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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01741311|
Recruitment Status : Recruiting
First Posted : December 4, 2012
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Risk Behavior Medication Adherence HIV||Behavioral: 3H+ (Holistic Health for HIV) Behavioral: HHRP+ (Holistic Health Recovery Program)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Secondary HIV Prevention and Adherence Among HIV-infected Drug Users|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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.
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.
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.
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.
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741311
|Contact: Brian Sibilio, B.S.||(203) email@example.com|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|Contact: Brian Sibilio, B.S. 203-781-4690 firstname.lastname@example.org|
|Principal Investigator: Michael C Copenhaver, Ph.D.|
|Principal Investigator:||Michael C Copenhaver, Ph.D.||University of Connecticut|