Clinical trial NCT06088277: Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
Official title: Texting in Community Health Center Dental Clinics to Reduce HIV Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Dental patients
Community Health Center Dental Clinics
Text messaging
HIV negative
HIV testing
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2023-10-18
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants that obtain HIV testing
timeFrame: 12 months
Secondary outcomes:
measure: Adherence to pre-exposure prophylaxis (PrEP)
timeFrame: baseline, 3 months, 6 months, 12 months
measure: PrEp Uptake
timeFrame: 3 months, 6 months, 12 months
measure: Condom use
timeFrame: 3 months, 6 months, 12 months
measure: Intravenous Drug Use (IDU)
timeFrame: 3 months, 6 months, 12 months
measure: Self-efficacy score
timeFrame: 6 months, 12 months
measure: Motivation to perform behaviours that reduce HIV risk
timeFrame: 3 months, 6 months, 12 months
measure: Outcome expectations regarding behaviors to reduce HIV risk.
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: South End Community Health Center
state: Massachusetts
city: Boston
country: United States
facility: East Boston Neighborhood Health Center
state: Massachusetts
Study officials:
affiliation: Boston University Goldman School of Dental Medicine
name: Michelle Henshaw, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References: