Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
CAMPS
Case Managers and Peer Support Groups (CAMPS) for Prophylaxis Adherence in Rheumatic Heart Disease
1 other identifier
interventional
209
1 country
1
Brief Summary
The objective of CAMPS is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease. Aim 1: Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies: (1) Usual care (Arm 1) (2) peer group + case manager strategy (Arm 2). Aim 2: Explore patient reported outcomes including treatment satisfaction, patient health-related quality of life, and care giver quality of life, in relation to support strategy and adherence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 18, 2024
January 1, 2024
12 months
August 12, 2022
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Secondary Prophylaxis Adherence
Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)
12 months
Secondary Outcomes (3)
Treatment satisfaction
6 months + 12 months
Patient health-related quality of life
enrollment, 6-months, 12-months
Caregiver health-related quality of life
enrollment, 6-months, 12-months
Study Arms (2)
Usual Care
NO INTERVENTIONReferral to a health facility (HC III, IV, or district hospital) that provide secondary antibiotic prophylaxis (every-28-day intramuscular benzathine benzylpenicillin G, BPG), receipt of a Ministry of Health secondary prophylaxis adherence booklet, and education for patient and family about the importance of SAP.
Peer Group + Case Manager
EXPERIMENTALUsual care + an assigned village health team member to provide weekly short message (SMS) (weeks 1-3) and phone (week 4) support for attendance of SAP visits and a VHT (village health team member) led peer support group held at the assigned SAP clinic of participants, that includes games/peer support/education.
Interventions
Assignment of a Village health team member to provide support to the family through SMS messages (weeks 1-3) and phone call (week 4), as well as home visits as needed if no contacts are reached. These contacts are intended to provide encouragement and education to participants and families to encourage SAP and peer group attendance. Peer groups will have simple play and support activities, led by the village health team member, to improve the experience of SAP for the participating children.
Eligibility Criteria
You may qualify if:
- Ages 5-17
- New diagnosis of latent rheumatic heart disease (RHD) as determined through school screening -
You may not qualify if:
- Medical contraindication to SAP (bleeding risk, allergy)
- Co-morbid conditions that have already resulted in prescription of SAP (typically HIV, sickle cell disease, renal disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tororo Health Distric
Tororo, Uganda
Related Publications (1)
de Loizaga S, Pulle J, Atanas O, Alepere J, Nambogo JL, Ndagire E, Kaudha G, Ollberding NJ, Okello E, Rwebembera J, Beaton A. Enhanced support for adherence to rheumatic heart disease prophylaxis for children in the public health system in Uganda (CAMPS): a pragmatic randomised trial. Lancet Glob Health. 2025 Apr;13(4):e707-e715. doi: 10.1016/S2214-109X(24)00527-8.
PMID: 40155108DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Our primary outcome, adherence to SAP, will be abstracted from copies of final Uganda Ministry of Health SAP booklets by a team member blinded to treatment allocation.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor, Pediatrics
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 16, 2022
Study Start
August 15, 2022
Primary Completion
August 9, 2023
Study Completion
September 1, 2023
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After publication of the primary study results (anticipated December 2024)
- Access Criteria
- Reasonable request for related research
De-identified individual participant data will be available to other investigators on reasonable request after publication of the primary results.