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NCT Number: NCT07296159

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

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.

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Key information

Conditions

Cervical Cancer Cervical Cancer Screening Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MySHARE+ mHealth Education Intervention

Other

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

Healthcare Provider Prompt

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daisy Le, PhD, MPH/MA

CONTACT

[email protected]

202-994-2061

Sponsors and collaborators

Lead sponsor

Daisy Le

Other

Registry information

Official study title

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

Acronym: MySHARE+

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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