Sexually Transmitted InfectionNCT01510262

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

A study testing Tailored Socio-Contextual Intervention in people with Sexually Transmitted Infection and HIV, run by University of Wisconsin, Milwaukee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sexually Transmitted Infection, HIV
What is being tested?: Tailored Socio-Contextual Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Milwaukee - Zilber School of Public Health
Milwaukee, Wisconsin, 53201

Other trials in United States

About this study

Official title: Repeat STI Patients: Tailored Socio-Contextual Intervention to Reduce HIV Risk

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.

Read the 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.

Conditions: Sexually Transmitted Infection, HIV
Being tested: Tailored Socio-Contextual Intervention, Standard of Care
Keywords: Repeat STI patients, HIV, Cost effectiveness, Resource scarce, Urban clinics
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tailored Socio-Contextual InterventionBehavioural
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:
4. The STI strengths-based prevention case management, or B. Standard care.
5. 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.
6. Conduct a qualitative evaluation. Investigators will sample repeaters and non-repeaters from the experimental group.
7. Conduct cost effectiveness analyses of intervention compared to the standard.
Standard of CareBehavioural
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.

Study groups in NCT01510262
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 month follow up visit

Secondary outcomes (6)

Health-Related Quality of Life
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.
Measured: Baseline, 4, 8, 12 month follow ups
Social Action Theory-Based Outcome Mediators
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.
Measured: Baseline, 4, 8, 12 month follow ups
Contextual factors - demographic variables
Demographic variables such as income, housing situation, relationship status, education level, and employment status will be used to characterize participants' economic and social circumstances.
Measured: Baseline, 4, 8, 12 month follow ups
STI Risk Behavior Assessment
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.
Measured: Baseline, 4, 8, 12 month follow ups
Contextual factors - general life context
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.
Measured: Baseline, 4, 8, 12 month follow ups
Contextual factors - social support
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.
Measured: Baseline, 4, 8, 12 month follow ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Dec 2016

First posted16 Jan 2012 (estimated)
Study startApr 2012
Primary completionJun 2015
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01510262
Sponsor's protocol ID: 3257547
Other IDs: R01MH089129-01A1
Status last verified: Oct 2017
First submitted: 5 Jan 2012
Last updated: 27 Oct 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 11368817
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.
PubMed 16385217
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.
PubMed 1958012
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.
PubMed 9918320
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.
PubMed 15716561
Gorsky RD. A method to measure the costs of counseling for HIV prevention. Public Health Rep. 1996;111 Suppl 1(Suppl 1):115-22.
PubMed 8862166
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.
PubMed 10907910
Hall JM, Stevens PE. Rigor in feminist research. ANS Adv Nurs Sci. 1991 Mar;13(3):16-29. doi: 10.1097/00012272-199103000-00005.
PubMed 1901470
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.
PubMed 9377126
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.
PubMed 9385717
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.
PubMed 19064372
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.
PubMed 11483124
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.
PubMed 10894291
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.
PubMed 19363651
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.
PubMed 17028993

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Sexually Transmitted Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repeat STI Patients: Tailored Socio-Contextual Intervention to Reduce HIV Risk
ClinicalTrials.gov ID: NCT01510262
Acronym / sponsor ID: 3257547
Conditions: Sexually Transmitted Infection, HIV
Keywords: Repeat STI patients, HIV, Cost effectiveness, Resource scarce, Urban clinics
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: University of Wisconsin, MilwaukeeUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Apr 2012 (actual)
Primary completion: Jun 2015 (actual)
Study completion: Dec 2016 (actual)
First posted: 16 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Tailored Socio-Contextual Intervention	Experimental	Behavioral: Tailored Socio-Contextual Intervention1. 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	Active comparator	Behavioral: Standard of CareCurrently, 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tailored Socio-Contextual Intervention1. 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.	Behavioural	Tailored Socio-Contextual Intervention
Standard of CareCurrently, 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.	Behavioural	Standard of Care

Primary outcome

STI Outcome Measures
Time frame: 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.

6 secondary outcomes

Health-Related Quality of Life
Time frame: Baseline, 4, 8, 12 month follow ups
Social Action Theory-Based Outcome Mediators
Time frame: Baseline, 4, 8, 12 month follow ups
Contextual factors - demographic variables
Time frame: Baseline, 4, 8, 12 month follow ups
STI Risk Behavior Assessment
Time frame: Baseline, 4, 8, 12 month follow ups
Contextual factors - general life context
Time frame: Baseline, 4, 8, 12 month follow ups
Contextual factors - social support
Time frame: Baseline, 4, 8, 12 month follow ups

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
Background: PubMed 11368817Carey 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.
Background: PubMed 16385217Ellen 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.
Background: PubMed 1958012Ewart 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.
Background: PubMed 9918320Fortenberry 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.
Background: PubMed 15716561Golden 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.
Background: PubMed 8862166Gorsky RD. A method to measure the costs of counseling for HIV prevention. Public Health Rep. 1996;111 Suppl 1(Suppl 1):115-22.
Background: PubMed 10907910Gunn 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.
Background: PubMed 1901470Hall JM, Stevens PE. Rigor in feminist research. ANS Adv Nurs Sci. 1991 Mar;13(3):16-29. doi: 10.1097/00012272-199103000-00005.
Background: PubMed 9377126Holtgrave 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.
Background: PubMed 9385717Macias 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.
Background: PubMed 19064372Mosack 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.
Background: PubMed 11483124Orr 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lance S Weinhardt, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tailored Socio-Contextual Intervention in people with Sexually Transmitted Infection and HIV, run by University of Wisconsin, Milwaukee at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

STI Outcome Measures (time frame: 12 month follow up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01510262, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.