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Completed

NCT Number: NCT01917994

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital Positive Health Program

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Messages

Behavioral

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.

Appointment Reminders

Behavioral

Primary outcomes

  1. Viral Load

    Time frame: 12 month

Secondary outcomes

  1. Missed Visit Proportion

    Time frame: 12 month

    Number of missed or "no show" visits divided by number of scheduled appointments

  2. Appointment Adherence

    Time frame: 12 month

    Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)

  3. Visit Constancy

    Time frame: 12 month

    At least one kept visit in each six-month period

  4. Attended All Scheduled Visits

    Time frame: 12 month

    Attended all scheduled visits

Other outcomes

  1. Time to Virologic Suppression

    Time frame: 12 month

  2. Sustained virologic suppression

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies

Acronym: Connect4Care

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2013
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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