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

NCT06989502 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2094

Last updated 2025-05-25

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

Co-creation (2016 to 2019) + Co-design (2023 to 2024)

It includes interventions implemented in a sequential way: a) The co-creation intervention (between 2016 and 2019), and b) the co-design intervention (between 2023 and 2024). In this group of sequential interventions, relevant stakeholders have already been engaged in the project and they would be familiar with the intervention components. Their participation this time will enable updating and refining the previous co-creation intervention through the co-design process. The intervention will encompass activities with the health service users and healthcare workers, in Peru, Nepal, and Mozambique

BEHAVIORAL

Co-design only (2023 to 2024)

The same intervention activities of the first group (between 2023 and 2024), but without having them involved in the previous co-creation process. In consequence, relevant stakeholders in the corresponding sites are not expected to be as engaged in the project (in contrast to the intervention that includes co-creation), and they would not be very familiar with the intervention components of COHESION-I. As in the first group, the intervention will encompass activities with the health service users and healthcare workers, in Peru, Nepal, and Mozambique

Sponsors & Collaborators

  • Eduardo Mondlane University

    collaborator OTHER
  • B.P. Koirala Institute of Health Sciences

    collaborator OTHER
  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • María Lazo-Porras, MD, MSc, PhD · Universidad Peruana Cayetano Heredia

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-17
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • Mozambique
  • Nepal
  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989502 on ClinicalTrials.gov