Rheumatic Heart Disease in ChildrenCAMPSPlusNCT07603297
Identifying Essential Elements of SAP Supports
A study testing Case Management Supports in people with Rheumatic Heart Disease in Children and Heart Disease, Valvular, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Rheumatic Heart Disease in Children, Heart Disease, Valvular
- What is being tested?
- Case Management Supports
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteUganda
- Study dates
- 21 Aug 2024to 27 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 5-20 years
- Have a diagnosis of RHD detected through school-based screening echocardiography
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying the Essential Elements of Case Managers and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
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.
- Being tested
- Case Management Supports
- Keywords
- rheumatic heart disease, secondary antibiotic prophylaxis, adherence, community health workers
- Medical subject headings
- Heart Valve Diseases, Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Management SupportsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Case Manager Only Intervention | Other | 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 Receives: Behavioral: Case Management Supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Secondary Antibiotic Prophylaxis Adherence
continuous measure of days of antibiotic coverage, assuming one injection provides coverage for 28 days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start21 Aug 2024
- Primary completion27 Sep 2025
- Study completion27 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603297
- Sponsor's protocol ID
- 2024-0163:CAMPS Plus
- Acronym
- CAMPSPlus
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only deidentified information would be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Essential Elements of Case Managers and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
- ClinicalTrials.gov ID
- NCT07603297
- Acronym / sponsor ID
- CAMPSPlus / 2024-0163:CAMPS Plus
- Keywords
- rheumatic heart disease, secondary antibiotic prophylaxis, adherence, community health workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 27 Sep 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Manager Only Intervention | Other | Behavioral: Case Management SupportsFor 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 |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Between the ages of 5-20 years
- Have a diagnosis of RHD detected through school-based screening echocardiography
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case Management SupportsParticipants 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 | Behavioural | Case Manager Only Intervention |
Primary outcome
Percent Secondary Antibiotic Prophylaxis Adherence
Time frame: 12 months
continuous measure of days of antibiotic coverage, assuming one injection provides coverage for 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided. Only deidentified information would be shared
Related trials for Rheumatic Heart Disease in Children
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Rheumatic Fever, Rheumatic Heart Disease in Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management Supports in people with Rheumatic Heart Disease in Children and Heart Disease, Valvular, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Secondary Antibiotic Prophylaxis Adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.