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

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. ^{1 2 3 4 5}

Is 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. ^{5 6 7 8 9}

How 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. ^{3 5 7 10 11}

Research Team

Gregory Aarons, PhD

Principal Investigator

University of California, San Diego

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

No improvement in survival of older women with cervical cancer-A nationwide study. [2021]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial. [2022]

4. Switzerland 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. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Global strategies for cervical cancer prevention and screening. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Cervical cancer treatment update: A Society of Gynecologic Oncology clinical practice statement. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Increasing cervical cancer screening at a non-government medical center in Lilongwe, Malawi. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Compliance with and acute hematologic toxic effects of chemoradiation in indigent women with cervical cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cervical cancer screening guidelines: An update. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Primary and Triage Cervical Screening Diagnostic Value of Methods for the Detection of Cervical Dysplasia. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial. [2022]