Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population (Connect4Care)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01917994|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : February 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Patient Adherence Mobile Technology||Behavioral: Text Messages Behavioral: Appointment Reminders||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Text Messages + Appointment Reminders
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
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.
Behavioral: Appointment Reminders
Active Comparator: 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
- Viral Load [ Time Frame: 12 month ]
- Missed Visit Proportion [ Time Frame: 12 month ]Number of missed or "no show" visits divided by number of scheduled appointments
- Appointment Adherence [ Time Frame: 12 month ]Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)
- Visit Constancy [ Time Frame: 12 month ]At least one kept visit in each six-month period
- Attended All Scheduled Visits [ Time Frame: 12 month ]Attended all scheduled visits
- Time to Virologic Suppression [ Time Frame: 12 month ]
- Sustained virologic suppression [ Time Frame: 12 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917994
|United States, California|
|San Francisco General Hospital Positive Health Program|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Katerina Christopoulos, MD||University of California, San Francisco|