HIV InfectionsNCT06088277
Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
A study testing TM HIV and TM HL in people with HIV Infections, run by Boston University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- TM HIV and TM HL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2024to 14 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
South End Community Health Center
Boston, Massachusetts, 02118
Mina Paul, DMD
- Recruiting
East Boston Neighborhood Health Center
Boston, Massachusetts, 02128
Mina Paul, DMD
About this study
Official title: 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.
- Conditions
- HIV Infections
- Being tested
- TM HIV, TM HL
- Keywords
- Dental patients, Community Health Center Dental Clinics, Text messaging, HIV negative, HIV testing
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TM HIVBehavioural
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 HLBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV text messages (TM HIV) | Experimental | Eligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing. Receives: Behavioral: TM HIV |
| TM HL | Active comparator | Eligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing.. Receives: Behavioral: TM HL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: baseline, 3 months, 6 months, 12 months
PrEp Uptake
Percentage of participants who started PrEP since the last assessment
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start16 Aug 2024
- Primary completion14 Apr 2027 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Michelle Henshaw, DDS, MPH, Principal investigator, Boston University Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088277
- Sponsor's protocol ID
- H-43228
- Other IDs
- UG3DE031249
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting in Community Health Center Dental Clinics to Reduce HIV Risk
- ClinicalTrials.gov ID
- NCT06088277
- Acronym / sponsor ID
- H-43228
- Conditions
- HIV Infections
- Keywords
- Dental patients, Community Health Center Dental Clinics, Text messaging, HIV negative, HIV testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV text messages (TM HIV) | Experimental | Behavioral: TM HIVEligible participants randomized into this arm will receive text messages to reduce the risk for HIV and promote HIV testing. |
| TM HL | Active comparator | Behavioral: TM HLEligible participants randomized into this arm will receive text messages to promote healthy living, but not specific to HIV risk or testing.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TM HIVParticipants 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. | Behavioural | HIV text messages (TM HIV) |
| TM HLParticipants 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. | Behavioural | TM HL |
Primary outcome
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.
7 secondary outcomes
Adherence to pre-exposure prophylaxis (PrEP)
Time frame: baseline, 3 months, 6 months, 12 months
PrEp Uptake
Time frame: 3 months, 6 months, 12 months
Condom use
Time frame: 3 months, 6 months, 12 months
Intravenous Drug Use (IDU)
Time frame: 3 months, 6 months, 12 months
Self-efficacy score
Time frame: 6 months, 12 months
Motivation to perform behaviours that reduce HIV risk
Time frame: 3 months, 6 months, 12 months
Outcome expectations regarding behaviors to reduce HIV risk.
Time frame: 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Henshaw, DDS, MPH principal investigator
Boston University Goldman School of Dental Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TM HIV and TM HL in people with HIV Infections, run by Boston University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Henshaw, DDS, MPH (:617-358-6111, mhenshaw@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that obtain HIV testing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.