Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 7868 792050


Educational Intervention to Improve Adherence to Anti Retro-viral Therapy (ART) among People Living with Human Immunodeficiency Virus (PLHIV) - A Randomized Controlled Trial

Bhaskaran Unnikrishnan, Arjun Banagi Yathiraj, Rekha Thapar, Prasanna Mithra, Nithin Kumar, Vaman Kulkarni, Ramesh Holla and Darshan BB

Background: Anti-retro-viral therapy (ART) has changed human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) from fatal disease to chronic illness, it does however requires almost perfect adherence for the medication to be therapeutically effective. Methodology: A study will be conducted among people living with Human Immunodeficiency Virus (PLHIV) aged 18 years and above, who are on ART at the ART center of Kasturba Medical College Hospital (KMCH), Attavar, Mangalore, India. Study consists of two phases: Phase I cross sectional study: A cross sectional study (n=409), has already been done to find out the level of adherence to ART using Adult AIDS Clinical Trials Group adherence follow-up questionnaire and the pre-testing for HIV related knowledge of the participants was done using HIV Knowledge Questionnaire. We observed the prevalence of non-adherence to be 27.1% (n=121) and HIV related knowledge was high among 127 (31.1%) and low among 282 (68.9%) PLHIV. Among the 121 non-adherents, 110 PLHIV will be included in the 2nd phase of the study using block randomization. Phase II randomized controlled trial (RCT): A sample size of 110 will be included in this study, which was calculated based on the statistical formula. Randomization of the participants will be done using block randomization method into intervention and control groups. HIV educational intervention will be provided for six months to the intervention group along with the standard patient care available at the hospital, whereas the control group will receive only the standard patient care available at the hospital for duration of six months. This will be followed by conduction of the first post-test at the end of 6th months among both the groups. The participants will be followed up for next 6 months and second post-test will be done at the end of 12th month for the assessment of study outcomes.