Sickle Cell DiseaseACCELERATENCT06318143
mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria
A study testing TASSH and SIM in people with Sickle Cell Disease, run by New York University at 1 site in Nigeria.
Trial summary
Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- TASSH and SIM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jul 2024to 31 May 2028
- Phase
- Interventional
- 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- SCD patients18 years older that have provided consent;
- Pediatric SCD patients aged 12 months to 17 years with an accompanying guardian and have provided informed consent or assent;
- Registration in the electronic medical records (EMR) database with clinical charts and received care at the local clinical sites or health facilities and not on HU therapy;
- Hb Genotype: SCD-SS, SCD-Sβo thal, SCD-SOArab (On a case by case basis, a severely affected person with SCD-SC may be offered HU therapy under a modified treatment protocol)
Who cannot join
- Any SCD patient not registered in the EMR database without informed consent or assent;
- Physically unable to participate in study activities;
- An SCD patient on HU
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Obiageli Nnodu contact
Nigeria1 site, 1 recruiting
- Recruiting
University Of Abuja Teaching Hospital
Abuja
Nnodu, +234-813-0610603, oennodu@gmail.com
About this study
Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is <1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria.
Read the detailed description
Aim 1: Using the EPIS framework as a guide, identify and characterize the capacity of 20 SPARC-NEt clinical sites to adopt SIM and adapt a tailored healthcare worker TASSH Training + Clinical reminders + Practice facilitation (TASSH TCP) for SCD management.
Aim 2: Evaluate in a cluster RCT, the effect of the TASSH TCP (experimental condition) vs. receipt of educational information only on TASSH TCP (control) on the adoption of SIM (primary outcome) across 20 SPARC-NEt clinical sites at 12 months. Hypothesis 1: The level of SIM adoption will be higher in the SPARC- NEt clinical sites randomized to the experimental condition than those in control.
Aim 3: Evaluate the mediators of SIM+TASSH TCP adoption, implementation fidelity, and sustainability across SPARC-NEt clinical sites at 12 and 24 months. Hypothesis 2: Inner organizational context, outer context, and implementation process will influence adoption, fidelity, and sustainability of SIM+TASSH TCP at clinical sites.
Impact: The study leverages the infrastructure of the SPARC-NEt (U01HL156942) of Nigeria to assess the adoption of HU among providers to improve SCD management in a manner that is scalable and sustainable across Nigeria and identify best practices for implementing HU therapy in resource constrained settings.
- Conditions
- Sickle Cell Disease
- Being tested
- TASSH, SIM
- 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.
TASSHBehavioural
Strategy for Hemoglobinopathies (TASSH) containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management (Figure 1A describes the components of the intervention).
SIMOther
Provision of information about task sharing (Education)
| Study group | Role | What they receive |
|---|---|---|
| SIM Only | Active comparator | Provision of information about task sharing (Education) Receives: Other: SIM |
| SIM + TASSH TCP | Experimental | replicable evidence-based task-sharing strategy,TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH) Receives: Behavioral: TASSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient numbers - screening
The number of patients taking HU identified through screening
Measured: 12 months
Patient numbers - proportion on HU
The proportion of patients that on HU based on the REACH Clinical Trial algorithm tailored for aged 12 months through adulthood using SPARCO HU Guidelines
Measured: 12 months
Patient numbers - dosage
Proportion of patients who maintained HU dosage
Measured: 12 months
Secondary outcomes (1)
Mediators
Secondary outcome measures are the mediators of SIM adoption and sustainability across the clinical sites at 12 and 24 months. The following measures will be used to assess the mediators of SIM via self-report. The mediators are based on the constructs of the EPIS including inner context characteristics of the clinics, intervention characteristics, and implementation process measures
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318143
- Sponsor's protocol ID
- U01HL168084
- Acronym
- ACCELERATE
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peprah E, Gyamfi J, Patena J, Kayalioglu H, Hameed T, Ogedegbe G, Do H, Ojji D, Adenikinju D, Ajaye Oba T, Nwegbu M, Isa H, Shedul G, Sopekan AY, Nnodu OE. An implementation trial to mAnage siCkle CELl disEase through incReased AdopTion of hydroxyurEa in Nigeria (ACCELERATE): Study protocol. PLoS One. 2025 Jan 8;20(1):e0311900. doi: 10.1371/journal.pone.0311900. eCollection 2025.
PubMed 39774400
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria
- ClinicalTrials.gov ID
- NCT06318143
- Acronym / sponsor ID
- ACCELERATE / U01HL168084
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 19 Mar 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.
Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is <1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria.
Detailed description
Aim 1: Using the EPIS framework as a guide, identify and characterize the capacity of 20 SPARC-NEt clinical sites to adopt SIM and adapt a tailored healthcare worker TASSH Training + Clinical reminders + Practice facilitation (TASSH TCP) for SCD management.
Aim 2: Evaluate in a cluster RCT, the effect of the TASSH TCP (experimental condition) vs. receipt of educational information only on TASSH TCP (control) on the adoption of SIM (primary outcome) across 20 SPARC-NEt clinical sites at 12 months. Hypothesis 1: The level of SIM adoption will be higher in the SPARC- NEt clinical sites randomized to the experimental condition than those in control.
Aim 3: Evaluate the mediators of SIM+TASSH TCP adoption, implementation fidelity, and sustainability across SPARC-NEt clinical sites at 12 and 24 months. Hypothesis 2: Inner organizational context, outer context, and implementation process will influence adoption, fidelity, and sustainability of SIM+TASSH TCP at clinical sites.
Impact: The study leverages the infrastructure of the SPARC-NEt (U01HL156942) of Nigeria to assess the adoption of HU among providers to improve SCD management in a manner that is scalable and sustainable across Nigeria and identify best practices for implementing HU therapy in resource constrained settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM Only | Active comparator | Other: SIMProvision of information about task sharing (Education) |
| SIM + TASSH TCP | Experimental | Behavioral: TASSHreplicable evidence-based task-sharing strategy,TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH) |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- SCD patients18 years older that have provided consent;
- Pediatric SCD patients aged 12 months to 17 years with an accompanying guardian and have provided informed consent or assent;
- Registration in the electronic medical records (EMR) database with clinical charts and received care at the local clinical sites or health facilities and not on HU therapy;
- Hb Genotype: SCD-SS, SCD-Sβo thal, SCD-SOArab (On a case by case basis, a severely affected person with SCD-SC may be offered HU therapy under a modified treatment protocol)
Key exclusion criteria (3 listed)
- Any SCD patient not registered in the EMR database without informed consent or assent;
- Physically unable to participate in study activities;
- An SCD patient on HU
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 |
|---|---|---|
| TASSHStrategy for Hemoglobinopathies (TASSH) containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management (Figure 1A describes the components of the intervention). | Behavioural | SIM + TASSH TCP |
| SIMProvision of information about task sharing (Education) | Other | SIM Only |
Primary outcome
Patient numbers - screening
Time frame: 12 months
The number of patients taking HU identified through screening
Patient numbers - proportion on HU
Time frame: 12 months
The proportion of patients that on HU based on the REACH Clinical Trial algorithm tailored for aged 12 months through adulthood using SPARCO HU Guidelines
Patient numbers - dosage
Time frame: 12 months
Proportion of patients who maintained HU dosage
1 secondary outcome
Mediators
Time frame: 12 months and 24 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 7 Jul 2026.
- Derived from this study: PubMed 39774400Peprah E, Gyamfi J, Patena J, Kayalioglu H, Hameed T, Ogedegbe G, Do H, Ojji D, Adenikinju D, Ajaye Oba T, Nwegbu M, Isa H, Shedul G, Sopekan AY, Nnodu OE. An implementation trial to mAnage siCkle CELl disEase through incReased AdopTion of hydroxyurEa in Nigeria (ACCELERATE): Study protocol. PLoS One. 2025 Jan 8;20(1):e0311900. doi: 10.1371/journal.pone.0311900. eCollection 2025.
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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.
Obiageli Nnodu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TASSH and SIM in people with Sickle Cell Disease, run by New York University at 1 site in Nigeria.
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 3 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 7 Jul 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 Nigeria. 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 Emmanuel Peprah, PhD (212-992-6085, ep91@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient numbers - screening (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06318143, which also lists 1 linked publication.
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 7 Jul 2026.