Effects of a Phone Call Intervention to Promote HAART Adherence
- Conditions
- Medication Adherence
- Interventions
- Behavioral: Phone call intervention, no phone call intervention
- Registration Number
- NCT01395771
- Lead Sponsor
- Baoshan Prefecture Center for Disease Control and Prevention
- Brief Summary
The adherence rate (95%) to HAART in the intervention group which receives a phone call will be higher than that(75%)of control group which does not receive a phone call.
- Detailed Description
According to above eligibility criteria, getting two eligible group patients, one which are patients newly required HAART (new cases) and the other who have received HAART for 1-3 years(old cases). All eligible patients in each group will be randomly assigned to intervention and control group by block randomization. Among of them, one group with a phone call intervention, the other without. New cases will be followed up for 3 months and study outcomes will be assessed at the baseline and the 2nd week, the 1st month and 2nd month, and the 3rd month. For the old cases, study outcomes will be assessed only at the baseline survey and at the 3rd month.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phone call Phone call intervention, no phone call intervention New cases and old cases will be randomly categorized into two groups,respectively,one is phone call intervention group, the other is no phone call intervention group.
- Primary Outcome Measures
Name Time Method Change from baseline HAART adherence within 3 months HAART adherence for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases HAART adherence will be assessed only at the baseline survey and the 3rd month follow-up Adherence will be measured at different time points within 3 months follow-up (study period)
- Secondary Outcome Measures
Name Time Method CD4 cell counts CD4 will be measured at the baseline survey and the 3rd month follow-up CD4 cell counts will be measured only at baseline survey and after 3 months
Change from baseline quality of life within 3 months Quality of life for new cases will be assessed at the baseline survey and the 2nd week, the 1st month and 2nd month, and the 3rd month. For old cases quality of life will be assessed only at the baseline survey and the end of the 3rd month Quality of life will be measured at different time points within 3 months study periods
Number of patients with side effects Number of side effects for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases the number of side effects will be assessed only at the baseline survey and the 3rd month follow-up The number of side effects will be measured at different time points within 3 months follow-up period
Number of opportunistic infection within 3 months Number of opportunistic infection for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases number of that will be assessed only at the baseline and the 3rd month follow-up Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)
Mortality Mortality will be assessed the 3rd month follow-up Measurement of the number of change of mortality
Trial Locations
- Locations (4)
Longling county hospital
🇨🇳Baoshan, Yunnan, China
Longyang district hospital
🇨🇳Baoshan, Yunnan, China
The first hospital of Baoshan Prefecture
🇨🇳Baoshan, Yunnan, China
Tengchong county hospital
🇨🇳Baoshan, Yunnan, China