An interventional study of Text Messages and Appointment Reminders in HIV, Patient Adherence and Mobile Technology, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Text Messages · Behavioral: Appointment Reminders
Participants in the control arm will receive text messages reminding them of HIV primary care appointments 48 hours before the scheduled appointment.
Behavioral: Appointment Reminders
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.
Viral Load
Time frame: 12 month
Missed Visit Proportion
Number of missed or "no show" visits divided by number of scheduled appointments
Time frame: 12 month
Appointment Adherence
Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)
Time frame: 12 month
Visit Constancy
At least one kept visit in each six-month period
Time frame: 12 month
Attended All Scheduled Visits
Attended all scheduled visits
Time frame: 12 month
Time to Virologic Suppression
Time frame: 12 month
Sustained virologic suppression
Time frame: 12 month
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco