STI Screening as a Combined HIV Prevention Platform for MSM in Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Unprotected Receptive Anal Intercourse (URAI) with Serodiscordant or Unknown Serostatus Partner
研究概览
简要总结
The investigators propose to develop and pilot an HIV prevention intervention based on rectal STI testing, counseling, and treatment for MSM in Peru. The investigators will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. The intervention is based on three interrelated objectives: 1) To use periodic rectal STI nucleic acid testing to identify the members of the MSM population at greatest short-term risk for HIV infection; 2) To provide single-dose antibiotic treatment to control the immune activation and mucosal inflammation caused by rectal GC/CT infection that increase cellular risk for HIV transmission; and 3) To use Personal Cognitive Counseling (PCC) to understand and modify recent high-risk sexual practices that led to rectal STI acquisition and that increase future HIV risk.
The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT infection to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence estimate) and 50 GC/CT-negative controls (matched by age and baseline frequency of URAI). GC/CT-infected participants will be given single-dose antibiotic therapy and randomized to receive single-session PCC (n=50) or standard post-test counseling (n=50). The primary outcome will be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary outcomes will assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact of GC/CT infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand IL-1β) in rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV incidence in GC/CT-infected and -uninfected MSM.
详细描述
Overview. The investigators plan to screen 750 behaviorally high-risk, HIV-uninfected MSM in order to enroll 100 subjects with rectal GC/CT infection and 50 uninfected controls. GC/CT-infected participants will receive single-dose antibiotic therapy and be randomized to receive either PCC or standard-of-care post-test counseling. GC/CT-negative participants will receive standard post-test counseling. Behavioral and biological assessments will be conducted at Baseline, 3-month and 6-month Follow-up visits. The primary outcome will be the effect of PCC on the prevalence of URAI with an HIV-infected or unknown status partner in the preceding 3-months. Secondary outcomes include feasibility/acceptability of the intervention, prevalence of persistent or recurrent GC/CT infection, change in rectal cytokine levels, and incidence of HIV infection.
Recruitment. Participants will be recruited from local HIV testing sites using the methods described above.
Screening Visit. The investigators will screen 750 MSM reporting at least one recent episode of unprotected receptive anal intercourse (URAI) for rectal GC/CT infection with a goal of identifying 100 GC/CT-positive participants (using a conservative 15% prevalence estimate and assuming 10% loss to follow-up over 6 months).
i) Rapid HIV Testing: After providing informed consent, all potential participants will undergo rapid HIV testing. Study staff will provide pre- and post-test risk reduction counseling based on the CDC's RESPECT-2 model (24) and screen for HIV at point of care using a 4th Generation Rapid HIV-1/2 assay (Alere Determine, Alere).
ii) Physical Examination: Potential participants will undergo routine physical examination to assess for signs of STI. Participants with evidence of proctitis (rectal discharge or inflammation) will be treated with Ceftriaxone 250 mg injection and Azithromycin 1 g oral and invited to enroll in the study based on symptomatic criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Assigned male sex at birth
- •HIV-uninfected
- •Reports receptive anal intercourse with an HIV-infected or unknown serostatus partner within the previous 6 months
- •Diagnosed with rectal gonorrhea and/or chlamydia infection (not applicable to GC/CT-uninfected controls)
排除标准
- •Unable to complete informed consent procedures
- •HIV-infected (according to laboratory testing)
研究组 & 干预措施
STI-Positive: PCC
MSM diagnosed with rectal GC and/or CT infection counseled for HIV prevention using Personalized Cognitive Counseling (PCC) and treated with appropriate antibiotic therapy
干预措施: PCC (Behavioral)
STI-Positive: Traditional Counseling
MSM diagnosed with rectal GC and/or CT infection counseled for HIV prevention using traditional risk reduction counseling and treated with appropriate antibiotic therapy
干预措施: Traditional Counseling (Behavioral)
STI-Negative
MSM without rectal GC and/or CT infection
结局指标
主要结局
Unprotected Receptive Anal Intercourse (URAI) with Serodiscordant or Unknown Serostatus Partner
时间窗: 6 Months
prevalence of self-reported URAI with an HIV-infected or unknown serostatus partner at 6-month Follow-up
次要结局
- Inflammatory Cytokine Levels in Rectal Mucosa(6 Months)
- Persistent or Recurrent Rectal GC/CT Infection(6 Months)
研究者
Jesse Clark
Associate Professor-in-Residence
University of California, Los Angeles