9.10. Sexually Transmitted Diseases (STIs)

Standard Operating Procedure for Surveillance of Sexually Transmitted Diseases (STIs) 

Effective Date: [Date]

Version: 1.0

Prepared by: [Name/Department]

Approved by: [Name/Department]

SEXUALLY TRANSMITTED INFECTIONS

Overview

Sexually transmitted infections (STIs) are a cause of considerable morbidity and have a huge impact on sexual and reproductive health worldwide. If HIV / AIDS is included, this group of diseases ranks among the five most important causes of healthy years of life lost in developing countries. 

Several viruses, bacteria and parasites are transmitted through sexual contact; however, eight in particular are responsible for the greatest incidence of STIs. Of these eight pathogens, four are curable: gonorrhoea, chlamydia, syphilis and trichomoniasis. The other four are viral pathogens which are incurable: HIV, hepatitis B, herpes simplex virus and human papillomavirus (HPV). Treatment of the viral infections is intended to either alleviate symptoms or modify the disease.

STIs are transmitted mainly by sexual contact, including vaginal, anal and oral sex. Some STIs are also spread through non-sexual means such as by blood or blood products. Several STIs can also be transmitted from mother to child during pregnancy and childbirth (e.g. HIV, hepatitis B, herpes, HPV, syphilis, chlamydia and gonorrhoea. STIs may be asymptomatic in some individuals. 

CHLAMYDIA

Chlamydia trachomatis infection can cause cervicitis, acute salpingitis, urethritis, epididymitis, or other diseases; however, the infection may be asymptomatic in women. Inclusion conjunctivitis and pneumonia in newborns can occur when the infection is acquired perinatally. C. trachomatis also causes trachoma and lymphogranuloma venereum.

The incubation period after sexual exposure is 5–7 days following which there may be a urethral discharge in males, and inapparent infection in females leading to cervicitis and salpingitis. Infection does not confer protection and re-infection is possible.

Surveillance Procedures: 

Step 1: Case Detection/ Laboratory Confirmation and Reporting – Healthcare Providers / Laboratory Personnel 

Immediately report all confirmed cases to the STI unit. (Note (Healthcare Providers): Patient notes should be submitted to STI unit as needed for proper follow up.) 

Case definition

Suspected case: Chlamydia may be suspected if one of the following is present:

• In males
  • Opaque urethral discharge
  • Urethral itching
  • Burning on urination
• In females
  • Genital discharge
  • Cervicitis
  • Salpingitis
• In babies 5–12 days old
  • Acute papillary conjunctivitis
  • Mucopurulent discharge from the eyes

Confirmed Case: A case that is laboratory confirmed (isolation of C. trachomatis by culture, OR demonstration of C. trachomatis in a clinical specimen by detection of antigen or nucleic acid).

Laboratory Diagnosis

Laboratory Confirmation

• Nucleic Acid Amplification tests (NAATs) in first catch urine, endocervical or vaginal swab in women or first catch urine and urethral swab in men (by PCR). 
• Demonstration by Giemsa staining of intracytoplasmic inclusions in epithelial cells from the genital tract, eye or respiratory tract is highly suggestive of Chlamydial infection.
• Demonstration of specific Chlamydial antigen by immunofluorescence is a definitive diagnosis.
• Isolation of Chlamydia in cell culture demands special techniques and may not be readily available in the region.
• ELISA for Chlamydial antigen detection.

Specimen Collection and Transport

• From adults
  • Urethral or endocervical swabs in transport medium placed at 4–8°C and transported in a cold box
  • Genital scrapings spread on a microscope slide, air dried and transported rapidly at room temperature
• From babies with conjunctivitis
  • Eye swab in transport medium or conjunctival scrapings on a microscope slide transported as above
• From babies with pneumonia
  • Tracheal aspirate in a sterile tube transported at 4–8°C.

Step 2: 

STI unit should share data to the Epidemiology unit without identifiers (as per country guidelines) 

Step 3: 

Data Management (Epi Unit) 

• Data should be cleaned and analysed 
• Preparation of a report should be done on the evolution of the epidemiological  situation of the disease 
• Dissemination of a periodic situation report 

GONORRHOEA

Surveillance Procedures: 

Step 1: Case Detection/ Laboratory Confirmation and Reporting – Healthcare Providers / Laboratory Personnel 

Immediately report all confirmed cases to the STI unit. (Note (Healthcare Providers): Patient notes should be submitted to STI unit as needed for proper follow up.) 

Gonorrhoea is caused by the gram-negative diplococcal bacteria, Neisseria gonorrhoeae, which is almost always transmitted by sexual contact. It typically infects epithelia of the cervix, urethra, rectum, pharynx, or conjunctivae, causing inflammation and purulent discharge. Gonorrhoea is a worldwide genital disease and the appearance of antibiotic resistant strains is an increasing concern. The incubation period is typically 2 – 7 days. Males present with a purulent urethral discharge and dysuria which may progress to epididymitis, while females have mild urethritis or cervicitis which may develop into endometritis or pelvic inflammatory disease.

Pharyngeal and anal infections occur in both sexes and rare complications include septicaemia, arthritis, skin lesions, endocarditis and meningitis.

Symptoms of urethral infection in men usually cause them to seek treatment early enough before sequelae develop. However, in women, gonococcal infections are frequently asymptomatic or might not produce identifiable symptoms until complications (e.g., pelvic inflammatory disease [PID]) have arisen. Pelvic inflammatory disease can lead to scaring of the fallopian tubes which results in ectopic pregnancy and infertility. (CDC, 2015)

Chronic maternal infection of the endocervix, often asymptomatic, may result in infection of the newborn and development of gonococcal conjunctivitis 1–5 days after birth. If untreated, this may lead to corneal ulcer perforation and blindness.

Case Definition

Suspected case

• Gonorrhoea is suspected in adults presenting with
  • Purulent discharge from the urethra
  • Dysuria
  • Vaginal discharge
  • Anal discharge
• In newborns, gonorrhoea is suspected if, 1–5 days after birth, the baby develops:
  • Redness and swelling of the conjunctivae
  • Mucopurulent or purulent discharge from the eyes

Probable case

• Identification of gram-negative intracellular diplococci in a male urethral smear or a female endocervical smear.  (CDC, 2013)

Confirmed case

• Isolation of typical gram-negative, oxidase-positive diplococcic by culture (presumptive Neisseria gonorrhoeae) from a clinical specimen, or 
• Demonstration of N. gonorrhoeae in a clinical specimen by detection of antigen or detection of nucleic acid via nucleic acid amplification (e.g., Polymerase Chain Reaction [PCR]) or hybridization with a nucleic acid probe.  (CDC, 2013)

Laboratory Diagnosis

Laboratory Confirmation

Infection with the gonococcus is confirmed by:

• Demonstration of gram-negative intracellular diplococci in a urethral smear obtained from a male or a female endocervical smear, or
• Identification of typical gram-negative, oxidase-positive diplococci by culture (presumptive Neisseria gonorrhoeae) from a clinical specimen, or
• Demonstration of N. gonorrhoeae in a clinical specimen by detection of antigen or nucleic acid (CDC, 2013)

Specimen Collection and Transport 

• From Adults:
  • Collect male urethral or female endocervical swabs, place immediately into pre-packaged bacterial transport medium or plate onto Thayer-Martin medium
  • Prepare smears of male urethral exudates on microscope slides and air dry
  • Collect scrapings from the endocervix and spread onto microscope slides
  • All specimens should be rapidly transported to the laboratory at room temperature to preserve bacterial viability or cellular integrity
• From babies:
  • Prepare conjunctival swabs and scrapings on microscope slides or place in transport medium and transport rapidly to the laboratory

Step 2: 

STI unit should share data to the Epidemiology unit without identifiers (as per country guidelines) 

Step 3: 

Data Management (Epi Unit) 

• Data should be cleaned and analysed 
• Preparation of a report should be done on the evolution of the epidemiological  situation of the disease 
• Dissemination of a periodic situation report 

SYPHILIS

Surveillance Procedures: 

Step 1: Case Detection/ Laboratory Confirmation and Reporting – Healthcare Providers / Laboratory Personnel 

Syphilis is a sexually transmitted infection caused by the bacteria Treponema pallidum; a spirochete, which is transmitted by contact with body fluids – semen, vaginal secretions, saliva, and blood – during the early stages of the disease (primary, secondary and early latent stages). During acute maternal infection the organism can cross the placenta causing congenital syphilis in the newborn. Untreated primary, secondary and latent syphilis infections in pregnancy typically result in several adverse pregnancy outcomes, including early foetal deaths/stillbirths, neonatal deaths, preterm/low-birth-weight babies and infected infants.

If untreated, the disease progresses through 3 stages: 

1. Primary syphilis appearing 3 weeks (range 9 – 90 days) after exposure as a solitary, painless chancre at the site of infection, usually in the vagina, penis or anus (the primary lesion begins as a raised papule and ulcerates before healing within 3 to 10 weeks).
2. Secondary syphilis, appearing 4 - 8 weeks later as generalized eruptions of the skin and mucous membranes, which characteristically affects the palms and soles. Large white or grey raised lesions develop in warm and moist areas of the body, such as the anus and labia called condyloma lata. Signs and symptoms of secondary syphilis resolve even without treatment.
3. In latent syphilis serology is positive but there are no clinical symptoms or signs. Latent syphilis is often divided in two phases: early latent syphilis (infection for less than two years) and late latent syphilis (infection for two years or more).
4. Around 25% of untreated patients will develop tertiary syphilis, which can affect any organ system up to 30 years or more after infection. The main clinical manifestations of tertiary syphilis are neurological disease (neurosyphilis), cardiovascular disease (cardio-syphilis) and gummatous lesions (gumma). (WHO, 2016) 

Primary syphilis, secondary syphilis and early latent syphilis are labelled early syphilis; while late latent syphilis and tertiary syphilis is called late syphilis. 

Surveillance of symptomatic sexually active persons permits early treatment and contact tracing. Serological screening of pregnant women provides information about latent and asymptomatic infection in this group and can be considered an approximation of syphilis prevalence in the general population.

Case Definition

Primary and secondary Syphilis

Probable case - An illness with ulcers (primary) or mucocutaneous lesions (secondary) and a reactive serological test (non-treponemal or treponemal). Primary syphilis lesions may occur on sites other than in the anogenital area (WHO, 2015).

Confirmed case - Demonstration of Treponema pallidum in clinical specimens by dark-field microscopy, direct fluorescent antibody Treponema pallidum test (DFA-TP), nucleic acid test or equivalent methods (WHO, 2015).

Latent  Syphilis 

No clinical signs or symptoms of syphilis and 

1. A reactive non-treponemal and treponemal test in a patient with no prior diagnosis of syphilis; or 
2. A non-treponemal test titre demonstrating fourfold or higher increase from the last nontreponemal test titre in a patient with a prior diagnosis of syphilis (WHO, 2015)

Congenital syphilis

The global surveillance case definition for congenital syphilis is as follows:

• A stillbirth, live birth or foetal loss at >20 weeks of gestation or weighing >500 g to a syphilis-seropositive mother without adequate syphilis treatment;

OR

• A stillbirth, live birth or child aged <2 years with microbiological evidence of syphilis infection (WHO, 2015)

Laboratory Diagnosis

Laboratory Confirmation

Infection with Treponema pallidum is confirmed by:

• Demonstration of the organism by dark-field or phase-contrast microscopy on exudates.
• Positive VDRL test confirmed by Treponema pallidum haemagglutination (TPHA) or fluorescent antibody (FTA).
• Rapid Plasma Reagin test, similarly confirmed.

Specimen Collection and Transport

• Collect exudates from lesions and prepare smears on microscope slides. Send to the laboratory at ambient temperature.
• Draw 5–10ml of blood into a sterile tube. Hold at room temperature for clot retraction. Remove serum and either transport immediately at 4–8°C or freeze for later shipment to the laboratory.

Step 2: 

STI unit should share data to the Epidemiology unit without identifiers (as per country guidelines) 

Step 3: 

Data Management (Epi Unit) 

• Data should be cleaned and analysed 
• Preparation of a report should be done on the evolution of the epidemiological situation of the disease 
• Dissemination of a periodic situation report 

GENITAL DISCHARGE SYNDROME

Infections with several sexually transmitted agents result in a urethral or vaginal discharge. The syndrome of genital discharge is the most frequently seen at health facilities and the use of a syndromic definition will, in many instances, simplify the reporting of sexually transmitted disease. 

Common causes of vaginal discharge syndrome include trichomoniasis, bacterial vaginosis and vulvovaginal candidiasis; gonococcal or chlamydial cervical infection are less frequent causes. Common causes of urethral discharge (UD) syndrome include Neisseria gonorrhoeae or Chlamydia trachomatis, Mycoplasma genitalium, Ureaplasma urealyticum and Trichomonas vaginalis.  (WHO, 2015)

Surveillance Procedures: 

Step 1: Case Detection/ Laboratory Confirmation and Reporting – Healthcare Providers / Laboratory Personnel 

Case Definition

• Vaginal discharge: An abnormal vaginal discharge with change in the quantity, consistency, colour or odour (with or without vulval itching or burning) (WHO, 2015)
• Urethral discharge: A discharge in men (with or without dysuria), seen at the urethral meatus, with or without milking/expressing the urethra (WHO, 2015)

Laboratory Diagnosis

Laboratory Confirmation

• This is not essential to syndromic STI surveillance. 
• If possible, a gram stain can be done to detect gram negative diplococci.
• If more sophisticated laboratory facilities are available, follow procedures listed under the individual diseases above.

Specimen Collection and Transport

• Prepare smears of urethral or genital discharges on microscope slides if a basic laboratory is available.

GENITAL ULCER SYNDROME

Sexually transmitted infections such as Herpes simplex, chancroid, lymphogranuloma venereum and syphilis may all present as an ulcerative condition of the genitalia, difficult to diagnose without sophisticated laboratory facilities. Surveillance of the genital ulcer syndrome will enable health authorities to monitor changes in incidence and plan appropriate interventions.

Case Definition

Genital ulcer disease: An ulcer (a visible break in the skin), with or without pain, on the penis, scrotum or rectum in men, and on the labia, vagina, cervix or rectum in women (WHO, 2015).

Laboratory Diagnosis

Laboratory Confirmation

• This is not essential to syndromic STI surveillance.
• If laboratory facilities exist, consultation should be held with the microbiologist concerning available tests and appropriate specimens.

Specimen Collection and Transport

• Vesicle fluid or material from the base of a recent ulcer can be collected by swab into viral transport medium if virology laboratories exist

Step 2: 

STI unit should share data to the Epidemiology unit without identifiers (as per country guidelines) 

Step 3: 

Data Management (Epi Unit) 

• Data should be cleaned and analysed 
• Preparation of a report should be done on the evolution of the epidemiological situation of the disease 
• Dissemination of a periodic situation report 

Notes:

Prevention and Control of Sexually Transmitted Diseases

• Community health and sex education should be ongoing and particularly directed towards pre-pubertal and adolescent age groups.
• Services should be provided for early diagnosis and treatment of STD. 
• Special attention should be given to ensuring that marginalized populations (such as men who have sex with men, sex workers, people who inject drugs, prison inmates, migrant populations and adolescents) have access to adequate health services.
• Infected persons should be counselled on measures of avoiding transmission.
• Sexual contacts of infected adults should be contacted for treatment and counselling
• Condom use for extra-marital sex should be promoted.

VIRAL HEPATITIS B

Overview

Viral Hepatitis B is a disease of insidious onset caused by the Hepatitis B virus. It is distributed worldwide and of moderate prevalence in the Caribbean. Infection in early childhood is usually asymptomatic but results in a high rate of development of the permanent carrier state. A high percentage of adult infections are symptomatic, but the rate of resolution and antibody development are also high. 

The incubation period is usually 30 to 180 days, with an average of 60–90 days. The multiple outcomes of viral Hepatitis B include acute hepatitis, and in the long term, chronic liver disease, cirrhosis and hepatocellular carcinoma. Acute infection and chronic infections are frequently asymptomatic in children. 

Hepatitis is transmitted by parenteral exposure to infected blood or blood products, by sexual contact and by infected mother to child in utero or perinatally. Donors of blood for transfusion are screened by interview and all blood and blood products are tested for the virus. Those at special risk are health care workers, dialysis patients and those requiring blood products, patients in mental institutions and drug users who share needles. These are also at special risk for Hepatitis C. 

The objectives of surveillance for hepatitis B are to: 

1. detect outbreaks of viral hepatitis;
2. monitor trends in incidence and identify risk factors for new infections;
3. estimate the prevalence of chronic infections;
4. estimate the burden of sequelae and mortality of chronic hepatitis, including cirrhosis, liver failure and carcinoma; and
5. provide data to inform the national vaccination programs.
6. assess the impact of this disease on the population and to select and implement the most appropriate control strategies.

Surveillance Procedures: 

Step 1: Case Detection/ Laboratory Confirmation and Reporting – Healthcare Providers / Laboratory Personnel 

Case Definition

A presumptive (suspected) case of acute hepatitis B: A person with either or both of the following:

• Discrete onset of an acute illness with fever, malaise, fatigue AND signs of liver damage (anorexia, nausea, jaundice, dark urine, right upper quadrant tenderness)

OR

• Raised alanine aminotransferase (ALT) levels more than ten times the upper limit of normal (400 IU/L) (WHO, 2020).

Laboratory confirmed acute hepatitis B: A laboratory-confirmed case meets the prospective case definition and is IgM anti-HBc positive (WHO, 2020).

Laboratory Diagnosis

Laboratory Confirmation

• Acute: IgM anti-HBc (IgM antibody to the core antigen of the Hepatitis B virus).  The presence of IgM specific for the Hepatitis B virus is diagnostic.
• Chronic: HBsAg (Hepatitis B surface Antigen) is present in high titre in the serum during acute disease, and in the carrier state.  If symptoms are present, a positive HBsAg test is accepted as diagnostic.
• HBeAg - The presence of Hepatitis ‘e’ antigen in an infected person indicates a high level of infectivity and is important in the management of pregnant women whose babies are at risk of contracting hepatitis and becoming permanent carriers.

Specimen Collection and Transport - Blood sample.

• As soon as the patient presents, collect 5 to 10ml of venous blood into a sterile tube. Forward to the laboratory on ice within 24 hours, accompanied by whatever patient data are then available.
• If immediate shipment is not possible, centrifuge the blood and transfer serum to a sterile tube with a secure cap. Store at –20°C and ship frozen. 
• Include patient, clinical and exposure data

Step 2: 

STI unit should share data to the Epidemiology unit without identifiers (as per country guidelines) 

Step 3: 

Data Management (Epi Unit) 

• Data should be cleaned and analysed 
• Preparation of a report should be done on the evolution of the epidemiological situation of the disease 
• Dissemination of a periodic situation report 

Notes: 

Control and Prevention

• Enforce strict discipline in blood banks, rejecting high risk donors 
• Offer personal counselling to patients on behaviours likely to transmit the virus.
• Attempt to trace sexual contacts and counsel. Hepatitis B immune globulin may be offered. 
• Maintain confidentiality of all collected data regarding risk behaviour.
• Determine, by analysis of surveillance data, the incidence of acute disease in the population and the prevalence of the chronic sequalae 
• Improve vaccine coverage of high-risk groups e.g. health care workers
• Implement a programme of infant vaccination, to prevent development of the carrier state 
• Launch a public awareness programme aimed at reducing high-risk behaviour

Note: Hepatitis B vaccine is recommended for children as a 3 or 4 dose regimen, including a birth dose to protect against perinatal transmission (WHO, 2020).