Texting in Community Health Center Dental Clinics to Reduce HIV Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Number of participants that obtain HIV testing
研究概览
简要总结
This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers.
The study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give informed consent and document consent via a signed and dated informed consent form in REDCap
- •Willing to comply with all study procedures and be available for the duration of the study
- •Be able to read either in English or Spanish
- •Be a dental clinic patient of record at one of our participating community health centers
- •Has at least one risk factor for HIV defined as self-report of at least one of the following: Men who have sex with men; multiple sex partners, or intravenous drug use
排除标准
- •Self-report of having HIV infection
- •Participating in another HIV study or another text message study
- •A woman who reports having sex exclusively with women
- •Does not have a mobile phone or other device which can receive text messages from Agile Health
- •Does not have unlimited texting on their mobile plan
- •Has not used any type of text messaging at least once in the past month
- •Single item literacy screening score of 2 or below.
研究组 & 干预措施
HIV text messages (TM HIV)
Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing.
干预措施: TM HIV (Behavioral)
TM HL
Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing..
干预措施: TM HL (Behavioral)
结局指标
主要结局
Number of participants that obtain HIV testing
时间窗: 12 months
The total number of participants that obtain HIV testing will be assessed from answers to a question in a study questionnaire.
次要结局
- Motivation to perform behaviours that reduce HIV risk(3 months, 6 months, 12 months)
- Outcome expectations regarding behaviors to reduce HIV risk.(3 months, 6 months, 12 months)
- Adherence to pre-exposure prophylaxis (PrEP)(baseline, 3 months, 6 months, 12 months)
- PrEp Uptake(3 months, 6 months, 12 months)
- Condom use(3 months, 6 months, 12 months)
- Self-efficacy score(6 months, 12 months)
- Intravenous Drug Use (IDU)(3 months, 6 months, 12 months)