HIV Clinical Trial
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.
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.
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