A Theoretical Framework for STD Epidemiology: From Transmission Dynamics to Program Design

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1 A Theoretical Framework for STD Epidemiology: From Transmission Dynamics to Program Design Kimberley Fox, MD, MPH Director, Global AIDS Program Thailand MOPH U.S. CDC Collaboration Bangkok, Thailand

2 Approaches to prevention of infectious diseases Biomedical Examples: vaccines, preventive therapy Behavioral Examples: handwashing, self-quarantine (ill persons avoid exposure to well persons) Structural Examples: negative pressure air flow in rooms for TB patients, beer tax to lower STD rates

3 Approaches to STD prevention (examples) Biomedical Screening and treatment Vaccines Behavioral Reduce risky sexual exposures (condoms, changes in norms for sexual behaviors, etc.) Structural Ensuring that stores in high-risk areas sell condoms

4 Gonorrhea Reported rates: United States, and the Healthy People year 2010 objective Rate (per 100,000 population) Gonorrhea 2010 Objective Note: The Healthy People 2010 (HP2010) objective for gonorrhea is 19.0 cases per 100,000 population.

5 Sir, the following paradigm shifts occurred while you were out.

6 First we must consider Why do STDs persist in our communities? A mathematical model Ro = β c D Ro = initial rate of secondary cases arising from a case β = efficiency of transmission c = measure of sexual behaviors related to partner change D = duration of infectiousness

7 Determinants of Transmission Efficiency (Ro=BcD) Infectivity or organism load of pathogen Co-infections Circumcision, cervical ectopy (susceptibility of host) Condoms, microbicides, other barriers

8 Estimates of Key Epidemiologic Parameters Necessary to Sustain Transmission of Five Different STDs (c=1/ßd) AGENT DURATION OF INFECTIOUSNESS (D) IN YEARS TRANSMISSION EFFICIENCY (ß) PER PARTNERSHIP MEAN PARTNER CHANGE RATE (c) PER YEAR N. gonorrhoeae No control 0.5 Control 0.5 C. trachomatis 0.2 T. pallidum No control Control HIV African parameters American parameters Haemophilus ducreyi 0.8 Produced from data collected by Brunham and Plummer, 1990

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10 A model of sexual transmission of HIV /10,000-1/1000 HIV RNA in Semen (Log10 copies/ml) 2? Transmission Threshold? 1/500-1/3 Stage of Disease Risk of Transmission 1/1000-1/100 1/50 Seroconversion Asymptomatic HIV Progression AIDS

11 High viral load in primary infection: a triple threat? Early Infection Chronic Infection Late Infection Biologic: HIV viral load Behavioral: unprotected sex Social: networks of high-risk persons According to mathematical models (Fraser 2006), the proportion of transmission that results from each stage of the disease is: Primary infection: 12% Asymptomatic chronic infection: 71% AIDS: 17% Although infectiousness is higher during early and late infection, the asymptomatic period is much longer.

12 Biologic evidence for STIs as co-factors for HIV transmission Presence of STI Increase in HIV infectiousness Increase in viral load in genital secretions Increase in susceptibility to HIV Disruption of epithelial barrier Increase in HIV-receptive cells Increase in receptors expressed per cell

13 Magnitude of the risk in epidemiologic studies 2- to 10-fold increased risk of HIV infection in persons with syphilis 2- to 8.5-fold increase in persons with HSV-2 2- to 9-fold increase in persons with gonorrhea, chlamydia, or trichomonas

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15 Levine, et al. J Infect Dis, 1998

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17 A model of sexual transmission of HIV /10,000-1/1000 HIV RNA in Semen (Log10 copies/ml) 2? Transmission Threshold? 1/500-1/3 Stage of Disease Risk of Transmission 1/1000-1/100 1/50 Seroconversion Asymptomatic HIV Progression AIDS

18 Effect of other STDs on sexual transmission of HIV (theoretical) STD Antibiotic Therapy HIV RNA in Semen (Log10 copies) Seroconversion Asymptomatic HIV Progression AIDS 2 Stage of Disease

19 Biological mechanisms for HIV transmission in uncircumcised men Foreskin susceptible to tears and abrasions Foreskin provides a mucosal environment conducive to survival of HIV and contains high densities of HIV target cells Circumcised glans penis protected by keratinized epithelium

20

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22 Determininants of Sexual Behaviors (Ro=BcD) Cultural and contextual norms Substance use (alcohol, illicit drugs) Economic pressures Gender-based hierarchical relationships

23 Lifetime STIs, by Number of Sex Partners since Age Eighteen (cases per 1,000) Partners since age Gonorrhea Syphillis Chlamydia

24 Distribution of Number of New Sexual Partners in Last Year

25 Individual-Level Factors that May Contribute to c Number of partners Rate of acquiring new partners Casual partners Sexual practices (dry sex, anal sex)

26 Core Groups for Selected STDs Chlamydia Gonorrhea Syphilis Chancroid

27 Gonorrhea as a Social Disease J. Potterat It s not how many partners, but who they are that counts

28 Source: MC Boily et al, The Network Matters

29 The Network Structure Can accelerate risk or protective behaviors for some people It can make the same behavior more or less risky depending on where an individual is located in the network. Provides a roadmap for where infection is going to travel Source: T. Valente, 2002.

30 Assortativeness Matters, Too Source: MC Boily et al, 2000.

31 And Then You Do the Calculations Source: MC Boily et al, 2000.

32 What do Asian HIV epidemics look like? FSW Clients Low or no risk males Multiple interlinked epidemics in higher risk populations MSM Low or no risk females IDUs Source: T. Brown, 2003

33 Males visiting sex workers in last year Country Percent clients Year Thailand 22% 10% 1990/1993 Cambodia 13% 2000 Japan 11% 1999 Philippines 7% 2000 Hong Kong/ 5% Early 1990s Singapore Conclusion: from 7 to 25% at risk of HIV Source: T. Brown, 2003

34 The number of clients largely explains differences in speed & severity Asian Epidemic Model Percent of adults living with HIV % 10% 20% male clients Source: T. Brown, 2006

35 Why were Thailand & Cambodia so serious? Asian Epidemic Model: 20% male clients with 0.8% females FSW Percent HIV By 2030, 23% of males, 8.6% of females HIV IDU FSW Gen male Gen female MSM Source: T. Brown, 2006

36 Determinants of Duration of Infectiousness (Ro=BcD) Natural history of infection Health care services quality accessibility Referral to services by partner or health care provider Health care seeking behaviors

37 STD Clinic Patient Survey, North Carolina: Duration of Symptoms Before Visit All Male Female Median number of days

38 Barriers to Access: STD Clinic in North Carolina 25 Percent of patients Waiting time Transp. Clinic hours Can't get appt. Not comf. Child care

39 STD Clinic Patient Survey, North Carolina Waiting Time Before Talking to Nurse or Doctor Percent of patients Median waiting time: 20 minutes

40 STD Clinic Patient Survey, North Carolina: Duration of Symptoms According to Mode of Transportation Car Median 5 days 27.9% waited more than one week Friend/Bus/Taxi/Walk Median 7 days 38.5% waited more than one week

41 Prevalences of Gonorrhea, Chlamydia, Syphilis, and HIV among NC Migrant Farmworkers Gonorrhea Chlamydia Syphilis (RPR &FTA+) Syphilis, ever (FTA+) HIV

42 Prevalences of Gonorrhea and Chlamydial Infection among Incarcerated Male Youth in NC Gonorrhea Chlamydia Syphilis (RPR & FTA+)

43 Quality of Services STD treatment with the wrong antibiotic doesn t reduce D Getting treatment right involves good history-taking, examination, and testing (when available), and using recommended treatment Antibiotic resistance may need to be considered

44 Gonococcal Isolate Surveillance Project (GISP) Percent of Neisseria gonorrhoeae isolates with decreased susceptibility or resistance to ciprofloxacin, Percent Decreased susc. Resistance Note: Resistant isolates have ciprofloxacin MICs >1 μg/ml. Isolates with decreased susceptibility have ciprofloxacin MICs of μg/ml. There were sixty-one (61) resistant isolates: one in 1991, one in 1993, two in 1994, eight in 1995, two in 1996, five in 1997, four in 1998, nineteen in 1999, and nineteen in Susceptibility to ciprofloxacin was first measured in GISP in 1990.

45 Estimates of Key Epidemiologic Parameters Necessary to Sustain Transmission of Five Different STDs (c=1/ßd) AGENT DURATION OF INFECTIOUSNESS (D) IN YEARS TRANSMISSION EFFICIENCY (ß) PER PARTNERSHIP MEAN PARTNER CHANGE RATE (c) PER YEAR N. gonorrhoeae No control Control C. trachomatis T. pallidum No control Control HIV African parameters American parameters Haemophilus ducreyi Source: Brunham and Plummer, 1990

46 Estimates of Key Epidemiologic Parameters Necessary to Sustain Transmission of Five Different STDs (c=1/ßd) AGENT DURATION OF INFECTIOUSNESS (D) IN YEARS TRANSMISSION EFFICIENCY (ß) PER PARTNERSHIP MEAN PARTNER CHANGE RATE (c) PER YEAR N. gonorrhoeae No control Control C. trachomatis T. pallidum No control Control HIV African parameters American parameters Haemophilus ducreyi Source: Brunham and Plummer, 1990

47 Without Antiretroviral Therapy HIV incidence HIV prevalence HIV-related deaths

48 With Antiretroviral Therapy HIV incidence HIV prevalence HIV-related deaths

49 ARV treatment scale-up (NAPHA) will Number of infection increase the prevalence of HIV 800, , , , , , , , Source: T. Brown, 2006 NO NAPHA Baseline (with NAPHA)

50 So now we re back to Why do STDs persist in our communities? (What makes Ro >1?) Ro = β c D Ro = initial rate of secondary cases arising from a case β = efficiency of transmission c = measure of sexual behaviors related to partner change D = duration of infectiousness

51 Core Groups for Selected STDs Chlamydia Gonorrhea Syphilis Chancroid

52 Geographic Core Areas Source: J. Potterat, 1985

53 Spatial Analysis The Spread of Disease Is Unavoidably Spatial EE Holmes Infection moves from individual to individual following a network of contacts within a population Local transmission Global (long-distance) transmission Bridge contacts

54 Geographic Information Systems Spatial data are stored in a map layer Data referenced to location on the earth's surface Source: D. Law, 2001

55 Geographic Distribution of STDs Case distribution No context Source: D. Law, 2001

56 Source: D. Law, 2001

57 Source: D. Law, 2001

58 Source: D. Law, 2001 Syphilis Distribution

59 Demographic and Social Factors Affecting c (behaviors) and D (services) Age structure and sex ratio of population Rapid demographic change Population growth Migration Shift from agricultural to wage-based economy Poverty Unstable power hierarchies

60 OUTBREAK INVESTIGATION Syphilis in Dade County

61 Infectious Syphilis in Miami-Dade County, Florida through June MSM Heterosexual men Women

62 Outbreak Investigation Objective(s) The investigation Case-control design: who are controls? What other sources of information might be useful? Laboratory studies? Questionnaire: what do you want to know?

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64 A Theoretical Framework for STD Epidemiology: From Transmission Dynamics to Program Design Part II

65 Role of STD Outbreak Investigations in STD Control Confirm the existence of a suspected outbreak Assess the extent of under reporting Determine risk factors for increased transmission Assess extent of emerging antimicrobial resistance Describe STD/HIV interrelationships in the setting of acute increases in morbidity Provide data for improving local STD/HIV prevention and control strategies

66 Methods for STD Outbreak Investigations Patient interviews, focus groups, and qualitative community assessment Detailed review of medical and laboratory records Retrospective and prospective case-control studies Intensive use of laboratory testing, including new diagnostic tests

67 Using a Theoretical Framework to Design STD and HIV Prevention Programs

68 Approaches to STD prevention: Decreasing transmission efficiency (Ro=βcD) Male condoms (HIV, gonorrhea) Female condoms (maybe) make condoms available, affordable, and appealing (normative) Microbicides (maybe) Reduce vaginal douching, which washes away normal flora Decrease efficiency of HIV transmission by treating other STDs

69 Condoms only work if they re used Must be: Available Affordable Appealing (normative)

70 Topical microbicides: 2 nd generation products and the future Viral Target Free virus Fusion/Attachment Reverse transcription Microbicide Savvy BufferGel PRO2000 Cellulose sulfate Tenofovir candidates in preclinical development 14 products in early safety trials 5 products in large-scale efficacy trials (first results expected in 2007) Microbicide could be commercially available by 2010

71 Randomized trial of circumcision in South Africa (ANRS trial) Number of subjects (ages 15-24y) Number of HIV acquisitions Acquisition rate per 100 personyears Control group Circumcision Relative risk = 0.4 (60% protection) Aubert et al, 2005.

72 Circumcision: Unresolved issues Efficacy in other populations and settings Impact of hygiene on transmission Age at circumcision Acceptability Feasibility Operations Safety

73 Genital herpes (HSV-2) and HIV prevention HSV-2 may account for up to 74% of new HIV infections in men and 22% in women in some populations (del Mar Pujades Rodriguez M et al. AIDS 2002;16:451-62) Two large placebo-controlled trials of HSV suppression for HIV prevention are ongoing: NIH study at 9 global sites, high-risk women and MSM, results 2007 Partners in Prevention, 14 sub-saharan African sites, discordant couples, results 2008

74 Antiretroviral (ARV) therapy as prevention Mechanisms In HIV-infected persons, reduces viral load In HIV-negative persons, prevents HIV infection of cells or replication in cells Uses PMTCT (for mother and child) proven effective HIV-infected persons some evidence Pre- and post-exposure prophylaxis under study

75 Rationale for pre- and post-exposure prophylaxis (PrEP) trials with tenofovir Nucleotide reverse transcriptase inhibitor Licensed by U.S. FDA for treatment of HIV Long half-life allowing once daily dosing Phase II/III studies safe and effective Prevents HIV infection in animal models Minimal drug-drug interactions Few resistance mutations Studies underway USA: gay men Thailand: injecting drug users West Africa: high-risk women

76 What s next for tenofovir PrEP? Combination tenofovir and FTC (Truvada) is being studied in: Botswana (young men and women) Peru (gay men) Scale-up issues Expansion beyond motivated study participants (how to find target group, adherence with/without DOT) Cost (who will benefit most from it?) Potential for resistance (how to treat persons who become infected while on tenofovir PrEP?)

77 Biomedical interventions: A note of caution Randomized controlled trial in South Africa has shown 60% lower incidence of HIV in circumcised men (reported 2005) According to transmission models, the benefit of circumcision to the man would be overcome by a 30% increase in risk behavior Similar concerns have been raised for other incompletely protective interventions: vaccines pre-exposure prophylaxis (maybe)

78 Approaches to STD prevention: Changing sexual behaviors (Ro= βcd) Desirable behavior changes increasing condom use delaying initiation of sexual intercourse reducing number of sexual partners Types of interventions individual-focused (enhanced counseling) community-level (peer opinion leaders) mass media messages

79 Increasing condom use turns epidemics around Percent of adults living with HIV % 40% 50% 60% 70% 80% condom use in sex work Source: T. Brown, 2006

80 In Thailand, focused prevention altered the course of the HIV epidemic C urrent H IV Infections in m illions Red line represents what might have been if behaviors had not changed in Thailand Infections prevented Source: T. Brown, 2006 With behavior change Without prevention

81 Sexual Network:Syphilis Among MSM in Miami-Dade County, Florida H H Syphilis Status H Uninfected Primary Secondary Early Latent H Known HIV positive

82 Can we use network information for health promotion? With complete information we could implement prophylaxis Can use it to change community norms Can use it to decide who should be the focus of interventions and how to segment the audience Source: T. Valente, 2002.

83 Network Data Types Network Data Type Instrument Result Survey Ego centric Sequential/ snowballing Sociometric Had sex the past 6 months? Provide first names of people had sex with? Contact trace recent sexual partners Ask for names of sexual partners Dichotomous Risk - Yes/NO Characterize sexual partners Identify specific individuals at risk Map sexual/ social network Locations Where had sex? Locate sites of opportunity & infection

84 Opinion Leaders: Individuals Who Receive the Most Nominations

85 Opinion Leaders Promoting Positive Behavior Change

86 Approaches to STD prevention: Reducing duration of infectiousness (Ro= βcd) Treatment of infected patients Treatment of sexual partners and suspects Screening to identify asymptomatic or latent infections (better for curable bacterial infections than for viral infections) Screening of pregnant women to prevent transmission to fetus/neonate Health services must be: high quality, accessible, affordable

87 Treatment of Exposed Persons (Sexual Partners) Patient or health care provider tells partner(s) that they need treatment Pre-emptive treatment Patient-provided partner therapy reduces rates of reinfection (azithromycin for chlamydial infection; Schillinger et al)

88 Screening Works But Has Limits

89 Region X Chlamydia positivity in year old women in family planning clinics, Percent Positive AK WA 0 OR ID Unadjusted Adjusted

90 Rescreening vs. Routine Testing of STD Patients Rescreening hin a recent study, 12% of rescreened patients had an STD (gonorrhea, chlamydia, syphilis, or HIV) hanother large study found 15% rate of reinfection with chlamydia among young women within 4 months (Schillinger et al) Routine testing hgonorrhea positivity rates 0.1%-4.5% (young women) hchlamydia positivity rates 2.8%-15.8% (young women)

91 Source: D. Law, 2001

92 Applications of Kriging to STD Prevention Estimate rate of STD over a continuous surface Evaluate spatial spread of STD through time Refine geographic descriptions of core, adjacent, periphery, etc. in urban areas Identify locations for resource allocation and interventions

93

94 STD intervention in Mwanza trial STD reference center in Mwanza town Training of health workers in syndromic treatment, health education, condom promotion Regular supply of effective STD drugs Regular supervisory visits to health centers Periodic visits to villages by health educators to promote treatment for symptomatic STDs

95

96 Factors possibly affecting impact of STI treatment on HIV infection Stage of the HIV epidemic Differences in proportional incidence of curable STIs (i.e., bacterial versus viral) Differences in incidence of STIs most strongly associated with HIV transmission (gonorrhea, syphilis, herpes, other ulcerative diseases) Symptomatic versus asymptomatic infection

97 Epidemics Evolve

98 Extensive prevention alters the course & creates a moving target HIV cases in Thailand 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Extramarital Female from Husband Sex worker Male from wife Male from sex worker Male sex with male Injection Drug User 0% Source: T. Brown, 2006

99 Preventing STDs and Sexually Transmitted HIV: Summary Three key factors maintain the circulation of STDs and sexually transmitted HIV Efficiency of transmission Sexual behaviors Duration of infectiousness Interventions can be designed to address these factors Biomedical interventions tend to address B Reducing risk behaviors and addressing access to quality health services remain critical in controlling STDs and preventing HIV spread

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