Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Rare Diseases

Uterine Cervical Neoplasms

Papilloma

Virus Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

HPV self testing offered by CHWs during home visits

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

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

Silvina Arrossi, PhD

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.

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

Study of HPV Self Testing Evaluation in the Province of Jujuy, Argentina

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.

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.

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.

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.

Ministerio de Salud de Jujuy

International Agency for Research on Cancer

National Council of Scientific and Technical Research, Argentina

Instituto Nacional del Cáncer, Argentina

PhD in Demography

HPV self testing offered by CHWs during home visits

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.

HPV Self Testing

HPV at Health Centers

Total

Age, Categorical

Sex: Female, Male

Argentina

Region of Enrollment

Never went to school/Primary (incomplete)

Primary (complete)/Secondary (incomplete)

Secondary complete

Tertiary (incomplete/complete)

Missing cases

Education Level

Public system

private/social security

Health insurance

Pap test in last four years

Silvina Arrossi, Phd

Self-tested women

HPV-tested

Screening Uptake

Acceptability

Population included in the HPV self-testing group to calculate CIN2+ detection rate includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.

CIN2+ Detection Rate

Population included in the HPV self-testing group to calculate positivity includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.

HPV Positivity

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

Annual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces.

Colonoscopy will be performed in case of a positive FIT.

FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.

annual FIT and colonoscopy in case of a positive test

colonoscopy with sedation

Enrique Quintero, MD, PhD

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.

The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

Participants were randomized to either colonoscopy or faecal occult blood test

Uptake to Colorectal Cancer Screening in Familial-risk Population

Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy

Hospital Universitario de Canarias

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Human Papilloma Virus (HPV) Self-testing to Increase Screening Uptake	NCT02095561	Cervical Intrae...	HPV self testin...	30 Years -	Instituto Nacional del Cáncer, Argentina
Uptake to Colorectal Cancer Screening in Familial-risk Population	NCT02567045	Colorectal Canc... Screening Uptak...	annual FIT and ... colonoscopy wit...	18 Years - 40 Years	Hospital Universitario de Canarias

Spots Global Cancer Trial Database for screening uptake