Effects of a Phone Call Intervention to Promote HAART Adherence (EPCIPHA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Baoshan Prefecture Center for Disease Control and Prevention.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Prince of Songkla University
Information provided by:
Baoshan Prefecture Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01395771
First received: June 18, 2011
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Medication Adherence
Behavioral: Phone call intervention, no phone call intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of a Phone Call Intervention to Promote HAART Adherence in Baoshan, China

Resource links provided by NLM:


Further study details as provided by Baoshan Prefecture Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Change from baseline HAART adherence within 3 months [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Adherence will be measured at different time points within 3 months follow-up (study period)


Secondary Outcome Measures:
  • Change from baseline quality of life within 3 months [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Quality of life will be measured at different time points within 3 months study periods

  • CD4 cell counts [ Time Frame: CD4 will be measured at the baseline survey and the 3rd month follow-up ] [ Designated as safety issue: No ]
    CD4 cell counts will be measured only at baseline survey and after 3 months

  • Number of patients with side effects [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)

  • Mortality [ Time Frame: Mortality will be assessed the 3rd month follow-up ] [ Designated as safety issue: No ]
    Measurement of the number of change of mortality


Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone call
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.
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395771

Locations
China, Yunnan
Longyang district hospital Recruiting
Baoshan, Yunnan, China, 678000
Contact: Junmei Duan, Bachelor    86-0875-2130187    892991901@qq.com   
Principal Investigator: Dongsheng Huang, Master         
The first hospital of Baoshan Prefecture Recruiting
Baoshan, Yunnan, China, 67800
Contact: Yikun Hu, Bachelor    86-0875-2120370      
Principal Investigator: Dongsheng Huang, Master         
Tengchong county hospital Recruiting
Baoshan, Yunnan, China, 678000
Contact: Tao Jiang, Bachelor    86-0875-5137151    jt4766@sina.com   
Principal Investigator: Dongsheng huang, Master         
Longling county hospital Recruiting
Baoshan, Yunnan, China, 67000
Contact: Chunyan Zhang, Bachelor    86-0875-6122353      
Principal Investigator: Dongsheng Huang, Master         
Sponsors and Collaborators
Baoshan Prefecture Center for Disease Control and Prevention
Prince of Songkla University
Investigators
Study Director: Weibing Zheng, Bachelor Baoshan CDC
  More Information

No publications provided

Responsible Party: Director of Weibin Zheng, Baoshan Prefecture Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01395771     History of Changes
Other Study ID Numbers: BSCDC2011HIV/AIDS, BSWSJ2011HIV/AIDS
Study First Received: June 18, 2011
Last Updated: July 15, 2011
Health Authority: China: Ministry of Health

Keywords provided by Baoshan Prefecture Center for Disease Control and Prevention:
Effect
Phone call
Intervention
Promote
HAART adherence

ClinicalTrials.gov processed this record on October 19, 2014