Cervical Cancer Screen-and-Treat Strategies for Cervical Cancer
(ACCESS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byGregory Aarons, PhD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Must be taking: Antiretrovirals
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. It is likely that participants can continue their current HIV treatment, as the study aims to integrate cervical cancer screening with existing HIV care.
What data supports the effectiveness of the treatment Core+ Enhanced Implementation Strategies, Core Implementation strategies for cervical cancer?
The research highlights that cervical cancer screening and prevention are highly effective when implemented properly, especially in low-resource settings. Strategies like patient reminders and educational programs have been shown to improve adherence to screening, which is crucial for early detection and treatment.
12345Is the cervical cancer screen-and-treat strategy safe for humans?
The research articles provided do not contain specific safety data for the cervical cancer screen-and-treat strategy or its related implementation strategies.
56789How does the screen-and-treat strategy for cervical cancer differ from other treatments?
The screen-and-treat strategy for cervical cancer is unique because it focuses on immediate treatment following a positive screening result, which is particularly beneficial in low-resource settings where follow-up can be challenging. This approach often uses non-cytology-based methods, such as visual inspection with acetic acid (VIA) and thermocoagulation, making it more accessible and feasible in areas with limited healthcare infrastructure.
3571011Eligibility Criteria
This trial is for women living with HIV in certain low- and middle-income countries. It aims to improve cervical cancer screening and treatment by using existing HIV care infrastructure.Inclusion Criteria
I am a woman living with HIV.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Integration of cervical cancer screening and treatment within existing HIV programs
12 months
Regular visits as per HIV program schedule
Follow-up
Participants are monitored for safety and effectiveness after treatment
15 months
Follow-up visits for post-treatment screening
Sustainment
Assessment of the sustainment of the integration of cervical cancer screening and treatment
3 months
Participant Groups
The ACCESS study compares two approaches: 'Core' strategies versus 'Core+' enhanced strategies, to integrate cervical cancer screen-and-treat services into HIV programs, assessing effectiveness through a cluster randomized design.
2Treatment groups
Experimental Treatment
Active Control
Group I: Core+ Enhanced Implementation StrategiesExperimental Treatment1 Intervention
Includes all of the Core implementation strategies and adds:
5. Community engagement using Health Beginning Initiative Model
6. Smart Cards to facilitate patient engagement
Group II: Core Implementation StrategiesActive Control2 Interventions
Core Implementation Strategies
1. Ongoing consultation
2. Educational meetings
3. Strengthen referral system
4. Prepare patients to be active participants
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC San DiegoLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
University of Nigeria NsukkaCollaborator
References
No improvement in survival of older women with cervical cancer-A nationwide study. [2021]This study aims to report trends in primary treatment and survival in cervical cancer (CC) to identify opportunities to improve clinical practice and disease outcome.
Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial. [2022]Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment.
Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial. [2022]Screen-and-treat approaches to cervical cancer prevention are an attractive option for low-resource settings, but data on their long-term efficacy are lacking. We evaluated the efficacy of two screen-and-treat approaches through 36 months of follow-up in a randomized trial.
Thousands of Women's Lives Depend on the Improvement of Poland's Cervical Cancer Screening and Prevention Education as Well as Better Networking Strategies Amongst Cervical Cancer Facilities. [2022]Proper targeted cancer prophylaxis reduces the incidence of cancer in all forms; this includes cancers with significant progression potential and poor prognosis. Based on the assumption that one of the risk factors of cervical cancer is the avoidance of screening tests, we analyzed the current scenario of cervical cancer (CC) screening and recommendations in Poland (country with a well-off socioeconomic status). Based on the comprehensive literature review concerning documents of guidelines and recommendations of various bodies, including national ones, data on the implementation of CC screening in Poland, and different models for medium-to-high-income countries, we proposed how the CC screening strategy could be improved. Finally, the new strategy was further developed for those who are prone to not being screened. The proposal on how to improve the Polish CC screening program is the following: refinement of the public education on CC risk factors, popularization of CC screening incentives amongst the public, and improvement of networking strategies between CC screening facilities ("cervical screening clinical"), allowing screenings to be more efficient and rapid. We believe that, to enhance the future quality of life of those with rapid CC progression by catching the disease preemptively and limiting the sequelae of the disease, we have to improve education and access to medical services.
Global strategies for cervical cancer prevention and screening. [2020]Cervical cancer is highly preventable and can be easily treated if detected at early stages. However there is disproportionate high burden of cervical cancer incidence and mortality in low-middle income (LMIC) country settings that lack organized screening and prevention programs. Robust evidence for prevention and screening of cervical cancer is currently available. However there are barriers for country specific adoption and implementation. These pose unique challenges such as organizing prevention and screening services delivery through the current health infrastructure, access to screening facilities, follow-up management and adequate linkages for confirmatory diagnosis and subsequent treatment. Overall cervical cancer screening rates and cancer screening among women still remains suboptimal in many LMIC's. Considering the complexities involved in organization, service uptake and delivery of population based cervical cancer prevention and screening programs, this article aims to provide evidence based appropriate, affordable and effective standardized cervical cancer prevention and screening guidelines that are operationally feasible to help adopt best practices for uniform adaptation and implementation leveraging with the existing public health care settings. Cost-effective strategies and tools to reduce cervical cancer burden worldwide to mitigate the existing disparities in cervical cancer burden between low-resourced and high-resourced settings are needed. The current cervical cancer prevention and screening guidelines are drawn from the most robust evidence generated from the randomised trials and cross-sectional studies undertaken in the socioeconomic, cultural and health systems context of varied geographic settings and therefore conform towards applicability for wide-scale, sustainable and uniform implementation of population based cervical cancer screening and prevention program.
Cervical cancer treatment update: A Society of Gynecologic Oncology clinical practice statement. [2023]Cervical cancer is the most commonly diagnosed gynecologic cancer worldwide. Although the incidence has declined with increased screening and higher uptake of human papillomavirus (HPV) vaccination in high-income countries, this disease remains the second highest cause of cancer mortality among women in low- and middle-income countries. In this clinical practice statement, we describe therapies for cervical cancer by treatment setting, as well as quality of life, financial toxicity, and disparities associated with this disease. In addition to chemotherapy and radiation, therapeutic strategies for cervical cancer include immune checkpoint blockade, antiangiogenics, and antibody-drug conjugates. Optimal treatment for recurrent cervical cancer remains an area of unmet need, necessitating further exploration of rational and innovative treatment approaches, including cell and immune-based therapies. Importantly, development of effective therapies for cervical cancer must incorporate strategies to ensure universal equitable access to HPV vaccination, screening, and treatment. Important consequences of the disease and treatment that impact quality of life must also be addressed. Patients with cervical cancer are at increased risk for financial toxicity, which can lead to downstream detrimental effects on physical, financial, and career outcomes. Underrepresentation of racial and ethnic minorities in gynecologic oncology clinical trials highlights the urgent need for collaborative and focused initiatives to bridge the significant divide and alleviate inequalities in the prevention and treatment of cervical cancer.
Increasing cervical cancer screening at a non-government medical center in Lilongwe, Malawi. [2021]Malawi has the highest incidence of and mortality rate due to cervical cancer in the world. This is largely because of inadequate screening and high rates of human immunodeficiency virus (HIV) infection, which greatly increases cervical cancer risk. We describe the implementation of a quality improvement program to increase use of cervical cancer screening at a non-government medical center in Lilongwe, Malawi. The intervention, developed and launched from March to August 2017, aimed to promote education among patients and clinicians about the importance of cervical cancer screening and improve accessibility of screening information within medical records. Visual inspection with acetic acid (VIA) was used to screen for cervical cancer. Women with a positive VIA were offered treatment using thermocoagulation. The number of VIA screenings conducted in 2016 (pre-intervention), 2017 (intervention), and 2018 (post-intervention) was 125, 234 and 456, respectively. Of the 815 women screened during this period, 36 (4.4%) had a VIA-positive result and 12 (1.5%) had suspect cancer. Of the VIA-positive women, 13 (36.1%) received same-day treatment with thermocoagulation. An interrupted time series regression revealed that there was a sustained increase in monthly screenings between the pre- and post-intervention period (β = 30.84; p = 0.006; 95% CI 9.72-51.97), suggesting that the intervention likely was effective in increasing cervical cancer screening. Our results demonstrate that focusing on developing sustainable solutions and improving system processes, without additional equipment or funding, significantly increased the number of women screened and should be considered in other settings to enhance cervical cancer prevention services.
Compliance with and acute hematologic toxic effects of chemoradiation in indigent women with cervical cancer. [2022]The goals of this work were to describe the compliance with and acute hematologic toxic effects of chemoradiation for cervical cancer in indigent women and to explore the likelihood that chemoradiation is effective outside research settings. We hypothesized that if compliance and toxicity are not limiting in this high-risk group of patients, the effectiveness of chemoradiation for cervical cancer in community settings is likely to mirror the efficacy demonstrated in clinical trials.
Cervical cancer screening guidelines: An update. [2023]Cervical cancer screening practices in the United States have been inefficient, with variable screening rates. Some women are screened too frequently, overmanaged, lost to follow-up, or are at risk and should be screened but are not. Timely screening, identification, and management of abnormal cervical cells is vital in order to prevent progression to cervical cancer. Educating, counseling, screening, and offering the human papillomavirus vaccine continue to be the primary methods of cervical cancer prevention practices. Guidelines and primary screening methods have been updated because of supporting evidence, and clinicians must stay up-to-date in order to provide effective patient care.
Primary and Triage Cervical Screening Diagnostic Value of Methods for the Detection of Cervical Dysplasia. [2022]Cervical cancer is a leading cause of mortality among women globally. Approaches to reduce cervical cancer incidence and mortality are "screen-and-treat," where positive primary test only is used in the treatment and "screen, triage and treat," where treatment is based on positive primary and triage tests with/without histological analysis.
Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial. [2022]Non-cytology-based screen-and-treat approaches for cervical cancer prevention have been developed for low-resource settings, but few have directly addressed efficacy.