NCT07248462

Brief Summary

Background Neglected Tropical Diseases (NTDs) are a group of diseases that are more common among the poorest people in the poorest countries. People affected by these conditions often experience pain, changes in their physical appearance, stigma and discrimination. As a result, they are more likely to experience mental distress including depression and anxiety. It is important that people affected by these conditions are found early, so that they can start treatment to stop the progression of the condition and to support their mental wellbeing. The World Health Organisation recently developed guidance that explains more about including mental health awareness and care as part of the management of people who have these conditions. This is called the Essential Care Package for NTDs, Stigma and Mental Health Conditions. However, so far there has been limited research about 'what works' when providing this package to people who need it. Aim of the study Through this study, we aim to understand 'How can the health system in Ghana provide the essential care package for people affected by skin NTDs for large groups of the population (at scale)?; and how to do this in a way that means everyone can access it (that is fair) and that is effective (works well)?' Methods/ Design In order to do this, we will develop a Ghanaian version of the Essential Care Package and associated resources to support its implementation. We will do this by including people affected by NTDs to help us understand the needs and priorities from their perspective. Working together with researchers, health workers and those who make decisions about health, people affected will be supported to identify their priorities and to take part in developing what will be included in this Ghanaian ECP. This will happen by using creative forms of research that encourage people to participate and through the process, with workshops to include their opinions scheduled throughout. Once this has been developed the Government will then start to introduce the Ghanaian ECP in selected study districts. At the same time, we will monitor and evaluate what is happening to understand what parts work well? who they work best for? in what settings? and for how long? We will carry out different types of research to understand who has access to this new package of services? (how fair is it?), how well it works? How the health workers and health system take up and use the new ECP? How the new ECP is rolled out and introduced as part of the health system? And whether it can be maintained and continue beyond the end of the study? Discussion Through this study, we hope that people affected by NTDs and mental health conditions will be able to access and use quality health services when they need them; that communities will have a better understanding about NTDs and mental health conditions; and that government departments will work better together to provide care for NTDs and mental health conditions together.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Nov 2025Feb 2027

Study Start

First participant enrolled

November 1, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Depression

    Depression as measured by PHQ-9

    From enrolment to the end of the intervention period 12 months later

  • anxiety

    Anxiety as measured by GAD-7

    From enrolment until end of intervention period 12 months later

  • Mental wellbeing

    Mental wellbeing as measured by Warwick mental wellbeing scale

    From enrolment until end of intervention period 12 months later

Secondary Outcomes (3)

  • Quality of Life

    From enrolment until end of intervention period 12 months later

  • Participation

    From enrolment until end of intervention 12 months later

  • Stigma

    Enrolment - end of intervention period 12 months later

Study Arms (1)

Persons affected by NTDs

EXPERIMENTAL

Persons affected by NTDs in 4 areas in Ghana (Ho, Hohoe, Bole and Ellembele)

Other: WHO Essential Care package for mental health and NTDs

Interventions

Participants will receive integrated mental health and NTD care, following the WHO essential care package, using a stepped-care model with interventions at different levels of the health system. There will be population and community-level initiatives (e.g. peer support groups, awareness raising), decentralised management of patients including health worker capcity strenghtening (e.g. mhGAP, screening as part of routine care), and referral into secondary or tertiary care.

Persons affected by NTDs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Affected by one of the target NTDs (leprosy, LF, buruli Ulcer, Yaws, Onchocersiasis)
  • Living in one of the intervention areas (Bole, Ho, Hohoe, Ellembele)
  • Aged 18 years and above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

LeprosyElephantiasis, FilarialBuruli UlcerOnchocerciasisYaws

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsFilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesMosquito-Borne DiseasesVector Borne DiseasesLymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, ParasiticSkin Diseases, InfectiousTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsSkin Diseases, Bacterial

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11