My Self-Sampling for HPV Awareness, Results, and Empowerment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MySHARE+ mHealth Education Intervention, Healthcare Provider Prompt.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Cervical Cancer Screening, HPV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Proportion of participants who received and used the mailed HPV self-sampling kit. [Time frame: 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]
- Proportion of participants who received all text messages and engaged with the MySHARE+ educational program. [Time frame: 6 months]
- Proportion of participants who were satisfied with the HPV self-sampling test. [Time frame: 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]
- Proportion of participants who unsubscribed from the MySHARE+ text-messaging program. [Time frame: 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]
Secondary outcome measures (2)
- Proportion of participants who completed an in-clinic follow-up Pap test since baseline. [Time frame: 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07296159 · 5K01CA276624