My Self-Sampling for HPV Awareness, Results, and Empowerment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorDaisy Le
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have an HIV diagnosis
Are between 30 to 65 years old
Have not had a Pap smear within the last 12 months or more.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
MySHARE+ mHealth Education Intervention
Other interventionParticipants 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 interventionProviders 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.
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: MySHARE+ InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Group C: Healthcare provider promptOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants who received and used the mailed HPV self-sampling kit.
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.
Time frame
1 month, 3 months, and 6 months2
Proportion of participants who reported the presence of technical issues with the MySHARE+ messages.
Feasibility of the MySHARE+ text-messaging program: number of participants who reported technical issues over the number of enrolled participants.
Time frame
1 month, 3 months, and 6 months3
Proportion of participants who received all text messages and engaged with the MySHARE+ educational program.
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.
Time frame
6 months4
Proportion of participants who were satisfied with the HPV self-sampling test.
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.
Time frame
1 month, 3 months, and 6 monthsSecondary outcomes
1
Proportion of participants who completed an in-clinic follow-up Pap test since baseline.
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.
Time frame
1 month, 3 months, and 6 months2
Proportion of participants with an HPV positive test who completed an in-clinic follow-up Pap test since baseline.
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.
Time frame
1 month, 3 months, and 6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daisy Le
Lead sponsor
George Washington University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: