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

Women assigned to this arm were invited to get a Pap testing at the Basic Health Unit

Women assigned to this arm were provided with a kit to engage in self-collection for HPV testing

Women assigned to this arm were given a choice between a Pap testing at the local Basic Health Unit or self-collection for HPV testing

Un/underscreened women received a home visit by a Community Health Worker and were scheduled an appointment for a Pap testing at the Basic Health Unit

Pap testing

Un/underscreened women received a home visit by a Community Health Worker and were given a kit to self-collect their own sampling for HPV testing at home

Self-collection for HPV testing

Un/underscreened women received a home visit by a Community Health Worker and were given a choice between scheduling an appointment for a Pap testing at the Basic Health Unit or self-collect their own sampling for HPV testing at home

Choice

Isabel C Scarinci, PhD

Our long-term goal is to decrease cervical cancer incidence and mortality among women in low- and middle-income countries (LMICs) by using the most efficacious and acceptable screening method, particularly among women who do not come to the clinic for their regular Pap testing. The purpose of this feasibility study is to compare three cervical cancer screening modalities (self-collection and HPV testing, Pap testing at the public health clinic, and choice between self-collection and HPV testing and Pap testing) among women who have not undergone cervical cancer screening within the past four years using a theory-based, culturally relevant intervention implemented by Community Health Workers (CHWs) via door-to-door visits. Three Basic Health Units (BHUs) within the public health system will be randomly assigned to one of the three screening modalities/conditions (self-collection and HPV testing, Pap testing at the local public health clinic, and choice between self-collection and HPV testing and Pap testing). CHWs will invite women who report not having been screened for cervical cancer in the past four years to participate in the study, and deliver a brief educational/behavioral session on cervical cancer and screening using a door-to-door approach under of one of the three conditions. The primary outcome will be adherence to cervical cancer screening. We hypothesize that (1) Women in the "choice" and "self-collection" groups will be more likely to engage in cervical cancer screening and display higher satisfaction with their screening than women assigned to the "Pap" with women assigned to the "choice" group having the highest adherence of the three groups; and (2) Within the "choice" group, more women will choose and complete self-collection than Pap test.

Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil

Self-Collection and HPV Testing in Unscreened Women: a Feasibility Study in Brazil

Adherence to cervical cancer screening by completing either the Pap testing or self-collection for HPV testing)

National Cancer Institute (NCI)

University of Alabama at Birmingham

Primary Investigator

Infections

Symptoms and General Pathology

Immune System Diseases

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Virus Diseases

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Syndrome

The intervention is a self-collected HPV test, followed by results counseling by phone when the result is available (usually 2-3 weeks). Women are encouraged to have Pap testing.

In the usual care arm, women do not receive the HPV test. They are encouraged to have Pap testing. In addition, there is a phone call as an attention control, where women are reminded to make a Pap test appointment about 2-3 weeks after the baseline visit.

The HPV self-collected test is followed by results counseling by phone when the result is available (usually 2-3 weeks). Women are encouraged to have Pap testing.

Self-Collected HPV Test

Usual Care

Hayley Mark, PhD, MPH, RN

Cervical cancer is the second most common type of cancer among women worldwide. Women with human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap tests in the year following diagnosis, and if both are normal, yearly thereafter. Nationally, only 25% of women meet this recommendation. The mean annual Pap testing rate for federally funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the Johns Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap testing rate of 59%. This occurred despite interventions to address adherence issues were implemented, including nurse case management, co-location of HIV and gynecology services, flexible scheduling, and continuity of care. Women keep their appointments for HIV primary care more often than for gynecology care in the Moore Clinic, so an intervention that takes place during a primary care visit could improve cervical cancer screening rates.

The availability of HPV testing provides a unique opportunity to increase perceived susceptibility to and severity of cervical cancer among women with HIV, and to encourage follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2% risk of developing CIN. HPV testing can be easily conducted by women themselves through self-collection in a primary care visit. Studies of women without HIV who do not have regular Pap testing have demonstrated that self-collected HPV testing and results counseling increases the overall screening rate, and women who test positive for HPV have a high rate of follow-up Pap testing. Self-collected HPV testing and results counseling could be utilized in the HIV primary care setting to promote Pap testing among women with HIV.

This study is a randomized trial to test whether receiving self-collected HPV testing and results counseling in HIV primary care will increase completion of Pap testing in a group of women attending the Johns Hopkins Hospital Moore Clinic for HIV Care. The study is informed by the Health Belief Model (HBM), which posits that screening behavior will increase if persons at risk for disease have a cue to action that increases their perception of susceptibility to and severity of the disease. In this study, the HPV test and results counseling are cues to action that also correctly identify those women at high risk for disease. To achieve these aims, 111 women who are late for Pap testing will be recruited for participation while they are at an HIV care appointment. They will be randomized to HPV self-collection and results counseling, or to receive usual care. Six months after enrollment, medical records will be reviewed for completion of Pap testing in the intervening months.

The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling

A Test of an Intervention to Improve Pap Testing Among Women With HIV

The outcome measure is the completion of Pap testing within 6 months of the baseline study visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil	NCT03713697	Cervical Cancer	Pap testing Self-collection... Choice	25 Years - 64 Years	University of Alabama at Birmingham
The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling	NCT01843478	HIV Infection	Self-Collected ... Usual Care	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for pap testing

Every month we try and update this database with for pap testing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pap testing

Every month we try and update this database with for pap testing cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pap testing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.