Clinical trial NCT00386035: Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants
Official title: HIV Transmission Risk Behavior Substudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Community Programs for Clinical Research on AIDS
First posted: 2006-10-11
Enrollment: 883
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected participants with a CD4+ cell count greater than 350 cells/mm3 currently receiving or not receiving ART.

Brief summary: The purpose of this study is to compare the effects of two different anti-HIV drug regimens on HIV transmission risk behavior among SMART study participants.

Detailed description: It is important to consider the role that HIV infected individuals play in ongoing HIV transmission. Different anti-HIV treatment regimens may lead to variations in HIV transmission risk behavior among HIV infected individuals. HIV infected people with viral loads of less than 1,000 copies/ml are less likely to transmit HIV through heterosexual sex. However, condom use sometimes decreases after individuals start combination antiretroviral therapy (ART); also, some studies have shown an increased rate in acquiring sexually transmitted infections (STIs) following initiation of ART, and those on ART may transmit a drug-resistant strain of HIV. In the SMART study, participants were randomly assigned to one of two treatment groups:

* Group 1 participants will follow a drug conservation (DC) regimen in which ART will be stopped or deferred until CD4 cell count drops below 250 cells/mm3, will be initiated until CD4 cell count is at least 350 cells/mm3, and then will be followed by episodic ART based on CD4 cell count.
* Group 2 participants will follow a viral suppression (VS) regimen in which ART is continued to keep viral loads as low as possible, regardless of CD4 cell count.

The purpose of this study is to compare how the DC and VS regimens affect HIV transmission risk behavior among SMART study participants.

At baseline, participants will complete a questionnaire about their sexual behavior during the previous 2 months. They will also undergo urine and blood collection for STI testing. These same procedures will occur at Months 4 and 12, then every year thereafter for the first 4 years that a participant is in the parent study. Participants and their physicians will be notified of STI testing results so that patients can be referred to appropriate care.

Eligibility criteria: Inclusion Criteria:

* Coenrollment in the SMART study
* Parent or guardian willing to provide informed consent, if applicable

Primary outcomes:
measure: To compare the DC group to the VS group for HIV transmission and risk behaviors
timeFrame: At the end of study
Secondary outcomes:
measure: To compare the VS group to the DC group on HIV transmission risk behavior in participants who are not on ART at enrollment
timeFrame: At the end of study
measure: To compare the effects of continuing ART in the VS group to stopping ART in the DC group on HIV transmission risk behavior among participants who are on ART at enrollment
timeFrame: At the end of study
measure: To evaluate the correlation between self-reported adherence to ART and HIV transmission risk behavior for participants on ART
timeFrame: At the end of study
measure: To compare the DC and VS groups for HIV transmission risk behavior in subgroups defined by age, gender, possible transmission category, HIV RNA level, and baseline genotypic resistance pattern.
timeFrame: At the end of study
measure: To evaluate the correlation between self-reported transmission risk behavior and the acquisition of certain sexually transmitted diseases as specified in the protocol.
timeFrame: At the end of study
measure: To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk
timeFrame: At the end of study
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: AIDS Healthcare Foundation CRS
state: California
city: Fresno
country: United States
facility: UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
state: California
city: Mill Valley
country: United States
facility: Dr. M. Estes Med. Practice CRS
state: California
city: Oakland
country: United States
facility: Dr. Robert Scott Med. Practice CRS
state: California
city: Oakland
country: United States
facility: East Bay AIDS Ctr. CRS
state: California
city: San Francisco
country: United States
facility: Dr. Shawn Hassler Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
state: California
city: San Francisco
country: United States
facility: Dr. Virginia Cafaro Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Dr. William Owen Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Castro-Mission Health Ctr. CRS
state: California
city: San Francisco
country: United States
facility: San Francisco VAMC, Infectious Diseases Clinic CRS
state: California
city: San Francisco
country: United States
facility: UCSF PHP, Gen. Internal Medicine Practice CRS
state: California
city: Boulder
country: United States
facility: Beacon Clinic at Boulder CRS
state: Colorado
city: Denver
country: United States
facility: Denver Infectious Diseases Consultants CRS
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente of Denver CRS
state: Colorado
city: Denver
country: United States
facility: Univ. of Colorado Health Science Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS - INSIGHT
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS
state: Colorado
city: Denver
country: United States
facility: Eastside Family Health Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: Denver VAMC CRS
state: Colorado
city: Wheat Ridge
country: United States
facility: Western Infectious Disease Consultants CRS
state: Colorado
city: Washington
country: United States
facility: Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
state: District of Columbia
city: Miami
country: United States
facility: Miami VAMC CRS
state: Florida
city: Decatur
country: United States
facility: Atlanta VAMC CRS
state: Georgia
city: Detroit
country: United States
facility: Harper Hosp., Detroit CRS
state: Michigan
city: Detroit
country: United States
facility: Wayne State Univ. CRS
state: Michigan
city: Detroit
country: United States
facility: Wayne State Univ. INSIGHT CRS
state: Michigan
city: Detroit
country: United States
facility: Detroit Community Health Connection, Inc. CRS
state: Michigan
city: Grand Rapids
country: United States
facility: McAuley Health Ctr. CRS
state: Michigan
city: Camden
country: United States
facility: Cooper Univ. Hosp. CRS
state: New Jersey
city: Camden
country: United States
facility: Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School- Adult Clinical Research Ctr. CRS
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease, Cape Clinical Trials CRS
state: New Jersey
city: Voorhees
country: United States
facility: The Early Intervention Program at Kennedy Hosp. CRS
state: New Jersey
city: Bronx
country: United States
facility: Bronx Prevention Center CRS
state: New York
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp. Ctr. CRS
state: New York
city: Bronx
country: United States
facility: Montefiore Med. Ctr., AIDS Ctr. CRS
state: New York
city: New York
country: United States
facility: St. Vincent Hosp. & Med. Ctr. CRS
state: New York
city: Eugene
country: United States
facility: PeaceHealth Med. Group - Hilyard Street Clinic CRS
state: Oregon
city: Portland
country: United States
facility: Multnomah County Health Dept., HIV Health Services Ctr. CRS
state: Oregon
city: Portland
country: United States
facility: Legacy Clinic Good Samaritan CRS
state: Oregon
city: Portland
country: United States
facility: The Research & Education Group-Portland CRS
state: Oregon
city: Portland
country: United States
facility: Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
state: Oregon
city: Portland
country: United States
facility: Kaiser Immune Deficiency Clinic of Portland CRS
state: Oregon
city: Portland
country: United States
facility: Legacy Clinic Emanuel CRS
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT - Dr. Jay Kostman CRS
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Univ. School of Medicine CRS
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Med. Ctr., Immunodeficiency Ctr. CRS
state: Pennsylvania
city: Fredericksburg
country: United States
facility: MediCorp, Infectious Disease Associates CRS
state: Virginia
city: Mechanicsville
country: United States
facility: Hanover Med. Park (Mechanicsville, VA) CRS
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
state: Virginia
city: Petersburg
country: United States
facility: Petersburg Health Care Alliance CRS
state: Virginia
city: Richmond
country: United States
facility: Vernon Harris East End Community Health Ctr. CRS
state: Virginia
city: Richmond
country: United States
facility: CrossOver Health Ctr. CRS
state: Virginia
city: Richmond
country: United States
facility: South Richmond Health Care Ctr. CRS
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VAMC CRS
state: Virginia
city: Richmond
country: United States
facility: VCU Health Systems, Infectious Disease Clinic CRS
state: Virginia
Study officials:
affiliation: Harlem AIDS Treatment Group, Harlem Hospital Center
name: Wafaa El-Sadr, MD, MPH
role: STUDY_CHAIR
affiliation: CPCRA Statistical and Data Management Center/CCBR
name: James Neaton, PhD
role: STUDY_CHAIR
References:
citation: Bunnell R, Ekwaru JP, Solberg P, Wamai N, Bikaako-Kajura W, Were W, Coutinho A, Liechty C, Madraa E, Rutherford G, Mermin J. Changes in sexual behavior and risk of HIV transmission after antiretroviral therapy and prevention interventions in rural Uganda. AIDS. 2006 Jan 2;20(1):85-92. doi: 10.1097/01.aids.0000196566.40702.28.
citation: Kozal MJ, Amico KR, Chiarella J, Schreibman T, Cornman D, Fisher W, Fisher J, Friedland G. Antiretroviral resistance and high-risk transmission behavior among HIV-positive patients in clinical care. AIDS. 2004 Nov 5;18(16):2185-9. doi: 10.1097/00002030-200411050-00011.
citation: Remien RH, Halkitis PN, O'Leary A, Wolitski RJ, Gomez CA. Risk Perception and sexual risk behaviors among HIV-positive men on antiretroviral therapy. AIDS Behav. 2005 Jun;9(2):167-76. doi: 10.1007/s10461-005-3898-7.