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 February 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: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention
HIV
Patient Adherence
Mobile Technology
Behavioral: Text Messages
Behavioral: Appointment Reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Viral Load [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917994

Contacts
Contact: Katerina Christopoulos, MD 415-476-4082 ext 440 christopoulos@php.ucsf.edu
Contact: Lara Coffin, MPH 415-632-5071 coffinl@php.ucsf.edu

Locations
United States, California
San Francisco General Hospital Positive Health Program Recruiting
San Francisco, California, United States, 94110
Contact: Lara Coffin, MPH    415-632-5071    coffinl@php.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jacqueline Tulsky, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01917994     History of Changes
Other Study ID Numbers: R01 DA032057
Study First Received: August 1, 2013
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014