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

Summary

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.

Conditions

• Sexually Transmitted Infection
• HIV

Interventions

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.

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Wisconsin, Milwaukee

  lead OTHER

Principal Investigators

• Lance S Weinhardt, PhD · UW Milwaukee Zilber School of Public Health & Medical College of Wisconsin Center for AIDS Intervention Research

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2015-06-30

Completion

2016-12-31

Countries

• United States

Study Locations