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

Not Applicable

Completed

• Conditions: HIV; AIDS; HIV Infections
• Interventions: Other: Cell Phone Intervention

• Registration Number: NCT00830622
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study Start: 2007-05
• Status Verified: 2009-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Last Update Submitted: 2010-06-18
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 536

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adherence to ART and HIV RNA suppression	6,12 months	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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Nairobi Clinics; 🇰🇪 Nairobi, Kenya