Effects of a Phone Call Intervention to Promote HAART Adherence

Baoshan Prefecture Center for Disease Control and Prevention300 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Medication Adherence

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Longling county hospital

Baoshan, Yunnan, China

RECRUITING

Longyang district hospital

Baoshan, Yunnan, China

RECRUITING

Tengchong county hospital

Baoshan, Yunnan, China

RECRUITING

Outcomes

Primary Outcomes

Change from baseline HAART adherence within 3 months

Adherence will be measured at different time points within 3 months follow-up (study period)

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

Secondary Outcomes

Change from baseline quality of life within 3 months

Quality of life will be measured at different time points within 3 months study periods

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

CD4 cell counts will be measured only at baseline survey and after 3 months

Time frame: 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

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

Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)

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

Data from ClinicalTrials.gov

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