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NCT01343654 · ClinicalTrials.gov registry record · NA

Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users

A NA study, sponsored by University of Virginia.

Completed
Registry status
NA
Development phase
54
Enrollment target

NCT01343654: Completed NA study, sponsored by University of Virginia.

NCT01343654 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01343654, a NA study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target

Study 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: 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 imp

Primary Outcome

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.

Interventions

  • BEHAVIORAL Treatment as usual
  • BEHAVIORAL Text messaging plus EMA

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2011-05
Est. Completion 2013-12
Phase NA
University of Virginia

449 total trials

What the finished NCT01343654 record still lists

NCT01343654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Treatment as usual is the first listed.

NCT01343654 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01343654 about?

NCT01343654 is a clinical study titled "Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users". 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 h...

What is the current status of trial NCT01343654?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2011-05. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01343654?

The interventions under investigation include: Treatment as usual (BEHAVIORAL), Text messaging plus EMA (BEHAVIORAL).

Who is sponsoring clinical trial NCT01343654?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01343654's enrollment target sits among peer trials

54 1268th of 2000 higher than 730 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01343654, the US trial registry maintained by the National Library of Medicine. NCT01343654 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.