Trial record 3 of 32 for:
" May 05, 2010":" June 04, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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
Recruitment status was Recruiting
Sponsor:
Universidad Peruana Cayetano Heredia
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
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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
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:
|
HIV/AIDS Adherence Appointment Cell Phone Cellular Phone Clinic Computers Controlled Clinical Trials, Randomized 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013