Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

Sponsor

Boston University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06088277

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR) (NIH)

266

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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, we 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: TM HIV Behavioral: TM HL	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Texting in Community Health Center Dental Clinics to Reduce HIV Risk

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants that obtain HIV testing [12 months]
The total number of participants that obtain HIV testing will be assessed from answers to a question in a study questionnaire.

Secondary Outcome Measures

Adherence to pre-exposure prophylaxis (PrEP) [baseline, 3 months, 6 months, 12 months]
Participants will be asked to complete a study questionnaire where they will be asked if they adhered to PrEP.
PrEp Uptake [3 months, 6 months, 12 months]
Percentage of participants who started PrEP since the last assessment
Condom use [3 months, 6 months, 12 months]
Percentage of participants who used condoms consistently within the last month or at their last sexual encounter since the start of the intervention.
Intravenous Drug Use (IDU) [3 months, 6 months, 12 months]
Among participants reporting IDU, percentage of participants who report using clean needles since the start of the intervention
Self-efficacy score [6 months, 12 months]
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.
Motivation to perform behaviours that reduce HIV risk [3 months, 6 months, 12 months]
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.
Outcome expectations regarding behaviors to reduce HIV risk. [3 months, 6 months, 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.