deltatrials
Recruiting NA INTERVENTIONAL 2-arm NCT05480930

Improving Nighttime Access to Care and Treatment; Part 4-Haiti (INACT4-H)

Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology in Haiti

Sponsor: Fogarty International Center of the National Institute of Health

Updated 8 times since 2022 Last updated: Jun 26, 2025 Started: Sep 27, 2022 Primary completion: Aug 31, 2027 Completion: Sep 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05480930, this NA trial focuses on Pediatrics and Telemedicine and remains actively recruiting participants. Sponsored by Fogarty International Center of the National Institute of Health, it has been updated 8 times since 2022, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Acute respiratory infection and diarrheal disease are the two leading causes of pediatric death between 1 month and 5 years of age globally. These common problems have well-established low-cost treatments. However, these treatments are most effective when administered early which is difficult in resource-limited settings, especially at night. Based on five years of formative NIH-funded research, the team has built a Telemedicine and Medication Delivery Service (TMDS) in Haiti to improve nighttime access to care and treatment for children called MotoMeds. The strategic plan is to design, deploy and evaluate MotoMeds by conducting four clinical studies titled Improving Nighttime Access to Care and Treatment (INACT1/2/3/4) in Haiti. INACT1-H was a needs assessment (2018-2019), INACT2-H was a pre-pilot deployment of MotoMeds that compared the congruence of clinical assessments at the call-center to in-person household assessments by providers (2019-2020), and INACT3-H was a pilot of a scalable model of MotoMeds that had provider assessment only at the call-center for most non-severe cases and had provider assessment at both the call-center and household for some non-severe/ moderate cases. In addition, the central call center serviced a geographically distant delivery zone, demonstrating proof of concept for a fully scaled model. INACT4-H will evaluate a...

Acute respiratory infection and diarrheal disease are the two leading causes of pediatric death between 1 month and 5 years of age globally. These common problems have well-established low-cost treatments. However, these treatments are most effective when administered early which is difficult in resource-limited settings, especially at night. Based on five years of formative NIH-funded research, the team has built a Telemedicine and Medication Delivery Service (TMDS) in Haiti to improve nighttime access to care and treatment for children called MotoMeds. The strategic plan is to design, deploy and evaluate MotoMeds by conducting four clinical studies titled Improving Nighttime Access to Care and Treatment (INACT1/2/3/4) in Haiti. INACT1-H was a needs assessment (2018-2019), INACT2-H was a pre-pilot deployment of MotoMeds that compared the congruence of clinical assessments at the call-center to in-person household assessments by providers (2019-2020), and INACT3-H was a pilot of a scalable model of MotoMeds that had provider assessment only at the call-center for most non-severe cases and had provider assessment at both the call-center and household for some non-severe/ moderate cases. In addition, the central call center serviced a geographically distant delivery zone, demonstrating proof of concept for a fully scaled model. INACT4-H will evaluate a digital clinical decision support (dCDS) tool designed for use at a pediatric TMDS in an interrupted time series study. The pre-intervention is use of the existing paper CDS tool and the intervention is use of the dCDS tool. This initiative is significant because it uses telemedicine and medication delivery to address one of the most fundamental challenges in pediatrics early access to pediatric healthcare.

Status Flow

~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2024 · 14 months · monthly snapshotRecruiting~Jan 2024 – ~May 2024 · 4 months · monthly snapshotRecruiting~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshotRecruiting~Jul 2025 – present · 9 months · monthly snapshotRecruiting~Jan 2026 – present · 3 months · monthly snapshot

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Recruiting NA

  2. Jul 2025 — Present [monthly]

    Recruiting NA

  3. Sep 2024 — Jul 2025 [monthly]

    Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  5. May 2024 — Jul 2024 [monthly]

    Recruiting NA

Show 3 earlier versions
  1. Jan 2024 — May 2024 [monthly]

    Recruiting NA

  2. Nov 2022 — Jan 2024 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  3. Sep 2022 — Nov 2022 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fogarty International Center of the National Institute of Health
  • University of Florida
Data source: University of Florida

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations