Clinical trials

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).

Breast cancer patients who receive endocrine therapy particularly aromatase inhibitors often experience aromatase inhibitors associated symptoms (AIMSS) such as joint and muscle pain along with stiffness and fatigue that can disrupt with daily activities and lead some patients to stop treatment early. A structured intervention program named AIMSS-CARE (Aromatase Inhibitor-associated Musculoskeletal Symptoms-Comprehensive Adapted Rehabilitation Evaluation) developed in China that combines exercise, education, symptom monitoring, and follow-up has been shown to reduce these symptoms and improve treatment adherence. This study will adapt this program for use in Ethiopia while testing its effectiveness to enhance pain management, treatment adherence and quality of life among Ethiopian breast cancer patients receiving endocrine therapy. The study will be conducted at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia. Eighty-eight patients will be randomly assigned to either the adapted intervention program or usual care. The research will also examine the feasibility and acceptability of the intervention to patients and healthcare providers, and what factors influence its successful implementation. Results will help determine whether this program can be used more widely in Ethiopia and other African cancer centers.

The goal of this pragmatic randomized control trial is to evaluate the effectiveness of three interventions in improving follow-up adherence among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia. The interventions include structured nurse-led telephone call reminders, home-visit reminders led by health extension workers, and application-based automated SMS text reminders. The main questions it aims to answer are: * Does structured nurse-led telephone call reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care? * Does home-reminder visits led by a Health Extension Worker (HEW) improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care? * Does app-based automated SMS reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care? Structured Nurse-Led Telephone Call Reminders * Participants will receive proactive phone call reminders for scheduled follow-up visits. * The intervention includes three rounds: initially at 4 months post-recruitment, then every 4 months for HIV-negative women over a year, and every 2 months for 6 months for women living with HIV. Home-Reminder Visits Led by HEW Health Extension Workers (HEWs) will conduct door-to-door visits to remind participants of their scheduled follow-up appointments. • Door-to-door Visits will occur initially at 4 months (for HIV-negative women) and 2 months (for HIV-positive women) post-recruitment, then every 2 months for 6 months for HIV-positive and every 4 months for 12 months for HIV-negative participants. App-Based Automated SMS Reminders * Participants will receive SMS-based reminders for their follow-up visits. * The intervention consists of three rounds: initial texts at 4 months and 2 months post-recruitment for HIV-negative and HIV-positive women, respectively, followed by reminders every 2 months for 6 months for HIV-positive women and every 4 months for 12 months for HIV-negative women.

The goal of this clinical trial is to test curcumin as an adjunct treatment in patients with cervical cancer receiving standard-of-care palliative radiation. The main questions it aims to answer are: 1. Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients feasible? Is conducting this study feasible? 2. Does adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients improve therapeutic responses? 3. Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients safe? 4. How much curcumin is absorbed into the body and how long will it stay in the body? Participants will: i. Take 250 mg curcumin capsules four times per day for 4-6 weeks in addition to the prescribed palliative radiotherapy. ii. Provide blood and urine samples for laboratory tests. iii. Provide blood samples to measure curcumin levels in their body. iv. Obtain CT-scan to measure their tumor response. v. Complete questioners to measure improvements to their quality of life, if any.