Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users

NCT01343654 | Completed DMC

• 1 other identifier: 15475
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will 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:

• 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
• 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
• 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.

Conditions

HIV Infections

Keywords

HIV medication adherence; drug use; rural; nonadherence to HIV medications

Outcome Measures

Primary Outcomes (1)

• Missed Visit Proportion (MVP)

  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.

  6 months

Secondary Outcomes (2)

• pharmacy refill data

  6 months

• Secondary: text messaged adherence and drug use data

  during 12 week intervention period

Study Arms (2)

Text messaging

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

Text messaging plus EMA BEHAVIORAL

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

Text messaging

Treatment as usual BEHAVIORAL

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

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Infectious Diseases Clinic

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

• Ingersoll K, Dillingham R, Reynolds G, Hettema J, Freeman J, Hosseinbor S, Winstead-Derlega C. Development of a personalized bidirectional text messaging tool for HIV adherence assessment and intervention among substance abusers. J Subst Abuse Treat. 2014 Jan;46(1):66-73. doi: 10.1016/j.jsat.2013.08.002. Epub 2013 Sep 9.

  PMID: 24029625 RESULT

• Ingersoll KS, Dillingham RA, Hettema JE, Conaway M, Freeman J, Reynolds G, Hosseinbor S. Pilot RCT of bidirectional text messaging for ART adherence among nonurban substance users with HIV. Health Psychol. 2015 Dec;34S(0):1305-15. doi: 10.1037/hea0000295.

  PMID: 26651472 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Karen S Ingersoll, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry and Neurobehavioral Sciences

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 28, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)