About this trial
Migration is a complex phenomenon with profound health implications. Every year, more than 350,000 Ethiopian women migrate to the Middle East legally, and many others illegally, seeking domestic work. Economic crisis, rising unemployment, and internal conflict contribute to this massive migration. Nevertheless, MDWs in the Middle East are subject to overwork; mental, sexual and reproductive health challenges; and limited healthcare access. Studies on MDWs are mostly exploratory or cross-sectional; longitudinal and intervention studies are lacking. Thus, this implementation science protocol outlines a study to develop, implement, and evaluate a multi-component health intervention for Ethiopian MDWs in the Middle East. The intervention integrates peer-support, digital skills training, self-help groups, and community empowerment, guided by risk stratification and using a mobile application. A cluster randomized controlled trial (RCT) will assess the intervention's population-level impact and cost-effectiveness over 24 months. A process evaluation will run in parallel to explore mechanisms of implementation and identify strategies for better optimization.
The study has three research questions (RQs):
RQ1 - What individual and work characteristics predict psychological distress among Ethiopian MDWs in the Middle East? To address this question, a cross-sectional survey will be conducted among MDWs in selected Middle East countries using a 21-item validated psychological distress scale (Depression, Anxiety and Stress Scale \[DASS-21\] as the outcome measure.
RQ2 - What is the effectiveness and impact of INNOVETH interventions among Ethiopian MDWs in the Middle East? Under this research question, the investigators aim to conduct pre-departure assessment, baseline survey, midline evaluation, and endline evaluation of the INNOVETH implementation. Process evaluation will also be conducted as the intervention proceeds.
Pre-departure assessment: a survey will be conducted among MDWs before their departure to the Middle East countries.
Baseline assessment: a cross-sectional survey will be conducted among Ethiopian MDWs three months after they migrate to the Middle East countries.
Midline evaluation: an interim survey will be conducted after 12 months of MDWs' departure.
Impact evaluation: after 24 months of implementing the intervention, endline survey will be conducted to assess programme population-level effects.
Process evaluation: the process evaluation will document intervention implementation, perceptions of feasibility and acceptability of the intervention throughout the trial period.
RQ3 - What is the cost-effectiveness of the INNOVETH interventions Under this research question, the investigators will assess the cost-effectiveness of the INNOVETH project, including providing guidance on maximal costs for a given level of effectiveness. Cost-effectiveness will also be interpreted against relevant willingness -to-pay (WTP) thresholds to determine value for money. Further, we will also examine the overall benefits of INNOVETH intervention in terms of quality of adjusted life years.
Overall, this project aims to improve mental, sexual reproductive health of Ethiopian MDWs in the Middle East. Results will be shared via peer-reviewed journals, policy briefs, stakeholder workshops, and open-access platforms. The project period is 4 years (Nov 2025 to October 2029).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18 years and older
"Fit" to travel to the Middle East Countries including Saudi Arabia, UAE, and Qatar.
Disqualifiers
Non-domestic migrant workers
"Fit" to travel to the Middle East Countries outside Saudi Arabia, UAE, and Qatar.
Trial design
Parallel
Treatments tested in this trial
Innoveth intervention package (peer support, mobile application, educational manuals, self-help group and counseling).
BehavioralThe intervention starts with an enhanced training package of psychosocial education on resilience and mental health, comprehensive sexual and reproductive health (SRH) education, and digital literacy training to equip MDWs with access to resources and support through a mobile application in their destination. The intervention will also leverage the mobile application to deliver educational materials in text and audio formats, which will only be available for the app in the intervention group. When MDWs visit their employment agency for routine pregnancy check in 48 hours before departure, we will install the INNOVETH mobile application, provide MDWs with training on digital literacy and using the mobile application to access health education, and link them with EWs for peer support. EWs will receive an intensive one-week training to enable them to support MDWs. EW will also invite some of the MDWs to join an SHG.
Usual care
Other interventionApp similar to the intervention app but only providing information available on the "Mengede" app, pre-departure health screening and 21 days skills training.
Treatment groups
Trial outcomes
Primary outcomes
Depression, Anxiety and Stress Scale-21 item (DASS-21)
Depression, Anxiety and Stress Scale-21 item (DASS-21) measures psychological distress and depression, anxiety and stress symptoms. It has 21 items with a scale ranging from never (0) to almost always (3). It has a maximum score of 63 and a minimum score of 0. Higher score indicates worse outcome (higher distress or higher depression, anxiety and stress symptoms). It has been used prevsiously in the study population and found to be feasible, acceptable and valid.
Secondary outcomes
A self-report questionnaire to assess self-reported sexual, emotional or physical violence.
The questionnaire assesses whether or not migrant domestic workers experienced sexual, emotional or physical violence. The questionnnaire asks particiapnts whether or not they experienced sexual, emotional or physical violence, using one question for each. If particiapnts respond "Yes" to the question, then they experienced violence, if "No" they didn't experience violence. While "Yes" is a worse outcome, "No" is a better outcome.
Questionnaire to assess knowledge and attitude of migrant domestic workers on mental, sexual and reproducitve health and services
Self-reported questionnaire developed by the research team to measure the knwoledge and attitude of migrant domestic workers on mental, sexual and reprodcutive health and servcies. The knowledge section has seven items with "Yes" or "No" response categories. The tool has a maximum score of 7 and a minimum score 0. Higher score indicates higher knwoledge or better outcome. The atttitude section has 12 items with response categories ranging from strongly disgree (1) to stongly agree (5). The scale has a minimum total score of 12 and a maximum score of 60. Higher score idnicates better outcome (desirable attitude).
Questionaire to collect information on change of MDWs' employer during the two years due to conflict
Self-reported questionanire developed by the research team aimed to assess whether or not MDWs changed employer one year and two years after intervention. This is a one item questionnaire, with a "Yes" or "No" response, which asks participants, whether or not they have changed their employer one year or two after the intervention started. While "Yes" is a worse outcome "No" is a better outcome.
Locations
Sponsors and contacts
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Addis Ababa University
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborator
Oslo Metropolitan University
Collaborator
Armauer Hansen Research Institute, Ethiopia
Collaborator
St. Paul's Hospital Millennium Medical College, Ethiopia
Collaborator
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