Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

HIV Clinical Trial

Official title:

Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741311
• Other study ID #: H12-050
• Secondary ID: R01DA032290
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2018

Study information

• Verified date: May 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• HIV
• Medication Adherence
• Risk Behavior

Intervention

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.
• HHRP+ (Holistic Health Recovery Program)
12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
University of Connecticut	APT Foundation, Inc., National Institute on Drug Abuse (NIDA), Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4. — View Citation

Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.	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.	Over a 9-month period
Other	ART non-adherence factors	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).	Over a 9-month period
Primary	The proportion of participants free from HIV-transmission risk	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.	Over a 9-month period
Secondary	Antiretroviral therapy (ART) adherence	ART Adherence will be assessed by self-report using the visual analogue scale (VAS) and pharmacy refill data.	Over a 9-month period

External Links

•   University of Connecticut Center for Health, Intervention, and Prevention (CHIP)