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NCT Number: NCT06088277

Texting to Reduce Human Immunodeficiency Virus (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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Boston Neighborhood Health Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TM HIV

Behavioral

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

Behavioral

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 outcomes

  1. Number of participants that obtain HIV testing

    Time frame: 12 months

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

Secondary outcomes

  1. Adherence to pre-exposure prophylaxis (PrEP)

    Time frame: 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.

  2. PrEp Uptake

    Time frame: 3 months, 6 months, 12 months

    Percentage of participants who started PrEP since the last assessment

  3. Condom use

    Time frame: 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.

  4. Intravenous Drug Use (IDU)

    Time frame: 3 months, 6 months, 12 months

    Among participants reporting IDU, percentage of participants who report using clean needles since the start of the intervention

  5. Self-efficacy score

    Time frame: 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.

  6. Motivation to perform behaviours that reduce HIV risk

    Time frame: 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.

  7. Outcome expectations regarding behaviors to reduce HIV risk.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Federo Hungria, MD, MSCR

CONTACT

[email protected]

617-358-6490

Michelle Henshaw, DDS, MPH

CONTACT

[email protected]

:617-358-6111

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Texting in Community Health Center Dental Clinics to Reduce HIV Risk

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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