Repeat STI Patients: Tailored Socio-Contextual Intervention to Reduce HIV Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- STI Outcome Measures
研究概览
简要总结
People who present repeatedly at Sexually Transmitted Infection (STI) clinics represent a key population for HIV prevention intervention research. Despite their heightened risk there is an absence of empirical research on strategies to intervene with repeat STI. Some STI-clinic based behavioral HIV prevention studies, focusing on the general STI patient population, have found that risk reduction interventions can reduce the incidence of a subsequent STI. Studies have shown that expedited treatment for STI patients' partners can reduce subsequent STI and enhancing partner notification can reduce risk for repeat infection. Those who go on to experience repeat infections, after they are provided with risk reduction services, are the focus of this project. Repeat STI literature noted, there have been no intervention studies conducted to lower STI/HIV risk specifically among people who are presenting with repeat STI.
The proposed study develops a risk reduction intervention designed for STI repeaters and evaluates the efficacy of this intervention and its cost-effectiveness. The investigators expect that the intervention for STI repeaters will be significantly more effective than standard care with regard to reducing participants' STI/HIV risks. However, even a highly-effective intervention is unlikely to be adopted if the outcomes come at a high cost. Administrators need to know how effective a "new" intervention is, but also if it is more cost-effective than the program it replaces.
Cost-effectiveness information also is critical to justify the "new" intervention to prevention funders (Milwaukee Department of Health), who are concerned not only with costs and effects, but also with the tradeoff between them. The proposed study will provide the comprehensive level of information about intervention effects and cost-effectiveness required by administrators and resource allocation decision makers to determine whether or not to fund or implement the intervention.
Hypothesis 1. The investigators expect a greater reduction in unprotected vaginal and anal intercourse in the prevention case management compared to the standard care condition.
Hypothesis 2. The hypothesis that the case management group will have a lower STI re-infection rate compared to the standard care group will be tested using each participant's repeat STI status over the 12 month FU period.
详细描述
This study is a five-year project to develop and test an intervention to reduce risk among people at high vulnerability for HIV infection: patients who present repeatedly at sexually transmitted infection clinics. Repeat bacterial sexually transmitted infections (STI) such as chlamydia, gonorrhea, trichomoniasis, and syphilis, and repeat visits to STI clinics for exposure and potential infection, indicate persistent high-risk sexual behavior. Recidivist patients further represent a significant proportion of public STI clinic visits. Repeat STI can increase the likelihood of HIV transmission during exposure and some recidivist patients may serve as "core transmitters," propagating an ongoing epidemic or endemic chain within a community. Repeat STI patients also face serious health risks from STI complications. In sum, STI repeaters present significant public health risks and place a large financial and resource burden on treatment systems.
Patients with repeat STI, by definition, are not adequately served by the prevention services currently provided by STI clinics. Thus, additional clinic-based services to reduce patients' risk of future infections of STI and HIV are warranted. Adequately addressing the needs of repeat STI patients will allow limited resources to be more heavily invested in services for first-time STI patients who are more likely than recidivist patients to be amenable to standard clinic-based risk-reduction interventions.
The HIV prevention field has largely been silent about assisting patients who present repeatedly with STI and STI risk; there are no published studies testing interventions specifically for repeat STI patients. In addition, most risk-reduction intervention research based in STI clinics has focused directly on the presenting problem of sexual risk behavior or addressed a single co-existing factor (substance use, depression). However, research suggests that repeat STI is related to a wide-ranging and complex configuration of contextual factors that varies by patient. Indeed, repeat STI is highest among communities with the highest rates of STI in general, which are characterized by myriad contextual challenges (unemployment, poverty).
Novel intervention approaches are needed to help repeat STI patients reduce their risk for HIV infection and for infecting others. Investigators propose to address these gaps in the HIV and STI prevention literature by focusing on a high-risk group of recidivist patients: economically disadvantaged urban African Americans. The intervention will help patients address broader, "risk-regulating" social and contextual factors identified by each patient (employment, housing, domestic violence, substance abuse). Investigators also will address individual risk behavior and affective and self-regulatory factors (fatalism, problem solving skills), that contribute to continued risk behavior and interfere with maintenance of risk reduction after an STI.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 or older;
- •Presentation for diagnosis of STI;
- •Previous bacterial STI diagnosis in the clinic more than 30 days ago and within the past 12 months;
- •No HIV-positive test result in the past; and
- •Written informed consent for participation.
排除标准
- •Not 18 or older;
- •Does not present for STI diagnosis;
- •No previous bacterial STI diagnosis in the clinic more than 30 days ago and within the past 12 months;
- •HIV-positive test result in the past; or
- •No written informed consent for participation.
研究组 & 干预措施
Tailored Socio-Contextual Intervention
- Develop strengths based case management intervention using input from interviews with repeat STI patients, consultants, & piloting.
- Recruit/enroll in the intervention 500 subjects (50% women; African American focus).
- After subjects receive STI diagnosis, treatment,& partner notification services, randomly assign subjects to:
A. The STI strengths-based prevention case management, or B. Standard care. 4. Assess participants' risk behavior, determinants of behavior & quality of life. Investigators will assess the incidence of new STI & test the efficacy of the intervention relative to control. 5. Conduct a qualitative evaluation. Investigators will sample repeaters and non-repeaters from the experimental group. 6. Conduct cost effectiveness analyses of intervention compared to the standard.
干预措施: Tailored Socio-Contextual Intervention (Behavioral)
Standard of Care
Currently, the total time spent in an STI exam w/men is 30 minutes & 60 w/women. More time is devoted to patients with sexual assault hx. Reason for the visit, symptoms, STI hx, contraception, condom use, number/gender of partners & number/type of sexual activities are assessed. The nurse takes a health hx and asks about typical HIV risks behavior. Due to time the risk assessment is 5 minutes. A risk reduction kit including condoms is issued. Information includes symptoms/treatment of STI, location of sexual health clinics, location of free condoms & testing/treatment resources. Referral information is provided when needed & more involved w/sexual assault survivors. Partner notification is conducted w/syphilis and HIV. This didactic process follows the medical model.
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
STI Outcome Measures
时间窗: 12 month follow up visit
Investigators wish to assess if patients contracted repeat STIs during the study. 1. Investigators will conduct STI clinic chart abstraction at 12-months post-enrollment to record subsequent episodes of STIs. Because the Milwaukee Health Department electronic STDMIS System includes data from CDC reportable tests conducted elsewhere, investigators will record STIs diagnosed at other sites. 2. Investigators will test for these STIs and HIV at the 12 month follow up visit. 3. Investigators will ask patients to report other STI diagnosed anywhere during the period.
次要结局
- Health-Related Quality of Life(Baseline, 4, 8, 12 month follow ups)
- Social Action Theory-Based Outcome Mediators(Baseline, 4, 8, 12 month follow ups)
- Contextual factors - demographic variables(Baseline, 4, 8, 12 month follow ups)
- STI Risk Behavior Assessment(Baseline, 4, 8, 12 month follow ups)
- Contextual factors - social support(Baseline, 4, 8, 12 month follow ups)
- Contextual factors - general life context(Baseline, 4, 8, 12 month follow ups)
研究者
Lance Weinhardt
Professor of Community and Behavioral Health Promotion
University of Wisconsin, Milwaukee