HPV Self-sampling for Underscreened Latinas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to learn if women of Hispanic/Latina ethnicity are willing to self-collect a cervico-vaginal sample for HPV testing. The main question the study will answer is:

• Does a brief educational intervention increase the feasibility and acceptability of HPV self-sampling among Hispanic/Latina women?

The study team will compare whether including a brief educational intervention with a mailed HPV self-sampling kit is more acceptable than receiving a mailed HPV self-sampling kit alone.

Participants will be asked to complete surveys at study entry (baseline) and then randomized to receive only the HPV self-sampling kit, or the kit plus a small group education that meets with a bilingual health educator.

Participants will then be contacted about one-month later to complete a follow-up survey. The study team will also measure the number of participants in each group who self-collect a sample and mail it in for HPV testing.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Unidos Contra el VPH

NCT06825689

Human Papilloma Virus (HPV) Cervical Cancers

RECRUITING NA

Human Papilloma Virus (HPV) Self-collection and Women Adherence

NCT05059015

Cervical Cancer HPV Infection

UNKNOWN NA

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

NCT03713697

Cervical Cancer

COMPLETED NA

Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening

NCT00977392

Health Status Unknown Precancerous Condition

COMPLETED

HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women

NCT03012932

Cervical Cancer Screening

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study team will recruit a sample of underscreened Latinas (n=100) who will be randomly assigned to either the educational intervention (n=50) or a control condition (n=50). Feasibility will be measured through study enrollment and intervention completion (defined as the proportion of women who self-collect a sample). Acceptability of intervention materials and self-sampling procedures will be measured using self-report surveys at follow-up assessments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Cervical Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mailed Kit Only Control

Participants receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing.

Group Type ACTIVE_COMPARATOR

HPV Self-Sampling

Intervention Type BEHAVIORAL

HPV self-sampling kit

Education Plus Mailed Kit

Participants receive information about cervical cancer risks and screening guidelines in a small-group format with a bilingual health educator. Participants also receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing.

Group Type EXPERIMENTAL

HPV Self-Sampling

Intervention Type BEHAVIORAL

HPV self-sampling kit

Group Education

Intervention Type BEHAVIORAL

Small-group education led by bilingual health educator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HPV Self-Sampling

HPV self-sampling kit

Intervention Type BEHAVIORAL

Group Education

Small-group education led by bilingual health educator

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Self-reported Hispanic/Latina ethnicity
* Assigned female sex at birth
* Age 30-65, consistent with guidelines for HPV DNA testing for cervical cancer screening
* Speak and read English or Spanish
* Computer or other device with internet connection
* Overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years).

Exclusion Criteria

* Prior diagnosis of cervical cancer or abnormality (e.g., dysplasia)
* Had a hysterectomy/removal of the cervix
* Compromised immune system (e.g., known HIV)
* Women who self-report that they are pregnant or are within three months after a pregnancy

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes