Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Immune System Diseases

Uterine Cervical Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Core Implementation Strategies

1. Ongoing consultation
2. Educational meetings
3. Strengthen referral system
4. Prepare patients to be active participants

Includes all of the Core implementation strategies and adds:

5. Community engagement using Health Beginning Initiative Model

6. Smart Cards to facilitate patient engagement

Core Implementation strategies

Core+ Enhanced Implementation Strategies

Gregory Aarons, PhD

Echezona Ezeanolue, MD, MPH

Joella Phillips, BA

Tonia Onyeka

While there has been a significant increase in the uptake of antiretroviral therapy among women living with HIV (WLHIV) in many low- and-middle income countries (LMICs), the coverage of cervical cancer screening and treatment (CCST) among WLHIV remains low. This study aims to leverage the available infrastructure for HIV care and treatment programs in Nigeria to integrate cervical cancer screening and treatment and conduct a cluster randomized, hybrid type III trial design to assess the comparative effectiveness of a Core set of implementation strategies versus a Core+ (enhanced) set of implementation strategies to implement cervical cancer screening, onsite treatment, referral and referral completion, treatment, and retention in care among WLHIV. The overarching goal is to improve the health and life expectancy of WLHIV with co-occurring cervical cancer.

Nigeria has one of the largest HIV epidemics in the world with 1.8 million people living with HIV infection. With an estimated female population of 102 million and HIV prevalence of 1.6% among adult females, Nigeria has the largest population of women and the 4th largest number of women living with HIV (WLHIV) in Africa. Although access to antiretroviral therapy (ART) among WLHIV in Nigeria has increased over the years, with over 98% of the 960,000 WLHIV on ART, AIDS-related mortality remains high. In 2020, 16,000 WLHIV died from AIDS- related illnesses including cervical cancer. A pilot implementation program in Nigeria demonstrated that leveraging the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) supported HIV programs for the provision of evidence-based cervical cancer screen-and-treat interventions in WLHIV is feasible. The pilot program demonstrated, however, that tailored implementation strategies will be needed to address specific multilevel barriers along the cancer control continuum in order to address adoption, reach, and sustainability that are necessary for successful scale-up. However, in many African countries with a high burden of both HIV and cervical cancer, there is a paucity of evidence-based implementation strategies to inform effective integration of HIV and cervical cancer services delivery. Objectives of this proposal are to: 1) Refine strategies to integrate cervical cancer screening, treatment and management within existing comprehensive HIV treatment programs and determine implementation readiness; 2) Determine the comparative effectiveness of a Core set of implementation strategies versus Core+ enhanced implementation strategies; and 3) assess sustainment of the integration of cervical cancer screening, treatment, and management intervention into HIV programs. The investigators have assembled a strong team from University of California San Diego, the University of Nigeria, Nsukka, and Northeastern University with expertise in implementation science, HIV care and research, and cancer care and research. Our proposal is responsive to the NCI request for applications (RFA) and consistent with the World Health Organization global plan of elimination of cervical cancer by 2030. If effective, the proposed project will result in a set of feasible, culturally adaptable, and sustainable implementation strategies to integrate evidence-based cervical cancer screening and treatment into HIV programs in order to improve the health and life expectancy of WLHIV.

ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services

Percent of WLHIV who had cervical cancer (CC) screening

Provider Report of Sustainment Scale (PRESS; Moullin et al., 2021). The PRESS has 3-items scored from 0 "not at all" to 4 "to a very great extent" where higher scores indicate better evidence-based practice sustainment.

Percent of WLHIV treated for pre-invasive cancer who had negative post treatment follow-up screen

University of Nigeria Nsukka

University of California, San Diego

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participating centers will retrospectively provide demographic, tumor, treatment and follow-up details on at least 25 consecutive patients with stage III NSCLC previously treated with curative intent chemoradiotherapy (concurrent or sequential) in the period between 2010 and 2013.

Participating centers will provide prospective data on patients with stage III NSCLC treated with curative intent concurrent chemoradiotherapy. Centers will be asked to include at least 25 consecutive cases following the training intervention and the successful local implementation of PET/CT for RTP in NSCLC.

Tom Konert, BSc

Wouter V Vogel, MD

Gerard G Hanna, MD

A part retrospective, part prospective cohort study to assess the difference in 2-year overall survival in patients with stage III NSCLC receiving chemoradiotherapy with curative intent in low and middle income countries before and after a training intervention on the use of PET/CT for radiotherapy treatment planning.

Over the years, the incidence of lung cancer has risen in some low and middle income countries due to the rise in tobacco use. Patients commonly present with lung cancer in an advanced stage (stage III and IV) are not suitable for surgical resection, but may be considered for radiotherapy. For patients in those countries who are not suitable for surgical resection, radiotherapy offers the best chance of cure, best improvement in local cancer control, best palliation and fewest side-effects. For accurate patient selection for curative treatment and accurate staging of lung cancer, the use of fused 18F-fluorodeoxyglucose Positron Emission Tomography/ Computed Tomography (FDG PET/CT) imaging has been shown to be superior to CT alone. It has also been shown to have a significant impact when used in the radiation treatment planning process and in particular for when used for target volume delineation, where a significant reduction in interobserver variation has been noted.

In recent years, many health care institutions in low and middle income countries have established Nuclear Medicine (NM) imaging in routine clinical practice in conjunction with modern Radiation Oncology (RO) facilities. The installation of hybrid PET/CT systems in these countries permits more the increased use of PET/CT for both staging and radiotherapy planning. However the successful implementation of PET/CT for radiotherapy planning (RTP) requires a degree of expertise to safely and accurately implement this imaging technique. A recently published review by the International Atomic Energy Agency (IAEA), about current trends in NM in developing countries showed there is still lack of expertise, equipment and human resources to gain benefit from this imaging technique. In RO, difficulties in the implementation of this technique are mainly related to inadequate training of staff and lack of local expertise.

Quality assurance of the PET/CT scanners might be compromised when not performed according to accepted nuclear medicine quality assurance standards. Therefore, there is a concern that, if used without appropriate training or expertise, suboptimal image quality may result and inappropriate interpretation of the PET/CT for RTP may occur. In this study to help provide PET Quality Control will be executed to aim for a standardized PET image quality that meets the minimum requirements of European Association of Nuclear Medicine standards. Participating centers will be assisted to earn the European Association of Nuclear Medicine (EANM) Research Ltd (EARL) accreditation. The quality of the imaging can be influenced by physiological and technical factors. The Standardized Uptake Value (SUV) allows for semi quantitative evaluation in PET imaging, and is influenced by these factors. Spatial resolution affects SUV values significantly and this parameter can differ a lot between multiple centers. The EANM NEMA NU 2001/2007 2 Image Quality Phantom allows for standardization of PET imaging between centers with different scanners, using the activity coefficient recovery curve (ACRC) as a parameter for quantification of this spatial resolution.

It is already known that FDG PET/CT based RTP enables appropriate selection of patients who will benefit from curative radiation therapy. One possible cause of failure in radiotherapy is the inability to accurately define the tumor edges. In these patients there are no other possible curative salvage treatment options and the disease is incurable. It is hoped that FDG PET/CT based RTP will improve tumor volume delineation (TVD) and hence improve outcomes following curative radiotherapy. There is also clear evidence that PET/CT standardizes TVD in patients with NSCLC. However, what is not known is the impact of PET/CT based TVD on patient outcomes such as survival as distinct from the benefit of PET/CT for patient selection for curative treatment. Furthermore, the impact of a training intervention on the use of PET/CT RTP in 2-year overall survival has not been studied to the best of our knowledge.

This study will evaluate the possible impact of the use of PET/CT for TVD on 2-year overall survival in patients with stage III NSCLC referred for curative intent radiotherapy with chemotherapy in low and middle income countries, this study involves a retrospective cohort study, a training intervention, and a prospective cohort study. The training intervention will focus on standard FDG PET/CT acquisition, FDG PET/CT image quality, staging procedure for FDG PET/CT acquisition and FDG PET/CT for RTP acquisition and Tumor Volume Delineation.

An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries

Determine the impact of PET/CT in RTP on 2-year overall survival rates for patients with stage III NSCLC receiving chemoradiotherapy with curative intent. Patients from the retrospective cohort will be selected from the institutional database and were treated between 2010 to 2013. Patients from the prospective cohort will be selected until the end of 2015.

Determine the impact of a PET/CT in RTP training intervention on tumor volume delineation for stage III NSCLC radiotherapy. Different parameters are used to determine the observer variation: Dice Index, median surface distances

Determine the quality of PET/CT scanners. Study baseline PET/CT imaging protocols and image acquisition characteristics with the following parameters: recovery coefficients, spatial resolution measurement, and calibration of SUV determination. All centers will participate in the EARL accreditation programme.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services	NCT06128304	HIV Cervical Cancer	Core Implementa... Core+ Enhanced ...	25 Years - 65 Years	University of California, San Diego
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services	NCT06128304	HIV Cervical Cancer	Core Implementa... Core+ Enhanced ...	25 Years - 65 Years	University of California, San Diego
An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries	NCT02247713	Non Small Cell ...		18 Years -	The Netherlands Cancer Institute
An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries	NCT02247713	Non Small Cell ...		18 Years -	The Netherlands Cancer Institute
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services	NCT06128304	HIV Cervical Cancer	Core Implementa... Core+ Enhanced ...	25 Years - 65 Years	University of California, San Diego

Spots Global Cancer Trial Database for low and middle income countries