Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

HIV Infections Clinical Trial

Official title:

Texting in Community Health Center Dental Clinics to Reduce HIV Risk

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088277
• Other study ID #: H-43228
• Secondary ID: UG3DE031249
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: Boston University
• Contact: Michelle Henshaw, DDS, MPH
• Phone: :617-358-6111
• Email: mhenshaw[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 266
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Dental and Craniofacial Research (NIDCR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PrEp Uptake	Percentage of participants who started PrEP since the last assessment	3 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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