NCT05533736

Brief Summary

An effectiveness-implementation sequential explanatory hybrid design type 2 was performed in two rural communities of Colombia. A quasi-experimental study with historical control (standard of care) was designed to estimate the effectiveness of community-based intervention using the Guaral+ST mobile application (app). Three implementation outcomes were evaluated: acceptability and usability by qualitative methods, and fidelity by quantitative methods

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

September 1, 2022

Last Update Submit

September 7, 2022

Conditions

Cutaneous Leishmaniasis, American

Outcome Measures

Primary Outcomes (4)

  • The effectiveness of community-based intervention using the Guaral+ST mobile application was evaluated by four outcomes: i. The number of follow-ups

    The number of follow-up contacts between patients and health system or community health workers.

    6 months

  • ii. Percent adherence to treatment

    Relation between the number of doses administrated and the number of doses formulated by the physicians x 100.

    6 months

  • iii. Adverse drug reactions

    Frequency of adverse drug reactions: number of adverse drug reactions

    6 months

  • iv. Therapeutic response

    * Cure: Completely re-epithelialised lesions on days 90 -180 after initiation of treatment * Failure: \>50% increase in ulcer size from baseline at any time during evaluation or incomplete re-epithelialised on days 90-180

    6 months

Secondary Outcomes (3)

  • Implementation of the community-based strategy to follow patients with cutaneous Leishmaniasis was evaluated by three outcomes. i. Acceptability

    6 months

  • ii. Usability

    6 months

  • iii. Fidelity

    6 months

Study Arms (2)

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

EXPERIMENTAL

Patients with cutaneous leishmaniasis are followed with the Guaral+ST app by Community Health Leaders. This intervention was not randomized

Other: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Control group: Standard of care

NO INTERVENTION

Control group: Standard of Care: Registers historical patients with cutaneous leishmaniasis is followed in the health facility by physicians according to national guidelines.

Interventions

Community based strategy to follow-up pactientes with Cutaneous LeishmaniasisOTHER

Community Health leaders follow patients using the Guaral+ST app at final of treatment, and on days 90 and 180 after initiating the treatment.

Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients followed by CHL with the app (effectiveness evaluation):
  • Diagnosis confirmed by microscopy of tissue smear or culture
  • Any age and gender
  • Medical prescription for antileishmanial treatment
  • Approved and signed informed consent
  • Availability of CHL to monitor treatment of the patients in the community
  • Clinical records of patients with confirmed CL at most two years prior to the start of this study
  • Any age and gender
  • Received antileishmanial treatment based on national guidelines
  • Residents of the rural areas of study sites
  • Voluntary participation in the monitoring of patients using the mobile app

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, 5930, Colombia

Location

Related Publications (7)

  • Navarro A, Rubiano L, Arango JD, Rojas CA, Alexander N, Saravia NG, Aronoff-Spencer E. Developing mobile health applications for neglected tropical disease research. PLoS Negl Trop Dis. 2018 Nov 1;12(11):e0006791. doi: 10.1371/journal.pntd.0006791. eCollection 2018 Nov.

    PMID: 30383809BACKGROUND

  • Carrion C, Robles N, Sola-Morales O, Aymerich M, Ruiz Postigo JA. Mobile Health Strategies to Tackle Skin Neglected Tropical Diseases With Recommendations From Innovative Experiences: Systematic Review. JMIR Mhealth Uhealth. 2020 Dec 31;8(12):e22478. doi: 10.2196/22478.

    PMID: 33382382BACKGROUND

  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PMID: 22310560BACKGROUND

  • Olliaro P, Grogl M, Boni M, Carvalho EM, Chebli H, Cisse M, Diro E, Fernandes Cota G, Erber AC, Gadisa E, Handjani F, Khamesipour A, Llanos-Cuentas A, Lopez Carvajal L, Grout L, Lmimouni BE, Mokni M, Nahzat MS, Ben Salah A, Ozbel Y, Pascale JM, Rizzo Molina N, Rode J, Romero G, Ruiz-Postigo JA, Gore Saravia N, Soto J, Uzun S, Mashayekhi V, Velez ID, Vogt F, Zerpa O, Arana B. Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. PLoS Negl Trop Dis. 2018 Jan 12;12(1):e0006141. doi: 10.1371/journal.pntd.0006141. eCollection 2018 Jan.

    PMID: 29329311BACKGROUND

  • Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

    PMID: 20957426BACKGROUND

  • Agarwal S, Perry HB, Long LA, Labrique AB. Evidence on feasibility and effective use of mHealth strategies by frontline health workers in developing countries: systematic review. Trop Med Int Health. 2015 Aug;20(8):1003-14. doi: 10.1111/tmi.12525. Epub 2015 May 14.

    PMID: 25881735BACKGROUND

  • Mieras LF, Taal AT, Post EB, Ndeve AGZ, van Hees CLM. The Development of a Mobile Application to Support Peripheral Health Workers to Diagnose and Treat People with Skin Diseases in Resource-Poor Settings. Trop Med Infect Dis. 2018 Sep 15;3(3):102. doi: 10.3390/tropicalmed3030102.

    PMID: 30274498BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Mucocutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis, CutaneousLeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 9, 2022

Study Start

March 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)