Education, MedicalIMPACTNCT05817370
Implementation of Anal Cancer Screening and Treatment in Nigeria
A study testing Enhanced Training on screening and treatment of HSIL (e-STH) in people with Education, Medical, run by University of Maryland, Baltimore at 1 site in Nigeria.
Trial summary
The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings. The second training protocol will be developed so tailored to the Nigerian setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Medical
- What is being tested?
- Enhanced Training on screening and treatment of HSIL (e-STH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNigeria
- Study dates
- 2 May 2023to 31 Aug 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Possess a medical degree in medical sciences (MBBS or equivalent)
- At least 2-5 years of experience working with clinical HIV/AIDS community
- Must be registered with the medical and dental council of Nigeria
- Possess a current medical practicing license
- Willing to work with the Sexual Gender Minority Community
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sylvia Adebajo contact
Nigeria1 site, 1 recruiting
- Recruiting
International Center for Advocacy on Right to Health (ICARH)
Abuja
Sylvia Adebajo, PhD, SAdebajo@mgic.umaryland.edu
About this study
Official title: Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)
The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings. The second training protocol will be developed so tailored to the Nigerian setting. Investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols.
Read the detailed description
In Aim 1, anal cancer screening and treatment based on standard training protocols of how to screen and treat high-grade intraepithelial lesions (HSILs) to prevent anal cancer as developed in high-income settings will be conducted. Investigators will identify barriers and facilitators with learning the procedure with standard training using the Consolidated Framework for Implementation Research (CFIR). In Aim 2, Investigators will identify strategies to modify the standard training to improve learning on a complicated procedure using the Expert Recommendations for Implementing Change (ERIC) framework. An implementation science committee will co-design and develop an enhanced training on Screening and Treatment of HSIL (e-STH) by matching the barriers identified with CFIR with strategies in ERIC. Investigators will then take an iterative improvement approach to test and refine the implementation of the enhanced training intervention to ensure that HSIL screening and treatment is readily adopted and maintained as part of HIV care. In Aim 3 (CLINICAL TRIAL AIM), Investigators will conduct a Hybrid Type 2 trial using an interrupted time series design to monitor and evaluate outcomes along the implementation continuum. The trial will be conducted at a single clinic to minimize variability. The participant (Physician) will have a pre-period of HSIL screening and treatment for 12 months after standard training. Next, investigators will roll out e-STH for 6 months. Then there will be a post-period of screening for 12 months to evaluate the impact of e-STH. Lastly, there will be 6 months of screening and treatment with minimal involvement of the investigative team to evaluate sustainability.
The study will compare e-STH to standard training in proportion of HSIL detected and treated with secondary outcomes evaluating reach, efficacy, implementation, and sustainability.
- Conditions
- Education, Medical
- Being tested
- Enhanced Training on screening and treatment of HSIL (e-STH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Training on screening and treatment of HSIL (e-STH)Behavioural
Tailored training developed to overcome key barriers and promote facilitators unique to implementing HSIL screening and treatment. The development will be driven by the implementation science committee over 3 iterations every 4 months for up to a year to refine the adoption of strategies with the greatest breadth to facilitate implementation.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Training on screening and treatment of HSIL (e-STH) | Experimental | Tailored training developed to overcome key barriers and promote facilitators unique to implementing HSIL screening and treatment. The development will be driven by the implementation science committee over 3 iterations every 4 months for up to a year to refine the adoption of strategies with the greatest breadth to facilitate implementation. Receives: Behavioral: Enhanced Training on screening and treatment of HSIL (e-STH) |
| Standard Screening and treatment of HSIL | No intervention | The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HSIL detection
Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)
Measured: 12 months and 30 months
Change in HSIL treatment
Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)
Measured: 12 months and 30 months
Secondary outcomes (4)
Change in Reach of intended population
Change in number screened per number eligible between the pre and post period
Measured: 12 months and 30 months
Change in Efficacy of conducting HSIL screening and treatment
Compare number needed to screen to reach a plateau in the detection of HSIL between the pre and post period
Measured: 12 months and 30 months
Change in Implementation of HSIL screening and treatment
Compare number of biopsies taken per screening between the pre and post period
Measured: 12 months and 30 months
Change in Maintenance of HSIL screening and treatment
Compare number who return for a 12-month screening between the pre and post period
Measured: 18 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start2 May 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The way a physician is trained on the detection of HSIL screening and treatment to prevent anal cancer will be modified so that the cancer prevention strategy is readily adopted for a low-to middle-income setting. An implementation science committee will guide the development of the modified training over 3 iterations every 4 months for up to a year. To test if the modified training improves implementation of anal cancer screening and treatment, the physician will first conduct screening after standard training for 12 months. Then the physician will conduct screening after the modified training for 12 months. Depending on the time of when the participants visit the clinic will determine which arm they are enrolled. There is no randomization and the arms are sequential.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rebecca Nowak, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817370
- Sponsor's protocol ID
- HP-00101383
- Other IDs
- U01CA275053
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)
- ClinicalTrials.gov ID
- NCT05817370
- Acronym / sponsor ID
- IMPACT / HP-00101383
- Conditions
- Education, Medical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Apr 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.
The study is a feasibility pilot trial testing 2 types of training protocols on a single physician. The first training protocol is the current standard and was developed in high-income settings. The second training protocol will be developed so tailored to the Nigerian setting. Investigators will test if the physician performs differently in their ability to conduct anal cancer screening and treatment between the 2 training protocols.
Detailed description
In Aim 1, anal cancer screening and treatment based on standard training protocols of how to screen and treat high-grade intraepithelial lesions (HSILs) to prevent anal cancer as developed in high-income settings will be conducted. Investigators will identify barriers and facilitators with learning the procedure with standard training using the Consolidated Framework for Implementation Research (CFIR). In Aim 2, Investigators will identify strategies to modify the standard training to improve learning on a complicated procedure using the Expert Recommendations for Implementing Change (ERIC) framework. An implementation science committee will co-design and develop an enhanced training on Screening and Treatment of HSIL (e-STH) by matching the barriers identified with CFIR with strategies in ERIC. Investigators will then take an iterative improvement approach to test and refine the implementation of the enhanced training intervention to ensure that HSIL screening and treatment is readily adopted and maintained as part of HIV care. In Aim 3 (CLINICAL TRIAL AIM), Investigators will conduct a Hybrid Type 2 trial using an interrupted time series design to monitor and evaluate outcomes along the implementation continuum. The trial will be conducted at a single clinic to minimize variability. The participant (Physician) will have a pre-period of HSIL screening and treatment for 12 months after standard training. Next, investigators will roll out e-STH for 6 months. Then there will be a post-period of screening for 12 months to evaluate the impact of e-STH. Lastly, there will be 6 months of screening and treatment with minimal involvement of the investigative team to evaluate sustainability.
The study will compare e-STH to standard training in proportion of HSIL detected and treated with secondary outcomes evaluating reach, efficacy, implementation, and sustainability.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The way a physician is trained on the detection of HSIL screening and treatment to prevent anal cancer will be modified so that the cancer prevention strategy is readily adopted for a low-to middle-income setting. An implementation science committee will guide the development of the modified training over 3 iterations every 4 months for up to a year. To test if the modified training improves implementation of anal cancer screening and treatment, the physician will first conduct screening after standard training for 12 months. Then the physician will conduct screening after the modified training for 12 months. Depending on the time of when the participants visit the clinic will determine which arm they are enrolled. There is no randomization and the arms are sequential.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Training on screening and treatment of HSIL (e-STH) | Experimental | Behavioral: Enhanced Training on screening and treatment of HSIL (e-STH)Tailored training developed to overcome key barriers and promote facilitators unique to implementing HSIL screening and treatment. The development will be driven by the implementation science committee over 3 iterations every 4 months for up to a year to refine the adoption of strategies with the greatest breadth to facilitate implementation. |
| Standard Screening and treatment of HSIL | No intervention | –The standard screening and treatment of HSIL outlined by the International Anal Neoplasia Society |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Possess a medical degree in medical sciences (MBBS or equivalent)
- At least 2-5 years of experience working with clinical HIV/AIDS community
- Must be registered with the medical and dental council of Nigeria
- Possess a current medical practicing license
- Willing to work with the Sexual Gender Minority Community
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Enhanced Training on screening and treatment of HSIL (e-STH)Tailored training developed to overcome key barriers and promote facilitators unique to implementing HSIL screening and treatment. The development will be driven by the implementation science committee over 3 iterations every 4 months for up to a year to refine the adoption of strategies with the greatest breadth to facilitate implementation. | Behavioural | Enhanced Training on screening and treatment of HSIL (e-STH) |
Primary outcome
Change in HSIL detection
Time frame: 12 months and 30 months
Evaluate change in HSIL detected between the pre and post period (standard vs e-STH)
Change in HSIL treatment
Time frame: 12 months and 30 months
Evaluate change in HSIL treated between the pre and post period (standard vs e-STH)
4 secondary outcomes
Change in Reach of intended population
Time frame: 12 months and 30 months
Change in Efficacy of conducting HSIL screening and treatment
Time frame: 12 months and 30 months
Change in Implementation of HSIL screening and treatment
Time frame: 12 months and 30 months
Change in Maintenance of HSIL screening and treatment
Time frame: 18 months and 36 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 30 Jul 2026.
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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.
Sylvia Adebajo 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 Enhanced Training on screening and treatment of HSIL (e-STH) in people with Education, Medical, run by University of Maryland, Baltimore 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 5 inclusion and 0 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 30 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 Rebecca Nowak, PhD (4107064642, rnowak@ihv.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HSIL detection (time frame: 12 months and 30 months). 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 30 Jul 2026.