A study to assess whether an information technology (IT) system with a cell phone interface, will improve treatment effectiveness in HIVâ??1 subjects.
- Conditions
- Health Condition 1: null- HIV-1 infected subjects initiated on first-line antiretroviral therapy
- Registration Number
- CTRI/2013/06/003777
- Lead Sponsor
- Janssen Infectious Diseases Diagnostics BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 584
1. Male or female adult subjects, aged between 18 and 65 years at screening.
2. Confirmed HIVâ??1 infection and eligible for HAART according to Indian treatment guidelines.
3. Antiretroviral treatmentâ??naïve being initiated on firstâ??line NNRTIâ??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 (e.g., being able to make and receive phone calls).
6. Ability to consent and comply with trial 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 first language is one of the languages in which the TAMA system is currently available, i.e.,English, Hindi, Marathi, Tamil, Telugu, Kannada, or Gujarati.
1. Previous exposure to any ARVs including motherâ??toâ??childâ??transmission (MTCT) prophylaxis.
2. Presence of acute opportunistic infections.3. Active alcohol and/or substance abuse in the opinion of the investigator.
4. Subject whose clinical condition interferes with appropriate use of cell phone (e.g., deafness, severe cognitive impairment).
5. Participation in an interventional trial. For patients who have participated in an interventional trial less than 3 months ago, it will be subject to the investigatorâ??s decision whether the subject can take part in the UNITE 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.
8. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or
decompensation (i.e., liver insufficiency), irrespective of liver enzyme levels.
9. Women pregnant at screening. If women become pregnant during the trial further participation is
subject to decision by participant and investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this trial is to evaluate the effect of access to TAMA, compared to no access, <br/ ><br>on the effectiveness of ARV therapy, as measured by the proportion of subjects with plasma viral load less than <br/ ><br>50 HIVâ??1 RNA copies/mL at Week 48Timepoint: Week 48
- Secondary Outcome Measures
Name Time Method -to determine and compare the adherence (for all subjects: subjectâ??reported adherence via the Mâ??MASRI questionnaire and in addition for subjects with access to TAMA: <br/ ><br>subjectâ??reported adherence information via the IT system <br/ ><br>-to determine first virologic response defined as drop in viral load to less than 400 HIVâ??1 RNA copies/mL at Week 24 of ARV treatment; <br/ ><br>- to determine final virologic response defined as less than 400 HIVâ??1 RNA copies/mL at Week 48 of ARV treatment; <br/ ><br>Timepoint: week 24 and 48