My Self-Sampling for HPV Awareness, Results, and Empowerment

Официальное название

A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Proportion of participants who received and used the mailed HPV self-sampling kit. [Срок оценки: 1 month, 3 months, and 6 months]
• Proportion of participants who reported the presence of technical issues with the MySHARE+ messages. [Срок оценки: 1 month, 3 months, and 6 months]
• Proportion of participants who received all text messages and engaged with the MySHARE+ educational program. [Срок оценки: 6 months]
• Proportion of participants who were satisfied with the HPV self-sampling test. [Срок оценки: 1 month, 3 months, and 6 months]
• Proportion of participants who were satisfied with the MySHARE+ text-messaging program [Срок оценки: 1 month, 3 months, and 6 months]
• Proportion of participants who unsubscribed from the MySHARE+ text-messaging program. [Срок оценки: 1 month, 3 months, and 6 months]
• Proportion of participants who returned the HPV self-sampling test within three months of enrollment. [Срок оценки: 1 month, 3 months]

Вторичные конечные точки (2)

• Proportion of participants who completed an in-clinic follow-up Pap test since baseline. [Срок оценки: 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. [Срок оценки: 1 month, 3 months, and 6 months]

Критерии участия

Aim 1 Provider Prompt: Healthcare and/or service provider to women living with HIV

Aim 2 RCT Pilot

Критерии включения

• Have an HIV diagnosis
• Are between 30 to 65 years old
• Have not had a Pap smear within the last 12 months or more.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07296159 · 5K01CA276624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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