Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine 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: NCT00432926 |
Recruitment Status
:
Completed
First Posted
: February 8, 2007
Last Update Posted
: September 28, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Substance Abuse Sexually Transmitted Diseases | Behavioral: EDGE counseling, no maintenance Behavioral: EDGE counseling, plus maintenance Behavioral: Attention control | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 429 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).
|
Behavioral: EDGE counseling, no maintenance
Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).
|
Experimental: 2
Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.
|
Behavioral: EDGE counseling, plus maintenance
Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.
|
Active Comparator: 3
An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
|
Behavioral: Attention control
An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
|
- Reduction of defined sexual risk behaviors [ Time Frame: 18 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV+
- Used methamphetamine at least twice in last two months
- At least some recent sexual partners were male
- At least some recent sexual activity has been high-risk for transmission of HIV
Exclusion Criteria:
- Current major psychiatric diagnosis
- Only HIV+ sex partners in past two months
- Consistently protected sex with HIV- or serostatus-unknown partners in last two months
- Sexually inactive in last two months
- Found out about HIV+ status less than two months ago

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432926
United States, California | |
Webster Building, 3500 Fifth Ave., Suite 102 | |
San Diego, California, United States, 92103 |
Principal Investigator: | Thomas L. Patterson, Ph.D. | University of California, San Diego |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Thomas L. Patterson, Principal Investigator, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00432926 History of Changes |
Other Study ID Numbers: |
R01DA021115 ( U.S. NIH Grant/Contract ) |
First Posted: | February 8, 2007 Key Record Dates |
Last Update Posted: | September 28, 2012 |
Last Verified: | September 2012 |
Keywords provided by Thomas L. Patterson, University of California, San Diego:
HIV STDs Methamphetamine abuse MSM HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Substance-Related Disorders Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Chemically-Induced Disorders Mental Disorders Infection Genital Diseases, Male Genital Diseases, Female |
Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |