MedDataX Logo

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

NCT ID: NCT01118767

Last Updated: 2021-11-22

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

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-01

Study Completion Date

2011-12-10

Brief Summary

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

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.

Detailed Description

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

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.

Conditions

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

HIV Adherence Sexual Behavior HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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 Sexually Transmitted Infection Survey Instrument Surveys Telephone Telephone, Cellular Text Unprotected Sex Viral Load result Vulnerable Populations WWW anti-retroviral therapy consumer informatics evidence base follow-up medication adherence medication compliance randomization randomized controlled study randomized trial randomly assigned safer sex treatment adherence user centered design web world wide web

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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

Cell phone intervention

Participant receives short text messages

Group Type EXPERIMENTAL

Cell phone intervention

Intervention Type OTHER

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

Standard of care

Participant receives standard of care support but not short text messages

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Cell phone intervention

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

Intervention Type OTHER

Eligibility Criteria

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

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.
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.

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role lead

Responsible Party

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

Walter Curioso Vilchez

Universidad Peruana Cayetano Heredia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Walter H Curioso, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Locations

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

Universidad Peruana Cayetano Heredia

Lima, , Peru

Site Status

Via Libre

Lima, , Peru

Site Status

Countries

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

Peru

Other Identifiers

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

R01TW007896

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01TW007896

Identifier Type: NIH

Identifier Source: org_study_id

View Link