China Antiretroviral Treatment Adherence for Life (AFL)

Antiretroviral Treatment Adherence for Life Pilot Study: Phases II and III

This study focuses on collecting and analyzing quantitative data related to adherence to antiretroviral treatment from patients in Dali, China, over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to antiretroviral treatment among the study population.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Electronic drug monitoring feedback data

Detailed Description

This study is a continuation of "Adherence for Life (AFL): Phase I: Exploratory Research" (H-25203), which focused on collecting and analyzing qualitative data on adherence to antiretroviral treatment (ART) among HIV-positive patients in Dali, Yunnan Province, China. Like Phase I, the AFL Pilot Study (Phases II and III) will be a collaborative effort between US researchers based in Boston, MA and Chinese researchers based in Beijing and Dali. The current study, Phases II and III, will focus on collecting and analyzing qualitative and quantitative data related to adherence to ART over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to ART among the study population. The questionnaires used in these phases of the study will draw on the results of Phase I as well as standardized instruments adapted to the Chinese context. The specific aims of the study are as follows: (1) To determine the best surrogate measure of ART adherence among the study population; (2) To determine ART adherence rates in this population; (3) To analyze the relationship between adherence factors and measured adherence rates; and (4) To generate preliminary effectiveness data on an intervention that makes use of electronic drug monitors (EDM) to improve ART adherence.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Dali, Yunnan, China
      • Dali Second People's Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients who are 18 years of age or older, currently on antiretroviral treatment or about to begin it, live in the study catchment area, and are willing to provide informed consent.

Exclusion Criteria:

• Persons below the age of 18 years, persons who are not currently on or about to start antiretroviral treatment, persons who live outside the study catchment area, or person not willing to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group patients were given their electronic drug monitoring feedback data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.	Behavioral: Electronic drug monitoring feedback data; All patients were given electronic drug monitors that can monitor pill-taking behavior. In the intervention arm, patients and their attending doctors were given the electronic drug monitoring data on pill bottle openings at each monthly visit for use in adherence counseling sessions. Control arm patients were not given their electronic drug monitoring feedback data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.
No Intervention: Comparison; The comparison group patients were not given the data from the electronic data monitoring feedback data. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Adherence, as Measured by Electronic Drug Monitors (EDM)	We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA <400 copies/ml) in analysis of the pre-intervention data, EDM 'proportion taken within dose time' (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time ([number of doses taken ±1 hour of dose time] / [total number of prescribed doses]).	Month 12 (last month of 6-month intervention period) and 6-month post-intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CD4 Count	Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)	Month 6, Month 12

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Beijing Ditan Hospital; Second People's Hospital, Dali
• Investigators: Principal Investigator: Lora L Sabin, PhD, Center for International Health and Development, Boston University

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: April 11, 2008
• First Submitted That Met QC Criteria: April 15, 2008
• First Posted (Estimate): April 18, 2008

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: treatment experienced; HIV antiretroviral treatment adherence intervention China; adherence to antiretroviral treatment
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: H-25495; GHS-A-00-03-00030-00 (Other Grant/Funding Number: GHS-A-00-03-00030-00)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No