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Identifying Essential Elements of SAP Supports

Identifying the Essential Elements of Case Managers and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07603297
Acronym
CAMPSPlus
Enrollment
335
Registered
2026-05-22
Start date
2024-08-21
Completion date
2025-09-27
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease, Valvular, Rheumatic Heart Disease in Children

Keywords

rheumatic heart disease, secondary antibiotic prophylaxis, adherence, community health workers

Brief 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

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.

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

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER
Uganda Heart Institute
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 20 Years
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

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)

Design outcomes

Primary

MeasureTime frameDescription
Percent Secondary Antibiotic Prophylaxis Adherence12 monthscontinuous measure of days of antibiotic coverage, assuming one injection provides coverage for 28 days

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026