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Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population (Connect4Care)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01917994
First received: August 1, 2013
Last updated: August 5, 2014
Last verified: August 2014

August 1, 2013
August 5, 2014
August 2013
April 2016   (final data collection date for primary outcome measure)
Viral Load [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01917994 on ClinicalTrials.gov Archive Site
  • Missed Visit Proportion [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Number of missed or "no show" visits divided by number of scheduled appointments
  • Appointment Adherence [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)
  • Visit Constancy [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    At least one kept visit in each six-month period
  • Attended All Scheduled Visits [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Attended all scheduled visits
Same as current
  • Time to Virologic Suppression [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Sustained virologic suppression [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Same as current
 
Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV
  • Patient Adherence
  • Mobile Technology
  • 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
  • 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.
    Interventions:
    • Behavioral: Text Messages
    • 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.
    Intervention: Behavioral: Appointment Reminders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • HIV-uninfected
  • Under age 18
  • Monolingual speaker of a language other than English
  • Unable to give informed consent
  • Undetectable viral load
  • Perfect appointment adherence
Both
18 Years and older
No
Contact: Katerina Christopoulos, MD 415-476-4082 ext 440 christopoulos@php.ucsf.edu
Contact: Lara Coffin, MPH 415-632-5071 coffinl@php.ucsf.edu
United States
 
NCT01917994
R01 DA032057
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Jacqueline Tulsky, MD University of California, San Francisco
University of California, San Francisco
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP