Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

NCT06088277 | Recruiting

• 2 other identifiers: H-43228UG3DE031249
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants that obtain HIV testing

  The total number of participants that obtain HIV testing will be assessed from answers to a question in a study questionnaire.

  12 months

Secondary Outcomes (7)

• 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

• Intravenous Drug Use (IDU)

  3 months, 6 months, 12 months

• Self-efficacy score

  6 months, 12 months

Study Arms (2)

HIV text messages (TM HIV)

EXPERIMENTAL

Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing.

Behavioral: TM HIV

TM HL

ACTIVE COMPARATOR

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

Behavioral: TM HL

Interventions

TM HIV BEHAVIORAL

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.

HIV text messages (TM HIV)

TM HL BEHAVIORAL

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.

TM HL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (2)

South End Community Health Center

Boston, Massachusetts, 02118, United States

RECRUITING

East Boston Neighborhood Health Center

Boston, Massachusetts, 02128, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Michelle Henshaw, DDS, MPH

  Boston University Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Henshaw, DDS, MPH

CONTACT

:617-358-6111; mhenshaw@bu.edu

Gabriel Federo Hungria, MD, MSCR

CONTACT

617-358-6490; gfedero@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: August 16, 2024
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 14, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)