My Self-Sampling for HPV Awareness, Results, and Empowerment

NCT ID: NCT07296159

Last Updated: 2025-12-22

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2028-12-31

Brief Summary

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The overall objective of this study is to conduct formative research and pilot test the provider-level and patient-level components of the My Self-Sampling for HPV Awareness, Results, and Empowerment (MySHARE+) intervention. MySHARE+ aims to harness the power of technology and apply a multilevel approach to promote the adoption of cervical cancer screening (HPV self-sampling; Pap triage adherence) among under/never-screened women living with HIV (WLH). The specific aims are to 1) identify facilitators and barriers to implementing a healthcare provider prompt in a primary care setting and 2) conduct a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and preliminary efficacy of a mHealth educational intervention in promoting cervical cancer awareness and HPV self-sampling among WLH.

Under aim 1: Providers of healthcare and/or social services to WLH will complete an online survey to identify barriers to implementing a healthcare provider prompt in a primary care setting and participate in semi-structured interviews to provide feedback on drafted prompts. Prompts will be piloted at one local clinic to improve patient-provider communication about cervical cancer screening, followed with semi-structured interviews with providers involved.

Under aim 2: Participants will be enrolled in a text messaging intervention and sent an HPV self-sampling test kit to return via mail. Participants in the intervention group will receive the full mHealth intervention while the control group will receive more generic text messages and reminders over the course of the study.

Detailed Description

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Conditions

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Cervical Cancer Cervical Cancer Screening HPV

Keywords

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Cervical cancer HPV HPV self-sampling mHealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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MySHARE+ Intervention

Participants will receive mHealth education via automated text messages.

Group Type EXPERIMENTAL

MySHARE+ mHealth Education Intervention

Intervention Type OTHER

Participants in the intervention group will receive detailed pre-tested educational theory-based SMS messaging and education over the course of four weeks.

Control

Participants will received a text message welcoming them to the project with a referral link to the NCI's cervical cancer screening website with monthly reminders over the span of six months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthcare provider prompt

Support with the development and refinement of provider prompt to improve communication about cervical cancer screening.

Group Type OTHER

Healthcare Provider Prompt

Intervention Type OTHER

Providers of healthcare and/or social services to WLH will complete an online survey to identify barriers to implementing an healthcare provider prompt in a primary care setting and participate in semi-structured interviews to provide feedback on drafted prompts. Prompts will be piloted at one local clinic to improve patient-provider communication about cervical cancer screening, followed with semi-structured interviews with providers involved.

Interventions

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MySHARE+ mHealth Education Intervention

Participants in the intervention group will receive detailed pre-tested educational theory-based SMS messaging and education over the course of four weeks.

Intervention Type OTHER

Healthcare Provider Prompt

Providers of healthcare and/or social services to WLH will complete an online survey to identify barriers to implementing an healthcare provider prompt in a primary care setting and participate in semi-structured interviews to provide feedback on drafted prompts. Prompts will be piloted at one local clinic to improve patient-provider communication about cervical cancer screening, followed with semi-structured interviews with providers involved.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have an HIV diagnosis
* Are between 30 to 65 years old
* Have not had a Pap smear within the last 12 months or more.

Exclusion Criteria

* Have had a history of hysterectomy or invasive cervical cancer
* Are currently pregnant or were pregnant in the past 3 months
* Are currently participating or enrolled in similar studies within the past year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daisy Le

OTHER

Sponsor Role lead

Responsible Party

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Daisy Le

PI

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Daisy Le, PhD, MPH/MA

Role: CONTACT

Phone: 202-994-2061

Email: [email protected]

Other Identifiers

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5K01CA276624

Identifier Type: NIH

Identifier Source: org_study_id

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