Expedited Partner Therapy and the HIV Prevention Cascade for MSM in Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 663
- 试验地点
- 2
- 主要终点
- Partner-confirmed notification
研究概览
简要总结
The HIV epidemic in Peru remains concentrated in the subpopulation of men who have sex with men (MSM), where the prevalence of disease has been estimated between 10-22% in recent epidemiologic surveys. Partner-based methods to limit the spread of HIV and STI co-infection, including partner notification and partner treatment, provide an important new strategy for HIV control in the region.
Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been fully evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines.
As a theoretical model, EPT integrates behavioral, social, and biomedical approaches to HIV/STI control in a comprehensive prevention intervention. Our proposed exploration of the social and behavioral dimensions of partner notification and treatment will provide a methodological structure for understanding the influence of EPT on behavioral decision-making processes, interpersonal factors that influence partner notification, and network patterns of STI transmission within MSM populations in Peru.
The proposed study includes a screening protocol to identify eligible MSM subjects for participation in our planned study of the effect of EPT on partner notification, treatment, and linkage to HIV prevention and care services. Potential participants will complete a behavioral survey and undergo physical examination and testing for HIV, syphilis, gonorrhea, and chlamydia. Participants diagnosed with Gonorrhea and/or Chlamydia (at any anatomic site) will be eligible for enrollment in our Partner Management study of EPT and the HIV prevention cascade among MSM in Peru.
Participants in the Partner Management study will be randomly assigned to receive either standard of care partner notification counseling or standard counseling along with a maximum of five antibiotic treatment packets to deliver to their recent sexual partners. Participants will be asked to return to the site after 21 days to report on their actual partner notification behavior, with differences in notification evaluated between the two groups. Participants will then work with a study counselor to identify their recent partners and, if the participant agrees, to provide contact information so that the study team can contact these partners. Study staff will either confirm that the partner has already been notified, or provide notification of their likely STI exposure. After informing partners of their STI exposure, staff will ask partners to provide verbal consent to a single question evaluation (whether or not the partner had previously been informed of their exposure) to verify participant-reported behavior. Partners will also be asked to visit the study site to complete a brief survey of their sexual practices and treatment-seeking behavior, as well as to undergo testing for HIV and STIs. All of the above data will be used to construct models of the spread of HIV and STIs in local MSM networks, and the potential effect of EPT on controlling the spread of STIs in this population.
详细描述
Background and Objectives. Expedited Partner Therapy (EPT) provides a framework to integrate STI control with HIV prevention through the sexual networks of men who have sex with men (MSM). Partner notification, testing, and treatment are the critical first steps of an HIV prevention cascade that bridges partner notification with linkage to HIV prevention services and population-scale reductions in HIV/STI incidence. EPT has been shown effective in reducing risks for STI re-exposure among heterosexual men and women but remains controversial for use with MSM. Previous studies of EPT with heterosexual couples have demonstrated significant decreases in the risk of recurrence for gonorrhea (GC), chlamydia (CT) and other STIs. Objections to the use of EPT with MSM center on the prevalence of undiagnosed HIV and syphilis among their partners, and fears that providing access to antibiotics will discourage STI-exposed individuals from seeking additional treatment. However, the evidence-based foundation for these objections is limited. In our previous pilot study of EPT for MSM with GC/CT in Peru, the odds of partner notification were significantly greater in the EPT arm (85.2%) than in the standard counseling arm (61.8%; OR=3.56). Additional research is needed to explore the use of EPT in MSM partnerships and to develop alternative conceptual frameworks capable of understanding the complex associations between EPT, STI control, and HIV prevention in MSM sexual networks. We hypothesize that EPT will increase the frequency of partner notification, encourage partners to seek HIV/STI counseling and testing, and promote linkage to HIV prevention and treatment services.
Differences in partnership formations and network structures of MSM necessitate correspondingly specific approaches to partner management. Heterosexual networks in previous partner therapy trials included a high frequency of stable or monogamous partnerships where HIV/STI risk could be localized and confined. In one study, the mean number of sexual partners in 3 months reported by men and women with GC/CT was 1.5. In another, 96% of women with CT named <2 recent partners, and most reported one. In these partnership contexts, EPT offers a simple method to control cyclical STI transmission in 2-core or 3-core networks of stable, recurrent sexual contacts. In contrast, sexual partnerships between MSM in the U.S. and Latin America are often part of large networks characterized by a diverse, concurrent mix of stable, casual, and anonymous partners. In a 2014 survey, MSM in Peru reported an average of 4.2 partners in the previous 30 days. The open structure of these decentralized, k-core networks limits the effectiveness of patient-delivered partner therapy in controlling cyclical STI re-transmission between stable partners. Instead, the primary benefit of EPT in these open-circuit networks lies in the potential to target HIV/STI prevention technologies to the highest risk nodes of diffuse and diverse sexual networks.
EPT offers an intervention ideally suited to Peru's local epidemiologic context. The Peruvian HIV epidemic is concentrated in the population of MSM and transgender women (TW) and associated with STI co-infection. In high-risk MSM populations, partner- and network-level characteristics have been found to be important factors contributing to HIV/STI acquisition. Sexual networks of at-risk MSM are often composed of a concurrent mix of stable/primary, casual (recurrent or single contact), anonymous, and/or commercial partners, with varying degrees of communication, trust, and responsibility. Although stable partners are considered "low-risk" for exposure to HIV/STIs, the lack of objective information on HIV/STI status and the increased likelihood of condomless intercourse in these partnership contexts lead to a high frequency of HIV/STI transmission. Casual sexual partners are often maintained concurrent with primary partners or anonymous contacts and contribute to the dissemination of HIV/STIs across diffuse social and geographic boundaries. Anonymous partners, by definition untraceable, are common and present significant challenges for STI control.
Previous research has emphasized how interpersonal contexts influence partner management tools. Internet systems encourage notification in casual partnerships with minimal interpersonal commitment and low perceived risk of re-exposure, while efforts to target prevention outreach to the dates and times of anonymous contacts have shown success. In contrast, EPT is most effective in stable or recurrent casual partnerships where trust and communication are assumed and the potential for STI re-exposure is high. While any comprehensive partner management strategy will require an array of systems to address the range of partnerships structuring MSM networks, EPT provides a critical tool to address HIV/STI transmission networks.
To evaluate the potential effectiveness of EPT for use with MSM, the investigators have identified three key questions:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Anatomically male at birth
- •Condomless anal intercourse with an HIV serodiscordant or unknown serostatus male or transgender female partner in the previous 6 months
- •18 years of age or older
- •Diagnosis of Gonorrhea and/or Chlamydia infection at any anatomic site at the Screening visit
排除标准
- •1) Inability to understand the study procedures or to provide informed consent
研究组 & 干预措施
Control
Participants in the control arm will receive standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling will be repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
Expedited Partner Therapy (EPT)
Participants in the EPT arm will receive up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention will be repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
干预措施: EPT (Behavioral)
结局指标
主要结局
Partner-confirmed notification
时间窗: 60 Days
Confirmation by named partners following notification of STI exposure by the index participant
Self-reported partner notification
时间窗: 21 Days
Participant self-report of notification of one or more sexual partners at 21-days Follow-up
Number of Participants Who Reported Any Partner Notification
时间窗: 21 Days
Number of participants who self-reported notification of one or more sexual partners at 21-days Follow-up.
Number of Partners Who Confirmed Notification
时间窗: 60 Days
Number of sexual partners who verbally confirmed notification of STI exposure by the index participant
次要结局
- Self-reported partner HIV/STI testing(21 Days)
- Partner confirmed HIV/STI testing(60 Days)
- Self-reported partner treatment(21 Days)
- Partner confirmed treatment(60 Days)
- Number of Participants Reporting Any Partner Treatment(21 Days)
- Number of Participants Reporting Any Partner HIV/STI Testing(21 Days)
- Number of Partners Who Confirmed Treatment(60 Days)
- Number of Partners Who Confirmed HIV/STI Testing(60 Days)
研究者
Jesse Clark
Associate Professor-in-Residence
University of California, Los Angeles
