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

Status:	Completed
Conditions:	Infectious Disease, HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	10/21/2012
Start Date:	November 2010
End Date:	December 2012
Contact:	Sheldon Morris, MD, MPh
Email:	shmorris@ucsd.edu
Phone:	619-543-8080

A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM

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.

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.

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

We found this trial at

sites

University of Southern California

Los Angeles, California 90033

213) 740-2311