Repeat Sexually Transmitted Infection (STI) Patients: Tailored Socio-Contextual Intervention to Reduce HIV Risk

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by University of Wisconsin, Milwaukee
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lance Weinhardt, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier:
NCT01510262
First received: January 5, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Sexually Transmitted Infection
HIV
Behavioral: Tailored Socio-Contextual Intervention
Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Repeat STI Patients: Tailored Socio-Contextual Intervention to Reduce HIV Risk

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Milwaukee:

Primary Outcome Measures:
  • STI Outcome Measures [ Time Frame: 12 month follow up visit ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Health-Related Quality of Life [ Time Frame: Baseline, 4, 8, 12 month follow ups ] [ Designated as safety issue: No ]
    Investigators will use the SF-36 version 2 (Quality Metric, 2008) to measure participants' quality of life as a secondary outcome. The 36-item scale assesses eight areas of physical and mental health: physical functioning, impact on physical roles, bodily pain, general health, vitality,social functioning, impacts of emotional factors on social roles, and mental health. The scale and its predecessor, the SF-36, have undergone extensive psychometric development.

  • Social Action Theory-Based Outcome Mediators [ Time Frame: Baseline, 4, 8, 12 month follow ups ] [ Designated as safety issue: No ]
    Investigators will assess the action states component of SAT, using a sexual risk reduction specific conceptualization, based on the Information-Motivation-Behavioral Skills model of Fisher & Fisher (1992). Investigators will assess social problem solving style to indicate more general self-regulation skills. Investigators will also assess HIV risk prevention knowledge, HIV risk behavior change motivation, HIV risk reduction skill and self-efficacy, problem solving, life optimism, fatalism, self-esteem, and health related locus of control.

  • Contextual factors - demographic variables [ Time Frame: Baseline, 4, 8, 12 month follow ups ] [ Designated as safety issue: No ]
    Demographic variables such as income, housing situation, relationship status, education level, and employment status will be used to characterize participants' economic and social circumstances.

  • STI Risk Behavior Assessment [ Time Frame: Baseline, 4, 8, 12 month follow ups ] [ Designated as safety issue: No ]
    Sexual risk behavior will be assessed with a Timeline Followback (TLFB) interview. First, the participant is presented with a calendar and asked to identify days that are personally significant. Second, the investigator defines sex in language understandable & consistent with guidelines. Third, the participant is asked to provide initials of all partners during the reporting period. For each, information is requested (sex; primary, casual, anonymous, HIV positive, IDU, or non-monogamous). Fourth, for each occasion of sexual activity, type of sex, condom use, and AODA are assessed.

  • Contextual factors - general life context [ Time Frame: Baseline, 4, 8, 12 month follow ups ] [ Designated as safety issue: No ]
    Social Context Inventory. Investigators will use a list of 54 commonly-experienced social and health issues, adapted from Carey et al., (1999), rated on a scale from 0 (not bothered) to 4 (bothered every day) to identify the salient problems faced by each participant at baseline. Because participants will present with a wide range of challenges beyond the STI, and the SBPCM intervention will focus on helping participants address areas that participants select, this measure will assess progress on goals set in intervention sessions.

  • Contextual factors - social support [ Time Frame: Baseline, 4, 8, 12 month follow ups ] [ Designated as safety issue: No ]
    The Social Provisions Scale (Cutrona, 1989) will be used to assess level, type, and satisfaction with available social supports. The global score is the average of 6 subscales: guidance, reliable alliance, worth reassurance, attachment, social integration, and opportunity for nurturance.


Estimated Enrollment: 500
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510262

Contacts
Contact: Lance S Weinhardt, PhD 414-229-5126 weinhard@uwm.edu
Contact: Kristin Hackl, MSW 414-955-7700. khackl@mcw.edu

Locations
United States, Wisconsin
University of Wisconsin Milwaukee - Zilber School of Public Health Not yet recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Lance S Weinhardt, PhD    414-229-5126    weinhard@uwm.edu   
Contact: Kristin Hackl, MSW    414-955-7700    khackl@mcw.edu   
Principal Investigator: Lance S Weinhardt, PhD         
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Investigators
Principal Investigator: Lance S Weinhardt, PhD UW Milwaukee Zilber School of Public Health & Medical College of Wisconsin Center for AIDS Intervention Research
  More Information

Additional Information:
Publications:

Responsible Party: Lance Weinhardt, Professor of Community and Behavioral Health Promotion, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT01510262     History of Changes
Other Study ID Numbers: 3257547, R01MH089129-01A1
Study First Received: January 5, 2012
Last Updated: January 13, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Wisconsin, Milwaukee:
Repeat STI patients
HIV
Cost effectiveness
Resource scarce
Urban clinics

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 29, 2014