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

NCT ID: NCT00830622

Last Updated: 2010-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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HIV AIDS HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Cell Phone Intervention

Intervention Type OTHER

Participant receives weekly SMS text messages from the health care provider.

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cell Phone Intervention

Participant receives weekly SMS text messages from the health care provider.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nairobi

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Medical Microbiology and Infectious Diseases, University of Manitoba

Principal Investigators

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Richard T Lester, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Joshua Kimani, MBChB

Role: STUDY_CHAIR

University of Manitoba / University of Nairobi

Francis A Plummer, MD, FRCPC

Role: STUDY_DIRECTOR

University of Manitoba

Locations

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University of Nairobi Clinics

Nairobi, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type BACKGROUND
PMID: 19022188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17086071 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29048966 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28716065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21071074 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19772596 (View on PubMed)

Other Identifiers

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CDC PEPFAR PHE KE.07.0045

Identifier Type: -

Identifier Source: secondary_id

H2007:037

Identifier Type: -

Identifier Source: org_study_id

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