HIVNCT05642858
Text Education About Cardiovascular Health and HIV (TEACH-HIV)
A study testing Digital Educational Messaging in people with HIV and Human Immunodeficiency Virus, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV, Human Immunodeficiency Virus, Cardiovascular Diseases
- What is being tested?
- Digital Educational Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2023to 1 Jul 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- At least 40 years of age
- English-speaking
Who cannot join
- Existing clinical atherosclerotic cardiovascular disease (ASCVD)
- Pregnant
- Unwilling/unable to provide informed consent
- Does not own a smartphone
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
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Megan McLaughlin, MD, MPH, teachhiv@ucsf.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Megan Mclaughlin, MD, MPH, teachhiv@ucsf.edu
About this study
The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).
- Being tested
- Digital Educational Messaging
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Educational MessagingBehavioural
Education via mobile phone text messages for up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention arm will receive education about HIV and heart disease risk via mobile phone text messages for up to 6 months. They will receive the text messages 3-5 times per week. The messages will include information about HIV and risk of heart disease and information about how to reduce heart disease risk. The intervention arm will also receive brief monthly surveys via a digital research platform. Receives: Behavioral: Digital Educational Messaging |
| Control Arm | No intervention | The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with controlled blood pressure
Proportion of participants with blood pressure < 130/80 mmHg as recorded in the electronic health record (EHR).
Measured: 6 months
Secondary outcomes (11)
Number of cardiovascular risk factors controlled
Total of 8 risk factors: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, blood pressure. Risk factors will be assessed using self-report and EHR data. Risk factor control will be defined based on the American Heart Association's (AHA) Life's Essential 8.
Measured: 6 months
Self-perceived cardiovascular risk
Measured by self-report using questions adapted from the patient and provider assessment of lipid management (PALM) registry.
Measured: 6 months
Systolic blood pressure
Evaluated using EHR data.
Measured: 6 months
Cholesterol
Non-HDL cholesterol, total cholesterol, LDL cholesterol (in mg/dL), as evaluated using EHR data.
Measured: 6 months
Physical activity
Minutes/week, measured via self-report using the International Physical Activity Questionnaire (IPAQ).
Measured: 6 months
Physical activity
Measured via step count.
Measured: 6 months
Mediterranean diet
Measured using the Mediterranean Eating Pattern for Americans (MEPA) tool, as scored by AHA's Life's Essential 8. Score ranges 0-16, with higher scores representing better outcomes.
Measured: 6 months
Proportion of current smokers
Measured via self-report.
Measured: 6 months
Blood sugar control
Evaluated using EHR data on hemoglobin A1c and fasting blood glucose. Blood sugar control will be defined based on the AHA's Life's Essential 8 definitions.
Measured: 6 months
Body mass index
Evaluated in kg/m2 using EHR data.
Measured: 6 months
Proportion of patients on guideline-based therapy
Proportion of patients on anti-hypertensive medications, statins, and aspirin, among those who meet criteria for therapy based on American Heart Association / American College of Cardiology (AHA/ACC) guidelines.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start12 Mar 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Megan McLaughlin, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642858
- Sponsor's protocol ID
- 22-36653
- Other IDs
- T32HL007731
- Status last verified
- Jun 2025
- First submitted
- 18 Nov 2022
- Last updated
- 8 Jun 2025
- 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Education About Cardiovascular Health and HIV (TEACH-HIV)
- ClinicalTrials.gov ID
- NCT05642858
- Acronym / sponsor ID
- 22-36653
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Dec 2022 (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.
The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Digital Educational MessagingThe intervention arm will receive education about HIV and heart disease risk via mobile phone text messages for up to 6 months. They will receive the text messages 3-5 times per week. The messages will include information about HIV and risk of heart disease and information about how to reduce heart disease risk. The intervention arm will also receive brief monthly surveys via a digital research platform. |
| Control Arm | No intervention | –The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV positive
- At least 40 years of age
- English-speaking
Key exclusion criteria (4 listed)
- Existing clinical atherosclerotic cardiovascular disease (ASCVD)
- Pregnant
- Unwilling/unable to provide informed consent
- Does not own a smartphone
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 |
|---|---|---|
| Digital Educational MessagingEducation via mobile phone text messages for up to 6 months. | Behavioural | Intervention Arm |
Primary outcome
Proportion of participants with controlled blood pressure
Time frame: 6 months
Proportion of participants with blood pressure < 130/80 mmHg as recorded in the electronic health record (EHR).
11 secondary outcomes
Number of cardiovascular risk factors controlled
Time frame: 6 months
Self-perceived cardiovascular risk
Time frame: 6 months
Systolic blood pressure
Time frame: 6 months
Cholesterol
Time frame: 6 months
Physical activity
Time frame: 6 months
Physical activity
Time frame: 6 months
Mediterranean diet
Time frame: 6 months
Proportion of current smokers
Time frame: 6 months
Blood sugar control
Time frame: 6 months
Body mass index
Time frame: 6 months
Proportion of patients on guideline-based therapy
Time frame: 6 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 8 Jun 2025.
- 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.
Megan McLaughlin, MD, MPH principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Educational Messaging in people with HIV and Human Immunodeficiency Virus, run by University of California, San Francisco 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 3 inclusion and 4 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 8 Jun 2025. 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 Megan McLaughlin, MD, MPH (628-206-8037, teachhiv@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with controlled blood pressure (time frame: 6 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 8 Jun 2025.