A Technology-enhanced and Multilevel Approach to Promote Cervical Cancer Prevention Among Women Living With HIV
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Daisy Le
- 入组人数
- 130
- 主要终点
- Proportion of participants who received and used the mailed HPV self-sampling kit.
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have an HIV diagnosis
- •Are between 30 to 65 years old
- •Have not had a Pap smear within the last 12 months or more.
排除标准
- •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.
结局指标
主要结局
Proportion of participants who received and used the mailed HPV self-sampling kit.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Proportion of participants who completed an in-clinic follow-up Pap test since baseline.(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.(1 month, 3 months, and 6 months)
研究者
Daisy Le
PI
George Washington University