A randomised controlled trial of mobile phones to influence adherence to first line antiretroviral treatment among human immunodeficiency virus (HIV) infected patients in South India
- Conditions
- Human immunodeficiency virus (HIV)Infections and Infestations
- Registration Number
- ISRCTN79261738
- Lead Sponsor
- European Union (EU) (Belgium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
1. Human immunodeficiency virus (HIV) seropositive
2. Aged between 18 - 60 years, either sex
3. Meet criteria to start ART (in India, ART is indicated for symptomatic patients with a World Health Organization [WHO] Clinical Stage 4 condition regardless of CD4 counts and plasma viral load; WHO Stage 3 condition with CD4 less than 350/mm^3 and in asymptomatic patients, with CD4 count less than 200/mm^3)
4. ART naive (i.e. no prior antiretroviral therapy or ART for less than 7 days)
5. Residence in the Southern Indian States with the ability to visit clinic regularly for follow-up visits
1. Severely ill (Karnofsky score less than 70) at the time of recruitment
2. Impaired renal function (creatinine greater than 2 times upper limit of normal)
3. Study participant already recruited in the same household
4. Non-availability of mobile telephone network
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to occurrence of virological failure (defined as having greater than 400 copies/ml on two consecutive measures at least one month apart. Date of failure is documented as the date of initial reading of the value greater than 400 copies/ml.
- Secondary Outcome Measures
Name Time Method Self-reported adherence expressed as a percentage