Clinical trial NCT01198418: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
HIV Infections
Keywords: STI
MSM
HIV
Prevention
Men having sex with men
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Southern California
name: California HIV/AIDS Research Program
First posted: 2010-09-10
Enrollment: 181
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: STI incidence
timeFrame: Baseline and follow-up visits every 3 months
Secondary outcomes:
measure: Evaluate risk factors of STIs
timeFrame: Baseline, follow-up visits every 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Torrance
country: United States
facility: University of California, Los Angeles (Harbor)
state: California
Study officials:
affiliation: UC San Diego AntiViral Research Center (AVRC)
name: Sheldon Morris, MD, MPh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Joel Milam, PhD
role: STUDY_CHAIR
References: