Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | September 2012 |
| End Date: | June 2018 |
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.
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).
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).
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:
We found this trial at
1
site
New Haven, Connecticut 06519
Principal Investigator: Michael C Copenhaver, Ph.D.
Phone: 203-781-4690
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