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

Sponsor
Daisy Le
Study ID
NCT07296159
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: MySHARE+ Intervention
    Participants will receive mHealth education via automated text messages.
  • 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.

Primary Outcome Measure

Proportion of participants who received and used the mailed HPV self-sampling kit. [ Time Frame: 1 month, 3 months, and 6 months ]

Central Contacts

Related Studies