Clinical trial NCT01058694: The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya
Official title: Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AIDS
Antiretroviral Therapy
Medication Adherence
HIV Infections
Keywords: Mobile phones,
Medication Adherence
Micro-Electrical-Mechanical Systems
HIV Infections
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Moi Univeristy
name: World Bank
name: Indiana University
name: Harvard University
name: Columbia University
name: University of California, San Diego
name: University of North Carolina
First posted: 2010-01-29
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: MEMS Adherence
timeFrame: 12 months follow up
Secondary outcomes:
measure: Frequency/incidence of ARV treatment interruptions
timeFrame: 12 months follow up
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Chulaimbo Rural Health Center
state: Maseno District
Study officials:
affiliation: Indiana University
name: John Sidle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moi University
name: Duncan Ngare, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Harsha Thirumurthy, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank
name: Markus Goldstein, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Joshua Graff-Zivin, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank
name: Damien de Walque, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Cristian Pop-Eleches, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School (HMS and HSDM)
name: David Bangsberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.