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Completed

NCT Number: NCT01359280

Nurse Delivered Cell Phone Adherence Intervention (Pick It UP)

Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. The study will also test the independent effects of an automated text message reminder system for sustaining adherence improvements. The intervention under study has utility for people living with HIV/AIDS In resource limited rural and urban settings.

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Key information

Conditions

Medication Adherence Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

This study is testing a theory-based HIV treatment adherence intervention delivered by cell phone to patients in urban and rural areas. Adherence to antiretroviral (ART) medications is necessary to achieve HIV suppression and non-adherence can lead to treatment resistant genetic variants of HIV. People living with HIV/AIDS often experience difficulty sustaining high-levels of treatment adherence. Most factors that interfere with adherence are unanticipated and occur between clinical visits, including depression, side effects, substance use, and lapses in pharmacy refill. We will conduct a randomized clinical trial to test a cell phone-delivered theory-based medication adherence counseling intervention. The intervention is grounded in Self-Regulation Model and utilizes unannounced pill counts to monitor adherence and guide corrective feedback within the counseling context. Using pill count adherence information for counseling allows providers to detect and correct patient non-adherence within a time frame that can head off viral resistance. An experimental factorial design will test the effects of counseling and a text message reminder system as well the interaction of counseling and text message components with 600 men and women receiving HIV treatment. Following screening, informed consent and baseline assessments participants will be randomized to one of four intervention conditions:(a) self-regulation counseling + regimen tailored text message reminders; (b) self-regulation counseling only; (c) control counseling + regimen tailored text reminders; or (d) control counseling only. The study will therefore use a 2 (self-regulation counseling) x 2 (text message reminders) full factorial deign with participants followed for 9 months post-intervention. The primary endpoints are medication adherence assessed by unannounced pill counts and HIV RNA (viral load). This newly developed intervention strategy is grounded in Self-Regulation Theory and is designed for use in clinical settings with limited resources.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • Currently taking HIV treatment medication with non-adherence

Exclusion criteria

  • Under age 18
  • Not HIV positive
  • Not taking HIV treatment medications
  • Adherent to HIV Medications

Treatment and study plan

Adherence counseling

Behavioral

5 Sessions of theory-based medication adherence counseling

General Health Counseling

Behavioral

5 sessions of health improvement counseling

Text Messages

Behavioral

Daily medication regimen tailored adherence reminders delivered by cell phone

Primary outcomes

  1. Chart Abstracted Viral Load

    Time frame: 12 months retrospective

    Patient HIV viral load is abstracted from medical records at baseline and at 12-month retrospective follow-up.

Secondary outcomes

  1. Unannounced Pill Count Adherence

    Time frame: Monthly

    Unannounced phone-based pill counts conducted monthly to obtain an objective measure of medication adherence

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Nurse Delivered Cell Phone Adherence Intervention

Acronym: PIU

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 24, 2011
Registry last updated
Dec 3, 2014

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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