Evaluation of Human Papilloma Virus (HPV) Self-testing to Increase Screening Uptake

Summary

Cervical cancer is a leading cause of mortality among women in developing countries. A key factor has been the failure to achieve good coverage. The development in the last years of HPV-DNA based tests has changed the scenario, because it combines a high performance to detect disease with a reduction of screening frequency. Through self-testing, HPV testing has the potential of reducing social and health service barriers faced by women to access screening.

This study is carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV testing has been introduced as a primary screening test for all women attending public health sector. The study was conducted between July 2012-December 2013, and supported by the Argentinean National Cancer Institute. The protocol was approved by the institutional review committees of the Ministry of Health of Jujuy.

This trial is a randomized by population clusters study that aims to assess the effectiveness of self-testing to increase coverage. The aims of this study are: a) to assess the self-test effectiveness to increase the participation of women in screening programs, b) to assess the self-test acceptability by women, c) to assess HPV self-test effectiveness measurement for the detection of CIN2+ lesions against cytology in primary screening.

An overall number of 200 community health workers (CHWs) from the Primary Health Care System (PHCS) of Jujuy will be randomized into two groups that will be named Self-test Group (ST) and Conventional Sample Group (CS):

1. ST Group: CHWs will invite eligible women of their area to choose between doing a self-test or having a conventional sample taken by a health professional of the closest health care center.
2. CS Group: CHWs will invite eligible women in their area to have a conventional sample taken by a health care professional of the nearest health care center.

In order to measure the self-test relative sensitivity against cytology to detect CIN2+ in primary screening, all the women in the Self-test Group who have decided to do the self-test and all the women of 30 years of age and older that were screened with cytology by the provincial program for the prevention of cervical cancer in 2011 will be considered.

A database built specifically for the study will be used; it will hold the list of eligible women to participate in the study. The records of women of 30 years of age and older residing in the areas included in the study will be imported from the PHCS databases.

In addition, the data surveyed by the study will be uploaded: randomization Group, presence of the woman at home during the CHW's visit, agreement to participate in the study, realization of self-test (in the corresponding group), and if appropriate, reasons for not doing the self-test. Lastly, the HPV Test realization will be uploaded importing the data on SITAM, (link of data done as from the identity card number).

Data Analysis

Self-test acceptability: Acceptability is defined as the number of women accepting the self-test against the number of women offered the option between the self-test and the conventional sample (proportion of women accepting the self-test). The acceptability in this population will be estimated as the average of acceptabilities calculated by CHW, as to control the impact of the CHWs on acceptability and reach an appropriate variance estimate. Besides, the variability introduced by the CHWs on acceptability will be studied and the results obtained by male and female CHWs will be compared, as well as those obtained by the CHWs in rural and urban areas.

Self-test effectiveness to enhance participation of women in screening and diagnosis: There will be a comparison of the percentage of women that did the HPV test in the Self-test group and the Conventional sample group. Three different coverage indicators will be considered for every CHW. These will be defined as the number of women screened within the field work regarding:

1. The number of women reached by the CHW who accepted participating in the study.
2. The number of eligible women for that CHW (regardless of whether the CHW was able to contact them or not).

The effect of the strategy (offering the self-test option against promotion of the conventional sample) will be estimated for each one of the coverage measures using a means difference test or a non-parametric test for independent samples.

CIN 2+ detection rate: The effectiveness of the HPV Self-test against screening cytology to detect CIN2+ will be estimated as the detection rates difference and as the detection rates ratio. In addition, there will be a comparison of the CIN2+ detection rate in the group of women who did the self-test against the total number of women in the province of Jujuy that were tested for HPV (conventional sample strategy + triage Pap test) until December 2012.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

OTHER

HPV self testing

Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.

Sponsors & Collaborators

• Ministerio de Salud de Jujuy

  collaborator OTHER_GOV

• International Agency for Research on Cancer

  collaborator OTHER

• National Council of Scientific and Technical Research, Argentina

  collaborator OTHER_GOV

• Instituto Nacional del Cáncer, Argentina

  lead OTHER_GOV

Principal Investigators

• Silvina Arrossi, PhD · National Council of Scientific and Technical Research, Argentina

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-01-31

Completion

2013-12-31

Countries

• Argentina