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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

The antiretroviral roll out for human immunodeficiency virus (HIV) in India (HIVIND) - strengthening capacity to promote adherence and patient follow-up in the context: a two-centre, randomised, controlled, open trial in South India to study an innovative approach using mobile phones delivery to promote adherence in antiretroviral naive, HIV+ Indian patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79261738
Enrollment
600
Registered
2009-07-24
Start date
2009-09-01
Completion date
Unknown
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus (HIV)

Interventions

Both arms will receive mobile telephones. However in the control arm, there will be no further interaction via the mobile phone. In the intervention arm, the mobile phone intervention will be as descr

Sponsors

European Union (EU) (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Self-reported adherence expressed as a percentage

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026