Clinical trial NCT00830622: Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya
Official title: A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
HIV Infections
Keywords: HIV/AIDS
Adherence
Antiretroviral Therapy, ART, ARV
Mobile phone, cell phone, telephone
Text message, SMS
Telemedicine
Africa
Resource-limited setting
Counseling, support
treatment experienced
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Nairobi
First posted: 2009-01-28
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.

Detailed description: This RCT study focuses on enrolling and following patients initiating ART. Note, a second parallel prospective cohort study enrolls and follows ART experienced patients who have already been taking ART for at least one year before and after the same intervention.

Eligibility criteria: Inclusion Criteria:

* HIV infected and starting antiretroviral therapy
* Adequate (daily) access to a cell phone
* Intending to attend the enrollment clinic for 2 years
* Consent to participate

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Adherence to ART and HIV RNA suppression
timeFrame: 6,12 months
Secondary outcomes:
measure: Retention
timeFrame: 6, 12 months
measure: Quality of Life (SF-12)
timeFrame: 3, 6, 9, 12 months
measure: Health (CD4, weight, progression to AIDS, all cause mortality)
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: University of Nairobi Clinics
Study officials:
affiliation: University of Manitoba
name: Richard T Lester, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba / University of Nairobi
name: Joshua Kimani, MBChB
role: STUDY_CHAIR
affiliation: University of Manitoba
name: Francis A Plummer, MD, FRCPC
role: STUDY_DIRECTOR
References:
citation: Lester R, Karanja S. Mobile phones: exceptional tools for HIV/AIDS, health, and crisis management. Lancet Infect Dis. 2008 Dec;8(12):738-9. doi: 10.1016/S1473-3099(08)70265-2. No abstract available.
citation: Lester RT, Gelmon L, Plummer FA. Cell phones: tightening the communication gap in resource-limited antiretroviral programmes? AIDS. 2006 Nov 14;20(17):2242-4. doi: 10.1097/QAD.0b013e3280108508. No abstract available.
citation: Linnemayr S, Huang H, Luoto J, Kambugu A, Thirumurthy H, Haberer JE, Wagner G, Mukasa B. Text Messaging for Improving Antiretroviral Therapy Adherence: No Effects After 1 Year in a Randomized Controlled Trial Among Adolescents and Young Adults. Am J Public Health. 2017 Dec;107(12):1944-1950. doi: 10.2105/AJPH.2017.304089. Epub 2017 Oct 19.
citation: Patel AR, Lester RT, Marra CA, van der Kop ML, Ritvo P, Engel L, Karanja S, Lynd LD. The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya. Health Qual Life Outcomes. 2017 Jul 17;15(1):143. doi: 10.1186/s12955-017-0708-7.
citation: Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
citation: Lester RT, Mills EJ, Kariri A, Ritvo P, Chung M, Jack W, Habyarimana J, Karanja S, Barasa S, Nguti R, Estambale B, Ngugi E, Ball TB, Thabane L, Kimani J, Gelmon L, Ackers M, Plummer FA. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol. Trials. 2009 Sep 22;10:87. doi: 10.1186/1745-6215-10-87.