Cervical CancerMySHARE+NCT07296159
My Self-Sampling for HPV Awareness, Results, and Empowerment
A study testing MySHARE+ mHealth Education Intervention and Healthcare Provider Prompt in people with Cervical Cancer and Cervical Cancer Screening, run by Daisy Le.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Cancer Screening, HPV
- What is being tested?
- MySHARE+ mHealth Education Intervention and Healthcare Provider Prompt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have an HIV diagnosis
- Are between 30 to 65 years old
- Have not had a Pap smear within the last 12 months or more.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV
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.
- Conditions
- Cervical Cancer, Cervical Cancer Screening, HPV
- Being tested
- MySHARE+ mHealth Education Intervention, Healthcare Provider Prompt
- Keywords
- Cervical cancer, HPV, HPV self-sampling, mHealth
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySHARE+ mHealth Education InterventionOther
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 PromptOther
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 group | Role | What they receive |
|---|---|---|
| MySHARE+ Intervention | Experimental | Participants will receive mHealth education via automated text messages. Receives: Other: MySHARE+ mHealth Education Intervention |
| Control | No intervention | 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 | Support with the development and refinement of provider prompt to improve communication about cervical cancer screening. Receives: Other: Healthcare Provider Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 3 months, and 6 months
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.
Measured: 1 month, 3 months, and 6 months
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.
Measured: 6 months
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.
Measured: 1 month, 3 months, and 6 months
Proportion of participants who were satisfied with the MySHARE+ text-messaging program
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.
Measured: 1 month, 3 months, and 6 months
Proportion of participants who unsubscribed from the MySHARE+ text-messaging program.
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
Measured: 1 month, 3 months, and 6 months
Proportion of participants who returned the HPV self-sampling test within three months of enrollment.
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.
Measured: 1 month, 3 months
Secondary outcomes (2)
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.
Measured: 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.
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.
Measured: 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daisy Le
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daisy Le, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296159
- Sponsor's protocol ID
- 5K01CA276624
- Acronym
- MySHARE+
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV
- ClinicalTrials.gov ID
- NCT07296159
- Acronym / sponsor ID
- MySHARE+ / 5K01CA276624
- Conditions
- Cervical Cancer, Cervical Cancer Screening, HPV
- Keywords
- Cervical cancer, HPV, HPV self-sampling, mHealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Daisy LeUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MySHARE+ Intervention | Experimental | Other: MySHARE+ mHealth Education InterventionParticipants will receive mHealth education via automated text messages. |
| Control | No intervention | –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 | Other: Healthcare Provider PromptSupport with the development and refinement of provider prompt to improve communication about cervical cancer screening. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have an HIV diagnosis
- Are between 30 to 65 years old
- Have not had a Pap smear within the last 12 months or more.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MySHARE+ mHealth Education InterventionParticipants in the intervention group will receive detailed pre-tested educational theory-based SMS messaging and education over the course of four weeks. | Other | MySHARE+ Intervention |
| Healthcare Provider PromptProviders 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. | Other | Healthcare provider prompt |
Primary outcome
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.
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.
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.
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.
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.
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MySHARE+ mHealth Education Intervention and Healthcare Provider Prompt in people with Cervical Cancer and Cervical Cancer Screening, run by Daisy Le.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daisy Le, PhD, MPH/MA (202-994-2061, daisyle@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.