Effectiveness of Mobile Phone Technology on Adherence and Treatment Outcomes Among HIV Positive Patients on ART
Condition: HIV
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The objective of this study was to determine the effectiveness of mobile phone technology
      (SMS and telephone call reminders) in improving adherence and treatment outcomes among HIV
      positive patients on ART in Malaysia.
    

Detailed description: 
      This study was a 2 arm, parallel group, randomized single blind clinical trial involving 242
      randomly selected and allocated adult Malaysian HIV positive patients who were enrolled into
      Antiretroviral Therapy (ART) care at Infectious Disease Clinic of Hospital Sungai Buloh,
      Malaysia. Recruitment commenced in January 2014 and follow up ended in December 2014. Each
      individual patient was followed up for a period of 6 months on ART. A reminder module
      (delivered via Short Message Service (SMS) and telephone call reminders) was developed based
      on the Theory of Planned Behavior. The reminder module which included standardized weekly SMS
      medication reminders (sent at 9am every Monday); SMS reminder 3 days prior to scheduled
      clinic appointments (individualized and sent at lunch time), and an average of 90sec lunch
      hour telephone call reminders a day prior to scheduled clinic appointment (in addition to
      standard care - routine adherence counselling) was delivered consistently for 24 weeks to
      respondents in the intervention group by two trained PLHIV (research assistants) while
      respondents in the control group received standard care only. Each patient in the
      intervention group had a minimum of three (during clinic visits at month 1, month 3 and month
      6) individual counselling sessions with the research assistants lasting an average of 15
      minutes per encounter. To ensure confidentiality, typical medication reminder text messages
      included a short slogan in Malay language "Apa khabar" "Ini untuk menberithau anda ubat"
      meaning "How are you?" "This is to remind you of your medications". Appointment reminder text
      message was "Apa khabar" "Tolong ingat tarikh temu janji lusa" meaning "How are you?"
      "Remember your appointment day after tomorrow" and telephone conversation was standardized
      and short, with the message "Apa khabar" "Tolong ingat tarikh temu janji besok" meaning "How
      are you?" "Remember your appointment tomorrow". Patients were not required to provide any
      responses to the text messages. However, a log of text message communications and telephone
      calls was recorded and kept.

      Upon enrollment and randomization to a treatment arm, baseline data on socio-demographic
      factors, clinical symptoms and adherence behavior of respondents was collected using
      modified, pre-validated, reliable, self-administered Adult AIDS Clinical Trial Group (AACTG)
      adherence questionnaire. The baseline medication adherence questionnaire consisting of nine
      sections was used to collect data on patient's understanding and level of preparedness to
      take HIV medications, level of psychosocial support from their friends and families, reasons
      for missing medications as well as period and number of missed medications. Other information
      collected were on patient's psychosocial symptoms and well-being, history of drug and alcohol
      use, socio-demographic characteristics, source of HIV infection and disclosure status, and
      review of their symptoms in the past 30 days. Responses to questions in sections A - E1 were
      graded on a 4-point Likert scale, sections E2 and I on a 5-point Likert scale, section F on a
      multiple scale (multiple choice, 2-point and 4-point scales), H on a 2-point scale, while
      section G had 5 questions on socioeconomic and demographic characteristics.

      Baseline weight, blood pressure, CD4 count, Viral load, as well as results of renal profile
      and liver function tests were also collected and recorded.

      Adherence measurement was repeated at 3 and 6 months follow-up using self-administered AACTG
      follow-up adherence questionnaires which consisted of eight sections (sections A - H) and a
      total of 49 questions graded on a combination of Likert and "Yes" or "No" scales, used for
      assessing how well the patient has adhered to their medications and specific instructions
      about their regimen within the past 3 months, with particular emphasis on the past four days.
      It also contained a review of their symptoms during the past four weeks as well as their
      current TB status and OI index. Section A consisted of a review of the respondent's current
      medications, by evaluating their understanding and knowledge of the treatment regimen in
      terms of drug name, frequency and strength of dosage, how long the patient has been on the
      regimen, number of pills per dose as well as number of doses missed in the past four days.
      This section was completed in a collaborative manner between the study personnel and the
      patient. Responses to questions in sections B, C, D & H were graded on a 5-point Likert
      scale, E on a 2-point scale, F on a 6-point scale, and G on a 4-point scale.

      CD4 count, viral load, weight, full blood count, liver function, renal profile and blood
      pressure measurements were repeated at 6 months follow-up period, and the results retrieved
      from laboratory records.

      Adherence scores were calculated using a standardized adherence index formula adopted from
      Reynolds et al.(2007). Data on regularity of respondents' scheduled clinic visits was
      obtained by the research assistants (for whom access was duly sought and provided by the
      hospital management) from the hospital's electronic medical records system using standardized
      data extraction forms and corroborated with drug refill appointments from pharmacy records.
      The research assistants accessed and recorded onto the data extraction forms, information on
      patient's TB status, opportunistic infection (OI) index and body weight from clinicians'
      notes in the electronic medical record system. Data extraction forms were reviewed
      periodically for completeness, correctness and accuracy by the site study coordinator.
    

Intervention name(s): Intervention (reminder module)
Intervention type(s): Behavioral
Intervention description(s): Reminder module (delivered via SMS and telephone call reminders)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care