Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer Screening | — | UNRESOLVED | — |
| HPV | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthcare Provider Prompt | Other | — | UNRESOLVED |
| MySHARE+ mHealth Education Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MySHARE+ Intervention
- description
- Participants will receive mHealth education via automated text messages.
- interventionNames
- Other: MySHARE+ mHealth Education Intervention
- type
- NO_INTERVENTION
- label
- Control
- 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.
- type
- OTHER
- label
- Healthcare provider prompt
- description
- Support with the development and refinement of provider prompt to improve communication about cervical cancer screening.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available