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

HIV Infections Clinical Trial

— CAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058694
• Other study ID #: 2008-005
• Status: Completed
• Phase: N/A
• First received: January 27, 2010
• Last updated: January 28, 2010
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• AIDS
• Antiretroviral Therapy
• HIV Infections
• Medication Adherence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Kenya	Chulaimbo Rural Health Center	Kisumu	Maseno District

Sponsors (8)

Lead Sponsor	Collaborator
Georgetown University	Columbia University, Harvard University, Indiana University, Moi Univeristy, University of California, San Diego, University of North Carolina, World Bank

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEMS Adherence		12 months follow up	No
Secondary	Frequency/incidence of ARV treatment interruptions		12 months follow up	No