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Completed

NCT Number: NCT00830622

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

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.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nairobi Clinics

Nairobi, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cell phone intervention

Other

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

Primary outcomes

  1. Adherence to ART and HIV RNA suppression

    Time frame: 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 outcomes

  1. Retention

    Time frame: 6, 12 months

  2. Quality of Life (SF-12)

    Time frame: 3, 6, 9, 12 months

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

    Time frame: 6, 12 months

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • University of Nairobi

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jan 28, 2009
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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