Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The pap-smear test result is sent by letter directly to the women. Women in need of follow up are in the letter recommended to contact their general practitioner.

In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.

Test result sent by letter

Test result conveyed by general practitioners

Peter Vedsted

Flemming Bro

Berit S Andersen

Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.

Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.

However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.

Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:

1. A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
2. Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).

The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.

Follow-up of Abnormal and Inadequate Smear-test Results

Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.

The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks. The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).

The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result.

University of Aarhus

Infections

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

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

Neoplasms, Squamous Cell

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Women will be offered HPV testing within the health facilities in the communities randomized to this arm. Women who test HPV positive will be referred to care at the sub-district and district hospitals (current standard of care).

Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals).

Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities.

Community-based testing with standard linkage to care

Community-based HPV testing with enhanced linkage to care

Megan J Huchko, MD, MPH

There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will

Community-Driven Cervical Cancer Prevention in Western Kenya

Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya

The investigators will determine the cost-effectiveness of the three strategies in this study: clinic-based testing with standard referral to care, community-health campaign testing w/ standard referral to care \& community based testing w/ enhanced linkage to care.

The investigators will compare the number of women who uptake HPV testing in the community health campaign arms compared to the number who uptake HPV testing in the clinic-based arms.

The investigators will compare the number of women accessing treatment for positive HPV results with standard linkage to care compared to the enhanced linkage to treatment strategy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Follow-up of Abnormal and Inadequate Smear-test Results	NCT02002468	Carcinoma in Si...	Test result sen... Test result con...	23 Years -	University of Aarhus
Community-Driven Cervical Cancer Prevention in Western Kenya	NCT02124252	Human Papilloma... Carcinoma in Si...	Community-based... Community-based...	25 Years - 65 Years	Duke University

Spots Global Cancer Trial Database for carcinoma in situ of uterine cervix