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Completed

NCT Number: NCT00661258

China Antiretroviral Treatment Adherence for Life

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dali Second People's Hospital

Dali, Yunnan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electronic drug monitoring feedback data

Behavioral

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.

Primary outcomes

  1. Mean Adherence, as Measured by Electronic Drug Monitors (EDM)

    Time frame: Month 12 (last month of 6-month intervention period) and 6-month post-intervention period

    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]).

Secondary outcomes

  1. Change in CD4 Count

    Time frame: Month 6, Month 12

    Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Beijing Ditan Hospital
  • Second People's Hospital, Dali

Registry information

Official study title

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

Acronym: AFL

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 18, 2008
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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