Sickle Cell DiseaseNCT05909657
Enablers and Barriers to Hydroxyurea Use for Sickle Cell Disease Jamaica
An observational study of Sickle Cell Disease, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Sickle cell disease (SCD) is associated with a lifetime of medical and socio-behavioural complications that require coordination of care from multidisciplinary teams. Access to adequate care for SCD is important as inadequate access can contribute to increased acute care utilization, disjointed care delivery, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- questionnaires (surveys)
- How many people
- 450 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Recruitment Patients and caregivers of children (ages < 18 years) with SCD will be recruited islandwide- specifically from the Sickle Cell Unit (SCU) located at the University of the West Indies (UWI) campus and from all four regional health authorities. Patients will be recruited when in a well state. Similarly healthcare providers - Physicians, Registered Nurses, and Pharmacists- will be recruited from each region. For the desk review there would be interviews conducted with the Director of logistics and the Director of individual benefits - NHF, Policy Director or designee at MOHW, NCD director - MOHW and the Health Service Director - MOHW.
Who may be able to join
- SCD Patients (ages 18 and over)
- Adult Caregivers of SCD Children/Adolescents under 18 years
- Healthcare Providers: Physicians, Nurses and Pharmacists who treat and interact with sickle cell patients
Who cannot join
- SCD patients below age 18 years
- SCD patients who are acutely ill
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
Sickle Cell Unit - Caribbean Institute for Health Research
Kingston, Saint Andrew Parish, Kingston 7
Monika Asnani, DM, PhD, 8769776151, monika.parshadasnani@uwimona.edu.jm
Vanessa Cumming, MBBS, MSPH, 8769776151, vanessa.cumming@uwimona.edu.jm
About this study
Official title: Access to Care for SCD Management in Jamaica: Enablers and Barriers to Hydroxyurea Utilization
Sickle cell disease (SCD) is associated with a lifetime of medical and socio-behavioural complications that require coordination of care from multidisciplinary teams. Access to adequate care for SCD is important as inadequate access can contribute to increased acute care utilization, disjointed care delivery, and earlier mortality for many SCD patients. Hydroxyurea (HU) is the first drug approved for the treatment of SCD and improves many adverse outcomes of SCD and yet its use remains sub-optimal. This mixed-methods study aims to identify the barriers and enablers that SCD patients, caregivers of children (under age 18 years), and health care providers (including physicians, nurses and pharmacists) identify for health care access and HU utilization. The findings may guide development and implementation of strategies to improve access to SCD healthcare and HU uptake which may result in significant benefits to patients, families and the healthcare system including possible reduction in healthcare utilization. Participants will be recruited from the Sickle Cell Unit, Kingston and from all four Jamaican regional health authorities. Questionnaires and interview guides for provider and patient/caregiver assessments are adapted, with permission, from the Sickle Cell Disease Implementation Consortium tools. The study will also examine data on HU usage from the National Health Fund of Jamaica since its addition of SCD to its list of chronic illnesses in 2015. All data collected will be de-identified and maintained in a secure database, with access limited to key personnel. There is minimal risk to participants. Participants will be selected only because of the specific problem under investigation, and not because of easy availability, diminished autonomy, or social bias.
- Conditions
- Sickle Cell Disease
- Being tested
- questionnaires (surveys)
- Keywords
- hydroxyurea, access to care, Jamaica
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires (surveys)Other
Also called in-depth interviews
Mixed-methods study. Both the qualitative interview guides and the questionnaire surveys are adapted from the Sickle Cell Disease Implementation Consortium (SCDIC) project which is a multicentre study occurring in the United States.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Disease patients = or > 18 years in Jamaica | surveys, interviews Receives: Other: questionnaires (surveys) | |
| Adult Caregivers of Sickle Cell Disease Children/Adolescents under 18 years | surveys, interviews Receives: Other: questionnaires (surveys) | |
| Healthcare Providers: SCD Physicians, Nurses and Pharmacists | surveys and interviews Receives: Other: questionnaires (surveys) |
What is being measured
The primary outcome is the main question the study is designed to answer.
surveys to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica
- Determine where people living with SCD access care and perceived barriers to receiving care.
In-depth interview guides will be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools.
Measured: 18 months
in-depth interviews to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica
Determine where people living with SCD access care and perceived barriers to receiving care.
In-depth interview guides will be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools.
Measured: 18 months
surveys to asses patients and caregivers experience using HU for SCD in Jamaica
- Assess the acceptability, accessibility, adherence, and satisfaction with HU therapy among patients and caregivers of patients with SCD cross sectional study using questionnaires adapted from the Sickle Cell Disease Implementation Consortium tools will be administered to patients, caregivers and healthcare professionals.
In-depth interview guides will also be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools, will be used
Measured: 18 Months
in-depth interviews to asses patients and caregivers experience using HU for SCD in Jamaica
Assess the acceptability, accessibility, adherence, and satisfaction with HU therapy among patients and caregivers of patients with SCD cross sectional study using questionnaires adapted from the Sickle Cell Disease Implementation Consortium tools will be administered to patients, caregivers and healthcare professionals. All measures will be self reported to assess acceptability, accessibility, adherence, and satisfaction with HU therapy based on experience and knowledge already held. Lower scores for acceptability, accessibility, adherence, and satisfaction connote a worse outcome, and better outcomes are associated with higher scores for these measures.
In-depth interview guides will also be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools, will be used
Measured: 18 Months
examine healthcare providers knowledge and attitudes toward providing HU for SCD in Jamaica using surveys
- Assess the knowledge, attitudes and barriers perceived by healthcare providers in provision of HU treatment cross sectional study using questionnaires adapted from the Sickle Cell Disease Implementation Consortium tools will be administered to patients, caregivers and healthcare professionals.
Measured: 18 months
In-depth interviews to examine healthcare providers knowledge and attitudes toward providing HU for SCD in Jamaica
Assess the knowledge, attitudes and barriers perceived by healthcare providers in provision of HU treatment by employing the use of in-depth interview guides adapted, with permission from the Sickle Cell Disease Implementation Consortium tools.
Measured: 18 months
Desk review of supply and benefits used for HU will be conducted in the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease
We will describe the process used to keep pharmacy supply of HU sufficient for numbers of patients living with SCD in different areas, how this supply of HU is prescribed to patients, when it is dispensed to patients and from which pharmacies (government or private), and which government or private insurance benefits are used by patients for the purposes of acquiring HU. This information will be collected to examine the efficiency of the health system in supplying HU to the SCD population A desk review will be conducted in the initial stages of the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease. This will provide an evaluation of data quality. This information will also be used for internal consistency, external comparisons and external consistency of population data. A guide from the Sickle Cell Disease Implementation Consortium tools, will be used with permission.
Measured: 18 months
A desk review assessment of the cost to patients in the health care system to deliver HU for patients living with Sickle Cell Disease in Jamaica
- Examine the cost associated with the use of HU in the health system to the SCD population A desk review will be conducted in the initial stages of the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease.
A guide from the Sickle Cell Disease Implementation Consortium tools, will be used with permission.
Measured: 10 months
Assessment of the health care system to deliver HU for patients living with Sickle Cell Disease in Jamaica by doing a desk review and defining where (pharmacies - private, government, or hospital) HU is made available in Jamaica.
- A count and qualitative examination of the availability of HU within the health system to the SCD population A desk review will be performed in the initial stages of the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease specifically if these gaps might include where HU is sourced in Jamaican pharmacies (as these are the last link in delivery of HU to patients with SCD).
A guide from the Sickle Cell Disease Implementation Consortium tools, will be used with permission.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909657
- Sponsor's protocol ID
- CREC-MN.008,2022/2023
- Status last verified
- Jun 2023
- First submitted
- 6 Apr 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients will be recruited when in a well state. Similarly healthcare providers - Physicians, Registered Nurses, and Pharmacists- will be recruited from each region. Those who choose to participate in the in-depth interviews will be invited to do so face to face or virtually using platforms such as Zoom or WhatsApp. The information obtained via the desk review will be anonymized as much as possible, no names will be utilized in the reporting of the transcripts. All study procedures will be conducted only once informed consent has been obtained.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Care for SCD Management in Jamaica: Enablers and Barriers to Hydroxyurea Utilization
- ClinicalTrials.gov ID
- NCT05909657
- Acronym / sponsor ID
- CREC-MN.008,2022/2023
- Conditions
- Sickle Cell Disease
- Keywords
- hydroxyurea, access to care, Jamaica
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jun 2023 (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.
Sickle cell disease (SCD) is associated with a lifetime of medical and socio-behavioural complications that require coordination of care from multidisciplinary teams. Access to adequate care for SCD is important as inadequate access can contribute to increased acute care utilization, disjointed care delivery, and earlier mortality for many SCD patients. Hydroxyurea (HU) is the first drug approved for the treatment of SCD and improves many adverse outcomes of SCD and yet its use remains sub-optimal. This mixed-methods study aims to identify the barriers and enablers that SCD patients, caregivers of children (under age 18 years), and health care providers (including physicians, nurses and pharmacists) identify for health care access and HU utilization. The findings may guide development and implementation of strategies to improve access to SCD healthcare and HU uptake which may result in significant benefits to patients, families and the healthcare system including possible reduction in healthcare utilization. Participants will be recruited from the Sickle Cell Unit, Kingston and from all four Jamaican regional health authorities. Questionnaires and interview guides for provider and patient/caregiver assessments are adapted, with permission, from the Sickle Cell Disease Implementation Consortium tools. The study will also examine data on HU usage from the National Health Fund of Jamaica since its addition of SCD to its list of chronic illnesses in 2015. All data collected will be de-identified and maintained in a secure database, with access limited to key personnel. There is minimal risk to participants. Participants will be selected only because of the specific problem under investigation, and not because of easy availability, diminished autonomy, or social bias.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease patients = or > 18 years in Jamaica | – | Other: questionnaires (surveys)surveys, interviews |
| Adult Caregivers of Sickle Cell Disease Children/Adolescents under 18 years | – | Other: questionnaires (surveys)surveys, interviews |
| Healthcare Providers: SCD Physicians, Nurses and Pharmacists | – | Other: questionnaires (surveys)surveys and interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recruitment Patients and caregivers of children (ages < 18 years) with SCD will be recruited islandwide- specifically from the Sickle Cell Unit (SCU) located at the University of the West Indies (UWI) campus and from all four regional health authorities. Patients will be recruited when in a well state. Similarly healthcare providers - Physicians, Registered Nurses, and Pharmacists- will be recruited from each region. For the desk review there would be interviews conducted with the Director of logistics and the Director of individual benefits - NHF, Policy Director or designee at MOHW, NCD director - MOHW and the Health Service Director - MOHW.
Key inclusion criteria (3 listed)
- SCD Patients (ages 18 and over)
- Adult Caregivers of SCD Children/Adolescents under 18 years
- Healthcare Providers: Physicians, Nurses and Pharmacists who treat and interact with sickle cell patients
Key exclusion criteria (2 listed)
- SCD patients below age 18 years
- SCD patients who are acutely ill
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 |
|---|---|---|
| questionnaires (surveys)Also: in-depth interviewsMixed-methods study. Both the qualitative interview guides and the questionnaire surveys are adapted from the Sickle Cell Disease Implementation Consortium (SCDIC) project which is a multicentre study occurring in the United States. | Other | Adult Caregivers of Sickle Cell Disease Children/Adolescents under 18 years, Healthcare Providers: SCD Physicians, Nurses and Pharmacists, Sickle Cell Disease patients = or > 18 years in Jamaica |
Primary outcome
surveys to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica
Time frame: 18 months
1. Determine where people living with SCD access care and perceived barriers to receiving care. In-depth interview guides will be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools.
in-depth interviews to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica
Time frame: 18 months
Determine where people living with SCD access care and perceived barriers to receiving care. In-depth interview guides will be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools.
surveys to asses patients and caregivers experience using HU for SCD in Jamaica
Time frame: 18 Months
3. Assess the acceptability, accessibility, adherence, and satisfaction with HU therapy among patients and caregivers of patients with SCD cross sectional study using questionnaires adapted from the Sickle Cell Disease Implementation Consortium tools will be administered to patients, caregivers and healthcare professionals. In-depth interview guides will also be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools, will be used
in-depth interviews to asses patients and caregivers experience using HU for SCD in Jamaica
Time frame: 18 Months
Assess the acceptability, accessibility, adherence, and satisfaction with HU therapy among patients and caregivers of patients with SCD cross sectional study using questionnaires adapted from the Sickle Cell Disease Implementation Consortium tools will be administered to patients, caregivers and healthcare professionals. All measures will be self reported to assess acceptability, accessibility, adherence, and satisfaction with HU therapy based on experience and knowledge already held. Lower scores for acceptability, accessibility, adherence, and satisfaction connote a worse outcome, and better outcomes are associated with higher scores for these measures. In-depth interview guides will also be adapted, with permission from the Sickle Cell Disease Implementation Consortium tools, will be used
examine healthcare providers knowledge and attitudes toward providing HU for SCD in Jamaica using surveys
Time frame: 18 months
5. Assess the knowledge, attitudes and barriers perceived by healthcare providers in provision of HU treatment cross sectional study using questionnaires adapted from the Sickle Cell Disease Implementation Consortium tools will be administered to patients, caregivers and healthcare professionals.
In-depth interviews to examine healthcare providers knowledge and attitudes toward providing HU for SCD in Jamaica
Time frame: 18 months
Assess the knowledge, attitudes and barriers perceived by healthcare providers in provision of HU treatment by employing the use of in-depth interview guides adapted, with permission from the Sickle Cell Disease Implementation Consortium tools.
Desk review of supply and benefits used for HU will be conducted in the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease
Time frame: 18 months
We will describe the process used to keep pharmacy supply of HU sufficient for numbers of patients living with SCD in different areas, how this supply of HU is prescribed to patients, when it is dispensed to patients and from which pharmacies (government or private), and which government or private insurance benefits are used by patients for the purposes of acquiring HU. This information will be collected to examine the efficiency of the health system in supplying HU to the SCD population A desk review will be conducted in the initial stages of the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease. This will provide an evaluation of data quality. This information will also be used for internal consistency, external comparisons and external consistency of population data. A guide from the Sickle Cell Disease Implementation Consortium tools, will be used with permission.
A desk review assessment of the cost to patients in the health care system to deliver HU for patients living with Sickle Cell Disease in Jamaica
Time frame: 10 months
8. Examine the cost associated with the use of HU in the health system to the SCD population A desk review will be conducted in the initial stages of the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease. A guide from the Sickle Cell Disease Implementation Consortium tools, will be used with permission.
Assessment of the health care system to deliver HU for patients living with Sickle Cell Disease in Jamaica by doing a desk review and defining where (pharmacies - private, government, or hospital) HU is made available in Jamaica.
Time frame: 18 months
9. A count and qualitative examination of the availability of HU within the health system to the SCD population A desk review will be performed in the initial stages of the study with the aim to identify potential gaps in the health care service delivery that may reduce the uptake of hydroxyurea by persons with sickle cell disease specifically if these gaps might include where HU is sourced in Jamaican pharmacies (as these are the last link in delivery of HU to patients with SCD). A guide from the Sickle Cell Disease Implementation Consortium tools, will be used with permission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No. Patients will be recruited when in a well state. Similarly healthcare providers - Physicians, Registered Nurses, and Pharmacists- will be recruited from each region. Those who choose to participate in the in-depth interviews will be invited to do so face to face or virtually using platforms such as Zoom or WhatsApp. The information obtained via the desk review will be anonymized as much as possible, no names will be utilized in the reporting of the transcripts. All study procedures will be conducted only once informed consent has been obtained.
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
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 Sickle Cell Disease, run by The University of The West Indies at 1 site in Jamaica.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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 Jamaica. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monika Asnani, DM, PhD (8769776151, monika.parshadasnani@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surveys to determine patient and caregiver access to HU and perceived barriers to HU use for SCD in Jamaica (time frame: 18 months). The study lists 9 primary outcomes in all. 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 6 Jul 2023.