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CompletedNCT07603297CAMPSPlusUpdated May 28, 2026

Identifying Essential Elements of SAP Supports

An interventional study of Case Management Supports in Rheumatic Heart Disease in Children and Heart Disease, Valvular, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in Uganda. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Aug 2024, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
335
Allocation
Non-randomized
Ages
5 Years to 20 Years
Sex
All
01

Study summary

CAMPS Plus is a non-randomized extension cohort to assess the non-inferiority of a case manager only (CM) intervention when compared to case manager plus peer support group (CM+PG) to support secondary antibiotic prophylaxis (SAP) adherence in children with RHD

Read the detailed description

The objective of CAMPS Plus is to determine the minimum intervention needed to achieve secondary antibiotic prophylaxis (SAP) adherence for children newly diagnosed with rheumatic heart disease to further increase affordability and feasibility at scale.

Aim 1: Determine the difference in 1-year SAP adherence rates of children newly diagnosed with RHD in Uganda receiving one of two support strategies: case manager only (CM) and case manager plus peer support group (CM + PG).

Aim 2: Explore implementation determinants among case managers, participants, and participant families to inform deployment of program at scale.

02

Conditions studied

  • Rheumatic Heart Disease in Children
  • Heart Disease, Valvular

Keywords

  • rheumatic heart disease
  • secondary antibiotic prophylaxis
  • adherence
  • community health workers
03

In context

Heart Valve Diseases

535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.

This study's enrollment of 335 is above the median of 100 across 291 interventional studies indexed under Heart Valve Diseases.

Browse Heart Valve Diseases studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between the ages of 5-20 years
  2. Have a diagnosis of RHD detected through school-based screening echocardiography

Exclusion criteria

Exclusion Criteria:

  1. Medical contraindication to SAP (e.g., bleeding risk, allergy)
  2. Co-morbid conditions that have already resulted in prescription of SAP (e.g., HIV, sickle cell disease, renal disease)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
335 participants (actual)

Study arms

  • Other
    Case Manager Only Intervention

    For this study, ALL participants will be assigned the same prophylaxis support strategy which consists of a calendar of injection dates plus assignment of a case manager who sends weekly text messages, reminder calls prior to scheduled penicillin injections, and home visits as needed. There will be 3 different cohorts based on their prior experience with prophylaxis supports as follows: Cohort 1: Children 5-20 years old that participated in the CAMPS trial between August 2022 and August 2023 and were randomized to enhanced supports (case manager plus peer group, CM+PG) intervention Cohort 2: Children 5-20 years old that participated in the CAMPS trial between August 2022 and August 2023 and were randomized to standard care (injection tracking booklet and referral to health center) intervention. Cohort 3: A prospectively recruited cohort drawn from school-based echocardiography screening who are generally comparable in age and sex distribution to the original CAMPS trial

    Behavioral: Case Management Supports

Interventions

  • BehavioralCase Management Supports

    Participants will be assigned a community case manager who will provide case management support which will include a calendar of injection dates, weekly text messages, reminder call prior to scheduled penicillin injections, and home visits as needed

06

What researchers measure

Primary outcomes

  1. Percent Secondary Antibiotic Prophylaxis Adherence

    continuous measure of days of antibiotic coverage, assuming one injection provides coverage for 28 days

    Time frame: 12 months

07

Study locations

1 site
  • Uganda Heart Institute
    Tororo, Uganda
08

References and documents

Individual participant data

Plan to share: Undecided — Only deidentified information would be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07603297
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Uganda Heart Institute
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Aug 21, 2024
Primary completion
Sep 27, 2025
Completion
Sep 27, 2025
Last update
May 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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