HIV Infections, Sexually Transmitted Infections
Conditions
Keywords
STI, MSM, HIV, Prevention, Men having sex with men
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.
Interventions
BEHAVIORALExperimental
Internet-based intervention that assesses transmission risk and provides prevention messages
Sponsors
University of California, Los Angeles
University of Southern California
California HIV/AIDS Research Program
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STI incidence | Baseline and follow-up visits every 3 months | * 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate risk factors of STIs | Baseline, follow-up visits every 3 months | * 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 |
Countries
United States
Outcome results
None listed