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

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ClinicalTrials.gov Identifier: NCT02095561
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborators:
Ministerio de Salud de Jujuy
International Agency for Research on Cancer
National Council of Scientific and Technical Research, Argentina
Information provided by (Responsible Party):
Silvina Arrossi, National Council of Scientific and Technical Research, Argentina

Brief 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.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Other: HPV self testing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Study of HPV Self Testing Evaluation in the Province of Jujuy, Argentina
Study Start Date : July 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HPV Self testing
HPV self testing offered by CHWs during home visits
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.

No Intervention: HPV at health centers
Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.



Primary Outcome Measures :
  1. Screening Uptake [ Time Frame: within 6 months after the intervention ]
    The primary outcome was screening uptake, defined as: a) the proportion of participant women with any HPV test (self-test or HPV at health centers) in the information system, in the 6 months after the CHW visit, and b) the proportion of women in the intervention group with a self-test in SITAM, in the same 6 month period.


Secondary Outcome Measures :
  1. Acceptability [ Time Frame: within 6 months ]
    Defined as the proportion of women from the intervention group who were offered self-testing and accepted, as documented in the questionnaire, independently of if they ended up with a test in the information system.

  2. CIN2+ Detection Rate [ Time Frame: within one year after the CHW visits ]
    calculated as the percentage of women with histologically confirmed CIN2+ over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.

  3. HPV Positivity [ Time Frame: within 6 months after the CHW visits ]
    Calculated as the percentage of women with positive HPV test over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • woman aged 30 or older
  • lived in a household visited by one of study CHWs

Exclusion Criteria:

  • hysterectomy
  • been treated for a precancerous lesion
  • with previous HPV test
  • pregnant
  • mentally-disabled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095561


Locations
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Argentina
Instituto Nacional Del Cáncer, Argentina
Ciudad de Buenos Aires, Argentina, C1067ABO
Sponsors and Collaborators
Instituto Nacional del Cáncer, Argentina
Ministerio de Salud de Jujuy
International Agency for Research on Cancer
National Council of Scientific and Technical Research, Argentina
Investigators
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Principal Investigator: Silvina Arrossi, PhD National Council of Scientific and Technical Research, Argentina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Silvina Arrossi, PhD in Demography, National Council of Scientific and Technical Research, Argentina
ClinicalTrials.gov Identifier: NCT02095561     History of Changes
Other Study ID Numbers: 01-1CU
First Posted: March 26, 2014    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014
Keywords provided by Silvina Arrossi, National Council of Scientific and Technical Research, Argentina:
HPV self testing
screening uptake
cervical cáncer
cervical intraepithelial neoplasia
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type