Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

This study is currently recruiting participants.
Verified February 2014 by University of Connecticut
Sponsor:
Collaborators:
Yale University
APT Foundation, Inc.
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01741311
First received: November 30, 2012
Last updated: February 27, 2014
Last verified: February 2014

November 30, 2012
February 27, 2014
September 2012
April 2017   (final data collection date for primary outcome measure)
The proportion of participants free from HIV-transmission risk [ Time Frame: Over a 9-month period ] [ Designated as safety issue: Yes ]
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.
The proportion of participants free from HIV-transmission risk [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01741311 on ClinicalTrials.gov Archive Site
Antiretroviral therapy (ART) adherence [ Time Frame: Over a 9-month period ] [ Designated as safety issue: Yes ]
ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.
Antiretroviral therapy (ART) adherence [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).
  • ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).
 
Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Risk Behavior
  • Medication Adherence
  • HIV
  • 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.
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
256
February 2018
April 2017   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
No
Contact: Brian Sibilio, B.S. (203) 781-4690 brian.sibilio@uconn.edu
United States
 
NCT01741311
H12-050, RO1DA032290
Yes
University of Connecticut
University of Connecticut
  • National Institute on Drug Abuse (NIDA)
  • Yale University
  • APT Foundation, Inc.
Principal Investigator: Michael C Copenhaver, Ph.D. University of Connecticut
University of Connecticut
February 2014

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