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

HIV Infections Clinical Trial

Official title:

A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830622
• Other study ID #: H2007:037
• Secondary ID: CDC PEPFAR PHE K
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: June 18, 2010
• Start date: May 2007
• Est. completion date: March 2010

Study information

• Verified date: January 2009
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• AIDS
• HIV
• HIV Infections

Intervention

Other:
• Cell Phone Intervention
Participant receives weekly SMS text messages from the health care provider.

Locations

Country	Name	City	State
Kenya	University of Nairobi Clinics	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	University of Nairobi

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Retention		6, 12 months	No
Secondary	Quality of Life (SF-12)		3, 6, 9, 12 months	No
Secondary	Health (CD4, weight, progression to AIDS, all cause mortality)		6, 12 months	No

External Links

•   Manitoba Resistance and Susceptibility to Infection Group