Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

Boston University

Status: Enrolling

Conditions: HIV Infections

Treatments: Behavioral: TM HIV; Behavioral: TM HL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06088277

UG3DE031249 (U.S. NIH Grant/Contract)

H-43228

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 2 patient groups

HIV text messages (TM HIV)

Experimental group

Description:

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

Treatment:

Behavioral: TM HIV

TM HL

Active Comparator group

Description:

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

Treatment:

Behavioral: TM HL