NCT01118767

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started May 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2011

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

May 6, 2010

Last Update Submit

November 12, 2021

Conditions

HIVAdherenceSexual BehaviorHIV Infections

Keywords

AdherenceAppointmentCell PhoneCellular PhoneClinicComputersControlled Clinical Trials, RandomizedHIV/AIDSHealth InformaticsHealth behaviorInformation TechnologyInternetInterventionMedicationPatient SatisfactionPatient Self-ReportPatientsPeruPhonePublic HealthPublic Health InformaticsRandomizedRandomized Controlled Clinical TrialsRandomized Controlled TrialsResearchSecondary PreventionSelf-ReportSex BehaviorSexual BehaviorSexually Transmitted DiseasesSexually Transmitted InfectionSurvey InstrumentSurveysTelephoneTelephone, CellularTextUnprotected SexViral Load resultVulnerable PopulationsWWWanti-retroviral therapyconsumer informaticsevidence basefollow-upmedication adherencemedication compliancerandomizationrandomized controlled studyrandomized trialrandomly assignedsafer sextreatment adherenceuser centered designwebworld wide web

Outcome Measures

Primary Outcomes (2)

  • Self-reported medication adherence

    12 months

  • HIV-1 viral load

    12 months

Secondary Outcomes (2)

  • CD4

    12 months

  • Self-reported HIV transmission risk behaviors

    12 months

Study Arms (2)

Cell phone intervention

EXPERIMENTAL

Participant receives short text messages

Other: Cell phone intervention

Standard of care

NO INTERVENTION

Participant receives standard of care support but not short text messages

Interventions

Cell phone interventionOTHER

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

Cell phone intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Via Libre

Lima, Peru

Location

MeSH Terms

Conditions

Sexual BehaviorHIV InfectionsAcquired Immunodeficiency SyndromeHealth BehaviorPatient SatisfactionSexually Transmitted DiseasesUnsafe SexMedication AdherenceTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

BehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health Care

Study Officials

  • Walter H Curioso, MD, MPH

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universidad Peruana Cayetano Heredia

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 10, 2011

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

PE(2)