Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

Texting in Community Health Center Dental Clinics to Reduce HIV Risk

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 Overview

• Status: Not yet recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: TM HIV; Behavioral: TM HL

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Henshaw, DDS, MPH; Phone Number: :617-358-6111; Email: mhenshaw@bu.edu
• Study Contact Backup: Name: Gabriel Federo Hungria, MD, MSCR; Phone Number: 617-358-6490; Email: gfedero@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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..	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to pre-exposure prophylaxis (PrEP)	Participants will be asked to complete a study questionnaire where they will be asked if they adhered to PrEP.	baseline, 3 months, 6 months, 12 months
PrEp Uptake	Percentage of participants who started PrEP since the last assessment	3 months, 6 months, 12 months
Condom use	Percentage of participants who used condoms consistently within the last month or at their last sexual encounter since the start of the intervention.	3 months, 6 months, 12 months
Intravenous Drug Use (IDU)	Among participants reporting IDU, percentage of participants who report using clean needles since the start of the intervention	3 months, 6 months, 12 months
Self-efficacy score	This outcome will be assessed using a one-item measure with a 5-point Likert scale where: 1 = "Not at all", 2 = "Somewhat", 3 = "Undecided", 4 = "Not really", and 5 = "Very much". HIgher scores are more favorable.	6 months, 12 months
Motivation to perform behaviours that reduce HIV risk	This outcome will be assessed using a one-item measure with a 5-point Likert scale where: 1 = "Not at all", 2 = "Somewhat", 3 = "Undecided", 4 = "Not really", and 5 = "Very much". HIgher scores are more favorable.	3 months, 6 months, 12 months
Outcome expectations regarding behaviors to reduce HIV risk.	This outcome will be assessed using a one-item measure with a 5-point Likert scale where: 1 = "Not at all", 2 = "Somewhat", 3 = "Undecided", 4 = "Not really", and 5 = "Very much". HIgher scores are more favorable.	3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Michelle Henshaw, DDS, MPH, Boston University Goldman School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dental patients; HIV testing; Text messaging; HIV negative; Community Health Center Dental Clinics
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: H-43228; UG3DE031249 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No