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

Primary Purpose

AIDS, Antiretroviral Therapy, Medication Adherence

Status

Completed

Phase

Not Applicable

Locations

Kenya

Study Type

Interventional

Intervention

Short Message Services to Support ARV therapy adherence

About this trial

This is an interventional supportive care trial for AIDS focused on measuring Mobile phones,, Medication Adherence, Micro-Electrical-Mechanical Systems, HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chulaimbo Rural Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Weekly SMS, brief message

Control Group

Daily SMS, Brief message

Daily SMS, Long Message

Weekly SMS, Long Message

Arm Description

Weekly SMS received on Monday at 12 noon

Receives a phone, but no messages.

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

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

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

Outcomes

Primary Outcome Measures

MEMS Adherence

Secondary Outcome Measures

Frequency/incidence of ARV treatment interruptions

Full Information

NCT ID

NCT01058694

First Posted

January 27, 2010

Last Updated

January 28, 2010

Sponsor

Georgetown University

Collaborators

Moi Univeristy, World Bank, Indiana University, Harvard University, Columbia University, University of California, San Diego, University of North Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01058694

Brief Title

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

Acronym

CAPS

Official Title

Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Georgetown University

Collaborators

Moi Univeristy, World Bank, Indiana University, Harvard University, Columbia University, University of California, San Diego, University of North Carolina

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AIDS, Antiretroviral Therapy, Medication Adherence, HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

720 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weekly SMS, brief message

Arm Type

Experimental

Arm Description

Weekly SMS received on Monday at 12 noon

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Receives a phone, but no messages.

Arm Title

Daily SMS, Brief message

Arm Type

Experimental

Arm Description

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

Arm Title

Daily SMS, Long Message

Arm Type

Experimental

Arm Description

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

Arm Title

Weekly SMS, Long Message

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Short Message Services to Support ARV therapy adherence

Intervention Description

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.

Primary Outcome Measure Information:

Title

MEMS Adherence

Time Frame

12 months follow up

Secondary Outcome Measure Information:

Title

Frequency/incidence of ARV treatment interruptions

Time Frame

12 months follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: