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

Study Overview
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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.

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

Conditions
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AIDS, Antiretroviral Therapy, Medication Adherence, HIV Infections

Intervention / Treatment
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* Behavioral: Short Message Services to Support ARV therapy adherence


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly SMS, brief message<br>Weekly SMS received on Monday at 12 noon | Behavioral: Short Message Services to Support ARV therapy adherence<br>* 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.<br>|
| Active Comparator: Control Group<br>Receives a phone, but no messages. | Behavioral: Short Message Services to Support ARV therapy adherence<br>* 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.<br>|
| Experimental: Daily SMS, Brief message<br>Receive daily brief message at 12 noon: This is your reminder | Behavioral: Short Message Services to Support ARV therapy adherence<br>* 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.<br>|
| Experimental: Daily SMS, Long Message<br>Receive a daily long message at 12 noon: This is your reminder + encouragement | Behavioral: Short Message Services to Support ARV therapy adherence<br>* 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.<br>|
| Experimental: Weekly SMS, Long Message<br>Weekly message sent at 12 noon on Mondays: This is your reminder + encouragement | Behavioral: Short Message Services to Support ARV therapy adherence<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEMS Adherence |  | 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency/incidence of ARV treatment interruptions |  | 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile phones,, Medication Adherence, Micro-Electrical-Mechanical Systems, HIV Infections