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Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

Primary Purpose

HIV, AIDS, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Cell Phone Intervention
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV focused on measuring HIV/AIDS, Adherence, Antiretroviral Therapy, ART, ARV, Mobile phone, cell phone, telephone, Text message, SMS, Telemedicine, Africa, Resource-limited setting, Counseling, support, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nairobi Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Cell Phone Intervention: participant receives weekly SMS text message from the health care worker.

SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker.

Outcomes

Primary Outcome Measures

Adherence to ART and HIV RNA suppression
Although many patients are seen every 3 months, study visits with questionnaires and viral load are completed at 0, 6, and 12 month scheduled follow-up visits.

Secondary Outcome Measures

Retention
Quality of Life (SF-12)
Health (CD4, weight, progression to AIDS, all cause mortality)

Full Information

First Posted
January 26, 2009
Last Updated
June 18, 2010
Sponsor
University of Manitoba
Collaborators
University of Nairobi
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1. Study Identification

Unique Protocol Identification Number
NCT00830622
Brief Title
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

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
University of Nairobi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cell Phone Intervention: participant receives weekly SMS text message from the health care worker.
Arm Title
2
Arm Type
No Intervention
Arm Description
SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker.
Intervention Type
Other
Intervention Name(s)
Cell Phone Intervention
Intervention Description
Participant receives weekly SMS text messages from the health care provider.
Primary Outcome Measure Information:
Title
Adherence to ART and HIV RNA suppression
Description
Although many patients are seen every 3 months, study visits with questionnaires and viral load are completed at 0, 6, and 12 month scheduled follow-up visits.
Time Frame
6,12 months
Secondary Outcome Measure Information:
Title
Retention
Time Frame
6, 12 months
Title
Quality of Life (SF-12)
Time Frame
3, 6, 9, 12 months
Title
Health (CD4, weight, progression to AIDS, all cause mortality)
Time Frame
6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T Lester, MD, FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Kimani, MBChB
Organizational Affiliation
University of Manitoba / University of Nairobi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis A Plummer, MD, FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
Facility Information:
Facility Name
University of Nairobi Clinics
City
Nairobi
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
19022188
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.
Results Reference
background
PubMed Identifier
17086071
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.
Results Reference
background
PubMed Identifier
29048966
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.
Results Reference
derived
PubMed Identifier
28716065
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.
Results Reference
derived
PubMed Identifier
21071074
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.
Results Reference
derived
PubMed Identifier
19772596
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.
Results Reference
derived
Links:
URL
http://www.mrsi.ca/
Description
Manitoba Resistance and Susceptibility to Infection Group

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Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

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