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Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users (TEXTR34)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01343654
First received: April 26, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Many drug users living with HIV demonstrate inadequate levels of medication adherence, and are at high risk for disengaging from care. HIV positive drug users are at even higher risk of poor medication adherence and treatment dropout when living far from treatment centers. Rural residence is common in the U.S. South where rates of new HIV infections are disproportionately high, especially among ethnic minorities. While there are efficacious interventions to improve HIV treatment adherence, only a few have targeted drug users, and these have required patients to come into research clinics for adherence interventions. Transportation problems, poverty, isolation, and stigma are known barriers to accessing adherence support among rural drug users with HIV.Additionally, most adherence interventions aim to increase adherence, but come too late, unable to respond in real time to adherence lapses to help patients re-initiate appropriate medication use while remaining in their natural environments. There is a pressing need to develop tailored, scalable interventions that detect nonadherence episodes in real time and enhance adherence to HIV treatment immediately. Building interventions upon familiar, existing technology could extend their reach into communities of non-urban patients living with HIV, overcoming common barriers to care, and could ultimately be scaled up to help drug using HIV+ patients nationwide.

The investigators propose to develop and test the feasibility and promise of a combined HIV adherence assessment and intervention application for rural drug users using an available, familiar technology whose reach will grow exponentially: text messaging via mobile phones. By 2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration projected by 2013. While technology adoption is often slower in under-served communities, the trend is different with mobile phone technology. African-Americans are using more mobile phone minutes per capita and increasing their use at a higher rate compared with other ethnic groups. This technology has great potential to reduce health disparities. In this project, the investigators will develop and test the feasibility and promise of a text messaging application and system using Ecological Momentary Assessment methods to detect nonadherence and drug use and immediately intervene to improve HIV treatment adherence in drug users living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a project in the Stage Model of Behavioral Therapy Development that will develop novel interventions and methods, and generate preliminary estimates of effect sizes that will determine whether a larger clinical trial with extended follow-up and cost-effectiveness evaluation is warranted.

The specific aims of this project are:

  1. To identify assessment and intervention features relevant to the adherence barriers and drug use patterns of rural and non-urban HIV+ drug users using formative methods including:

    • structured interviews and focus groups to identify specific barriers to adherence and engagement in care and needs related to drug craving and drug use that should be addressed by the intervention
    • iterative usability testing of components and drafts of the intervention
  2. To create a text messaging mobile phone application and system (Treatment Extension by Texting, Text) to assess and improve HIV treatment adherence and drug use in real time

    --Text will be built upon a piloted unidirectional personalized text phone application and system, STeM, and will include pre- and post-programming usability testing

  3. To test the feasibility and promise of the assessment and intervention tool in a randomized pilot trial of rural HIV+ drug users with detectable viral load (VL) comparing Text to usual care

    • Feasibility: Identify recruitment rates, consent rates, participant flow, completion rates, and variance of key covariates and outcome variables
    • Promise: determine point estimates and the precision of effects for primary and secondary adherence outcomes including pharmacy refills and unannounced pill counts (medication adherence), missed visit percentage (treatment engagement), VL, and drug craving and drug use.

Condition Intervention
HIV Infections
Behavioral: Text messaging plus EMA
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT of a Text Messaging Adherence Assessment & Intervention Tool for Rural HIV+ Drug Users

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Missed Visit Proportion (MVP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary outcome measure for ADHERENCE is missed visit proportion (MVP) across a 6 month follow-up period, used to derive the sample size for this stage 1 RCT. The primary outcome measure for DRUG USE is a Timeline Follow-back to gather 90 day retrospective reports of daily drug use.


Secondary Outcome Measures:
  • pharmacy refill data [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Secondary outcome measures for adherence will be unannounced telephone pill counts and pharmacy refill data; these will be assessed and used to plan a larger, more definitive study, if the intervention shows promise. Pharmacy compliance can be measured directly in the large subset of patients who fill their prescription through the Virginia ADAP Program. Unannounced pill counts conducted by phone can be assessed for all participants and used to measure medication adherence.

  • Secondary: text messaged adherence and drug use data [ Time Frame: during 12 week intervention period ] [ Designated as safety issue: No ]
    We will have daily data from participants' text messages about their adherence behavior. Comparing texts sent by participants about adherence to TLFB will allow us to test the level of agreement about adherence by two distinct measures, one (TLFB) with known properties. Differences in the magnitude and direction of the effect of the intervention for different outcomes will help us choose an outcome for the larger trial, and may shed light on the particular aspects of behavior that the text messaging tool can influence.


Enrollment: 54
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text messaging
Participants randomized to this arm will receive a mobile phone if needed, and the 12 week personalized text messaging/EMA intervention
Behavioral: Text messaging plus EMA
Personalized, tailored text messaging to prompt medication adherence, with EMA random queries about nonadherence and drug use, and two-way messaging for participants to report critical events
Active Comparator: Treatment as usual
Participants randomized to this arm will receive treatment as usual in the ID clinics and in the communities for nonadherence and drug use problems
Behavioral: Treatment as usual
usual care in one of the three participating ID clinics, along with usual care (if any) in the community for problematic drug and alcohol use

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • 18 or older
  • has a detectable viral load
  • reports use of at least one illicit drug in last 30 days
  • requires ART
  • able to receive mobile phone service at home address

Exclusion Criteria:

  • lack of English proficiency
  • planning to move out of area in the next six months
  • inability to provide consent.

Note regarding "inability to provide consent": Traditionally, some patients with HIV whom we evaluate for potential participation in research studies are not able to provide informed consent, either due to significant cognitive decline, or their designation of someone else as their legal proxy. When this occurs, we do not offer them study participation because legally, they are unable to consent, even if currently, their cognitive capacities seem intact. We have generally assessed this through a series of branching questions to determine their legal and cognitive capacity for consent.

  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: NCT01343654

Locations
United States, Virginia
UVA Infectious Diseases Clinic
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia
  More Information

Publications:
Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01343654     History of Changes
Other Study ID Numbers: 15475
Study First Received: April 26, 2011
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
HIV medication adherence
drug use
rural
nonadherence to HIV medications

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014