Innovative Health Intervention for Ethiopian Migrant Domestic Workers in the Middle East

NCT07784023 | Not Yet Recruiting DMC

• 2 other identifiers: INNOVETH/KAME/2025318322/Z/24/Z
• Study Type: interventional
• Target: 4,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Mental Health; Sexual and Reproductive Health

Keywords

Migrant domestic worker; Health Intervention; Ethiopia; Middle East

Outcome Measures

Primary Outcomes (1)

• 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.

  DASS-21 measures overall distress and symptoms in the preceeding two weeks.

Secondary Outcomes (3)

• A self-report questionnaire to assess self-reported sexual, emotional or physical violence.

  Pre-departure, basline (2 to 3 months after depqarture, one year after departure and two years after departure.

• Questionnaire to assess knowledge and attitude of migrant domestic workers on mental, sexual and reproducitve health and services

  Pre-departure, baseline, one year from the start of the intervention and two years from the start of the intervention.

• Questionaire to collect information on change of MDWs' employer during the two years due to conflict

  One year and two years after intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants in this arm will receive the INNOVETH intervention. The intervention package includes mobile application, psychosocial education on mental health and sexual and reproductive health, peer support, self-help group and counseling by specialists.

Behavioral: Innoveth intervention package (peer support, mobile application, educational manuals, self-help group and counseling).

Control arm

OTHER

Participants in the control arm will recieve the usual care, which includes app similar to the intervention app but only providing information available on the "Mengede" app, medical screening pre-departure, and 21 day skills training before deparure.

Other: Usual care

Interventions

Innoveth intervention package (peer support, mobile application, educational manuals, self-help group and counseling). BEHAVIORAL

The 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.

Intervention arm

Usual care OTHER

App similar to the intervention app but only providing information available on the "Mengede" app, pre-departure health screening and 21 days skills training.

Control arm

Eligibility Criteria

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

You may qualify if:

• Age: 18 years and older
• "Fit" to travel to the Middle East Countries including Saudi Arabia, UAE, and Qatar.

You may not qualify if:

• Non-domestic migrant workers
• "Fit" to travel to the Middle East Countries outside Saudi Arabia, UAE, and Qatar.

Sponsors & Collaborators

• Addis Ababa University: lead
• Armauer Hansen Research Institute, Ethiopia: collaborator
• Oslo Metropolitan University: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• St. Paul's Hospital Millennium Medical College, Ethiopia: collaborator

Related Links

• This is the website for the project.

MeSH Terms

Conditions

Psychological Well-Being; Coitus

Interventions

Self-Help Groups; Counseling

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kassahun H Mekonnen, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

• Sanni M Ali, PhD

  Londond School of Hygiene and Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Kassahun H Mekonnen, PhD

CONTACT

+251911697732; kasshabmek@gmail.com

Sanni M Ali, PhD

CONTACT

+447361551207; Sanni.Ali@lshtm.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The trial is a cluster RCT. A two-arm, cluster RCT design will be used for this study to prevent information contamination (spillover effects). Cluster refers to a district, administrative and geographical migration hotspot in Ethiopia where MDWs originate. Districts will be randomised (1:1) to receive the INNOVETH intervention or standard care.

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share