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

Study Overview
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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.

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

Conditions
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HIV, AIDS, HIV Infections

Intervention / Treatment
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* Other: Cell Phone Intervention


Participation Criteria
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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 Exclusion Criteria: Not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cell Phone Intervention: participant receives weekly SMS text message from the health care worker. | Other: Cell Phone Intervention<br>* Participant receives weekly SMS text messages from the health care provider.<br>|
| No Intervention: 2<br>SOC: Participant receives standard of care support but not weekly SMS text messages from the health care worker. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Adherence, Antiretroviral Therapy, ART, ARV, Mobile phone, cell phone, telephone, Text message, SMS, Telemedicine, Africa, Resource-limited setting, Counseling, support, treatment experienced