Sickle Cell DiseaseRECIPENCT06385886
Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease
An observational study of Sickle Cell Disease, run by RTI International at 9 sites in United States.
Trial summary
The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated… 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?
- Linkage Coordinator
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Jun 2023to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Sickle Celle Disease (SCD) who are unaffiliated from SCD care specialists
Who may be able to join
- Persons must be >/= 18 years of age
- Persons must have confirmed SCD
- Persons not seen by a SCD specialist > 1 year +/- 3 months
- Literacy in English will be required of the consenting patient or parent/guardian
Who cannot join
- Persons < 18 years of age
- Persons that are unable to provide informed consent and do not have a designated care-giver that can consent on his/her behalf
- Persons with sickle cell trait (as per hemoglobin electrophoresis)
- Persons seen by a SCD specialist < 1 year +/1 3 months
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30901
Robert Gibson, PhD, (706) 721-1005, rogibson@augusta.edu
- Recruiting
University of Alabama, Birmingham (UAB)
Birmingham, Alabama, 35233
Julie Kanter, MD, (205) 934-0435, jkanter@uabmc.edu
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Lewis Hsu, MD, PhD, 312-355-5019, lewhsu@uic.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Ravi Talati, 216.444.5437, walterk15@ccf.org
- Recruiting
University of Texas at Houston
Houston, Texas, 77030
Modupe Idowu, (713) 486-5660, Modupe.Idowu@uth.tmc.edu
- Recruiting
University of Tennessee at Memphis
Memphis, Tennessee, 38163
Ugochi Ogu, 901.545.8535, uogu@uthsc.edu
- Recruiting
University of California, San Francisco (UCSF)
Oakland, California, 94609
Marsha Treadwell, PhD, (510) 428-3356, marsha.treadwell@ucsf.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nadia Ali, 215-615-6555, nadia.ali.07@gmail.com
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Sanjay Shah, 602-933-0920, sshah2@phoenixchildrens.com
About this study
The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?
Read the detailed description
The goal of RECIPE (Recruitment and Engagement in Care to Impact Practice Enhancement) for Sickle Cell Disease is to find unaffiliated patients with SCD using three distinct pathways (Community, Hospital, Surveillance) engage them in care using linkage coordinators (LCs; a successful method adapted from HIV care), and understand the contextual factors and implementation support needed to ensure these methodologies can be further scaled up at a national level. This study is significant because information about unaffiliated patients with SCD who are not actively engaged in the health system has not been systematically collected and studied in the past. Information comes only from experienced clinicians, community groups, patient advocates, and word of mouth. The lack of data about this population is problematic because current implementation studies focus on the barriers related to affiliated patients, with no known strategies identified to engage unaffiliated patients. No previous studies have evaluated the best methods for locating and then engaging and maintaining unaffiliated patients in specialty SCD care. This study will contribute to the literature by optimizing different pathways for finding unaffiliated patients, as well as providing evidence on what may work best in different clinical care settings and among different patients to address barriers to care in hard-to-reach populations.
- Conditions
- Sickle Cell Disease
- Being tested
- Linkage Coordinator
- Keywords
- Sickle Cell Disease Care, Unaffiliated patients, Linkage Coordinator
- 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.
Linkage CoordinatorBehavioural
The Linkage Coordinator (LC) will be the initial contact with unaffiliated SCD patients to establish a relationship, champion preventative services, and support them in engaging with an SCD specialist by helping patients address barriers to care. Study staff will provide initial and ongoing training to the LC to ensure they have adequate support to effectively engage with patients.
| Study group | Role | What they receive |
|---|---|---|
| Individuals diagnosed with Sickle Cell Disease (SCD) but not receiving care from an SCD specialist. | Individuals diagnosed with Sickle Cell Disease (SCD) but unaffiliated from SCD specialist care. These individuals will be connected to a linkage coordinator (trained staff) to provide a patient-centered approach to engagement with SCD specialist care. Receives: Behavioral: Linkage Coordinator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of unaffiliated patients
Identification of patients through hospital, surveillance, and community-based pathways.
Measured: Beginning of enrollment - end of study (up to 5 years)
Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist
Rate of affiliation of participants previously unaffiliated with SCD-specific care with an SCD specialist who are now connected to a linkage coordinator and an SCD-specific care with SCD specialist.
Measured: Beginning of enrollment - end of study (up to 5 years)
Secondary outcomes (1)
Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites
Once investigators optimize methods for finding and engaging unaffiliated patients with SCD, it is necessary to expand efforts to other SCD sites. The study will expand to include 2 additional sites and begin to assess rate of affiliation of participants previously unaffiliated with SCD-specific care with an SCD specialist who are now connected to a linkage coordinator and an SCD-specific care with SCD specialist.
Measured: After methods are optimized - end of study (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start8 Jun 2023
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Kanter, MD, Principal investigator, University of Alabama, Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385886
- Sponsor's protocol ID
- 1R01HL158807-01A1
- Acronym
- RECIPE
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06385886
- Acronym / sponsor ID
- RECIPE / 1R01HL158807-01A1
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease Care, Unaffiliated patients, Linkage Coordinator
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Apr 2024 (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 observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?
Detailed description
The goal of RECIPE (Recruitment and Engagement in Care to Impact Practice Enhancement) for Sickle Cell Disease is to find unaffiliated patients with SCD using three distinct pathways (Community, Hospital, Surveillance) engage them in care using linkage coordinators (LCs; a successful method adapted from HIV care), and understand the contextual factors and implementation support needed to ensure these methodologies can be further scaled up at a national level. This study is significant because information about unaffiliated patients with SCD who are not actively engaged in the health system has not been systematically collected and studied in the past. Information comes only from experienced clinicians, community groups, patient advocates, and word of mouth. The lack of data about this population is problematic because current implementation studies focus on the barriers related to affiliated patients, with no known strategies identified to engage unaffiliated patients. No previous studies have evaluated the best methods for locating and then engaging and maintaining unaffiliated patients in specialty SCD care. This study will contribute to the literature by optimizing different pathways for finding unaffiliated patients, as well as providing evidence on what may work best in different clinical care settings and among different patients to address barriers to care in hard-to-reach populations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with Sickle Cell Disease (SCD) but not receiving care from an SCD specialist. | – | Behavioral: Linkage CoordinatorIndividuals diagnosed with Sickle Cell Disease (SCD) but unaffiliated from SCD specialist care. These individuals will be connected to a linkage coordinator (trained staff) to provide a patient-centered approach to engagement with SCD specialist care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Sickle Celle Disease (SCD) who are unaffiliated from SCD care specialists
Key inclusion criteria (4 listed)
- Persons must be >/= 18 years of age
- Persons must have confirmed SCD
- Persons not seen by a SCD specialist > 1 year +/- 3 months
- Literacy in English will be required of the consenting patient or parent/guardian
Key exclusion criteria (4 listed)
- Persons < 18 years of age
- Persons that are unable to provide informed consent and do not have a designated care-giver that can consent on his/her behalf
- Persons with sickle cell trait (as per hemoglobin electrophoresis)
- Persons seen by a SCD specialist < 1 year +/1 3 months
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 |
|---|---|---|
| Linkage CoordinatorThe Linkage Coordinator (LC) will be the initial contact with unaffiliated SCD patients to establish a relationship, champion preventative services, and support them in engaging with an SCD specialist by helping patients address barriers to care. Study staff will provide initial and ongoing training to the LC to ensure they have adequate support to effectively engage with patients. | Behavioural | Individuals diagnosed with Sickle Cell Disease (SCD) but not receiving care from an SCD specialist. |
Primary outcome
Identification of unaffiliated patients
Time frame: Beginning of enrollment - end of study (up to 5 years)
Identification of patients through hospital, surveillance, and community-based pathways.
Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist
Time frame: Beginning of enrollment - end of study (up to 5 years)
Rate of affiliation of participants previously unaffiliated with SCD-specific care with an SCD specialist who are now connected to a linkage coordinator and an SCD-specific care with SCD specialist.
1 secondary outcome
Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites
Time frame: After methods are optimized - end of study (up to 5 years)
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 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Julie Kanter, MD principal investigator
University of Alabama, Birmingham (UAB)
9 sites 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 RTI International at 9 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Lisa A Cox, MS (770-407-4908, lacox@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of unaffiliated patients (time frame: Beginning of enrollment - end of study (up to 5 years)). The study lists 2 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 22 Jun 2025.