Clinical trial NCT05817370: Implementation of Anal Cancer Screening and Treatment in Nigeria
Official title: Integrated Model for the Prevention of Anal Cancer Using Screen and Treat for High-grade Intraepithelial Lesions (IMPACT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Education, Medical
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-04-18
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Possess a medical degree in medical sciences (MBBS or equivalent)
2. At least 2-5 years of experience working with clinical HIV/AIDS community
3. Must be registered with the medical and dental council of Nigeria
4. Possess a current medical practicing license
5. Willing to work with the Sexual Gender Minority Community

Exclusion Criteria:

Primary outcomes:
measure: Change in HSIL detection
timeFrame: 12 months and 30 months
measure: Change in HSIL treatment
timeFrame: 12 months and 30 months
Secondary outcomes:
measure: Change in Reach of intended population
timeFrame: 12 months and 30 months
measure: Change in Efficacy of conducting HSIL screening and treatment
timeFrame: 12 months and 30 months
measure: Change in Implementation of HSIL screening and treatment
timeFrame: 12 months and 30 months
measure: Change in Maintenance of HSIL screening and treatment
timeFrame: 18 months and 36 months
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: International Center for Advocacy on Right to Health (ICARH)
Study officials:
References: