Identifying Essential Elements of SAP Supports (CAMPSPlus)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Heart Disease, Valvular; Rheumatic Heart Disease in Children

Treatments: Behavioral: Case Management Supports

Study type: Interventional

Funder types: Other

Identifiers

NCT07603297

2024-0163:CAMPS Plus

Details and patient eligibility

About

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

Full 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.

Enrollment: 335 patients

Sex: All

Ages: 5 to 20 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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335 participants in 1 patient group

Case Manager Only Intervention

Other group

Description:

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

Treatment:

Behavioral: Case Management Supports