NCT07296159Not yet recruiting
My Self-Sampling for HPV Awareness, Results, and Empowerment
A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 18 Dec 2025
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Daisy Le
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT07296159
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 1 Jan 2027 to the primary completion date, 31 Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have had a history of hysterectomy or invasive cervical cancer
Other
- Are currently pregnant or were pregnant in the past 3 months
- Are currently participating or enrolled in similar studies within the past year.
Who the study is looking for
- Have an HIV diagnosis
- Are between 30 to 65 years old
- Have not had a Pap smear within the last 12 months or more.
Criteria the registry did not label
- Aim 1 Provider Prompt: Healthcare and/or service provider to women living with HIV
- Aim 2 RCT Pilot
Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.