Recruiting

HIV Risk

Sponsor:

Boston University

Code:

NCT06088277

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TM HIV

TM HL

Study Details

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.

Conditions

HIV Infections

Study ID

NCT06088277

Start date

Aug 16, 2024

Status verified date

Jun, 2026

Completion date

Apr 14, 2027

Anticipated

Primary completion date

Apr 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

266 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: TM HL

Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing..

Interventions

TM HIV

Participants will receive 5 intervention text messages (TM) about HIV risk and testing per week for the first 3 months and 3 messages per week for the last 3 months of the intervention.

TM HL

Participants will receive 5 intervention text messages (TM) about promoting healthy living (HL) per week for the first 3 months and 3 messages per week for the last 3 months of the intervention.

Primary outcome measure

  • Number of participants that obtain HIV testing [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Michelle Henshaw, DDS, MPH

:617-358-6111mhenshaw@bu.edu

Gabriel Federo Hungria, MD, MSCR

617-358-6490gfedero@bu.edu

Locations

South End Community Health Center

Recruiting

Boston, Massachusetts, United States, 02118

East Boston Neighborhood Health Center

Recruiting

Boston, Massachusetts, United States, 02128

More Information

Sponsor

Boston University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Dental patients
  • Community Health Center Dental Clinics
  • Text messaging
  • HIV negative
  • HIV testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-07-01.