Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

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

A Cobas PCR (polymerase chain reaction) Female swab sample Packet will be sent directly to women with a study invitation letter and instructions. Response rate will be measured.

An invitation to order a Cobas PCR Female swab sample Packet through an online application will be sent. Response rates will be measured.

An invitation to call the coordinating midwife with questions and concerns regarding screening will be sent. The coordinating midwife can help the participant order a Cobas PCR Female swab sample Packet or book a standard screening visit, if desired. Response rates will be measured

The standard, annual renewed invitation to cervical screening will be sent (control, routine practice). Response rate will be measured as a baseline.

The cobas® PCR Female Swab Sample Kit is used to collect and transport vaginal swab specimens self-collected.

Cobas PCR Female swab sample Packet

The standard, annual renewed invitation to cervical screening.

Routine practice

Joakim Dillner, MD

The main purpose is to develop and test an IT-infrastructure to provide more individualized ways of inviting and reaching women who have not participated, despite having been invited with annual reminders, in cervix cancer screening program during a ten year period.

BACKGROUND Non-participation in the screening program is the main risk factor for cervical cancer (Andrae et al JNCI, 2008). Therefore it is important to reduce barriers to screening and facilitate participation in the screening program for cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations.

Results from a population-based, randomized study in western Sweden concluded that by offering HPV self-sampling kits to screening non-attendees, 17% of cervical cancer cases could be avoided. Offering self-sampling kits to women who have not attended screening in the organized program, can lead to greater participation without substantial increases in the overall health care costs. While there is a growing body of evidence supporting the use of self-sampling, it is unclear how this strategy can be implemented effectively in the context of an organized screening program. An alternative is to offer women the chance to speak with a coordinating midwife who can answer questions and address concerns regarding screening. It is unclear how the results of different research studies should be put into practical use within an organized screening program. Currently, women who have not attended screening are sent an annual reminder invitation. We want to examine whether these alternative strategies (self-sampling and contact with a midwife) may work as well, or better, than current strategy of reminder invitations to non-attenders.

AIM The aim of this randomized health services study is therefore both to test the feasibility of providing alternative strategies instead of the customary reminder invitations to women in Stockholm (so-called feasibility study, primary aim), and whether such strategies will increase overall participation in screening (secondary aim).

STUDY DESIGN AND METHODOLOGY A new IT infrastructure for ordering a self-sampling kit has been developed by LabMed, KI. This in conjunction with the screening database, will be used to identify and invite women who are long-term non-participants in cervical screening. Women who have not participated for ten years, despite annual reminder invitations, will be identified and randomized to one of four strategies.

1. A validated HPV self-sampling kit will be sent directly to women with a study invitation letter and instructions.
2. An invitation to order an HPV self-sampling kit through an online application will be sent.
3. An invitation to call the coordinating midwife with questions and concerns regarding screening will be sent.
4. The standard annual reminder invitation will be sent (control, routine practice)

Women who choose to participate will be sampled and monitored according to the standards of care in the regional cancer screening program. HPV-positive women will be followed by colposcopy and biopsy according to standard clinical guidelines. Women will be invited over the course of 3 months. All letters will be printed in advance with pre-marked dates. Batches will be sent out weekly and checked against changes in the population registry data (for individuals that have moved, taken a smear, died, or unregistered, invitation letters will be sorted out and those individuals marked in the database).

2 Notation and abbreviations

* PNR = person nummer, personal ID number 3 Study population 3.1 Inclusion criteria
* Women who have lived in Stockholm for the past 10 years and have been sent annual reminder at least once per year for 10 years without attending screening.

Specific selection process:

Include women without an "H-prov" on record for the past 10 years Include women have actively been sent a reminder invitation (invitation type=1) during 10 years time. In other words, resident in Stockholm for the past 10 years.

Include women over the age of 33 3.2 Exclusion criteria Women who have opted out of the screening program Hysterectomized Return to sender Changed PNR Women who are marked as Expired=1. Women who have reason marked for being unregistered but are not marked as is unregistered=1.

Women who are due to receive their reminder invitation in the next 3 months 4 Statistical analyses Selection of the study population Randomization A random selection of 8000 women will be chosen from all women meeting the study inclusion criteria.

These 8000 women will be randomized to the 4 study arms (age-stratified 30-50 and 51-60).

The selection of the study population and the randomization to study arms will be carried out by Anna Stoltenberg, Statistician at RCC and outside of the study group 1.

Follow-up - study end date 2016-12-31

IT-system Development for Reaching Cervix Cancer Screening Non-attenders

IT-system Development for Individualization of Cervix Cancer Screening and Implementation of New Strategies to Reach Non-attenders

Our intention is to share data, but a plan for how this will be done in practise has not been written.

Regional Cancer Centre Stockholm Gotland

Karolinska Institutet

Professor

Infections

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Acetic Acid

Retinol acetate

Door-to-door recruitment of women for self-collected HPV testing

Community health meeting recruitment of women for self-collected HPV testing

Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.

Self-collected HPV testing for cervical cancer screening

Gina Ogilvie, MD

Sheona Mitchell-Foster, MD

Carolyn Nakisige, MD

The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.

This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.

Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.

A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.

The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.

Pragmatic cluster randomized control trial

Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)

Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial

Data will be available on request through study investigators.

Measured using years of lives saved compared between each study arm and the ICER

Evaluating reach, fidelity, barriers and facilitators of implementation in each arm from the community and health system perspective using mixed methods

Assess men's knowledge level of HPV and cervical cancer and determine which factors impact the supportiveness towards a partner seeking screening.

Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type

Total number of women who test positive for HPV out of the total number of samples obtained

Total number of women who test positive for STIs out of total number of women who test positive for HPV; total number of women who test negative for STIs out of total number of women who test positive for HPV; total number of women who test positive for STIs out of total number of women who test negative for HPV; total number of women who test negative for STIs out of total number of women who test negative for HPV

Association (adjusted OR) estimated between HPV and HIV; other STIs

Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.

Mediation analysis using counterfactual approach to assess mediating effect of patient reported experience, knowledge change and co-infection status with other STIs on engagement in care after positive HR-HPV test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IT-system Development for Reaching Cervix Cancer Screening Non-attenders	NCT02750124	Human Papilloma... Cervical Cancer	Cobas PCR Femal... Routine practic...	33 Years - 60 Years	Karolinska Institutet
Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)	NCT04000503	Human Papilloma... Human Papilloma... Papillomavirus ... Cervical Cancer Pre-Cancerous D...	Self-collected ...	25 Years - 49 Years	University of British Columbia

Spots Global Cancer Trial Database for human papillomavirus dna tests