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Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

Primary Purpose

HIV Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TM HIV
TM HL
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Dental patients, Community Health Center Dental Clinics, Text messaging, HIV negative, HIV testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HIV text messages (TM HIV)

    TM HL

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    PrEp Uptake
    Percentage of participants who started PrEP since the last assessment
    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.
    Intravenous Drug Use (IDU)
    Among participants reporting IDU, percentage of participants who report using clean needles since the start of the intervention
    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.
    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.
    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.

    Full Information

    First Posted
    October 12, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Boston University
    Collaborators
    National Institute of Dental and Craniofacial Research (NIDCR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088277
    Brief Title
    Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
    Official Title
    Texting in Community Health Center Dental Clinics to Reduce HIV Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston University
    Collaborators
    National Institute of Dental and Craniofacial Research (NIDCR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Dental patients, Community Health Center Dental Clinics, Text messaging, HIV negative, HIV testing

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    266 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HIV text messages (TM HIV)
    Arm Type
    Experimental
    Arm Description
    Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing.
    Arm Title
    TM HL
    Arm Type
    Active Comparator
    Arm Description
    Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing..
    Intervention Type
    Behavioral
    Intervention Name(s)
    TM HIV
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    TM HL
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of participants that obtain HIV testing
    Description
    The total number of participants that obtain HIV testing will be assessed from answers to a question in a study questionnaire.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Adherence to pre-exposure prophylaxis (PrEP)
    Description
    Participants will be asked to complete a study questionnaire where they will be asked if they adhered to PrEP.
    Time Frame
    baseline, 3 months, 6 months, 12 months
    Title
    PrEp Uptake
    Description
    Percentage of participants who started PrEP since the last assessment
    Time Frame
    3 months, 6 months, 12 months
    Title
    Condom use
    Description
    Percentage of participants who used condoms consistently within the last month or at their last sexual encounter since the start of the intervention.
    Time Frame
    3 months, 6 months, 12 months
    Title
    Intravenous Drug Use (IDU)
    Description
    Among participants reporting IDU, percentage of participants who report using clean needles since the start of the intervention
    Time Frame
    3 months, 6 months, 12 months
    Title
    Self-efficacy score
    Description
    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.
    Time Frame
    6 months, 12 months
    Title
    Motivation to perform behaviours that reduce HIV risk
    Description
    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.
    Time Frame
    3 months, 6 months, 12 months
    Title
    Outcome expectations regarding behaviors to reduce HIV risk.
    Description
    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.
    Time Frame
    3 months, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michelle Henshaw, DDS, MPH
    Phone
    :617-358-6111
    Email
    mhenshaw@bu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriel Federo Hungria, MD, MSCR
    Phone
    617-358-6490
    Email
    gfedero@bu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michelle Henshaw, DDS, MPH
    Organizational Affiliation
    Boston University Goldman School of Dental Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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