STI Self-swab Testing At the Time of Telemed Medication Abortion Provision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Utilization of self-collected STI screening at the time of telemedicine medication abortion provision
研究概览
简要总结
The goal of this interventional study is to provide more access to STI testing for patients who seek abortion care through telemedicine, particularly for those whose access to STI testing is otherwise limited. The main questions it aims to answer are:
What is the acceptability, feasibility, and utilization of self-collected STI screening at the time of telemedicine medication abortion provision?
How does the uptake of such a service among patients receiving telemedicine abortion care compare to the population of patients who seek in-person medication abortion care?
What are the positivity rates for STIs in among patients receiving telemedicine medication abortion care compared to the positivity rates for a contemporaneous, in-clinic population?
What is the average time to between testing and treatment for patients who test positive for an STI using the self-collection service?
Researchers will compare the intervention group to a contemporaneous, in-clinic population on uptake of STI screening, as well as on positivity rates for the STIs tested.
Participants will be asked to perform self-swab collection for STI testing for gonorrhea, chlamydia, and trichomonas. They will be instructed to send their specimens to a lab using prepaid postage. Upon completion of sample collection and shipping, they will be asked to complete a survey assessing basic demographic information, as well as acceptability and feasibility of the intervention. Patients who test positive for an STI will be promptly provided/referred to treatment.
详细描述
Study Design:
This is an explorative cohort study that will assess the accessibility, feasibility, and utilization of a new intervention: at-home, self-collected STI testing at the time of medication abortion received through telemedicine services.
The study will take place within the Complex Family Planning clinic, the Options Center in Honolulu, Hawaii.
The intervention group will be recruited from the telemedicine medication abortion patients.
This group will be compared to the control group with data pulled from a chart review of a comparison cohort of patients seen for in-clinic medication abortion during a contemporaneous period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients of the Queen Medical Center Options Center clinic seeking telemedicine medication abortion.
- •Patients for whom, according to the CDC guidelines for STI Testing11, STI testing is indicated, or patients who desire STI screening
- •Age 14 and over
- •Can speak and read English
- •Displays capacity for informed consent
排除标准
- •Home address that is not located in the state of Hawai'i
- •Incarcerated
- •Unwilling to perform vaginal swab collection
结局指标
主要结局
Utilization of self-collected STI screening at the time of telemedicine medication abortion provision
时间窗: 1) up to one year 2) up to one year
Utilization rates will be reported as a percentage. Both enrollment in the study, as well as utilization of the actual STI testing services, will be reported as measures of utilization. The former (1) will be reported as the percentage of eligible patients who chose to enroll in the study, while the latter (2) will be reported as the percentage of enrolled patients who submitted samples for STI testing.
Acceptability of self-collected STI screening at the time of telemedicine medication abortion provision
时间窗: Up to two weeks after completion of the intervention
Acceptability will be measured using a modified version of the Digital Health Acceptability Questionnaire (DHAQ) which is a validated survey that is used to assess acceptability and feasibility of telehealth-based interventions. The first five questions (1-5) are validated to assess attitude toward the service as a means to address healthcare needs, while the second five questions (6-10) address individual capacity and effort to use the telehealth intervention. A copy of this survey can be found in Table A. This is a 10 question survey of Likert scales from 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". We will calculate median and IQR across the domains of the DHAQ to determine a median acceptability score, which will be calculated using the scores from questions 1-5.
Feasibility of self-collected STI screening at the time of telemedicine medication abortion provision
时间窗: 1) Up to two weeks after completion of the intervention
Feasibility will be measured using a modified version of the Digital Health Acceptability Questionnaire (DHAQ) which is a validated survey that is used to assess acceptability and feasibility of telehealth-based interventions. The first five questions (1-5) are validated to assess attitude toward the service as a means to address healthcare needs, while the second five questions (6-10) address individual capacity and effort to use the telehealth intervention. A copy of this survey can be found in Table A. This is a 10 question survey of Likert scales from 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". We will calculate median and IQR across the domains of the DHAQ to determine a median acceptability score, which will be calculated using the scores from questions 6-10.
次要结局
- Comparison of uptake and STI positivity rates between the telehealth and in-clinic population(up to one year)
- Time elapsed between test result and prescription for treatment for patients who have a positive test for STI(one week)
研究者
Olivia Manayan, MD MPH
Principal Investigator
Queen's Medical Center