Repeat Sexually Transmitted Infection (STI) Patients: Tailored Socio-Contextual Intervention to Reduce HIV Risk
NCT ID: NCT01510262
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2012-04-30
2016-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Tailored Socio-Contextual Intervention
1. Develop strengths based case management intervention using input from interviews with repeat STI patients, consultants, \& piloting.
2. Recruit/enroll in the intervention 500 subjects (50% women; African American focus).
3. 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.
Tailored Socio-Contextual Intervention
1. Develop strengths based case management intervention using input from interviews with repeat STI patients, consultants, \& piloting.
2. Recruit/enroll in the intervention 500 subjects (50% women; African American focus).
3. 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.
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.
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.
Interventions
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Tailored Socio-Contextual Intervention
1. Develop strengths based case management intervention using input from interviews with repeat STI patients, consultants, \& piloting.
2. Recruit/enroll in the intervention 500 subjects (50% women; African American focus).
3. 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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Wisconsin, Milwaukee
OTHER
Responsible Party
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Lance Weinhardt
Professor of Community and Behavioral Health Promotion
Principal Investigators
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Lance S Weinhardt, PhD
Role: PRINCIPAL_INVESTIGATOR
UW Milwaukee Zilber School of Public Health & Medical College of Wisconsin Center for AIDS Intervention Research
Locations
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University of Wisconsin Milwaukee - Zilber School of Public Health
Milwaukee, Wisconsin, United States
Countries
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References
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Mosack KE, Weinhardt LS, Kelly JA, Gore-Felton C, McAuliffe TL, Johnson MO, Remien RH, Rotheram-Borus MJ, Ehrhardt AA, Chesney MA, Morin SF. Influence of coping, social support, and depression on subjective health status among HIV-positive adults with different sexual identities. Behav Med. 2009 Winter;34(4):133-44. doi: 10.3200/BMED.34.4.133-144.
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Related Links
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Co-PI's Home Institution
Other Identifiers
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3257547
Identifier Type: -
Identifier Source: org_study_id