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Completed Not applicable Interventional

Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users

ClinicalTrials.gov ID: NCT01343654

Public ClinicalTrials.gov record NCT01343654. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

RCT of a Text Messaging Adherence Assessment & Intervention Tool for Rural HIV+ Drug Users

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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: 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.

Study identification

NCT ID
NCT01343654
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Virginia
Other
Enrollment
54 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2011
Primary completion
Aug 31, 2013
Completion
Nov 30, 2013
Last update posted
Feb 14, 2018

2011 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UVA Infectious Diseases Clinic Charlottesville Virginia 22903

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01343654, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 14, 2018 · Synced Sep 7, 2026

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