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

NCT01510262 | Completed

• 2 other identifiers: 3257547R01MH089129-01A1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Repeat STI patients; HIV; Cost effectiveness; Resource scarce; Urban clinics

Outcome Measures

Primary Outcomes (1)

• STI Outcome Measures

  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.

  12 month follow up visit

Secondary Outcomes (6)

• 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 - general life context

  Baseline, 4, 8, 12 month follow ups

Study Arms (2)

Tailored Socio-Contextual Intervention

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Tailored Socio-Contextual Intervention BEHAVIORAL

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

Standard of Care BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Wisconsin Milwaukee - Zilber School of Public Health

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (21)

• Carey MP, Carey KB, Maisto SA, Gordon CM, Weinhardt LS. Assessing sexual risk behaviour with the Timeline Followback (TLFB) approach: continued development and psychometric evaluation with psychiatric outpatients. Int J STD AIDS. 2001 Jun;12(6):365-75. doi: 10.1258/0956462011923309.

  PMID: 11368817 BACKGROUND

• Ellen JM, Gaydos C, Chung SE, Willard N, Lloyd LV, Rietmeijer CA. Sex partner selection, social networks, and repeat sexually transmitted infections in young men: a preliminary report. Sex Transm Dis. 2006 Jan;33(1):18-21. doi: 10.1097/01.olq.0000187213.07551.a6.

  PMID: 16385217 BACKGROUND

• Ewart CK. Social action theory for a public health psychology. Am Psychol. 1991 Sep;46(9):931-46. doi: 10.1037//0003-066x.46.9.931.

  PMID: 1958012 BACKGROUND

• Fortenberry JD, Brizendine EJ, Katz BP, Wools KK, Blythe MJ, Orr DP. Subsequent sexually transmitted infections among adolescent women with genital infection due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Trichomonas vaginalis. Sex Transm Dis. 1999 Jan;26(1):26-32. doi: 10.1097/00007435-199901000-00005.

  PMID: 9918320 BACKGROUND

• Golden MR, Whittington WL, Handsfield HH, Hughes JP, Stamm WE, Hogben M, Clark A, Malinski C, Helmers JR, Thomas KK, Holmes KK. Effect of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med. 2005 Feb 17;352(7):676-85. doi: 10.1056/NEJMoa041681.

  PMID: 15716561 BACKGROUND

• Gorsky RD. A method to measure the costs of counseling for HIV prevention. Public Health Rep. 1996;111 Suppl 1(Suppl 1):115-22.

  PMID: 8862166 BACKGROUND

• Gunn RA, Fitzgerald S, Aral SO. Sexually transmitted disease clinic clients at risk for subsequent gonorrhea and chlamydia infections: possible 'core' transmitters. Sex Transm Dis. 2000 Jul;27(6):343-9. doi: 10.1097/00007435-200007000-00008.

  PMID: 10907910 BACKGROUND

• Hall JM, Stevens PE. Rigor in feminist research. ANS Adv Nurs Sci. 1991 Mar;13(3):16-29. doi: 10.1097/00012272-199103000-00005.

  PMID: 1901470 BACKGROUND

• Holtgrave DR, Pinkerton SD. Updates of cost of illness and quality of life estimates for use in economic evaluations of HIV prevention programs. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Sep 1;16(1):54-62. doi: 10.1097/00042560-199709010-00009.

  PMID: 9377126 BACKGROUND

• Macias C, Farley OW, Jackson R, Kinney R. Case management in the context of capitation financing: an evaluation of the strengths model. Adm Policy Ment Health. 1997 Jul;24(6):535-43. doi: 10.1007/BF02042831. No abstract available.

  PMID: 9385717 BACKGROUND

• 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.

  PMID: 19064372 BACKGROUND

• Orr DP, Johnston K, Brizendine E, Katz B, Fortenberry JD. Subsequent sexually transmitted infection in urban adolescents and young adults. Arch Pediatr Adolesc Med. 2001 Aug;155(8):947-53. doi: 10.1001/archpedi.155.8.947.

  PMID: 11483124 BACKGROUND

• Pinkerton SD, Holtgrave DR, DiFranceisco W, Semaan S, Coyle SL, Johnson-Masotti AP. Cost-threshold analyses of the National AIDS Demonstration Research HIV prevention interventions. AIDS. 2000 Jun 16;14(9):1257-68. doi: 10.1097/00002030-200006160-00024.

  PMID: 10894291 BACKGROUND

• Weinhardt LS, Galvao LW, Stevens PE, Masanjala WH, Bryant C, Ng'ombe T. Broadening research on microfinance and related strategies for HIV prevention: commentary on Dworkin and Blankenship (2009). AIDS Behav. 2009 Jun;13(3):470-3. doi: 10.1007/s10461-009-9561-y. Epub 2009 Apr 11. No abstract available.

  PMID: 19363651 BACKGROUND

• Weinhardt LS, Mosack KE, Swain GR. Development of a computer-based risk-reduction counseling intervention: acceptability and preferences among low-income patients at an urban sexually transmitted infection clinic. AIDS Behav. 2007 Jul;11(4):549-56. doi: 10.1007/s10461-006-9163-x. Epub 2006 Sep 22.

  PMID: 17028993 BACKGROUND

• Weinhardt LS, Kelly JA, Brondino MJ, Rotheram-Borus MJ, Kirshenbaum SB, Chesney MA, Remien RH, Morin SF, Lightfoot M, Ehrhardt AA, Johnson MO, Catz SL, Pinkerton SD, Benotsch EG, Hong D, Gore-Felton C; National Institute of Mental Health Healthy Living Project Team. HIV transmission risk behavior among men and women living with HIV in 4 cities in the United States. J Acquir Immune Defic Syndr. 2004 Aug 15;36(5):1057-66. doi: 10.1097/00126334-200408150-00009.

  PMID: 15247559 BACKGROUND

• Shain RN, Piper JM, Newton ER, Perdue ST, Ramos R, Champion JD, Guerra FA. A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women. N Engl J Med. 1999 Jan 14;340(2):93-100. doi: 10.1056/NEJM199901143400203.

  PMID: 9887160 BACKGROUND

• Hosenfeld CB, Workowski KA, Berman S, Zaidi A, Dyson J, Mosure D, Bolan G, Bauer HM. Repeat infection with Chlamydia and gonorrhea among females: a systematic review of the literature. Sex Transm Dis. 2009 Aug;36(8):478-89. doi: 10.1097/OLQ.0b013e3181a2a933.

  PMID: 19617871 BACKGROUND

• Warner L, Klausner JD, Rietmeijer CA, Malotte CK, O'Donnell L, Margolis AD, Greenwood GL, Richardson D, Vrungos S, O'Donnell CR, Borkowf CB; Safe in the City Study Group. Effect of a brief video intervention on incident infection among patients attending sexually transmitted disease clinics. PLoS Med. 2008 Jun 24;5(6):e135. doi: 10.1371/journal.pmed.0050135.

  PMID: 18578564 BACKGROUND

• Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.

  PMID: 1594721 BACKGROUND

• Cutrona CE. Ratings of social support by adolescents and adult informants: degree of correspondence and prediction of depressive symptoms. J Pers Soc Psychol. 1989 Oct;57(4):723-30. doi: 10.1037//0022-3514.57.4.723.

  PMID: 2795439 BACKGROUND

Related Links

• Co-PI's Home Institution

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lance S Weinhardt, PhD

  UW Milwaukee Zilber School of Public Health & Medical College of Wisconsin Center for AIDS Intervention Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Community and Behavioral Health Promotion

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 16, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

US (1)