Intervention and Supply Care.

·      Basic investigations: PCV, Hepatitis B and C screening, syphilis / VDRL screening, and Urinalysis.

·      STI test and treatment

·      Ano-genital wart management

·      Pre exposure Prophylaxis

·      Post exposure Prophylaxis

·      Enrolment into HIV care

·      ART initiation +/- Cotrimoxazole Preventive Therapy (CPT)

·      Follow up visits

·      Viral load services

Basic investigations: PCV, Hepatitis B and C screening, syphilis / VDRL screening, and Urinalysis.

PACKED CELL VOLUME (PCV):

PCV is the measurement of the percentage of red blood cells (RBCs) in blood.

Clinical Significance:

It is used to assess for anemia (low RBCs in blood) or polycythemia (elevated RBCs in blood). Certain medical conditions or medications can cause either anemia or polycythemia.

For instance, Zidovudine (a drug used in HIV treatment) has been shown to cause anemia. Other causes of Anemia include Nutritional deficiencies – folate, Vit B12; hookworm infestation; cancer and cancer treatment; severe malaria, etc. Anemia presents with symptoms such as weakness, paleness of skin and mucous membrane, dizziness, shortness of breath, chest pain, kidney problems. When identified, Anemia can be treated through dietary supplementations, oral medications like ferrous sulphate, erythropoietin injections and blood transfusions, depending on the perceived cause.

Polycythemia is the rarer of the two forms of abnormal PCV levels. Causes of polycythemia include Chronic obstructive pulmonary disease (COPD), sleep apnea, etc. Headache, blurred vision, hypertension are the common manifestations of polycythemia.

PCV testing and Result Interpretation:

Blood sample for PCV, like other laboratory tests are taken under standard universal safety measures. Within the capillary tubes with a closed end, samples are spun in a centrifuge and values are read.

Reference range for PCV varies according to sex and region.

For males = 40-52%

For non-pregnant females = 37-47%

For pregnant women = greater than or equal to 33% (vs 30% in Nigeria)

Thus, PCV level below the lower limit of normal signifies Anemia, while values above the upper limit of normal indicates Polycythemia.

Some conditions can cause falsely elevated or reduced PCV – Severe burns and dehydration (vomiting and diarrhea) can cause abnormally elevated PCV, while fluid overload leading to hemodilution can give falsely low PCV.

HEPATITIS B AND C VIRUS SCREENING:

Hepatitis B and C viruses are DNA and RNA viruses respectively, causing inflammation of the liver. Disease may be acute or chronic – Acute if less than 6months and Chronic if more. Infection is blood-borne through unprotected sex, sharing of needles and sharps, transfusion of unscreened contaminated blood products, etc.

Clinical features of hepatitis B and C depends on whether it is in acute or chronic phase, albeit the two may superimpose. Acute manifestations may include fever, jaundice, vomiting, diarrhea, dark-colored urine, while chronic features are weight loss, anemia, spider naevi, gynecomastia, ascites, hepatosplenomegaly, etc.

Indications for screening:

–       Routinely done during enrolment into HIV care and treatment – coinfection of HIV with hepatitis B and C have poorer outcomes.

–       Individuals with clinical features of liver diseases, such as jaundice.

–       As part of initial tests during enrolment into antenatal care.

–       As part of annual staff medical check-up.

–       Blood products prior to transfusion

Importance of the screening:

Hepatitis B and C infections may progress to cirrhosis and hepatocellular carcinoma, hence the need for early identification and treatment.

Who are at risk?

–       People who frequently require blood and blood products, such as sickle cell patients

–       Recipients of solid organ transplantation and dialysis patients

–       People in prisons

–       People who inject drugs

–       People with multiple sexual partners

–       Households and sexual contacts of chronic HBV patients

–       Healthcare workers who may be exposed to blood and blood products

–       Travelers to endemic areas who have not completed their HBV vaccine series.

Blood Sample Collection and Interpretation:

Rapid test methods are employed in the screening of both hepatitis B and C viruses, using client’s serum or plasma. HBsAg and anti-HCV antibody are screened for hepatitis B and hepatitis C viruses, respectively. Results are repeated as either positive or negative by reading the test strips after appropriate time.

Treatment:

Infection with hepatitis B and C viruses does not always require treatment as the immune system can clear it in some cases. However, chronic cases should be started on medications after initial viral load and genotyping (as in the case of Hepatitis C virus) – Some genotypes respond better to certain drugs.

Regardless of the stage of hepatitis, i.e. whether acute or chronic, all clients with HIV and hepatitis B and/or C coinfection should be treated. The goal of treatment is Cure. Medications like Sofosbuvir/Ledipasvir have shown good outcomes for hepatitis C, while Tenofovir (a drug included as first line therapy for HIV) is effective in hepatitis B treatment.

Subsequent scheduled follow-up monitoring with serial viral load and abdominal ultrasound scans, as necessary to identify complications – cirrhosis and hepatocellular carcinoma.

Prevention:

–       Correct and consistent condom and lubricant use

–       Routine antenatal screening and treatment

–       Infant Hepatitis B vaccination

–       Adult 3-course hepatitis B vaccination at 0, 1, 6 months in high risk individuals.

SYPHILIS/VDRL SCREENING:

VDRL means venereal disease research laboratory. VDRL test is a screening test for syphilis. Syphilis is an infection caused by the organism Treponema pallidum.

Mode of Spread:

Syphilis is a sexually transmitted disease, spread via person-to-person transmission through contact with the syphilitic sore, aka chancre. Infected pregnant women can also transmit it to their unborn babies. Genital sores caused by syphilis make it easier to acquire HIV infection sexually.

Clinical presentation:

Clinical features depend on the stage of the disease – primary, secondary, tertiary, latent, neonatal.

Most commonly, primary syphilis presents as a solitary painless sore, also known as Chancre, usually involving the genitalia, rectum, or mouth. Multiple sores can also occur. Chancre usually heals within 3-6weeks regardless of whether the individual was treated or not.

Symptoms of secondary syphilis include skin rash involving the palms and soles, usually follows the chancre. Others include fever, swollen lymph nodes, patchy hair loss.

Tertiary syphilis is rare and can be fatal. Can appear some years after the initial infection. Features depends on the affected organs.

Neonatal syphilis occurs following mother-to-child transmission. Symptoms include developmental delays, seizures, and death if untreated.

Testing:

Initial test for syphilis is “screening” tests using non treponemal tests – VDRL or RPR (rapid plasma reagin)

Following the screening test, a “confirmatory” test is carried out. This includes Treponemal tests – FTA-ABS, TP-PA, enzyme linked immunoassays.

Plasma or serum samples are obtained and used for these rapid tests. Results are read by trained professionals as reactive or non-reactive.

Some factors/conditions may give false VDRL test results. Common causes of false positive VDRL result include malaria, autoimmune diseases like rheumatoid arthritis and SLE, carcinoma, viral pneumonia, HIV, Tuberculosis, lyme disease, pregnancy, etc. False negative VDRL can be seen in early and late stage syphilis.

Treatment:

Duration of treatment of syphilis depends on the stage.

Primary, secondary, and early latent syphilis- Intramuscular benzathine penicillin G 2.4million units STAT

Tertiary and late latent syphilis- Intramuscular benzathine penicillin G 2.4million units weekly for 3 consecutive weeks

Neonatal syphilis – Intravenous penicillin G for 10days

If penicillin allergic, PO doxycycline 100mg 2x daily for 14days is used as a 2nd line therapy.

Prevention:

–       Correct and consistent condom and lubricant use

–       Routine antenatal screening and treatment prevents mother-to-child transmission

–       Partner based interventions, notably partner notification limits spread.

URINALYSIS

This is a test done routinely using urine sample. It detects biochemical and physiological changes in the body. It is one of the most important tests carried out in the laboratory for a variety of reasons – screening, diagnosis, and monitoring response to treatment.

Indications and Medical Significance:

–       Done routinely prior to PrEP (pre-exposure prophylaxis for HIV) enrolment and refill or enrolment into HIV care, to identify presence of protein in the urine, which could be a marker of renal impairment, a contraindication to initiation of PrEP.

–       To identify Urinary tract infections in suspected cases – positive nitrite and elevated leucocyte count in urine.

–       To identify possible kidney stones, parasitosis or urinary tract malignancies – presence of blood in urine (macroscopic hematuria) in those not currently menstruating or engaging in strenuous exercises.

–       To identify Diabetes Mellitus (DM) – presence of glucose and ketones in urine in non-starving individuals.

–       Drug screening and pregnancy tests – these tests are done using urine samples, but they test for substances that are not included in a typical urinalysis.

Sample collection and testing:

Urinalysis involves checking for the appearance, concentration, and contents of urine. To get the most accurate results, samples may need to be collected midstream using a clean-catch method as follows:

–       Cleanse the urinary opening – males should wipe the tip of the penis, while females should part the labia and clean from front to back using non-alcohol wipes.

–       Begin to urinate into the toilet

–       Pass the universal sample bottle into your urine stream

–       Urinate 30-59 milliliters into the collection container

–       Submit the sample to the laboratory within 60minutes of collection

In the laboratory, the scientist deeps the dipstick into the container containing the urine. After appropriate timing, a semi-quantitative measurement of leucocytes, ketones, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity (SG), blood, pH and ascorbic acid is done.

A urinalysis alone does not provide a definitive diagnosis. Depending on the reason for the test, abnormal test results may or may not require additional tests and follow-up.

STI TEST AND TREATMENT

STI means sexually transmitted Infections. In other words, they are Infections acquired through unprotected sex. This can occur in age group, but commonest amongst young people. There are certain risk factors that predispose individuals to STI, viz-a-viz:

–       Unprotected sexual intercourse

–       Alcohol and recreational drug use

–       Multiple sex partners

–       Being young

–       HIV coinfection (presence of HIV facilitates the spread of other STIs)

Clinical Manifestations:

Based on the presence or absence of symptoms, STIs can be broadly classified into 2 categories – SYMPTOMATIC and ASYMPTOMATIC STIs.

–       Asymptomatic STIs: Not all individuals with STI present with symptoms. Those who are asymptomatic are referred to as “CARRIERS” as they can still spread infections despite having no obvious symptoms.

–       Symptomatic STIs: Most people with STIs are symptomatic. Common symptoms include: Abnormal vaginal discharge and itching, Urethral discharge, Anal discharge and ulceration, painful and frequent urination, Menstrual irregularities, papules in the genitalia, painful ulcers, etc.

Causative Organisms:

Several organisms have been implicated in the etiology of STIs, ranging from bacteria, virus, fungi to protozoa. Common ones are Neisseria gonorrhoeae, Chlamydia trachomatis, Hemophilus ducreyi, Treponema pallidum, Herpes simplex virus, Human papilloma virus, Trichomonas vaginalis, Candida albicans, amongst others.

Diagnosis:

In addition to the clinical features (for symptomatic individuals), laboratory tests using appropriate specimen aid in accurate diagnosis of STIs. Important Laboratory tests for STIs include, but not limited to:
High vaginal swab microscopy, culture and sensitivity (m/c/s) – Candida albicans, trichomonas vaginalis

Endocervical swab m/c/s – Nesisseria gonorrhoeae, Chlamydia trachomatis

Urethral swab m/c/s

Rectal and mucosal swab m/c/s

Urinalysis

Urine m/c/s

Venereal disease research laboratory test (VDRL) and Darkfield microscopy – Treponema pallidum (Syphilis)

HIV screening as its presence facilitates the spread of other STIs

NB: Most culture results take 48-72hours, but empirical treatment may be commenced while awaiting results.

Treatment:

Good news is – most STIs can be treated. Contact tracing is important here, i.e sexual partners of infected individuals must be treated alongside; this reduces the recurrence rate. Also, compliance with prescribed medications is paramount for successful treatment, and avoid unprotected intercourse while on treatment as it could be spread when treatment hasn’t fully been effected.

Following diagnosis, medications – oral, Intravenous (IV) and Intramuscular (IM) antibiotic, antifungal, antiviral drugs may be prescribed as follows:

Gonorrhea and Chlamydia – IM ceftriaxone 250mg stat/ Tab Cefixime 400mg stat + tab Azithromycin 2g

                                                   stat/caps Doxycycline 100mg BD for 1 week

Vulvovaginal candidiasis – tab Fluconazole 150mg stat or vaginal pessary clotimazole or miconazole

                                                nocte for 6days

Herpes genitalis – 1st episode = Tab Acyclovir 400mg TID for 7-10days

                              – Subsequent episodes = Tab Acyclovir 400mg TID for 5days (as episodic therapy started

                                 within 1day of the appearance of the lesion or during the prodromal phase)

Syphilis – for primary, secondary, and early latent stages = IM Benzathine Penicillin G 2.4 million units

                                                                                                         stat

              –  for tertiary, latent syphilis = IM Benzathine Penicillin G 2.4 million units weekly for 3

                                                                    consecutive weeks

             –   for Neurosyphilis = IV aqueous penicillin G 18-24 million units daily for 14days +/- IM

                                                    Benzathine penicillin 2.4 million units stat

            –   If allergic to penicillin = caps doxycycline 100mg BD for 14days

Trichomoniasis – Tab metronidazole or tinidazole 2g stat OR Tab Metronidazole 500mg BD for 7days

                               (Avoid alcohol while on either of these drugs)

PREVENTION:

–       Wearing cotton underwear

–       Avoid Antibiotic misuse

–       Correct and consistent use of condom and lubricant

ANOGENITAL WART MANAGEMENT

Warts are fleshy growth on the mucosal surfaces of the body. As the name implies, anogenital warts occur in the anogenital area – vagina, penis, scrotum, anus. It is caused by a virus – Human papilloma virus (HPV), usually the serotypes 6 and 11. Transmitted majorly through unprotected sexual intercourse and prolonged skin-to-skin contact, HPV is highly contagious, hence the need to treat it and use condoms at all times!

Clinical manifestations range from occasional pains and itching of the affected areas, to florid cauliflower growths.

Treatment: Yes, warts can be treated!   Modalities of treatment include:

–       Cryotherapy – This involves the use of liquid nitrogen applied on the warts using spray canister. The frozen warts thaws, shrinks, and falls off over time. This is usually done by trained health care provider. Usually one session is needed, except in recurrent cases.

Certain precautionary measures must be carried out to facilitate wound healing and prevent wound infection post treatment, such as:

a)     Sitz bath twice daily

b)     Use of metronidazole solution, soaked cotton wool and changed 6hourly

–       Podophyllin ointment mixed with petroleum jelly and applied to the warts several times. Care must be taken to avoid spilling podophyllin ointment on the surrounding normal skin – this can do more harm than good.

–       Surgical removal of warts – usually reserved for very huge warts.

Recurrence: Warts can recur, even after appropriate treatment, and some asymptomatic individuals can spread the causative virus, hence the importance of correct and consistent condom and lubricant use.

PRE-EXPOSURE PROPHYLAXIS (PrEP):

Pre-exposure prophylaxis or PrEP as it is more commonly called is a two-drug combination taken to prevent HIV infection. It is “PRE” because it is taken before exposure (or high-risk sexual behavior) to stop one from getting HIV, as opposed to “POST-exposure prophylaxis” which is taken after engaging in the high-risk behavior, not before.

Eligible Individuals:

–       People who regularly engage in high-risk behaviors

–       Adults who have no underlying renal impairment or other existing comorbidities

Who Should not be on PrEP?

–       HIV positive individuals

–       Individuals with kidney problems or other serious medical conditions

–       Pregnant and breastfeeding women

Enrolment into PrEP:

Now that you know what PrEP means and who are eligible for it, the decision to commence PrEP becomes easier. Prior to getting the prescription, enrolment into the program and laboratory testing are a MUST.

Part of the enrolment involves PrEP intake screening, which involves answering questions mapped to identify eligible candidates and to rule out non-eligible ones.

After the paper work, the individual is sent to the laboratory for tests – urinalysis (aims to identify the presence of protein in the urine, which could signify an underlying kidney problem) and of course, HIV test to determine the HIV status of the client(REMEMBER: HIV positive individuals CANNOT be on PrEP).

If HIV negative and normal urinalysis result, PrEP is prescribed.

Medications and dosing:

PrEP is a combination of Tenofovir (300mg) and Lamivudine (300mg) in one pill, taken once daily by mouth, preferably at a particular time of the day, consistently for as long as being sexually active.

CLINIC VISITS:

At the initial visit, clients are given one-month supply and at subsequent visits, three-months. The initial short appointment is to ascertain adherence to drugs and any possible side effects of the drugs the individual might have, as well as adherence counselling.

During each clinic visit, a repeat HIV and urinalysis tests are carried out to determine the HIV status and kidney function as these markers would determine whether the client is still eligible for PrEP refill. In the event of marked proteinuria, i.e. protein in the urine, PrEP is temporarily withdrawn, and the cause of the proteinuria investigated. It would then be restarted if/when proteinuria resolves. If HIV test comes out positive while on PrEP, it is referred to as SEROCONVERSION; this client is then started on HIV treatment, and not PrEP. There could be several reasons for seroconversion, such as:

–       Self-discontinuation of PrEP while still engaging in high-risk behaviors

–       Poor compliance with drugs, mostly because of consistently missed doses while still engaging in high-risk behaviors.

OTHER IMPORTANT POINTS TO NOTE:

–       PrEP protects you ONLY if you use the drug consistently and correctly.

–       While on PrEP, ensure correct and consistent use of condom as PrEP prevents HIV only and not other STIs like gonorrhea and chlamydia.

–       Within the first week of starting PrEP, it is not uncommon to feel dizzy and weak, but these abate within one week.

–       PrEP is safe!

POST-EXPOSURE PROPHYLAXIS (PEP):

PEP is a three-drug combination taken preferably within 72hours of possible exposure to HIV. This is for individuals who are not on pre-exposure prophylaxis. Exposure risk can be classified into HIGH and LOW.

Low risk exposure includes:

–       Unprotected sex or condom breakage with partner of unknown HIV status

–       Unprotected sex with asymptomatic or HIV positive partner with undetectable viral load

–       Small volume/ drops of blood on mucous membrane or broken skin

High risk exposure includes:

–       Sexual assault

–       Unprotected sex or condom breakage with HIV positive partner with unsuppressed viral load

–       Large bore needle or deep injury

–       Large volume blood or blood splash on mucous membrane or broken skin

Enrolment into PEP:

Before getting prescription of PEP, client must go through some processes, mainly screening using designed questionnaire to ensure eligibility as well as identify other needs of the individual – social, psychological, etc., and some laboratory investigations.

Certain lab tests are done to identify HIV and other STIs, viz:

–       HIV test

–       Urinalysis

–       Hepatitis B test

–       Hepatitis C test

–       VDRL (screening for syphilis)

–       B-hcG (pregnancy test where appropriate)

If HIV negative with normal urinalysis, PEP is then prescribed.

If HIV positive, client is enrolled into HIV care.

NB: MEDICATIONS for PEP and HIV might be the same, but Post-exposure and HIV CARE are not exactly the same.

Medications and dosing:

Upon successful screening, a three-drug combination is prescribed for 28 days – Lamivudine (300mg) + Tenofovir (300mg) + Dolutegravir (50mg). This is one-pill-a-day prescription, to be taken by mouth, preferably at a specific time of the day. As with all medications, compliance is key to successful treatment. Medication is best started within 72hrs of possible HIV exposure.

Follow-up visits:

Following drug completion, clients are expected to return to the facility for serial HIV testing at 6weeks, 3months and 6months post-exposure.

At each visit, client’s risk of HIV exposure is reassessed and counselled on PrEP (pre-exposure prophylaxis) if high-risk

ART INITIATION, FOLLOW-UP, AND COTRIMOXAZOLE PREVENTIVE THERAPY:

Following voluntary counseling and testing for HIV, individuals with positive retroviral screening results are initiated into HIV care. Prior to starting clients on ART (antiretroviral therapy), they are assessed for anxiety and depression using the hospital anxiety and depression scale (HADS) to identify individuals with overt anxiety and depressive illnesses. Clinical needs of clients are also assessed using the clinical needs and assessment form, as well clinical evaluation using adult initial clinical evaluation form where questions aimed at identifying clients with symptoms of tuberculosis, serious drug allergies and adverse events, and important medical history are obtained.

Adherence counselling is also initiated as part of the ART initiation protocol to ensure client’s adherence to the medications which are to be prescribed.

Next, the ART card is filled, including client’s biodata, hospital number, dates of HIV confirmation and enrolment, clinical stage at initiation (to be determined by the doctor). Vital signs – blood pressure, anthropometry measurements – height and weight are done and recorded. These readings are necessary as they serve as baseline for future referrals.

In the doctor’s consultation room, clients are assessed for symptoms of tuberculosis, anogenital warts and other opportunistic infections. Complaints from clients are also documented. Enrolled clients are then prescribed appropriate ART drug combinations, Isonaizid (anti-tuberculosis drug used in this context to prevent tuberculosis; usually given for 6months to protect against tuberculosis over a two-year period), and other medications as the case may be. ART prescription for first timers is usually for 1 month. This is to facilitate early identification of adverse drug reactions, and to ensure client’s adherence. With subsequent visits, clients can be given longer refills and appointments.

FOLLOW-UP:

Follow-up visits are usually less rigorous than the first. At the reception, a client’s hospital folder is retrieved using an assigned hospital number. Anthropometric measurements and vital signs are taken, and if client is due for periodic viral load test, they are taken to the laboratory for blood sample collection, and then the folder is forwarded to the doctor’s office for review. During the consultation with the doctor, client is assessed for drug adherence, possible drug side effects experienced, opportunistic infections, anogenital warts or any complaints. All complaints and necessary information are documented in the folder. A Prescription for ART refill and other medications are raised and then the date of the next appointment (usually 3months if client is less than 1 year into ART, or less if non-adherent to drugs, elevated viral load test result or having other medical problems) is written on the client’s hospital card. Those doing well on their medications, with no complaints can be given up to 6months refill, according to the doctor’s discretion.

COTRIMOXAZOLE PREVENTIVE THERAPY (CPT):

Cotrimoxazole is a fixed-dose combination of 2 antimicrobials – sulphamethoxazole and trimethoprim that covers a range of bacterial, fungal, and protozoan infections. CPT is a feasible, well tolerated and inexpensive intervention for people living with HIV/AIDS to reduce HIV-related morbidity and mortality.

Indications:

–       HIV reactive individuals with low CD4 count

–       HIV reactive individuals with tuberculosis coinfection regardless of CD4 count

–       Prevention of malaria and serious bacterial infections in PLWHIV

–       Prevention of Pneumocystis jirovecii pneumonia in PLWHIVA

–       HIV-exposed Infants (infants born to HIV reactive mothers), starting at 4-6weeks after birth until HIV has been excluded.

Contraindications:

–       People with sulpha-allergy (in which case dapsone 2mg/kg once daily can be prescribed as an alternative)

–       Severe renal impairment (creatinine clearance < 15ml/min/1.73m2)

–       Porphyria

–       Pregnant women at term

–       Megaloblastic anemia due to folate deficiency

Dosage:

Double strength = 960mg (800mg sulphamethoxazole + 160mg trimethoprim) once daily

Single strength = 480mg (400mg sulphamethoxazole + 80mg trimethoprim) once daily

Suspension cotrimoxazole also available for children

When to stop:

–       In case of severe adverse drug reaction

–       Those who are clinically stable with immune recovery, as evidenced by rise in CD4 count or fall in viral load.

VIRAL LOAD:

Viral load is a term used to describe the amount of HIV in the blood, i.e. the number of copies of HIV RNA per millilitre of blood. Viral load testing in HIV care is for HIV seropositive individuals who have already been commenced on antiretroviral therapy (ART). Unit of measurement is in copies per ml.

Medical Significance of Viral load:

It is used to determine virologic failure of treatment, as the aim of HIV treatment is to achieve virologic suppression, i.e. undetectable viral load, which presently is viral load < 20 copies per ml. Studies have shown that HIV seropositive individuals with viral load less than 200 copies/ml DO NOT transmit the virus.

Persistently elevated viral load signifies either poor adherence to medications by the client or ineffectiveness of the therapy – thus, this is an important tool in clinical decision making.

Test Intervals:

Timing of viral load testing varies. Ideally, it is done 6months after the initiation of ART for treatment-naïve people, and if the 1st viral load result is less than 200 copies/ml, it is then done annually subsequently.

However, If the 1st viral load is greater than 200, testing is repeated in 3months, with 1month clinic appointments during the 3month period, and attendant continued adherence counselling to ensure clients are compliant with their ART.

Sample Collection and Processing:

Blood samples of due clients are taken under standard Universal safety precautions. 10mls of venous blood is drawn into the appropriate, well-labelled specimen bottle, with the accompanying forms and registers filled. The arranged bottles in a cool transport container with the necessary forms are moved to the testing facility. Results are usually available as from 2weeks after the sample collection.