NCT01058694

Brief Summary

The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
Last Updated

January 29, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

January 27, 2010

Last Update Submit

January 28, 2010

Conditions

AIDSAntiretroviral TherapyMedication AdherenceHIV Infections

Keywords

Mobile phones,Medication AdherenceMicro-Electrical-Mechanical SystemsHIV Infections

Outcome Measures

Primary Outcomes (1)

  • MEMS Adherence

    12 months follow up

Secondary Outcomes (1)

  • Frequency/incidence of ARV treatment interruptions

    12 months follow up

Study Arms (5)

Weekly SMS, brief message

EXPERIMENTAL

Weekly SMS received on Monday at 12 noon

Behavioral: Short Message Services to Support ARV therapy adherence

Control Group

ACTIVE COMPARATOR

Receives a phone, but no messages.

Behavioral: Short Message Services to Support ARV therapy adherence

Daily SMS, Brief message

EXPERIMENTAL

Receive daily brief message at 12 noon: "This is your reminder"

Behavioral: Short Message Services to Support ARV therapy adherence

Daily SMS, Long Message

EXPERIMENTAL

Receive a daily long message at 12 noon: "This is your reminder + encouragement"

Behavioral: Short Message Services to Support ARV therapy adherence

Weekly SMS, Long Message

EXPERIMENTAL

Weekly message sent at 12 noon on Mondays: "This is your reminder + encouragement"

Behavioral: Short Message Services to Support ARV therapy adherence

Interventions

Short Message Services to Support ARV therapy adherenceBEHAVIORAL

Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.

Control GroupDaily SMS, Brief messageDaily SMS, Long MessageWeekly SMS, Long MessageWeekly SMS, brief message

Eligibility Criteria

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

You may qualify if:

  • Patients who had been on ARV therapy at the Chulaimbo Rural Health Center for a maximum of three months and providing consent to participate in the study.

You may not qualify if:

  • Patients who had been on ARV therapy for more than 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulaimbo Rural Health Center

Kisumu, Maseno District, Kenya

Location

Related Publications (1)

  • Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825-34. doi: 10.1097/QAD.0b013e32834380c1.

    PMID: 21252632DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication AdherenceHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • John Sidle, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Duncan Ngare, Phd

    Moi University

    PRINCIPAL INVESTIGATOR

  • Harsha Thirumurthy, Phd

    University of North Carolina

    PRINCIPAL INVESTIGATOR

  • Markus Goldstein, Phd

    World Bank

    PRINCIPAL INVESTIGATOR

  • Joshua Graff-Zivin, Phd

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Damien de Walque, Phd

    World Bank

    PRINCIPAL INVESTIGATOR

  • Cristian Pop-Eleches, Phd

    Columbia University

    PRINCIPAL INVESTIGATOR

  • David Bangsberg, MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 29, 2010

Study Start

June 1, 2007

Primary Completion

December 1, 2008

Study Completion

July 1, 2009

Last Updated

January 29, 2010

Record last verified: 2010-01

Locations

KE(1)