Cervical Cancer Screen-and-Treat Strategies for Cervical Cancer

(ACCESS Trial)

Recruiting at 1 trial location

Overseen By Echezona Ezeanolue, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Antiretrovirals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

2436 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cervical cancer screening and treatment for women living with HIV in Nigeria. It compares two strategies: a core set of actions, such as educational meetings and strengthening referrals (Core Implementation Strategies), and an enhanced version that adds community engagement and smart cards for better patient involvement (Core+ Enhanced Implementation Strategies). The goal is to determine which approach most effectively helps women get screened and treated for cervical cancer. Women living with HIV are eligible to participate. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance healthcare strategies for women with HIV.

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 prior data suggests that these implementation strategies are safe for cervical cancer screening and treatment among women living with HIV?

Previous studies have found that both Core and Core+ Enhanced Implementation Strategies are generally safe. These strategies aim to improve cervical cancer screening and treatment for women living with HIV. The Core strategies include consultations, educational meetings, and improved referral systems, while Core+ adds community involvement and smart cards to help patients stay engaged in their care.

Research has shown these strategies are well-tolerated because they do not involve new drugs or risky medical procedures. Instead, they focus on improving healthcare processes. No reports of negative effects related to these strategies have emerged, suggesting they are safe for participants. The goal is to enhance existing healthcare systems, posing minimal risk to those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cervical cancer screen-and-treat strategies because they aim to enhance patient participation and community involvement, which are not typically emphasized in standard treatment protocols. Unlike traditional methods that often focus solely on medical interventions, the Core+ Enhanced Implementation Strategies incorporate community engagement through the Health Beginning Initiative Model and utilize Smart Cards for better patient engagement. These additions have the potential to strengthen the overall effectiveness of screening and treatment processes by fostering a more informed and active patient population, potentially leading to earlier detection and improved outcomes.

What evidence suggests that this trial's implementation strategies could be effective for cervical cancer screening and treatment among women living with HIV?

Research has shown that combining cervical cancer screening and treatment with existing HIV care can be effective for women living with HIV. In this trial, participants will follow different strategies. One group will receive Core Implementation Strategies, including ongoing consultation, educational meetings, strengthening the referral system, and preparing patients to be active participants. Another group will receive Core+ Enhanced Implementation Strategies, which add community involvement and smart cards to the basic strategies. Early results suggest that these enhanced strategies could boost patient participation and treatment success. Although the trial is ongoing, these methods appear promising for improving cervical cancer screening and treatment rates among women in Nigeria with HIV. ^{1 2 3 4 6}

Who Is on the Research Team?

Gregory Aarons, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Core+ Enhanced Implementation Strategies
• Core Implementation strategies

Trial Overview 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.

How Is the Trial Designed?

Group I: Core+ Enhanced Implementation Strategies Experimental Treatment 1 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 Strategies Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

University of Nigeria Nsukka

Collaborator

Trials

3

Recruited

30,200+

Published Research Related to This Trial

This study aims to improve cervical cancer screening adherence among women in Portugal through a stepwise intervention approach, starting with customized text messages and progressing to phone calls and face-to-face appointments, in a randomized controlled trial involving eligible women from urban and rural areas.

The primary goal is to measure the effectiveness of these interventions in increasing the proportion of women who participate in screening, compared to the standard care of receiving a written letter, with results expected to inform future public health strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Firmino-Machado, J., Mendes, R., Moreira, A., et al.[2022]

In a study involving 6,637 South African women, the HPV-and-treat approach significantly reduced the cumulative detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) after 36 months, with only 1.5% of women developing CIN2+ compared to 5.6% in the control group.

The visual inspection-and-treat approach also reduced CIN2+ cases but was less effective than the HPV-and-treat method, indicating that HPV DNA testing is a more effective strategy for cervical cancer prevention in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial. Denny, L., Kuhn, L., Hu, CC., et al.[2022]

Cervical cancer screening in Poland is currently underutilized, and improving public education about risk factors and screening incentives could significantly enhance screening rates.

The proposed strategy includes better networking among screening facilities to make the process more efficient, which could lead to earlier detection and better outcomes for patients at risk of rapid cervical cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Śniadecki, M., Poniewierza, P., Jaworek, P., et al.[2022]

Cervical cancer is highly preventable and treatable if detected early, yet low-middle income countries face significant challenges in implementing effective screening and prevention programs, leading to high incidence and mortality rates.

This article proposes evidence-based, cost-effective guidelines for cervical cancer prevention and screening that are tailored to the existing healthcare infrastructure in low-resource settings, aiming to improve service delivery and reduce disparities in cervical cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global strategies for cervical cancer prevention and screening. Pimple, SA., Mishra, GA.[2020]

A quality improvement program in Lilongwe, Malawi, successfully increased cervical cancer screenings from 125 in 2016 to 456 in 2018, demonstrating the effectiveness of educational initiatives and improved access to screening information.

The intervention led to a sustained increase in monthly screenings, indicating that enhancing system processes can significantly boost cervical cancer prevention efforts without needing extra resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing cervical cancer screening at a non-government medical center in Lilongwe, Malawi. Kakani, P., Kojima, N., Banda, BA., et al.[2021]

Cervical cancer remains a leading cause of cancer mortality among women in low- and middle-income countries, despite advances in screening and HPV vaccination in wealthier nations, highlighting the need for improved access to preventive measures and treatments.

Current treatment options for cervical cancer include chemotherapy, radiation, and newer therapies like immune checkpoint inhibitors and antibody-drug conjugates, but there is still a significant unmet need for effective treatments for recurrent cases, emphasizing the importance of innovative approaches and equitable access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cancer treatment update: A Society of Gynecologic Oncology clinical practice statement. Girda, E., Randall, LM., Chino, F., et al.[2023]

In a study of 317 women aged 18-46 in Eastern Kenya, HPV DNA-PCR testing showed the highest sensitivity (95.5%) and specificity (92.6%) for detecting cervical neoplasia compared to Pap smear and VIA tests, indicating it is the most effective primary screening method.

HIV-infected women had a significantly higher prevalence of cervical abnormalities, with HPV DNA-PCR and Pap smear tests providing better diagnostic accuracy for this group, suggesting that tailored screening approaches are necessary for HIV-infected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and Triage Cervical Screening Diagnostic Value of Methods for the Detection of Cervical Dysplasia. Njue, JK., Muturi, M., Kamau, L., et al.[2022]

Cervical cancer screening in the U.S. is currently inefficient, with issues such as over-screening, under-screening, and loss to follow-up, highlighting the need for improved practices.

Education, counseling, and the HPV vaccine are essential components of cervical cancer prevention, and updated guidelines emphasize the importance of timely screening and management of abnormal cervical cells to prevent cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cancer screening guidelines: An update. Shami, S., Coombs, J.[2023]

In a randomized clinical trial involving 6555 women aged 35 to 65, both HPV DNA testing and visual inspection with acetic acid (VIA) as screen-and-treat approaches significantly reduced the prevalence of high-grade cervical cancer precursor lesions (CIN 2+) compared to a delayed evaluation group, with results showing 0.80% in the HPV group and 2.23% in the VIA group at 6 months versus 3.55% in the control group.

The study demonstrated that both screening methods are safe, with only minor complications reported after cryotherapy, indicating that these resource-appropriate strategies can effectively prevent cervical cancer in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial. Denny, L., Kuhn, L., De Souza, M., et al.[2022]

About 29% of the 65 indigent women with cervical cancer did not complete their prescribed chemoradiation treatment, which may affect the overall effectiveness of the therapy in real-world settings.

Despite the treatment challenges, no patients experienced fatal hematologic complications, indicating that while compliance is an issue, the immediate safety of the chemoradiation regimen appears to be acceptable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with and acute hematologic toxic effects of chemoradiation in indigent women with cervical cancer. Abu-Rustum, NR., Lee, S., Correa, A., et al.[2022]

Over the past three decades, the 5-year relative survival rate for cervical cancer has improved from 68% to 74%, particularly in patients with locally advanced disease, where survival increased from 38% to 60%.

Despite advancements in treatment, older patients (75+) are less likely to receive preferred surgical treatments, leading to stable survival rates in this age group, highlighting a need for improved clinical practices for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No improvement in survival of older women with cervical cancer-A nationwide study. Wenzel, HHB., Bekkers, RLM., Lemmens, VEPP., et al.[2021]

Citations

1. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1228434/full

Rapid implementation mapping to identify ... In this study, we describe the use of a virtual online approach for implementation mapping (steps 1–3) to identify implementation determinants, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38468266/

protocol for a cluster randomized hybrid type III trial in Nigeria Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10926605/

protocol for a cluster randomized hybrid type III trial in Nigeria This study will be the first to test the effectiveness of tailored implementation strategies (IS) for cervical cancer screening and treatment ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06128304

ACCESS: Accelerating Cervical Cancer Elimination ... This study aims to leverage the available infrastructure for HIV care and treatment programs in Nigeria to integrate cervical cancer screening and treatment ...

5. researchgate.net researchgate.net/figure/Matching-core-and-enhanced-implementation-strategies-to-implementation-determinants-Key_fig2_373203129

Matching core and enhanced implementation strategies to ... Conclusion The present study highlights the use of concept mapping for prevention science, particularly in exploratory studies for understanding cervical cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12292880/

Advancements in Cervical Cancer Screening: Enhancing HPV ... Enhanced efforts to predict, prevent, and treat cervical cancer early can significantly improve survival rates. The systematic review provides ...