Texting in Community Health Center Dental Clinics to Reduce HIV Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Boston University
- Enrollment
- 266
- Locations
- 2
- Primary Endpoint
- Number of participants that obtain HIV testing
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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..
Intervention: TM HL (Behavioral)
Outcomes
Primary Outcomes
Number of participants that obtain HIV testing
Time Frame: 12 months
The total number of participants that obtain HIV testing will be assessed from answers to a question in a study questionnaire.
Secondary Outcomes
- 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)