NCT07603297

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Rheumatic Heart Disease in ChildrenHeart Disease, Valvular

Keywords

rheumatic heart diseasesecondary antibiotic prophylaxisadherencecommunity health workers

Outcome Measures

Primary Outcomes (1)

  • Adherence among Cohort 3 and Cohort 1 (Non-inferiority)

    adherence to secondary antibiotic prophylaxis, as continuous measure of days of coverage

    12 months

Secondary Outcomes (2)

  • Adherence among Cohort 2 (pre/post, CM alone superior to SC)

    12 months

  • Adherence among Cohort 1 (pre/post, durability of CM alone vs CM+PG)

    12 months

Study Arms (3)

Cohort 1

OTHER

Children 5-20 years old that participated in the original CAMPS trial between August 2022 and August 2023 and were randomized to enhanced supports (case manager plus peer group, CM+PG) intervention. For the CAMPS Plus study, participants will be provided case management support only which includes calendar of injection dates, weekly text messages, reminder call prior to scheduled penicillin injections, and home visits as needed

Behavioral: Case Management Supports

Cohort 2

OTHER

Children 5-20 years old that participated in the original CAMPS trial between August 2022 and August 2023 and were randomized to standard care (injection tracking booklet and referral to health center) intervention. For the CAMPS Plus study, participants will be provided case management support which includes calendar of injection dates, weekly text messages, reminder call prior to scheduled penicillin injections, and home visits as needed

Behavioral: Case Management Supports

Cohort 3

OTHER

A prospectively recruited cohort drawn from school-based echocardiography screening who are generally comparable in age and sex distribution to the original CAMPS cohort, who will receive case management support which includes calendar of injection dates, weekly text messages, reminder call prior to scheduled penicillin injections, and home visits as needed

Behavioral: Case Management Supports

Interventions

Case Management SupportsBEHAVIORAL

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age5 Years - 20 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale, Male
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uganda Heart Institute

Tororo, Uganda

Location

MeSH Terms

Conditions

Heart Valve DiseasesRheumatic Heart Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

August 21, 2024

Primary Completion

September 27, 2025

Study Completion

September 27, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

UG(1)