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

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

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.

Study Overview

• Status: Unknown
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: Phone call intervention, no phone call intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Baoshan, Yunnan, China, 67000
      • Recruiting
      • Longling county hospital
      • Contact: Chunyan Zhang, Bachelor; Phone Number: 86-0875-6122353
      • Principal Investigator: Dongsheng Huang, Master
    • Baoshan, Yunnan, China, 678000
      • Recruiting
      • Longyang district hospital
      • Principal Investigator: Dongsheng Huang, Master
      • Contact: Junmei Duan, Bachelor; Phone Number: 86-0875-2130187; Email: 892991901@qq.com
    • Baoshan, Yunnan, China, 678000
      • Recruiting
      • Tengchong county hospital
      • Principal Investigator: Dongsheng Huang, Master
      • Contact: Tao Jiang, Bachelor; Phone Number: 86-0875-5137151; Email: jt4766@sina.com
    • Baoshan, Yunnan, China, 67800
      • Recruiting
      • The first hospital of Baoshan Prefecture
      • Principal Investigator: Dongsheng Huang, Master
      • Contact: Yikun Hu, Bachelor; Phone Number: 86-0875-2120370

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Mortality	Measurement of the number of change of mortality	Mortality will be assessed the 3rd month follow-up

Collaborators and Investigators

• Sponsor: Baoshan Prefecture Center for Disease Control and Prevention
• Collaborators: Prince of Songkla University
• Investigators: Study Director: Weibing Zheng, Bachelor, Baoshan CDC

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: June 18, 2011
• First Submitted That Met QC Criteria: July 15, 2011
• First Posted (Estimate): July 18, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Intervention; Effect; Phone call; Promote; HAART adherence
• Other Study ID Numbers: BSCDC2011HIV/AIDS; BSWSJ2011HIV/AIDS (Other Grant/Funding Number: Grantor)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No