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

NCT02095561 | Completed Results DMC

• 1 other identifier: 01-1CU
• Study Type: interventional
• Target: 6,013
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Intraepithelial Neoplasia

Keywords

HPV self testing; screening uptake; cervical cáncer; cervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

• Screening Uptake

  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.

  within 6 months after the intervention

Secondary Outcomes (3)

• Acceptability

  within 6 months

• CIN2+ Detection Rate

  within one year after the CHW visits

• HPV Positivity

  within 6 months after the CHW visits

Study Arms (2)

HPV Self testing

EXPERIMENTAL

HPV self testing offered by CHWs during home visits

Other: HPV self testing

HPV at health centers

NO INTERVENTION

Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.

Interventions

HPV self testing OTHER

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.

HPV Self testing

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional del Cáncer, Argentina: lead
• Ministerio de Salud de Jujuy: collaborator
• International Agency for Research on Cancer: collaborator
• National Council of Scientific and Technical Research, Argentina: collaborator

Study Sites (1)

Instituto Nacional Del Cáncer, Argentina

Ciudad de Buenos Aires, C1067ABO, Argentina

Location

Related Publications (1)

• Arrossi S, Thouyaret L, Herrero R, Campanera A, Magdaleno A, Cuberli M, Barletta P, Laudi R, Orellana L; EMA Study team. Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial. Lancet Glob Health. 2015 Feb;3(2):e85-94. doi: 10.1016/S2214-109X(14)70354-7.

  PMID: 25617202 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Silvina Arrossi, Phd
• Organization: INSTITUTO NACIONAL DEL CÁNCER, ARGENTINA

silviarrossi2020@gmail.com

541152390562

Study Officials

• Silvina Arrossi, PhD

  National Council of Scientific and Technical Research, Argentina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Demography

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 9, 2020
• Results First Posted: April 29, 2014

Record last verified: 2020-08

Locations

AR (1)