MedDataX Logo

Nurse Delivered Cell Phone Adherence Intervention (Pick It UP)

NCT ID: NCT01359280

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Adherence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adherence Counseling + Text Messages

Participants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone.

Group Type EXPERIMENTAL

Adherence Counseling

Intervention Type BEHAVIORAL

5 Sessions of theory-based medication adherence counseling

Text Messages

Intervention Type BEHAVIORAL

Daily medication regimen tailored adherence reminders delivered by cell phone

Adherence Counseling Only

Participants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building.

Group Type EXPERIMENTAL

Adherence Counseling

Intervention Type BEHAVIORAL

5 Sessions of theory-based medication adherence counseling

General Health Counseling Only

Participants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building.

Group Type PLACEBO_COMPARATOR

General Health Counseling

Intervention Type BEHAVIORAL

5 sessions of health improvement counseling

General Health Messages + Text Messages

Participants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone.

Group Type PLACEBO_COMPARATOR

General Health Counseling

Intervention Type BEHAVIORAL

5 sessions of health improvement counseling

Text Messages

Intervention Type BEHAVIORAL

Daily medication regimen tailored adherence reminders delivered by cell phone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adherence Counseling

5 Sessions of theory-based medication adherence counseling

Intervention Type BEHAVIORAL

General Health Counseling

5 sessions of health improvement counseling

Intervention Type BEHAVIORAL

Text Messages

Daily medication regimen tailored adherence reminders delivered by cell phone

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seth Kalichman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seth C Kalichman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01NR012962-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H10-332

Identifier Type: -

Identifier Source: org_study_id