HIV Transmission Risk Behavior Substudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 883
- 试验地点
- 58
- 主要终点
- To compare the DC group to the VS group for HIV transmission and risk behaviors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coenrollment in the SMART study
- •Parent or guardian willing to provide informed consent, if applicable
排除标准
- 未提供
研究组 & 干预措施
1: DC Group
HIV infected participants who will stop or defer ART until the CD4 cell count drops below 250 cells/mm3 and who discontinue ART when CD4 cell count reaches above 350 cells/mm3. Participants are followed by episodic ART based on CD4 cell count.
干预措施: Delayed ART (Drug)
2: VS Group
HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.
干预措施: Continuous ART (Drug)
结局指标
主要结局
To compare the DC group to the VS group for HIV transmission and risk behaviors
时间窗: At the end of study
次要结局
- 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.(At the end of study)
- To evaluate the correlation between self-reported transmission risk behavior and the acquisition of certain sexually transmitted diseases as specified in the protocol.(At the end of study)
- To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk(At the end of study)
- To evaluate the correlation between self-reported adherence to ART and HIV transmission risk behavior for participants on ART(At the end of study)
- To compare the VS group to the DC group on HIV transmission risk behavior in participants who are not on ART at enrollment(At the end of study)
- 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(At the end of study)