Clinical trial NCT02677675: Effectiveness of Mobile Phone Technology on Adherence and Treatment Outcomes Among HIV Positive Patients on ART
Official title: Effectiveness of Mobile Phone Technology in Improving Adherence and Treatment Outcomes Among HIV Positive Patients on Antiretroviral Therapy (ART) in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2016-02-09
Enrollment: 242
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All HIV positive patients aged 15 - 65 years, assessed and eligible for ART commencement.
* All ART eligible patients who have valid telephone numbers and can read text messages.

Exclusion Criteria:

* All HIV positive patients already commenced (current) or restarting ART due to previous default and/or lost-to-follow-up status
* Pregnant HIV-positive ART patients
* Foreigners

Primary outcomes:
measure: Adherence (improved scheduled clinic attendance and medication adherence self-report)
timeFrame: Change from baseline adherence at 3 months and at 6 months
Secondary outcomes:
measure: Immunological (improved CD4 count)
timeFrame: Change from baseline CD4 count at 6 months
measure: Virological (decreased viral load)
timeFrame: Change from baseline viral load at 6 months
measure: Clinical (Improved weight)
timeFrame: Change from baseline weight at 6months
measure: Clinical (TB status)
timeFrame: Change from baseline TB status at 6 months
measure: Clinical (Opportunistic infection index)
timeFrame: Change from baseline Opportunistic Infection (OI) index at 6 months
Other outcomes:
Locations:
Study officials:
References: