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Clinical Trials/NCT01058694
NCT01058694CompletedNot Applicable

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

Georgetown University1 site in 1 country720 target enrollmentStarted: June 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
720
Locations
1
Primary Endpoint
MEMS Adherence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Weekly SMS, brief message

Experimental

Weekly SMS received on Monday at 12 noon

Intervention: Short Message Services to Support ARV therapy adherence (Behavioral)

Control Group

Active Comparator

Receives a phone, but no messages.

Intervention: Short Message Services to Support ARV therapy adherence (Behavioral)

Daily SMS, Brief message

Experimental

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

Intervention: Short Message Services to Support ARV therapy adherence (Behavioral)

Daily SMS, Long Message

Experimental

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

Intervention: Short Message Services to Support ARV therapy adherence (Behavioral)

Weekly SMS, Long Message

Experimental

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

Intervention: Short Message Services to Support ARV therapy adherence (Behavioral)

Outcomes

Primary Outcomes

MEMS Adherence

Time Frame: 12 months follow up

Secondary Outcomes

  • Frequency/incidence of ARV treatment interruptions(12 months follow up)

Investigators

Sponsor Class
Other

Study Sites (1)

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