Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
ConditionHIV Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TM HIV
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
266 Participants
are divided into 2 treatment groupsGroup A: HIV text messages (TM HIV)Experimental treatment 1 intervention
Group B: TM HLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
baseline, 3 months, 6 months, 12 months2
PrEp Uptake
Percentage of participants who started PrEP since the last assessment
Time frame
3 months, 6 months, 12 months3
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.
Time frame
3 months, 6 months, 12 months4
Intravenous Drug Use (IDU)
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Source ClinicalTrials.gov