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

Primary Purpose

Sexually Transmitted Infections, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring STI, MSM, HIV, Prevention, Men having sex with men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 18 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.

Exclusion Criteria:

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

Sites / Locations

  • University of Southern California
  • University of California, San Diego
  • University of California, Los Angeles (Harbor)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based counseling

Survey Alone

Arm Description

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.

Completes surveys monthly about their sexual and drug use behaviors

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate risk factors of STIs
Compare:a)self reported levels of unsafe sex among HIV-infected men b)intention to start ARV among HIV-infected men not currently on ARV will increase during 12 mos. participation in an internet risk reduction intervention compared to survey instrument alone Compare self-reported among HIV-infected men during 12 mos. participation as measured by those reporting 100% disclosure in an internet risk reduction intervention compared to survey instrument alone Collect genital tract secretions of semen for future study

Full Information

First Posted
September 8, 2010
Last Updated
May 8, 2020
Sponsor
University of California, San Diego
Collaborators
University of California, Los Angeles, University of Southern California, California HIV/AIDS Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT01198418
Brief Title
A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
Official Title
A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2010 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
November 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
University of California, Los Angeles, University of Southern California, California HIV/AIDS Research Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH). Duration: 48 weeks Sample Size: 200 subjects (100 per arm) that will be randomized Study Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior. Stratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections, HIV Infections
Keywords
STI, MSM, HIV, Prevention, Men having sex with men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Survey Alone
Arm Type
No Intervention
Arm Description
Completes surveys monthly about their sexual and drug use behaviors
Intervention Type
Behavioral
Intervention Name(s)
Experimental
Intervention Description
Internet-based intervention that assesses transmission risk and provides prevention messages
Primary Outcome Measure Information:
Title
STI incidence
Description
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.
Time Frame
Baseline and follow-up visits every 3 months
Secondary Outcome Measure Information:
Title
Evaluate risk factors of STIs
Description
Compare:a)self reported levels of unsafe sex among HIV-infected men b)intention to start ARV among HIV-infected men not currently on ARV will increase during 12 mos. participation in an internet risk reduction intervention compared to survey instrument alone Compare self-reported among HIV-infected men during 12 mos. participation as measured by those reporting 100% disclosure in an internet risk reduction intervention compared to survey instrument alone Collect genital tract secretions of semen for future study
Time Frame
Baseline, follow-up visits every 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 18 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. Exclusion Criteria: Uncontrolled psychiatric condition. Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Morris, MD, MPh
Organizational Affiliation
UC San Diego AntiViral Research Center (AVRC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel Milam, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California, Los Angeles (Harbor)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.cctg.ucsd.edu
Description
(organization's website)

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

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