My Self-Sampling for HPV Awareness, Results, and Empowerment (MySHARE+)

December 18, 2025 updated by: Daisy Le

A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daisy Le, PhD, MPH/MA
  • Phone Number: 202-994-2061
  • Email: daisyle@gwu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Aim 1 Provider Prompt: Healthcare and/or service provider to women living with HIV

Aim 2 RCT Pilot

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MySHARE+ Intervention
Participants will receive mHealth education via automated text messages.
Other: 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.
No Intervention: 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.
Other: Healthcare provider prompt
Support with the development and refinement of provider prompt to improve communication about cervical cancer screening.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who received and used the mailed HPV self-sampling kit.
Time Frame: 1 month, 3 months, and 6 months
Feasibility of the mailed HPV self-sampling program: number of participants who received and used the HPV self-sampling test over the number of enrolled participants.
1 month, 3 months, and 6 months
Proportion of participants who reported the presence of technical issues with the MySHARE+ messages.
Time Frame: 1 month, 3 months, and 6 months
Feasibility of the MySHARE+ text-messaging program: number of participants who reported technical issues over the number of enrolled participants.
1 month, 3 months, and 6 months
Proportion of participants who received all text messages and engaged with the MySHARE+ educational program.
Time Frame: 6 months
Feasibility of the MySHARE+ text-messaging program: number of participants who received and engaged with 100% of the MySHARE+ messages over the number of participants enrolled in the text-messaging program.
6 months
Proportion of participants who were satisfied with the HPV self-sampling test.
Time Frame: 1 month, 3 months, and 6 months
Acceptability of the HPV self-sampling test: number of participants satisfied with the HPV self-sampling test (e.g., understanding of instructions, ease of use, degree of pain and bleeding associated with use, and willingness to use self-sample HPV testing regularly using a 5-point Likert scale) over the number of enrolled participants.
1 month, 3 months, and 6 months
Proportion of participants who were satisfied with the MySHARE+ text-messaging program
Time Frame: 1 month, 3 months, and 6 months
Acceptability of the MySHARE+ text messaging program: number of participants with rated satisfaction items as four or higher from a 5-point Likert scale over the number of enrolled participants.
1 month, 3 months, and 6 months
Proportion of participants who unsubscribed from the MySHARE+ text-messaging program.
Time Frame: 1 month, 3 months, and 6 months
Acceptability of the MySHARE+ text messaging program: number of participants who unsubscribed from the MySHARE+ text-messaging program over the number of enrolled participants. An unsubscription rate of 15% or less will be considered acceptable
1 month, 3 months, and 6 months
Proportion of participants who returned the HPV self-sampling test within three months of enrollment.
Time Frame: 1 month, 3 months
Preliminary efficacy of the HPV self-sampling and the MySHARE+ mHealth program: number of participants who returned the HPV self-sampling test within three months of enrollment over the number of enrolled participants.
1 month, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who completed an in-clinic follow-up Pap test since baseline.
Time Frame: 1 month, 3 months, and 6 months
Preliminary efficacy of the HPV self-sampling and the MySHARE+ mHealth program: number of participants who completed an in-clinic Pap test over the number of enrolled participants.
1 month, 3 months, and 6 months
Proportion of participants with an HPV positive test who completed an in-clinic follow-up Pap test since baseline.
Time Frame: 1 month, 3 months, and 6 months
Preliminary efficacy of the HPV self-sampling and the MySHARE+ mHealth program: number of participants with an HPV positive test who completed an in-clinic Pap test over the number of participants with an HPV+ test.
1 month, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daisy Le

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5K01CA276624 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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