HIVConnect4CareNCT01917994
Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population
A study testing Text Messages and Appointment Reminders in people with HIV and Patient Adherence, run by University of California, San Francisco at 1 site in United States.
Trial summary
Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Patient Adherence, Mobile Technology
- What is being tested?
- Text Messages and Appointment Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- HIV-infected
- Age 18 or over
- English-speaking
- Able to give informed consent
- Have a cell phone and willing to send/receive up to 25 text messages/month
- Detectable viral load plus either 1) new to clinic (no more than 2 primary care visits) or 2) history of poor retention (one missed visit or lack of six-month visit constancy in the past year)
Who cannot join
- HIV-uninfected
- Under age 18
- Monolingual speaker of a language other than English
- Unable to give informed consent
- Undetectable viral load
- Perfect appointment adherence
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital Positive Health Program
San Francisco, California, 94110
About this study
Official title: Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies
Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Regular HIV care has also been associated with a decrease in HIV transmission risk behavior. Despite the proven health and prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the United States are estimated to meet current retention in care standards and even fewer - only about 25% - are estimated to be virologically suppressed.
The Behavioral Model for Vulnerable Populations provides a useful framework for understanding broad areas that may impact adherence to care and treatment. Individual-level domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and need (e.g., co-morbidities) factors, and structural domains include, for example, features or the clinic and the provider-patient relationship.
Read more
Short message service (SMS) technology represents a new and exciting tool to help retain HIV-infected patients in care and treatment. SMS interventions have been deployed successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan Africa, where two randomized trials have showed clear benefits. A pilot study conducted in our clinic suggests that use of SMS messages to promote adherence to care and treatment in the urban HIV-infected poor is both feasible and acceptable.
The investigators believe that combining SMS technology with content-specific messages designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can improve retention in care and virologic suppression for an urban public hospital population living with HIV, thus the investigators propose the following specific aims.
Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves virologic suppression [primary outcome] and retention in care [secondary outcome] for a vulnerable urban HIV-infected population through a randomized trial of this technology compared to SMS appointment reminders alone. Retention in care will also be analyzed as a mediator of virologic suppression. Exploratory outcomes include time to virologic suppression, sustained virologic suppression, emergency department utilization and antiretroviral adherence, as well as levels of depression, positive affect, social support and empowerment.
Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of patient use of this technology, and; 3) the preferred frequency and content of intervention messages.
Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.
- Conditions
- HIV, Patient Adherence, Mobile Technology
- Being tested
- Text Messages, Appointment Reminders
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagesBehavioural
The intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication.
Appointment RemindersBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Text Messages + Appointment Reminders | Experimental | Participants in the intervention arm will receive supportive, informational, or motivational text messages three times a week for one year in addition to text message reminders about HIV primary care appointments. Receives: Behavioral: Text Messages; Behavioral: Appointment Reminders |
| Appointment Reminders | Active comparator | Participants in the control arm will receive text messages reminding them of HIV primary care appointments 48 hours before the scheduled appointment. Receives: Behavioral: Appointment Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load
Measured: 12 month
Secondary outcomes (4)
Missed Visit Proportion
Number of missed or "no show" visits divided by number of scheduled appointments
Measured: 12 month
Appointment Adherence
Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)
Measured: 12 month
Visit Constancy
At least one kept visit in each six-month period
Measured: 12 month
Attended All Scheduled Visits
Attended all scheduled visits
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katerina Christopoulos, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917994
- Sponsor's protocol ID
- R01DA032057
- Acronym
- Connect4Care
- Status last verified
- Feb 2017
- First submitted
- 1 Aug 2013
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.
PubMed 25551175Christopoulos KA, Riley ED, Carrico AW, Tulsky J, Moskowitz JT, Dilworth S, Coffin LS, Wilson L, Johnson-Peretz J, Hilton JF. A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Clin Infect Dis. 2018 Aug 16;67(5):751-759. doi: 10.1093/cid/ciy156.
PubMed 29474546
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies
- ClinicalTrials.gov ID
- NCT01917994
- Acronym / sponsor ID
- Connect4Care / R01DA032057
- Conditions
- HIV, Patient Adherence, Mobile Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Aug 2013 (estimated)
- 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.
Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Regular HIV care has also been associated with a decrease in HIV transmission risk behavior. Despite the proven health and prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the United States are estimated to meet current retention in care standards and even fewer - only about 25% - are estimated to be virologically suppressed.
The Behavioral Model for Vulnerable Populations provides a useful framework for understanding broad areas that may impact adherence to care and treatment. Individual-level domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and need (e.g., co-morbidities) factors, and structural domains include, for example, features or the clinic and the provider-patient relationship.
Short message service (SMS) technology represents a new and exciting tool to help retain HIV-infected patients in care and treatment. SMS interventions have been deployed successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan Africa, where two randomized trials have showed clear benefits. A pilot study conducted in our clinic suggests that use of SMS messages to promote adherence to care and treatment in the urban HIV-infected poor is both feasible and acceptable.
The investigators believe that combining SMS technology with content-specific messages designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can improve retention in care and virologic suppression for an urban public hospital population living with HIV, thus the investigators propose the following specific aims.
Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves virologic suppression [primary outcome] and retention in care [secondary outcome] for a vulnerable urban HIV-infected population through a randomized trial of this technology compared to SMS appointment reminders alone. Retention in care will also be analyzed as a mediator of virologic suppression. Exploratory outcomes include time to virologic suppression, sustained virologic suppression, emergency department utilization and antiretroviral adherence, as well as levels of depression, positive affect, social support and empowerment.
Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of patient use of this technology, and; 3) the preferred frequency and content of intervention messages.
Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messages + Appointment Reminders | Experimental | Behavioral: Text Messages, Behavioral: Appointment RemindersParticipants in the intervention arm will receive supportive, informational, or motivational text messages three times a week for one year in addition to text message reminders about HIV primary care appointments. |
| Appointment Reminders | Active comparator | Behavioral: Appointment RemindersParticipants in the control arm will receive text messages reminding them of HIV primary care appointments 48 hours before the scheduled appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-infected
- Age 18 or over
- English-speaking
- Able to give informed consent
- Have a cell phone and willing to send/receive up to 25 text messages/month
Key exclusion criteria (6 listed)
- HIV-uninfected
- Under age 18
- Monolingual speaker of a language other than English
- Unable to give informed consent
- Undetectable viral load
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 |
|---|---|---|
| Text MessagesThe intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication. | Behavioural | Text Messages + Appointment Reminders |
| Appointment Reminders | Behavioural | Appointment Reminders, Text Messages + Appointment Reminders |
Primary outcome
Viral Load
Time frame: 12 month
4 secondary outcomes
Missed Visit Proportion
Time frame: 12 month
Appointment Adherence
Time frame: 12 month
Visit Constancy
Time frame: 12 month
Attended All Scheduled Visits
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 25551175Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.
- Derived from this study: PubMed 29474546Christopoulos KA, Riley ED, Carrico AW, Tulsky J, Moskowitz JT, Dilworth S, Coffin LS, Wilson L, Johnson-Peretz J, Hilton JF. A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Clin Infect Dis. 2018 Aug 16;67(5):751-759. doi: 10.1093/cid/ciy156.
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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. This study is not recruiting at the moment.
Katerina Christopoulos, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messages and Appointment Reminders in people with HIV and Patient Adherence, run by University of California, San Francisco at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917994, which also lists 2 linked publications.
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 Feb 2017.