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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01118767
Other study ID # R01TW007896
Secondary ID R01TW007896
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2010
Est. completion date December 10, 2011

Study information

Verified date November 2021
Source Universidad Peruana Cayetano Heredia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date December 10, 2011
Est. primary completion date December 1, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cell phone intervention
Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages

Locations

Country Name City State
Peru Universidad Peruana Cayetano Heredia Lima
Peru Via Libre Lima

Sponsors (2)

Lead Sponsor Collaborator
Universidad Peruana Cayetano Heredia Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Peru, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported medication adherence 12 months
Primary HIV-1 viral load 12 months
Secondary CD4 12 months
Secondary Self-reported HIV transmission risk behaviors 12 months
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