Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru (Cell-POS)

November 12, 2021 updated by: Walter Curioso Vilchez, Universidad Peruana Cayetano Heredia
The investigators propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV-positive patients in Peru.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adherence to ART is critical for treatment success at the individual level and to avoid the onset of resistant strains of HIV. In Peru, where ART has recently been introduced, adherence to HIV treatment has not yet been addressed properly. Innovative approaches using information technologies such as cell phones are needed to increase adherence to ART for people with HIV/AIDS. The specific aims of the study are to: 1) Conduct formative research to assess culturally-specific behavioral messages to be included in the computer-based system; 2) Develop and test an interactive computer-based system using cell phones to enhance adherence to ART and to deliver HIV transmission risk reduction messages; 3) Evaluate the impact of the system on antiretroviral adherence and sexual risk behaviors.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia
      • Lima, Peru
        • Via Libre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-positive healthy male or female aged greater than or equal to 18
  • Currently on ART
  • Patients with a mobile phone for their personal use (not shared)
  • Patients who know how to retrieve read text messages on their mobile phone
  • Signed and dated written informed consent prior to admission to the study

Exclusion Criteria:

  • Patients whose clinical condition might have interfered with the study (e.g., deafness, serious mental illness, mental retardation)
  • Patients unable to give their informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cell phone intervention
Participant receives short text messages
Other: Cell phone intervention
Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages
No Intervention: Standard of care
Participant receives standard of care support but not short text messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported medication adherence
Time Frame: 12 months
12 months
HIV-1 viral load
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
CD4
Time Frame: 12 months
12 months
Self-reported HIV transmission risk behaviors
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Peruana Cayetano Heredia

Collaborators

Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Walter H Curioso, MD, MPH, Universidad Peruana Cayetano Heredia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 10, 2011

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01TW007896 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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