A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)

NCT01198418 | Completed

• 1 other identifier: CCTG 592
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 3

Brief Summary

This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.

Conditions

Sexually Transmitted Infections; HIV Infections

Keywords

STI; MSM; HIV; Prevention; Men having sex with men

Outcome Measures

Primary Outcomes (1)

• STI incidence

  * To compare the composite STI incidence of syphilis or Chlamydia trachomatis (CT) or Neisseria gonorrhea (GC) at any mucosal site among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone. * To compare the incidence of nonspecific urethritis by urinalysis and testing for Mycoplasma genitalum and trichomonas sp. among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.

  Baseline and follow-up visits every 3 months

Secondary Outcomes (1)

• Evaluate risk factors of STIs

  Baseline, follow-up visits every 3 months

Study Arms (2)

Internet-based counseling

EXPERIMENTAL

Completes surveys monthly about their sexual and drug use behaviors as well as receives information designed to help reduce the chances of getting an STI.

Behavioral: Experimental

Survey Alone

NO INTERVENTION

Completes surveys monthly about their sexual and drug use behaviors

Interventions

Experimental BEHAVIORAL

Internet-based intervention that assesses transmission risk and provides prevention messages

Internet-based counseling

Eligibility Criteria

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

You may qualify if:

• HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values \> 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.
• years of age or older.
• Male.
• At least one of the following:
• An HIV negative or unknown status sexual partner in the past three months.
• A sexually transmitted disease in the past 1 year (other than HIV).
• More than 2 male partners in past year.
• Unprotected anal sex in past 3 month.
• Capable of signing written informed consent.
• Read and comprehend English
• Adequate computer skills for study.

You may not qualify if:

• Uncontrolled psychiatric condition.
• Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, Los Angeles: collaborator
• University of Southern California: collaborator
• California HIV/AIDS Research Program: collaborator

Study Sites (3)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, Los Angeles (Harbor)

Torrance, California, 90502, United States

Location

Related Links

• (organization's website)

MeSH Terms

Conditions

Sexually Transmitted Diseases; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheldon Morris, MD, MPh

  UC San Diego AntiViral Research Center (AVRC)

  PRINCIPAL INVESTIGATOR

• Joel Milam, PhD

  University of California, San Diego

  STUDY CHAIR

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: Clinical Professor

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: July 9, 2010
• Primary Completion: October 18, 2017
• Study Completion: November 9, 2017
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

US (3)