NCT01395771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

4 months

First QC Date

June 18, 2011

Last Update Submit

July 15, 2011

Conditions

Medication Adherence

Keywords

EffectPhone callInterventionPromoteHAART adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change from baseline quality of life within 3 months

    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 will be measured at the baseline survey and the 3rd month follow-up

  • Number of patients with side effects

    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 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

    Mortality will be assessed the 3rd month follow-up

Study Arms (1)

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.

Behavioral: Phone call intervention, no phone call intervention

Interventions

Phone call intervention, no phone call interventionBEHAVIORAL

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.

Phone call

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Longling county hospital

Baoshan, Yunnan, 67000, China

RECRUITING

Longyang district hospital

Baoshan, Yunnan, 678000, China

RECRUITING

Tengchong county hospital

Baoshan, Yunnan, 678000, China

RECRUITING

The first hospital of Baoshan Prefecture

Baoshan, Yunnan, 67800, China

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Weibing Zheng, Bachelor

    Baoshan CDC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 18, 2011

First Posted

July 18, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

CN(4)