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Completed

NCT Number: NCT07603297

Identifying Essential Elements of SAP Supports

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

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Key information

Conditions

Rheumatic Heart Disease in Children Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Disease, Valvular Heart Diseases Heart Valve Diseases Infections Rheumatic Fever Rheumatic Heart Disease Streptococcal Infections

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uganda Heart Institute

Tororo, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Case Management Supports

Behavioral

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

Primary outcomes

  1. Percent Secondary Antibiotic Prophylaxis Adherence

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Uganda Heart Institute

Registry information

Official study title

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

Acronym: CAMPSPlus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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