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

NCT00830622 | Completed

• 2 other identifiers: H2007:037CDC PEPFAR PHE KE.07.0045
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6,12 months

Secondary Outcomes (3)

• Retention

  6, 12 months

• Quality of Life (SF-12)

  3, 6, 9, 12 months

• Health (CD4, weight, progression to AIDS, all cause mortality)

  6, 12 months

Study Arms (2)

1

EXPERIMENTAL

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

Other: Cell Phone Intervention

2

NO INTERVENTION

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

Interventions

Cell Phone Intervention OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• University of Nairobi: collaborator

Study Sites (1)

University of Nairobi Clinics

Nairobi, Kenya

Location

Related Publications (6)

• 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.

  PMID: 19022188 BACKGROUND

• 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.

  PMID: 17086071 BACKGROUND

• 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.

  PMID: 29048966 DERIVED

• 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.

  PMID: 28716065 DERIVED

• 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.

  PMID: 21071074 DERIVED

• 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.

  PMID: 19772596 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Richard T Lester, MD, FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Joshua Kimani, MBChB

  University of Manitoba / University of Nairobi

  STUDY CHAIR

• Francis A Plummer, MD, FRCPC

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 22, 2010

Record last verified: 2009-01

Locations

KE (1)