Effects of a Phone Call Intervention to Promote HAART Adherence

Medication Adherence Clinical Trial

— EPCIPHA  

Official title:

Effects of a Phone Call Intervention to Promote HAART Adherence in Baoshan, China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01395771
• Other study ID #: BSCDC2011HIV/AIDS
• Secondary ID: BSWSJ2011HIV/AID
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2011
• Last updated: July 15, 2011
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: Baoshan Prefecture Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• Phone call intervention, no phone call intervention
Biweekly phone call intervention +routine service will be assigned to intervention group of new cases and old cases. Only routine service will be assigned to the control group of abovementioned two kind of cases.

Locations

Country	Name	City	State
China	Longling county hospital	Baoshan	Yunnan
China	Longyang district hospital	Baoshan	Yunnan
China	Tengchong county hospital	Baoshan	Yunnan
China	The first hospital of Baoshan Prefecture	Baoshan	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
Baoshan Prefecture Center for Disease Control and Prevention	Prince of Songkla University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline HAART adherence within 3 months	Adherence will be measured at different time points within 3 months follow-up (study period)	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	No
Secondary	Change from baseline quality of life within 3 months	Quality of life will be measured at different time points within 3 months study periods	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	No
Secondary	CD4 cell counts	CD4 cell counts will be measured only at baseline survey and after 3 months	CD4 will be measured at the baseline survey and the 3rd month follow-up	No
Secondary	Number of patients with side effects	The number of side effects will be measured at different time points within 3 months follow-up period	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	No
Secondary	Number of opportunistic infection within 3 months	Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)	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	No
Secondary	Mortality	Measurement of the number of change of mortality	Mortality will be assessed the 3rd month follow-up	No