A clinical trial to study the impact of TAMA(Treatment Advice by Mobile Alerts) on usage and its patterns in HIV-1 Infected subjects and clinics
- Conditions
- Health Condition 1: null- HIV-1 infected subjects
- Registration Number
- CTRI/2012/12/003228
- Lead Sponsor
- Janssen Pharmaceutical NV part of JohnsonJohnson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Subjects who meet all of the following criteria are eligible for this trial.
1.Male or female adult subjects, aged 18-65 (both years inclusive) years at screening.
2.Confirmed HIV-1 infection.
3.ARV treatment-naïve patients on first-line NNRTI-based HAART.
4.Owning a cell phone that is only used by the subject himself/herself.
5.Having the ability to use basic cell phone functions
6.Ability to consent and comply with study procedures.
7.General medical condition, in the investigatorâ??s opinion, does not interfere with the assessments and the completion of the trial.
8.Subjectâ??s preferred language of interaction with TAMA system is one of the languages in which TAMA will be currently made available, i.e., English, Hindi, Marathi, Tamil, Telugu or Kannada.
Subjects must not have any of the following characteristics.
1.Previous exposure to any ARVs (including mother-to-child-transmission prophylaxis) of more than 6 months
2.Presence of acute opportunistic infections.
3.Active alcohol and/or substance abuse.
4.Subject whose clinical condition interferes with appropriate use of cell phone (e.g., deafness, severe cognitive impairment).
5.Participation in any other concurrent interventional study.
6.Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subjects safety or adherence to the trial protocol.
7.Life expectancy of less than 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study objective is to evaluate and analyze patient usage of TAMA over 12 weeksTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method oneTimepoint: None