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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Universidad Peruana Cayetano Heredia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01118767
First received: May 6, 2010
Last updated: June 15, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
HIV
Adherence
Sexual Behavior
HIV Infections
Other: Cell phone intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru

Resource links provided by NLM:


Further study details as provided by Universidad Peruana Cayetano Heredia:

Primary Outcome Measures:
  • Self-reported medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HIV-1 viral load [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD4 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Self-reported HIV transmission risk behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118767

Contacts
Contact: Walter H Curioso, MD, MPH 511 3190028 walter.curioso@upch.pe

Locations
Peru
Universidad Peruana Cayetano Heredia Recruiting
Lima, Peru
Contact: Walter H Curioso, MD, MPH    511 3190028    walter.curioso@upch.pe   
Principal Investigator: Walter H Curioso, MD, MPH         
Sub-Investigator: Patricia J Garcia, MD, MPH         
Via Libre Recruiting
Lima, Peru
Contact: Walter H Curioso, MD, MPH    511 3190028    walter.curioso@upch.pe   
Contact: Robinson Cabello, MD    511 2039900      
Sub-Investigator: Robinson Cabello, MD         
Principal Investigator: Walter H Curioso, MD, MPH         
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Investigators
Principal Investigator: Walter H Curioso, MD, MPH Universidad Peruana Cayetano Heredia
  More Information

Additional Information:
No publications provided

Responsible Party: Walter H. Curioso, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01118767     History of Changes
Other Study ID Numbers: R01TW007896, R01TW007896
Study First Received: May 6, 2010
Last Updated: June 15, 2010
Health Authority: Peru: Ethics Committee

Keywords provided by Universidad Peruana Cayetano Heredia:
Adherence
Appointment
Cell Phone
Cellular Phone
Clinic
Computers
Controlled Clinical Trials, Randomized
HIV/AIDS
Health Informatics
Health behavior
Information Technology
Internet
Intervention
Medication
Patient Satisfaction
Patient Self-Report
Patients
Peru
Phone
Public Health
Public Health Informatics
Randomized
Randomized Controlled Clinical Trials
Randomized Controlled Trials
Research
Secondary Prevention
Self-Report
Sex Behavior
Sexual Behavior
Sexually Transmitted Diseases

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014