Not Yet RecruitingNot Applicable

Implementation of the COmmunity HEalth System InnovatiON Project in Low- and Middle- Income Countries

Mozambique, Nepal, Peru2,094 participantsStarted 2025-05-17

Plain-language summary

The COHESION-I project will evaluate the effects of the co-creation intervention (2016 to 2019) and the co-design intervention (2023 to 2024) on improving (a) health system responsiveness, and (b) patient satisfaction, at the primary health care level, in Peru, Nepal and Mozambique, in relation to chronic diseases (hypertension, and diabetes mellitus), as well as specific neglected tropical diseases. Each intervention has been tailored to the context and characteristics of each one of the aforementioned low- and middle-income countries. For this quasi-experimental study, three arms were established: the co-creation (2016 to 2019) + co-design (2023 to 2024) arm; the co-design only (2023 to 2024) arm; and the control group (no intervention; usual care). The evaluation will be composed of four types of evaluations: quantitative; qualitative; economic; and process evaluation

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for PHC users with diabetes, hypertension, and/or NTDs: * Males or females aged 18 years and over, from the selected sites * Having used the health services in the previous three months * Diagnosis (or estimated risk) of diabetes mellitus type 2, hypertension, or neurocysticercosis * Must be able to listen to radio programs, or other audio material Inclusion Criteria for PHC users without diabetes, hypertension, and/or NTDs: * Males or females aged 18 years and over, from the selected sites * Having used the health services in the previous three months * Must be able to listen to radio programs, or other audio material Exclusion Criteria for PHC users without diabetes, hypertension, and/or NTDs: \- Diagnosis (or estimated risk) of diabetes mellitus type 2, hypertension, or neurocysticercosis The criteria mentioned above refer solely to the quantitative evaluation. For the other types of evaluation, some different populations will be included (such as healthcare workers, local authorities and other stakeholders).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Satisfaction (PS)

Timeframe: Month 1 (baseline), Month 5 (pre-intervention), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention), Month 21 (follow-up)

Health System Responsiveness (HSR)

Timeframe: Month 1 (baseline), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention)

Quality of Life (QoL)

Timeframe: Month 1 (baseline), Month 9 (pre-intervention), Month 21 (follow-up)

Trial details

NCT IDNCT06989502

SponsorUniversidad Peruana Cayetano Heredia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

María Lazo-Porras, MD, MSc, PhD

511-2416978 maria.lazo@upch.pe

View on ClinicalTrials.gov More Hypertension trials