Medication AdherenceEPCIPHANCT01395771
Effects of a Phone Call Intervention to Promote HAART Adherence
A study testing Phone call intervention, no phone call intervention in people with Medication Adherence, run by Baoshan Prefecture Center for Disease Control and Prevention at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Phone call intervention, no phone call intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- May 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Longling county hospital
Baoshan, Yunnan, 67000
Chunyan Zhang, Bachelor, 86-0875-6122353
Dongsheng Huang, Master
- Recruiting
Longyang district hospital
Baoshan, Yunnan, 678000
Junmei Duan, Bachelor, 86-0875-2130187, 892991901@qq.com
Dongsheng Huang, Master
- Recruiting
Tengchong county hospital
Baoshan, Yunnan, 678000
Tao Jiang, Bachelor, 86-0875-5137151, jt4766@sina.com
Dongsheng huang, Master
- Recruiting
The first hospital of Baoshan Prefecture
Baoshan, Yunnan, 67800
Yikun Hu, Bachelor, 86-0875-2120370
Dongsheng Huang, Master
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Phone call intervention, no phone call intervention
- Keywords
- Effect, Phone call, Intervention, Promote, HAART adherence
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call intervention, no phone call interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Phone call | Experimental | 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. Receives: Behavioral: Phone call intervention, no phone call intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HAART adherence within 3 months
Adherence will be measured at different time points within 3 months follow-up (study period)
Measured: 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 (5)
Change from baseline quality of life within 3 months
Quality of life will be measured at different time points within 3 months study periods
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Mortality will be assessed the 3rd month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baoshan Prefecture Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Prince of Songkla University
- Investigators
- Weibing Zheng, Bachelor, Study director, Baoshan CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395771
- Sponsor's protocol ID
- BSCDC2011HIV/AIDS
- Other IDs
- BSWSJ2011HIV/AIDS
- Acronym
- EPCIPHA
- Status last verified
- Jul 2011
- First submitted
- 18 Jun 2011
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Phone Call Intervention to Promote HAART Adherence in Baoshan, China
- ClinicalTrials.gov ID
- NCT01395771
- Acronym / sponsor ID
- EPCIPHA / BSCDC2011HIV/AIDS
- Conditions
- Medication Adherence
- Keywords
- Effect, Phone call, Intervention, Promote, HAART adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baoshan Prefecture Center for Disease Control and PreventionOther government
- Collaborators
- Prince of Songkla University
- Study start
- May 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone call | Experimental | Behavioral: Phone call intervention, no phone call interventionNew 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone call intervention, no phone call interventionBiweekly 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. | Behavioural | Phone call |
Primary outcome
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
Adherence will be measured at different time points within 3 months follow-up (study period)
5 secondary outcomes
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
CD4 cell counts
Time frame: CD4 will be measured at the baseline survey and the 3rd month follow-up
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
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
Mortality
Time frame: Mortality will be assessed the 3rd month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Zheng, Bachelor study director
Baoshan CDC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call intervention, no phone call intervention in people with Medication Adherence, run by Baoshan Prefecture Center for Disease Control and Prevention at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.