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Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741311
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Yale University
APT Foundation, Inc.
Information provided by (Responsible Party):
Michael Copenhaver, University of Connecticut

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
The proportion of participants free from HIV-transmission risk [ Time Frame: Over a 9-month period ]
A self-reported assessment will measure several aspects of HIV risk-taking behaviors, including a measurement of any high risk behavior (sexual or injection-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors. "Any" risk behavior will be dichotomously parsed as those who have engaged in HIV transmission risk behaviors with those of unknown or HIV negative status. Urine toxicology tests will also be used to collect substance use data.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
The proportion of participants free from HIV-transmission risk [ Time Frame: 9 months ]
Our HIV self-reported assessment will measure several aspects of HIV risk-taking behaviors, including a measurement of "any" high risk behavior (sexual or injection-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors. "Any" risk behavior will be dichotomously parsed as those who have engaged in HIV transmission risk behaviors with those of unknown or HIV negative status. Urine toxicology tests will also be used to collect substance use data.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Antiretroviral therapy (ART) adherence [ Time Frame: Over a 9-month period ]
ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Antiretroviral therapy (ART) adherence [ Time Frame: 9 months ]
ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2012)
  • ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data. [ Time Frame: Over a 9-month period ]
    Viral load (VL) will be measured in terms of mean change in VL from baseline to the final (9-month) follow-up point. An alternative approach will be the proportion of subjects with a non-detectable (<400 and <50 copies/mL) VL, and mean change in cluster of differentiation 4 (CD4) lymphocyte count. Missing VL will be treated as VL>400 or VL>50 copies/mL.
  • ART non-adherence factors [ Time Frame: Over a 9-month period ]
    Non-adherence factors will be measured these using standardized instruments including the following: Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) criteria for substance use disorders, Mini-International Neuropsychiatric Interview (M.I.N.I.) for depressive symptoms, active drug use (urine toxicology screening using the National Institute on Drug Abuse's 4-panel test measuring heroin, cocaine, oxycodone, benzodiazepines and marijuana levels), and neurocognitive impairment (using the Neurocognitive Impairment Scale).
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
  • ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data. [ Time Frame: 9 months ]
    Viral load (VL) will be measured in terms of mean change in VL from baseline to the final (9-month) follow-up point. An alternative approach will be the proportion of subjects with a non-detectable (<400 and <50 copies/mL) VL, and mean change in cluster of differentiation 4 (CD4) lymphocyte count. Missing VL will be treated as VL>400 or VL>50 copies/mL.
  • ART non-adherence factors [ Time Frame: 9 months ]
    We will measure these using standardized instruments including the following: Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) criteria for substance use disorders, Mini-International Neuropsychiatric Interview (M.I.N.I.) for depressive symptoms, active drug use (urine toxicology screening using the National Institute on Drug Abuse's 4-panel test measuring heroin, cocaine, oxycodone, benzodiazepines and marijuana levels), and neurocognitive impairment (using the Neurocognitive Impairment Scale).
 
Descriptive Information
Brief Title  ICMJE Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
Official Title  ICMJE Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
Brief Summary This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or sexual risk behavior.
Detailed Description

HIV-infected drug users (DUs) remain a target population as they represent a significant vector for the transmission of new HIV infections (Avants et al., 2004; Margolin et al., 2003), which occur through preventable drug- and sex-related HIV risk behaviors. Though numerous evidence-based HIV risk reduction interventions are now widely available as complete intervention packages, few evidence-based interventions have been designed for implementation within common drug treatment community-based organizations (CBOs), such as methadone maintenance programs (MMPs), where many high-risk HIV-infected drug users seek treatment. Moreover, the few evidence-based interventions that are applicable to drug treatment CBOs are not designed to be "community-friendly" and, hence, are unlikely to be implemented as intended or durable within these critical settings.

The investigators have developed a significantly shortened version of the comprehensive evidence-based Holistic Health Recovery Program (HHRP; Avants et al., 2004; Margolin et al., 2003). This shortened version, Holistic Health for HIV (3H+), has demonstrated feasibility and acceptability as well as preliminary evidence of effectiveness in an uncontrolled study within a resource-limited drug treatment CBO. Therefore, this randomized controlled comparative effectiveness trial (RCT) will test the efficacy and cost-effectiveness of 3H+ versus the original gold standard evidence-based intervention(EBI), Holistic Health Recovery Program for HIV+s (HHRP+), targeting HIV+ drug users (DUs).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Risk Behavior
  • Medication Adherence
  • HIV
Intervention  ICMJE
  • Behavioral: 3H+ (Holistic Health for HIV)
    Four weekly HIV-risk reduction groups and an additional booster group held at week twelve summarizing the previous sessions' content, designed for opioid-dependent individuals living with HIV.
  • Behavioral: HHRP+ (Holistic Health Recovery Program)
    12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.
Study Arms  ICMJE
  • Experimental: 3H+ Group
    3H+ (Holistic for HIV) group patients will receive the standard of drug treatment care (i.e., methadone maintenance treatment and case management) plus four weekly 60-minute HIV risk reduction groups, and a 60-minute booster session at 12 weeks, led by two facilitators trained and supervised by a licensed clinical psychologist. 3H+ is an HIV risk reduction and ART adherence intervention that provides coping skills training and is delivered in a group modality, addressing high risk drug- and sex-related HIV risk behaviors and ART adherence for opioid-dependent individuals living with HIV.
    Intervention: Behavioral: 3H+ (Holistic Health for HIV)
  • Active Comparator: HHRP+ Group
    HHRP+ (Holistic Health Recovery Program) is comprised of 12 two-hour weekly manual-guided group sessions with comprehensive HIV risk reduction content that addresses the medical, emotional, and spiritual needs of opioid-dependent individuals living with HIV. Each session is designed to last 2 hours and is co-facilitated by two trained facilitators, who address potential motivational conflicts of HIV+ individuals by providing them with self-protective as well as altruistic reasons for examining and changing their HIV risk behaviors and improving adherence behavior. Material is presented using cognitive remediation strategies.
    Intervention: Behavioral: HHRP+ (Holistic Health Recovery Program)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
133
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
256
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV positive
  • Opioid dependent and enrolled in methadone maintenance treatment
  • Report drug- or sex-related HIV risk behavior in previous 6 months
  • Able to read and understand the questionnaires, the Audio Computer Assisted Self Interview (ACASI), and consent form
  • Available for the full duration of the study with no anticipated circumstances impeding participation
  • Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of the PI who is a licensed clinical psychologist in Connecticut.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741311
Other Study ID Numbers  ICMJE H12-050
R01DA032290 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Copenhaver, University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Yale University
  • APT Foundation, Inc.
Investigators  ICMJE
Principal Investigator: Michael C Copenhaver, Ph.D. University of Connecticut
PRS Account University of Connecticut
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP