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The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya

NCT ID: NCT01058694

Last Updated: 2010-01-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Several studies have shown that proper adherence to treatment regimens is essential for the effectiveness of ARV therapy (e.g Wools-Kaloustian et al. 2006). There is also evidence in that in some treatment programs in Africa, adherence rates are not always high (Gill et al. 2005). Even in settings where adherence levels are found to be high, numerous factors have been identified as being relevant, although the causal effects are unknown (Castro, 2006). As ARV treatment programs are scaled up in Africa, it is essential to understand the socio-economic determinants of adherence to ARV treatment, as well as the impact of interventions to support high levels of adherence. A secondary objective of this study is to understand the socio-economic impacts of higher adherence.

Conditions

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AIDS Antiretroviral Therapy Medication Adherence HIV Infections

Keywords

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Mobile phones, Medication Adherence Micro-Electrical-Mechanical Systems HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Weekly SMS, brief message

Weekly SMS received on Monday at 12 noon

Group Type EXPERIMENTAL

Short Message Services to Support ARV therapy adherence

Intervention Type BEHAVIORAL

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 Group

Receives a phone, but no messages.

Group Type ACTIVE_COMPARATOR

Short Message Services to Support ARV therapy adherence

Intervention Type BEHAVIORAL

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.

Daily SMS, Brief message

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

Group Type EXPERIMENTAL

Short Message Services to Support ARV therapy adherence

Intervention Type BEHAVIORAL

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.

Daily SMS, Long Message

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

Group Type EXPERIMENTAL

Short Message Services to Support ARV therapy adherence

Intervention Type BEHAVIORAL

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.

Weekly SMS, Long Message

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

Group Type EXPERIMENTAL

Short Message Services to Support ARV therapy adherence

Intervention Type BEHAVIORAL

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.

Interventions

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Short Message Services to Support ARV therapy adherence

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who had been on ARV therapy for more than 3 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moi Univeristy

OTHER

Sponsor Role collaborator

World Bank

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Georgetown Public Policy Institute

Principal Investigators

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John Sidle, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Duncan Ngare, Phd

Role: PRINCIPAL_INVESTIGATOR

Moi University

Harsha Thirumurthy, Phd

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Markus Goldstein, Phd

Role: PRINCIPAL_INVESTIGATOR

World Bank

Joshua Graff-Zivin, Phd

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Damien de Walque, Phd

Role: PRINCIPAL_INVESTIGATOR

World Bank

Cristian Pop-Eleches, Phd

Role: PRINCIPAL_INVESTIGATOR

Columbia University

David Bangsberg, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

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Chulaimbo Rural Health Center

Kisumu, Maseno District, Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 21252632 (View on PubMed)

Other Identifiers

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2008-005

Identifier Type: -

Identifier Source: org_study_id