Clinical trial NCT01395771: Effects of a Phone Call Intervention to Promote HAART Adherence
Official title: Effects of a Phone Call Intervention to Promote HAART Adherence in Baoshan, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Keywords: Effect
Phone call
Intervention
Promote
HAART adherence
Lead sponsor: Baoshan Prefecture Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
Collaborators: name: Prince of Songkla University
First posted: 2011-07-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Chinese patients with HIV/AIDS aged ≥ 18 years and for the newly required HAART patients, mainly based on their CD4 \< 350 cells/mm3. But irrespective of CD4 cells for old patients who are under treatment for 1-3 years.

Exclusion criteria:

* Patients who have the inability to communicate at the beginning of study and who haven't got opportunistic infection(this item is only for new cases), who are non-Baoshan registered residence, who are foreigners, prisoners and pregnants, who have no mobile phone.

Primary outcomes:
measure: Change from baseline HAART adherence within 3 months
timeFrame: 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
Secondary outcomes:
measure: Change from baseline quality of life within 3 months
timeFrame: 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
measure: CD4 cell counts
timeFrame: CD4 will be measured at the baseline survey and the 3rd month follow-up
measure: Number of patients with side effects
timeFrame: 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
measure: Number of opportunistic infection within 3 months
timeFrame: 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
measure: Mortality
timeFrame: Mortality will be assessed the 3rd month follow-up
Other outcomes:
Locations:
city: Baoshan
country: China
facility: Longling county hospital
state: Yunnan
city: Baoshan
country: China
facility: Longyang district hospital
state: Yunnan
city: Baoshan
country: China
facility: Tengchong county hospital
state: Yunnan
city: Baoshan
country: China
facility: The first hospital of Baoshan Prefecture
state: Yunnan
Study officials:
affiliation: Baoshan CDC
name: Weibing Zheng, Bachelor
role: STUDY_DIRECTOR
References: