STD Risk Reduction for Heterosexual Methamphetamine Users

NCT00344214 | Completed

• 2 other identifiers: R01MH061146DAHBR 9A-ASPQ
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of a sexual risk reduction intervention in reducing sexual risk behavior in HIV uninfected, heterosexual people who use methamphetamine.

Conditions

Substance-Related Disorders; HIV Infections; Sexually Transmitted Diseases

Keywords

HIV; STDs; Methamphetamine

Outcome Measures

Primary Outcomes (1)

• Frequency of unprotected oral, anal, or vaginal sex

  Measured at Months 4, 8, and 12

Secondary Outcomes (4)

• Depressive symptoms

  Measured at Months 4, 8, and 12

• Methamphetamine use

  Measured at Months 4, 8, and 12

• STI incidence (gonorrhea, Chlamydia)

  Measured at Month 12

• HIV serostatus

  Measured at Month 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive the tri-focal cognitive behavioral therapy - social skills training counseling program

Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program

2

ACTIVE COMPARATOR

Participants will receive the standard care comparison condition

Behavioral: Standard care

Interventions

Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program BEHAVIORAL

This condition is a Theory-Based Counseling Program. The program will involve nine 90-minute face-to-face counseling sessions that use CBT and strategies associated with social cognitive theory. The theory addresses three treatment domains, including mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices.

1

Standard care BEHAVIORAL

Standard care involves nine weekly, face-to-face individual counseling sessions that provide standard care in relation to sexual risk, methamphetamine use, and depression. The sexual risk component is a modified version of Project RESPECT 1 (CDC, Atlanta) that focuses on educational materials and personal risk appraisal. The meth component is a modified version of the 12-step drug abstinence program developed by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) (Project MATCH). The depression component is an educational approach based primarily on materials provided by the National Alliance on Mental Illness (NAMI) and the National Institute of Mental Health (NIMH).

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV uninfected
• Use of methamphetamine via snorting or smoking at least once a month for the 2 months prior to study entry
• Heterosexual
• History of unprotected sex within 2 months prior to study entry

You may not qualify if:

• Current diagnosis of a major psychiatric disorder with psychotic or suicidal symptoms
• History of consistent use of condoms or dental dams for oral, vaginal, or anal sex with all partners within 2 months prior to study entry
• Currently trying to get pregnant or get a partner pregnant

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

HIV Neurobehavioral Research Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; HIV Infections; Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas L. Patterson, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

US (1)