on health-promotion topics and access to service providers. The sessions took place once a week for six weeks, in a room in the common area of the designated hotels. In one hotel, the common area having no door, the discretion of the exchanges couldn’t be assured, therefore the group sessions took place in the city’s family planning building next door to the hotel.

Written information (control intervention): After the administration of the initial survey, all participants were given a leaflet with written information on local medical and non-medical service providers in their area. It included contact details, addresses, itinerary using public transportation and pictograms to make it more accessible to participants who didn’t read or didn’t read French.

The goal of these interventions was to assess whether outreach public health interventions involving community health workers in the place of residence, whether individually or in group, had a positive impact on the participants’ healthcare access and utilization. It was compared to receiving only written information.

Each intervention lasted for six weeks. As they were initiated in different locations directly following the administration of the first survey, they were not initiated simultaneously everywhere. Their implementation stretched from May to July 2017. The participants were not contacted again until the onset of the second survey in January 2018.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Health care access is measured through survey questions at baseline and at 8 months.

Secondary outcome measures

Acceptability of the interventions is measured through survey questions at 8 months in the second survey.

Overall trial start date

01/09/2016

Overall trial end date

14/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Housed in the surveyed hotel
2. Born outside of France and not French at birth
3. Identify as a woman
4. Aged ≥18

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

N/A

Recruitment start date

10/04/2017

Recruitment end date

24/05/2017

Locations

Countries of recruitment

France

Trial participating centre

CRIDUP Institute of Demography research center - University Paris 1 - Pantheon Sorbonne
90 rue de Tolbiac
Paris
75013
France

Sponsor information

Organisation

CRIDUP Institute of Demography Research Center at University Paris 1 Pantheon Sorbonne

Sponsor details

90 rue de Tolbiac
Paris
75013
France
(+33) 01 44 07 86 46
idup@univ-paris1.fr

Sponsor type

University/education

Website

https://www.pantheonsorbonne.fr/ufr/idup/

Organisation

Observatoire du Samusocial de Paris

Sponsor details

40 avenue Philippe Auguste
Paris
75013
France
(+33) 01 43 71 13 22
f.riou@samusocial-75.fr

Sponsor type

Research organisation

Website

https://www.samusocial.paris/lobservatoire

Organisation

Pantheon-Sorbonne University

Sponsor details

Sponsor type

Not defined

Website

http://www.univ-paris1.fr/

Funders

Funder type

Industry

Funder name

Agence Nationale de la Recherche

Alternative name(s)

French National Research Agency, ANR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

France

Funder name

Fondation Sanofi Espoir

Alternative name(s)

Sanofi Espoir Foundation, THE SANOFI ESPOIR FOUNDATION, La Fondation Sanofi Espoir

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

France

Funder name

Fondation Macif

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

HRA Pharma

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/06/2019: The protocol has been uploaded as an additional file (not peer-reviewed). 28/02/2019: Trial's existence confirmed by the Sanofi Espoir Foundation.