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

Daisy Le

Status: Begins enrollment in 3 months

Conditions: HPV; Cervical Cancer Screening; Cervical Cancer

Treatments: Other: Healthcare Provider Prompt; Other: MySHARE+ mHealth Education Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07296159

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

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 3 patient groups

MySHARE+ Intervention

Experimental group

Description:

Participants will receive mHealth education via automated text messages.

Treatment:

Other: MySHARE+ mHealth Education Intervention

Control

No Intervention group

Description:

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.

Healthcare provider prompt

Other group

Description:

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

Treatment:

Other: Healthcare Provider Prompt