Effectiveness of Mobile Phone Technology on Adherence and Treatment Outcomes Among HIV Positive Patients on ART

NCT02677675 | Completed DMC

• 1 other identifier: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Adherence (improved scheduled clinic attendance and medication adherence self-report)

  Medication adherence was measured based on adherence ratio (for each of the 4 days prior was calculated as 1 minus (number of doses missed for the day/number of doses prescribed); adherence index based on formula adapted from Reynolds et al, 2007; and adherence category (\>95% = Good adherence; 80-95% = Fair adherence; and \<80% = Poor adherence) (WHO 2005). Scheduled clinic attendance was measured and categorized based on the number of scheduled clinic visits attended, number of times defaulted and whether or not the patient was lost-to-follow-up (a) Regular clinic attendee - a person who has never missed any scheduled clinic appointment (b) Defaulter - a person who has missed one or more scheduled clinic appointment, for any reason(s) (c) Lost-to-follow-up - a person is said to be lost to follow up if s/he refuses to show up for scheduled clinic visit for 3 consecutive months, after 3 consecutive attempts to track the client and bring them back on treatment.

  Change from baseline adherence at 3 months and at 6 months

Secondary Outcomes (5)

• Immunological (improved CD4 count)

  Change from baseline CD4 count at 6 months

• Virological (decreased viral load)

  Change from baseline viral load at 6 months

• Clinical (Improved weight)

  Change from baseline weight at 6months

• Clinical (TB status)

  Change from baseline TB status at 6 months

• Clinical (Opportunistic infection index)

  Change from baseline Opportunistic Infection (OI) index at 6 months

Study Arms (2)

Intervention (reminder module)

EXPERIMENTAL

A "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)

Behavioral: Intervention (reminder module)

Control (standard care)

NO INTERVENTION

Control group received standard care only (routine adherence counselling and paper-based appointment scheduling)

Interventions

Intervention (reminder module) BEHAVIORAL

Reminder module (delivered via SMS and telephone call reminders)

Intervention (reminder module)

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Ministry of Health, Malaysia: collaborator

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Researcher

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 9, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 9, 2016

Record last verified: 2016-02