Rheumatic Heart Disease in ChildrenSHIELD 3 AdaptNCT07666048
Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease
An observational study of Rheumatic Heart Disease in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness and implementation of enhanced Secondary Antibiotic Prophylaxis (SAP) supports using a hybrid type 1 effectiveness-implementation design. The purpose is to determine whether enhanced SAP supports will increase average SAP adherence in Brazil and Timor-Leste. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatic Heart Disease in Children
- What is being tested?
- CHW Delivered SAP Adherence Supports
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes children, adolescents, and adults living with rheumatic heart disease (RHD), their caregivers, community health workers (CHWs), and healthcare workers (HCWs) in Brazil and Timor-Leste. Participants will be recruited from health centers and RHD registries within the public health systems.
Who may be able to join
- Adults living with rheumatic heart disease (RHD): age ≥18 years; diagnosed with RHD; prescribed secondary antibiotic prophylaxis (SAP)
- Guardians of children living with RHD: age ≥18 years; caregiver/guardian of a child aged 5-17 years with diagnosed RHD who is prescribed SAP
- Children living with RHD: age 12-17 years; diagnosed with RHD; prescribed SAP
- Community health workers (CHWs): age ≥18 years; associated with a healthcare center providing care to patients with RHD
- Healthcare workers (HCWs): age ≥18 years; employed at a healthcare center providing care to patients with RHD; able to provide informed consent in English or the local language
Who cannot join
- Adults living with RHD: medical contraindication to SAP; inability to provide informed consent (e.g., significant cognitive or communication impairment precluding participation)
- Guardians of children living with RHD: child has a medical contraindication to SAP; inability to provide informed consent
- Children living with RHD: medical contraindication to SAP; inability to provide informed assent (e.g., significant cognitive or communication impairment precluding participation)
- Community health workers: none
- Healthcare workers: none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cincinnati Children's Hospital- Heart Institute
Cincinnati, Ohio, 45229
About this study
The goal of this clinical trial is to test the effectiveness and implementation of enhanced Secondary Antibiotic Prophylaxis (SAP) supports using a hybrid type 1 effectiveness-implementation design. The purpose is to determine whether enhanced SAP supports will increase average SAP adherence in Brazil and Timor-Leste. The study will enroll people living with Rheumatic Heart Disease (RHD) and Community Health Workers (CHWs) participating in the intervention.
The main questions it aims to answer are:
Read more
- Whether CHW-led supports delivered within the community improve mean SAP adherence at 12 months post-intervention.
- Whether the intervention demonstrates acceptability, feasibility, uptake and engagement.
Researchers will compare baseline and post-intervention SAP adherence data for the 12 months prior to and following intervention rollout to see if CHW-delivered supports increase adherence.
Read the detailed description
The first aim will utilize a non-controlled, pre-post design to evaluate CHW-led supports delivered within the community on SAP adherence. The composition of the SAP adherence supports will be finalized prior to implementation and will be comprised of a CHW-delivered package of supports covering patient reminders, education, and connection to care. The final package will reflect solutions that are easy for CHWs to deliver, acceptable to patients and families, and well aligned with local context, resources, and cultural norms. SAP adherence for the 12 months prior to and following intervention rollout will be captured from facility-based paper records, triangulated with prophylaxis cards of individual patients and the ACT registry once it is established at both sites. At enrollment, each participant will be assigned an anonymized study ID, and demographic data will be collected along with RHD history. CHWs in a ratio of approximately 1:10 patients will be selected for training, with training delivered through a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, and supervised field practice. Ongoing mentorship will be provided throughout the training period to ensure readiness, fidelity, and confidence before CHWs deliver the intervention.
The second aim will be guided by the Integrative Behavioral Model to examine implementation outcomes and mechanisms underlying behavior change related to SAP adherence. A subset of relevant constructs from the outer and inner setting domains of the Consolidated Framework for Implementation Research will augment the IBM. Participants will include people living with RHD, CHWs, and key informants. Quantitative data collection will include program activity logs completed weekly by participating CHWs and a patient knowledge and perception survey developed locally based on the General Attitudes Towards Medication Questionnaire with additional questions capturing IBM constructs. Semi-structured qualitative interviews will follow best practices, including recording with consent, post-interview debriefing, ongoing reflexivity memoing, and maintenance of detailed memos and field notes. Interview guides informed by the IBM and selected CFIR constructs will address perspectives related to acceptability, feasibility, uptake, and engagement.
Quantitative and qualitative analyses will occur in parallel. Descriptive statistics will summarize survey results and aggregate measures of patient engagement and CHW adoption. Joint displays will be constructed to visually compare qualitative and quantitative findings and examine convergence in themes or patterns. Qualitative data will be analyzed using thematic content analysis, with a codebook developed based on the IBM, CFIR, and open coding of initial interviews. All transcripts will be independently coded deductively by one study team member and reviewed by another, with disagreements resolved by consensus.
- Conditions
- Rheumatic Heart Disease in Children
- Being tested
- CHW Delivered SAP Adherence Supports
- Keywords
- Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease, SAP for RHD, SAP Adherence, Secondary Antibiotic Prophylaxis Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW Delivered SAP Adherence SupportsBehavioural
A CHW-delivered package of supports covering patient reminders, education, and connection to care. The final composition of the SAP adherence supports will be finalized prior to implementation to ensure alignment with local context, resources, and cultural norms. CHWs will be trained using a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, supervised field practice, and ongoing mentorship to ensure readiness, fidelity, and confidence before delivering the supports.
| Study group | Role | What they receive |
|---|---|---|
| Pre Intervention | Participants contribute SAP adherence data during the 12-month pre-intervention period. Adherence will be captured from facility-based paper records, triangulated with prophylaxis cards of individual patients and the ACT registry once established. Demographic data and RHD history will be collected at enrollment, and each participant will be assigned an anonymized study ID. This arm reflects routine care prior to the rollout of CHW-delivered SAP adherence supports. | |
| Post Intervention Period | Participants contribute SAP adherence data during the 12-month post-intervention period after implementation of a CHW-delivered package of supports. The support package will be finalized prior to implementation and will include patient reminders, education, and connection to care. CHWs will be trained using a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, supervised field practice, and ongoing mentorship to ensure readiness, fidelity, and confidence before delivering the intervention. Receives: Behavioral: CHW Delivered SAP Adherence Supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the adapted CHW-led SAP support intervention
Proportion of participants reporting the intervention as acceptable (e.g., via standardized acceptability surveys)
Proportion of intended intervention components successfully implemented (fidelity/adoption)
Measured: 24 months
Secondary outcomes (4)
Proportion of participants achieving adequate SAP adherence
Receipt of ≥80% of scheduled secondary antibiotic prophylaxis injections
Measured: 12 months
Participant engagement with CHW-led support components
Frequency of response to SMS reminders Participation in peer group activities Completion of scheduled CHW contacts
Measured: 2 months
Number and type of adaptations made to the intervention
Documented modifications using human-centered design methods (e.g., interviews, co-design workshops)
Measured: 5 months
Feasibility of intervention delivery by CHWs
Proportion of planned CHW activities completed CHW-reported ease of delivery (survey/interviews)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Menzies School of Health Research, University of Washington, Uganda Heart Institute, Federal University of Minas Gerais
- Responsible party
- Sponsor
- Investigators
- Sarah de Loizaga, Medical Doctor, Principal investigator, Children's Hospital Medical Center, CincinnatiAndrea Beaton, Medical Doctor, Study director, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666048
- Sponsor's protocol ID
- 2026-0308
- Acronym
- SHIELD 3 Adapt
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease
- ClinicalTrials.gov ID
- NCT07666048
- Acronym / sponsor ID
- SHIELD 3 Adapt / 2026-0308
- Conditions
- Rheumatic Heart Disease in Children
- Keywords
- Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease, SAP for RHD, SAP Adherence, Secondary Antibiotic Prophylaxis Adherence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- American Heart Association, Menzies School of Health Research, University of Washington, Uganda Heart Institute, Federal University of Minas Gerais
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jun 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.
The goal of this clinical trial is to test the effectiveness and implementation of enhanced Secondary Antibiotic Prophylaxis (SAP) supports using a hybrid type 1 effectiveness-implementation design. The purpose is to determine whether enhanced SAP supports will increase average SAP adherence in Brazil and Timor-Leste. The study will enroll people living with Rheumatic Heart Disease (RHD) and Community Health Workers (CHWs) participating in the intervention.
The main questions it aims to answer are:
- Whether CHW-led supports delivered within the community improve mean SAP adherence at 12 months post-intervention.
- Whether the intervention demonstrates acceptability, feasibility, uptake and engagement.
Researchers will compare baseline and post-intervention SAP adherence data for the 12 months prior to and following intervention rollout to see if CHW-delivered supports increase adherence.
Detailed description
The first aim will utilize a non-controlled, pre-post design to evaluate CHW-led supports delivered within the community on SAP adherence. The composition of the SAP adherence supports will be finalized prior to implementation and will be comprised of a CHW-delivered package of supports covering patient reminders, education, and connection to care. The final package will reflect solutions that are easy for CHWs to deliver, acceptable to patients and families, and well aligned with local context, resources, and cultural norms. SAP adherence for the 12 months prior to and following intervention rollout will be captured from facility-based paper records, triangulated with prophylaxis cards of individual patients and the ACT registry once it is established at both sites. At enrollment, each participant will be assigned an anonymized study ID, and demographic data will be collected along with RHD history. CHWs in a ratio of approximately 1:10 patients will be selected for training, with training delivered through a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, and supervised field practice. Ongoing mentorship will be provided throughout the training period to ensure readiness, fidelity, and confidence before CHWs deliver the intervention.
The second aim will be guided by the Integrative Behavioral Model to examine implementation outcomes and mechanisms underlying behavior change related to SAP adherence. A subset of relevant constructs from the outer and inner setting domains of the Consolidated Framework for Implementation Research will augment the IBM. Participants will include people living with RHD, CHWs, and key informants. Quantitative data collection will include program activity logs completed weekly by participating CHWs and a patient knowledge and perception survey developed locally based on the General Attitudes Towards Medication Questionnaire with additional questions capturing IBM constructs. Semi-structured qualitative interviews will follow best practices, including recording with consent, post-interview debriefing, ongoing reflexivity memoing, and maintenance of detailed memos and field notes. Interview guides informed by the IBM and selected CFIR constructs will address perspectives related to acceptability, feasibility, uptake, and engagement.
Quantitative and qualitative analyses will occur in parallel. Descriptive statistics will summarize survey results and aggregate measures of patient engagement and CHW adoption. Joint displays will be constructed to visually compare qualitative and quantitative findings and examine convergence in themes or patterns. Qualitative data will be analyzed using thematic content analysis, with a codebook developed based on the IBM, CFIR, and open coding of initial interviews. All transcripts will be independently coded deductively by one study team member and reviewed by another, with disagreements resolved by consensus.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Intervention | – | –Participants contribute SAP adherence data during the 12-month pre-intervention period. Adherence will be captured from facility-based paper records, triangulated with prophylaxis cards of individual patients and the ACT registry once established. Demographic data and RHD history will be collected at enrollment, and each participant will be assigned an anonymized study ID. This arm reflects routine care prior to the rollout of CHW-delivered SAP adherence supports. |
| Post Intervention Period | – | Behavioral: CHW Delivered SAP Adherence SupportsParticipants contribute SAP adherence data during the 12-month post-intervention period after implementation of a CHW-delivered package of supports. The support package will be finalized prior to implementation and will include patient reminders, education, and connection to care. CHWs will be trained using a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, supervised field practice, and ongoing mentorship to ensure readiness, fidelity, and confidence before delivering the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes children, adolescents, and adults living with rheumatic heart disease (RHD), their caregivers, community health workers (CHWs), and healthcare workers (HCWs) in Brazil and Timor-Leste. Participants will be recruited from health centers and RHD registries within the public health systems.
Key inclusion criteria (5 listed)
- Adults living with rheumatic heart disease (RHD): age ≥18 years; diagnosed with RHD; prescribed secondary antibiotic prophylaxis (SAP)
- Guardians of children living with RHD: age ≥18 years; caregiver/guardian of a child aged 5-17 years with diagnosed RHD who is prescribed SAP
- Children living with RHD: age 12-17 years; diagnosed with RHD; prescribed SAP
- Community health workers (CHWs): age ≥18 years; associated with a healthcare center providing care to patients with RHD
- Healthcare workers (HCWs): age ≥18 years; employed at a healthcare center providing care to patients with RHD; able to provide informed consent in English or the local language
Key exclusion criteria (5 listed)
- Adults living with RHD: medical contraindication to SAP; inability to provide informed consent (e.g., significant cognitive or communication impairment precluding participation)
- Guardians of children living with RHD: child has a medical contraindication to SAP; inability to provide informed consent
- Children living with RHD: medical contraindication to SAP; inability to provide informed assent (e.g., significant cognitive or communication impairment precluding participation)
- Community health workers: none
- Healthcare workers: none
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 |
|---|---|---|
| CHW Delivered SAP Adherence SupportsA CHW-delivered package of supports covering patient reminders, education, and connection to care. The final composition of the SAP adherence supports will be finalized prior to implementation to ensure alignment with local context, resources, and cultural norms. CHWs will be trained using a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, supervised field practice, and ongoing mentorship to ensure readiness, fidelity, and confidence before delivering the supports. | Behavioural | Post Intervention Period |
Primary outcome
Feasibility and acceptability of the adapted CHW-led SAP support intervention
Time frame: 24 months
Proportion of participants reporting the intervention as acceptable (e.g., via standardized acceptability surveys) Proportion of intended intervention components successfully implemented (fidelity/adoption)
4 secondary outcomes
Proportion of participants achieving adequate SAP adherence
Time frame: 12 months
Participant engagement with CHW-led support components
Time frame: 2 months
Number and type of adaptations made to the intervention
Time frame: 5 months
Feasibility of intervention delivery by CHWs
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Sarah de Loizaga, Medical Doctor principal investigator
Children's Hospital Medical Center, Cincinnati
Andrea Beaton, Medical Doctor study director
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator, Assistant Professor (5136364432, Sarah.deLoizaga@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the adapted CHW-led SAP support intervention (time frame: 24 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 13 Oct 2026.