FEDERAL MINISTRY OF HEALTH
DEPARTMENT OF PUBLIC HEALTH
GUIDELINES
for
CLINICAL MANAGEMENT OF
TB AND HIV/AIDS
RELATED CONDITIONS
IN NIGERIA
GLOSSARY OF ABBREVIATIONS USED IN THIS BOOK:
AFB
AIDS
ART
Acid Fast Bacillus
Acquired Immune Deficiency Syndrome
Anti-Retroviral Therapy
DOTS
EIA
EID
Directly Observed Treatment Short Course
Enzyme Immuno Assay
Early Infant Diagnosis
EPTB
FCT
FGN
FMOH
Extra-Pulmonary Tuberculosis
Federal Capital Territory
Federal Government of Nigeria
Federal Ministry of Health
HAART
Highly Active Anti retro viral
HCT
HIV Counseling and Testing
HIV
Human Immunodeficiency Virus
INH
Isoniazid
IPT
Isoniazid Preventative Therapy
IMDR-TB
Multi-Drug Resistant Tuberculosis
NGO
Non-governmental Organization
NTBLCP
National Tuberculosis and Leprosy Control Programme
NTBLTC
National Tuberculosis and Leprosy Training Centre
NASCP National AIDS and STD control Programme
NNRTI
NRTI
OI
Non-Nucleoside Reverse Transcriptase Inhibitor
Nucleoside Reverse Transcriptase Inhibitor
Opportunistic infections
PB
PEP
PHC
Pulmonary Tuberculosis
Post Exposure
Primary Health Care
PI
Protease inhibitor
PLWHA
PPM
People Living with HIV and AIDS
Public-Private Mix for DOTS
RNA
Ribonucleic Acid
TB
WHO
Tuberculosis
World Health Organization
1
List of Contributors
The Minstry of Health would like to thank all those who actively participated in the
adaption of the Gidelines for Clincal Management of TB/HIV related conditions in
Nigeria. In particular, the Ministry wishes to acknowledge the inputs of the following
individuals:
Dr. A. Nasidi
Dr. Ngozi Njepuome
Dr, M. Kabir
Dr. E.B.A. Coker
Dr. Annette Akinsete
Ben C. Nwobi
Dr. J. O. Obasanya
Dr. A.O. Awe
Dr. P. Patrobas.
Dr. C.O. Chukwuekezie
Dr. Nyarmuryekunge K. M.
Dr. T. Odusote
Dr. I. Uko
Dr. Mohammed Ibrahim
Dr. Soji Akinleye
Dr. N. Gwarzo
Dr. K. Samson
Dr. Abdul Habib
Mrs. N. Chukwurah
Dr. U. I. Gebi
Mrs. A. O. Tubi
Dr. M. Gidado
Dr. J. Chukuwu
Ope Abegunde
Dr. Bola Gobir
Dr. Pat Matemilola
Dr. C. C. Asadu
Dr. A. F. Omoniyi
Dr. B.A. Inuwa
Dr. Sam Ogiri
Dr. P. Patrobas
Dr. Dan Onyejekwe
Dr. F. O. Soyinka
Dr. Ogunshola
2
FOREWORD
The Human immunodeficiency virus (HIV) pandemic presents a massive
challenge to the control of Tuberculosis (TB) at all levels. TB is also the leading
infectious killer of people living with HIV/AIDS. The deadly interaction of TB
and HIV affects millions of people in Nigeria, threatens public health, and
stretches the already weak infrastructure of the health sector.
Every year thousands of our people are lost to this unholy alliance between TB
and HIV, families are wiped out and this creates a growing tide of orphans and
vulnerable children who are at heightened risk to the disease.
. The document was developed with input from all stakeholders to provide guidance for
Health workers in managing TB/HIV related conditions in Nigeria.
Dr. A. Nasidi
Director of Public Health.
Federal Ministry of Health.
16th September, 2008
3
ACKNOWLEDGEMENT:
The Federal Ministry of Health wishes to express its gratitude to the numerous
individuals and developmental partners who worked with the Ministry to adapt the
TB care with TB/HIV co-management IMAI modules.
We wish to express our appreciation to all the development partners, the World
Health Organization (WHO), the USG and members of the International
Federation of Anti-Leprosy Association (ILEP) for their support and active
participation in the whole process of developing the Guidelines.
Finally the efforts of the staff of the Federal Ministry of Health which resulted in
the development and production of this document are highly appreciated.
Dr. N. Njepuome
Head of HIV/AIDS/TB Control Division
Department of Public Health,
Federal Ministry of Health
4
TABLE OF CONTENTS
Page Number
Glossary of Abbreviations
1
List of Contributors
2
Foreword
4-5
Introduction
6-8
Basic Information on Diagnosis and Management
Tuberculosis among dually infected patients
of
9-16
Basic Information on Diagnosis and Management of HIV
among dually infected patients
17-27
Opportunistic Infections
28
IPT
28-29
CPT
30-32
Prevention of TB and HIV in health care settings
32-34
PEP
34-42
Annexes
37-41
5
INTRODUCTION
Tuberculosis (TB) remains a serious public health problem in Nigeria. As at 2003, the
Directly Observed Treatment Short Course (DOTS) Strategy was being implemented in
36 states and the Federal Capital Territory (FCT). The number of all patients detected
was 46,596 while 28,173 were smear positive.
Similarly the HIV/AIDS epidemic is on the increase. In the period between 1991 and
2003, the HIV sero-prevalence increased from 1.8% to 5.0%. (Nigeria National Sentinel
Survey, 2003). HIV is known to increase the burden of Tuberculosis. The prevalence of
HIV among TB patients is 19.1%. (Nigeria National Sentinel Survey, 2001). On the other
hand, it is estimated that TB is the leading cause of death among People Living With
HIV/AIDS (PLWHA) and is responsible for 14-54% of HIV/AIDS deaths globally
(WHO Stop TB Dept. estimates 2002). Therefore, it is imperative that health workers be
on the alert for interactions between these two diseases and learn to manage conditions
arising from them competently.
1
OBJECTIVES OF THE GUIDELINES
These Guidelines are targeted at general health care providers working at the facility
level. They are meant to assist them in identifying common conditions associated with
TB, HIV/AIDS and TB/HIV co-infection with a view to managing them appropriately.
Medical officers who have been managing cases of TB or HIV/AIDS will also find these
Guidelines useful especially as it pertains to the management of TB/HIV co-infection.
The Guidelines outline the steps that general health providers are expected to take when
managing TB or HIV/AIDS patients who could be co-infected and also point out the
stage at which these patients need to be referred to a medical officer. While recognizing
that there is a lot that general health care providers can do in the management of TB and
HIV/AIDS cases, general health care workers are not expected to perform the
functions of medical officers.
2.
ACCESSING TB/HIV CARE/SERVICES
2.1
TB/HIV Care
PLWHA and TB patients should have access to a variety of services/care aimed at
improving their quality of life. The starting point should be the counseling of individuals
for TB and HIV at Out-Patient Department (OPD) as well those suspects attending TB
clinics. The services available include:
• Counseling for TB and TB/HIV interactions
• Counseling for HIV testing
• HIV Testing
• Diagnosis of TB
• Treatment of TB
• Preventing TB in PLWHA using Isoniazid
• Preventing common opportunistic infections using Cotrimoxazole in PLWHA
6
•
•
•
Alleviating common conditions associated with HIV/AIDS e.g. oral thrush, sore
throat, skin infections and diarrhea (palliative care)
Anti-retroviral Therapy (ART) for HIV-positive clients
Community and home-based care and support
2.2
Accessing TB and HIV/AIDS services
a.
Recommended procedure for every TB suspect (see Annex 1 - Management
of TB suspects)
• Take history and do physical examination
• Diagnose TB (refer to Diagnostic Flow Chart)
• Start DOTS if TB is diagnosed
• All suspects and TB patients should be offered HCT
• Refer for HCT if unavailable
b.
Recommended procedure for HIV-positive TB patients
• Ascertain that pre-test counseling has been done.
• Give post-test counseling
• Continue DOTS
• Give treatment for common conditions complained of by the patients. (e.g.
pain, oral thrush and diarrhea )
•
Refer if patient’s condition deteriorates
• Refer for possible Anti-Retroviral Treatment (ART)
c.
Recommended procedure for HIV-negative TB patients
• Ascertain that pre-test counseling has been done
• Give post-test counseling
• Provide education on the need for TB treatment adherence
• Educate in HIV prevention, which should include abstinence, faithfulness and
/ or condom use
• Continue DOTS
• Advise patients to repeat test after 3 to 6 months
d.
Recommended procedure for TB-positive patients with unknown HIV status
• Offer patient pre-test counseling
• Do HIV test
• Offer post-test counseling
• Follow procedures in b and c depending on results
• Continue DOTS
e.
Recommended procedure for an HIV-positive patient with unknown TB
status
• Confirm HIV result
• Take history and do physical examination
• Diagnose TB (refer to TB Diagnosis flow chart)
• Manage as appropriate
7
f.
Recommended procedure for HIV/AIDS patients referred to TB treatment
centres
• Take history and do physical examination
• Do (Acid Fast Bacilli) AFB microscopy
• Diagnose TB
• Start DOTS if TB is diagnosed
• Refer to medical officer if AFB microscopy is negative.
PLWHA diagnosed with TB who are on ART should be referred to a medical
officer.
3. TUBERCULOSIS
Introduction
TB is a bacterial disease caused by Mycobacterium tuberculosis, an organism also known
as tubercle bacilli or acid-fast bacilli (AFB). Tuberculosis infection occurs when a
person carries the tubercle bacilli in the body but in small numbers and in a dormant
state. Tuberculosis disease, however, occurs when the tubercle bacilli multiply and
become numerous enough to overcome the body’s defenses and produce signs and
symptoms. These signs and symptoms could be suggestive of pulmonary TB (PTB)
where the lungs are the primary organ affected or Extra-pulmonary TB (EPTB) when
other organs are affected.
3.1
DIAGNOSIS OF TB
The mainstay of the management of TB is the Directly Observed Treatment Short Course
(DOTS) strategy. In the DOTS strategy, a diagnosis of TB diagnosis is made after
microscopy examination of three sputum samples. The three sputum specimens should
be collected within 48 hours as shown in the table below:
Table 3.1 Guide to Sputum Collection
Days
Day 1
Sample
Sample 1
(Spot)
Sample 2
Day 2
Sample 3
(Spot)
Explanation
Patient provides an ‘on the spot’ sample under supervision.
(Patient is then given the sputum container to take home for
an early morning sample (sample 2) for the following day
Patients produces and brings ‘early morning sample’ to the
clinic
Patient produces another ‘on the spot’ sample under
supervision
The three sputum specimens for diagnosis and two for follow-up patients should be
adhered to strictly by all DOTS centres and any other TB diagnostic centres to avoid
situation where some states (e.g. Lagos) adopt different methods.
8
See Annex 1 for flow chart on the diagnosis of Tuberculosis after collection of
sputum samples.
Note that HIV patients may present with Extra-pulmonary TB or may be smear negative.
3.2
CLASSIFICATION OF TB PATIENTS – CASE DEFINITIONS
In order to prescribe appropriate treatment, case definitions according to results of
sputum microscopy and previous treatment are important. TB patients are classified as
follows:
1. New Case (N): A patient who has never had treatment for TB or who has taken
anti-TB drugs for less than four weeks.
2. Relapse (R): A TB patient who was previously treated for TB, received Category
1(new case) treatment and was declared cured or completed a full course of
treatment and has once again developed sputum smear-positive TB.
3. Treatment failure (F): A patient who while on Category 1 treatment, remained
or became smear-positive again five months or later after commencement of
treatment.
4. Return after default (RAD): A TB patient who completed at least one month of
treatment (category 1) and returned smear-positive after at least 8 weeks of
interruption of treatment.
5. Transfer in (T. I.): A TB patient already registered for treatment in one LGA
who is transferred to another LGA where (s)he continues treatment.
6. Other (O): A TB patient who does not easily fit into any of the above case
definitions and who is smear-positive
3.3
TREATMENT OF TB
3.3.1
Diagnostic Categories
Based on case definition, all TB patients (adults and children) fall into a diagnostic
category for treatment, as shown in the table below.
Table 3.2 Anti-TB Treatment Categories
Category
Category 1
Category 2
Duration in months/ Drug Indication
Combination
2RHZE/6EH
Short-course chemotherapy for
new cases
2STHZE, 1RHZE/5RHZE
Re-treatment chemotherapy for
relapses, failures, RAD and others
3.3.2
Treatment Regimens
A treatment regimen consists of two phases
1. The initial intensive phase of fully supervised daily administration of drugs is 2
months for new cases (Cat. 1) and 3 months for re-treatment cases (Cat. 2).
9
2. The continuation phase of treatment for new cases (Cat. 1) is 6 months of
monthly drug collection by the patient, and is usually self-administered. For retreatment cases, the continuation phase is 5 months and should be supervised
daily or thrice weekly.
3.3.3
Drugs and dosages for TB treatment
The drugs used in the treatment of TB are:
R – Rifampicin;
E – Ethambutol
H – Isoniazid;
S – Streptomycin
Z – Pyrazinamide ;
The dosages for the different categories and regimens are shown in the following tables
Treatment Regimens: Fixed Dose Combinations (FDC) ADULTS
Category 1 Regimen for New Cases): 2RHZE/6EH or 4RH
Regimen
Pre-treatment weight
55-70 kg
38-54 kg
> 70 kg
Intensive phase: daily supervised for 2 months
Combined tablet of RHZE (150mg + 75mg + 400mg
+ 275mg)
Continuation phase: daily for 6 months
(monthly collection)
Combined tablet of EH (400mg + 150mg)
*OR
Continuation phase: daily supervised for 4 months
Combined tablet of RH (150mg + 75mg)
30-37 kg
5
4
3
2
2
2
2
1
5
4
3
2
Remark: If the patient weighs less than 30 kg, he should be given loose tablets.
Category 2 Regimen for Relapses, Failures, RAD and Others: 2SRHZE/RHZE/5RHE
Regimen
> 70 kg
Intensive phase: daily supervised for 3 months
Combined tablet of RHZE (150mg + 75mg + 400mg +
275mg)
Pre-treatment weight
55-70 kg 38-54 kg 30-37 kg
5
4
3
2
1 gram
1 gram
0.75
gram
0.5 gram
5
4
3
2
Add in the first two months daily:
Streptomycin
Continuation phase: daily intake for 5 months, supervised
Combined tablet of RHE (150mg + 75mg + 275mg)
i. Streptomycin should NOT be given to pregnant women.
ii. Patients >45 years should not be given more than 0.75g of streptomycin irrespective of
weight
10
CHILDREN (0-14 YEARS)
Category 1 Regimen for New Cases: 2RHZ/4RH
Regimen
21-29 kg
Pre-treatment weight
11-20 kg 5-10 kg
< 5 kg
Intensive phase: daily supervised for 2 months
Combined tablet of RHZ (60mg+30mg+150mg)
4
3
2
1
Continuation phase: daily for 4 months
(monthly collection)
Combined tablet of RH (60mg + 30mg)
4
3
2
1
Children with severe forms of TB (TB meningitis, Disseminated TB, TB Spine, TB
pericarditis) should have streptomycin added during Intensive Phase.
Category 2 Regimen for Relapses, Failures, RAD and Others: 2SRHZ/RHZ/5RH
Regimen
Intensive phase: daily supervised for 3 months
21-33 kg
(S) Streptomycin(daily for 2 months)
0.5gram
0.5 gram
0.25gram
(H) Isoniazid 100 mg )
(R) Rifampicin 150 mg ) combined tablet
2
1
½
2
1
½
2
1
½
2
1
½
(Z) Pyrazinamide 400 mg
Continuation phase: daily supervised for 5 months
(H) Isoniazid 100 mg )
(R) Rifampicin 150 mg ) combined tablet
3.3.4
Pre-treatment weight
11-20 kg
5-10 kg
Monitoring treatment
Monitoring progress of tuberculosis patients while on treatment is an essential part of
case management. This is to ascertain the effectiveness of the drugs in killing M.
tuberculosis as well as assessing improvement in the patient’s clinical state. Monitoring
is done through the following methods:
•
•
Sputum microscopy:
Clinical:
•
Drug intake:
Examine sputum for AFB at specified intervals
Conduct clinical assessment including
assessment
Assess patient’s records for regularity.
weight
Two sputum smear examinations (taken as two early morning samples within 2 days) are
done at different points during treatment:
• For smear-positive patients:
End of the 2nd month for new cases or 3rd month for re-treatment cases
End of 5th month
End of 7th month
11
•
For smear-negative patients only at the end of the 2nd month.
Table 3.6: Guide to monitoring TB treatment
End
month
End
month
End
month
End
month
of
2nd
of
rd
of
of
3
th
Examine
Weight
Sputum for AFB Assessment
Smear Smear
+ve
– ve
Examine drug
compliance
Yes
Yes
Cat 2
only
No
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
No
Yes
Yes
5
th
7
3.3.5 Side-effects of anti-TB drugs
Adequate treatment of each case for the full duration of the prescribed regimen is very
important if success in treatment is to be achieved. Anti-TB drugs, however, are toxic and
side-effects may occur. Some of these side-effects require treatment to be stopped
immediately while some others require only treatment modification as shown in the tables
below:
Table 3.7 Adverse drug reactions that require treatment to be stopped
SIDE-EFFECT
POSSIBLE
CAUSE
General reaction including shock, Rifampicin
purpura and fever
Pyrazinamide
Streptomycin
Impairment of vision in a patient Ethambutol
on Ethambutol
Jaundice (Yellowness of the eye) Isoniazid
Rifampicin
Pyrazinamide
ACTION
STOP treatment and refer to the
medical officer.
Note:
1. Patients who are pregnant must not be given streptomycin due to the risk of damage
to the ear of the fetus
2. Children below 6 years must not be given Ethambutol due to the risk of damage to the
eyes
12
Table 3.8 Adverse drug reactions that do not require treatment interruption
SIDE-EFFECT
POSSIBLE
CAUSE
Giddiness (staggering / loss Streptomycin
of balance)
Severe nausea & vomiting
Rifampicin
Skin rash in a patient not on Isoniazid
Thiacetazone
Streptomycin
Pyrazinamide
Numbness
or
tingling Isoniazid
sensation on the extremities
Joint pains
Pyrazinamide
Red/orange coloured urine
Rifampicin
ACTION
Reduce dosage by one quarter, but if it
persists for more than one week stop and
refer to the Medical Officer.
Give the Rifampicin after food
If patient is clinically well (not advanced
TB or serious forms such as meningitis or
disseminated disease) stop and resume
when the reaction has subsided.
If symptoms recur, refer to Medical Officer
Supplement with tab. Vit. B6 at a dose of 5
mg daily
Check the dosage by weight as it is usually
caused by over-dosage.
Easily alleviated with Aspirin (600 mg tds x
5 days). Pcm 25mg/Kg recommended for
children
Reassure patient
Note:
1. Any change to the treatment regimen due to side effects must be made only after
careful consideration.
2. Challenging and desensitization should be done in referral hospitals only. See
NTBLCP Guide for Medical Officers.
3.3.6 Treatment interruption
New cases: Any individual who has not come to receive his/her treatment for two
consecutive days during the intensive phase, or has failed to collect drugs for two
weeks after the expected date during the continuation phase should be regarded as
having interrupted treatment and therefore be traced. Defaulter tracing visit should be
carried out and the corresponding report attached to the treatment card.
Re-treatment Regimen: Any individual who has not come to receive his/her treatment
for two consecutive days should be regarded as having interrupted treatment and
therefore be traced. Defaulter tracing visit be carried out and the corresponding report
attached to the treatment card .
Table 3.9 Interruption of anti-TB treatment – Action required
Interruption for less than 1 month
• Trace patient (home visits, phone call etc)
• Identify the cause of interruption and find solution if possible.
• Continue treatment and prolong it to compensate for missed doses.
13
Interruption for 1-2 months
Action 1
Action 2
Duration
Action
Continue
treatment
• Trace patient (home If smear-negative or
and prolong it to
visits, phone call etc) Extra Pulmonary TB
compensate for missed
• Identify the cause of (EPTB)
doses
interruption and find
Continue
treatment
solution
where If one or more smear Treatment
received:
and prolong it to
is positive
possible
< 5 months
compensate for missed
• Do 3 sputum smears.
doses
Continue treatment
> 5 months
Category
1:
start
while waiting for
category
2
treatment.
results
Category 2: refer (may
evolve to chronic)
Interruption for 2 months or more (defaulter)
• Do 3 sputum Negative smear or Clinical decision on individual basis
EPTB
whether to restart or continue treatment, or
smears
no further treatment
• Identify
the
Start
category
2
or
more Category 1
cause
of One
treatment
interruption and smear-positive
find solution if
Category 2
Refer (may evolve to
possible
chronic)
• No
treatment
while waiting for
results
4.
HIV/AIDS
Introduction
Acquired Immune Deficiency Syndrome (AIDS) is caused by a virus known as the
Human Immunodeficiency Virus (HIV). Since the first description of AIDS in 1981,
infection has been on the increase. By the end of 2002, there were an estimated
42,000,000 adults and children living with HIV or AIDS. Of these 28,500,000 were
living in sub-Saharan Africa. Nigeria has also witnessed a corresponding increase in the
prevalence of HIV/AIDS.
HIV damages the human immune system, thereby impairing the capacity of the body to
fight infectious organisms. As HIV infection progresses and immunity declines, patients
become more susceptible to infections. These include TB, pneumonia, recurrent fungal
infections and herpes zoster – these are known as opportunistic infections (OI) and they
account for most of the ill health associated with HIV/AIDS. There is ample evidence
that active management of OIs in persons living with HIV/AIDS as an adjunct to
HAART greatly reduces the mortality and morbidity associated with HIV infection.
14
4.1
LABORATORY DIAGNOSIS OF HIV INFECTION
Laboratory diagnosis of HIV infection is based on the demonstration of antibody in
plasma or serum, and of virus in the blood. The virus can be demonstrated in the blood
with nucleic acid-based tests (PCR for proviral DNA and RT-PCR for plasma viral
RNA), culture and p24 antigen assay. With the technology that is available at present,
HIV antibodies are detectable within four to six weeks of infection, and within 24 weeks
in virtually all infected individuals. However, the virus can be detected in plasma at least
one week earlier. This period of absent antibody in the presence of virus in plasma is
called the “window period”.
A person who has recently been infected may not yet be making antibodies to the virus. The HIV
test detects the antibodies to the virus, not the virus itself. In this case, the test would not detect
antibodies against HIV in the blood. This time is often called the window period
There are 2 categories of tests for diagnosis of HIV infection. The first is the detection of
antibodies (immune response to presence of virus) in a patient’s blood sample. The
second is the detection of the virus in a patient’s blood sample. The choice of which one
to use is driven by age, time of exposure and cost.
4.1.1 Antibody Tests
The most widely available way of identifying HIV-infected individuals is the detection of
HIV antibodies in serum or plasma samples. HIV diagnostic tests are extremely reliable,
and are highly sensitive and specific. The reliability of the tests depends on proper
collection and testing on the part of the laboratory test. The table below shows the main
methods of testing for HIV antibodies.
Table 4.1 Available HIV Testing Methods
HIV Testing Method
Advantages
EIA
–
Enzyme •
Immuno
Assay
(Formerly known as
ELISA)
•
Simple/Rapid Tests
•
•
•
•
•
Less
expensive
than
immunoblot (Western Blot)
US$ 0.75 – 1.75 per test
Large numbers of sera can be
tested daily
Sensitive and Specific
Can take less than 10
minutes)
Less
expensive
than
immunoblot (Western Blot)
US$ 1-2 per test
No specialized equipment
necessary (some are non-cold
chain dependent)
Supplied as single-use tests
so individual specimens can
Disadvantages
•
•
•
•
Some specialized lab
equipment necessary
Skilled technical staff
Steady power supply
A whole kit (90 – 100
samples) has to be used
15
Immunoblot
•
•
•
be tested
The gold standard in terms of •
reliability, sensitivity and
specificity
A confirmatory test
Very specialized
Expensive
health use
for
public
Note: Rapid tests and EIA are subject to false negative and positive results, while
Western Blot is expensive and subject to indeterminate results.
4.1.2.
•
•
•
•
Antigen detection methods:
DNA PCR – useful and reliable test
RNA PCR (viral load) – this is the most sensitive test
P24 – this is not routinely used. It is very specific but a negative result does not
rule out infection
Viral culture – time consuming (4 weeks) and very expensive
4.1.3. Serial and Parallel testing algorithm
Serial testing algorithm refers to the use of 2 screening tests sequentially to test for HIV
antibody. If the initial screening is negative, no further testing is required. If the initial
test is positive, it is followed by one more test. The first test should be the most sensitive
test and the second test should be very specific, and be based on antigen source different
from that of the first test. Samples that produce discordant results in the two tests are
subjected to further testing.
Parallel testing involves the use of two screening tests performed simultaneously.
Samples reactive to both tests are regarded as positive, however, those with discordant
results require further testing. Parallel testing is performed to minimize the chances of
false negative results. It ensures sensitivity and guards against technical errors. It is often
used when a very sensitive test is not available for the initial screening, and when the
concordance of two tests is to be evaluated.
The WHO in 2004 recommended either a serial or double rapid testing protocol in order
to scale up VCT and enhance access to ARV in resource-limited countries as illustrated
below.
16
Figure 4.1
WHO Parallel versus Serial testing algorithm (WHO, 2004)
Parallel Testing
Serial Testing
Blood Sample
Blood Sample
Test 1
Test 2
Both
Positive
Both
Negative
Give
Result
Give
Result
Test 1
Discordant Result
Retest after 6
weeks, if still
discordant refer
to reference lab
Negative
Positive
Result
Give
Result
Test 2
Positive
Result
Discordant
Result
Give
Result
Retest after 6
weeks, if still
discordant refer
to reference lab
17
4.2
HIV DIAGNOSIS IN CHILDREN
4.2.1 Children less than 18 months
By 18 months, a child may still have circulating maternal antibodies; consequently, a
positive HIV antibody test on a child 18 months or less could be due to antibodies from
the mother and not the child. Therefore, Early Infant Diagnosis (EID), a PCR-based
detection method, is the test of choice in this age group. The antigen detection test may
also be used. The optimal time for antigen detection test in non-breastfeeding children is
2-3 months and in breastfeeding children, 3 months after completion.
4.2.2 Children more than 18 months
Antibody detection is very useful and reliable for children over 18 months. The only
exception is a patient in the window period (2-12 weeks post exposure) where antibodies
may not be present at a detectable level. If it is suspected that the patient is in the
window period then antigen testing is recommended or repeat antibody testing after 3
months.
4.3 ANTI-RETROVIRAL THERAPY (ART)
4.3.1 Classes of ARVs
There are 4 classes currently available for treatment based on the site / mechanism of
action (see Table 4.2). Other classes are at various stages of development.
ARV classes and their mechanisms of actions
• Non-nucleoside reverse transcriptase inhibitors (NNRTIs) stop HIV production by
binding directly onto the reverse transcriptase enzyme thus preventing the
transcription of viral RNA to DNA.
A member of this class expected in the clinic soon is etravirine.
•
Nucleoside reverse transcriptase inhibitors (NRTIs) incorporate themselves into
the DNA of the virus, thereby stopping the building process. The resulting DNA
is incomplete and cannot create a new virus. Nucleotide Reverse Transcriptase
Inhibitor (NRTIs) acts at the same stage of the viral life cycle as the NNRTIs, but
do not require being phosphorylated in-vivo for effective antiretroviral activity.
•
Protease inhibitors (PIs) work at the last stage of the virus reproduction cycle.
They prevent HIV from being successfully assembled and released from the
infected CD4 cell.
•
Fusion inhibitors bind to gp41 and prevent this from binding to chemokine
receptors resulting in failure of HIV lipid bi-layer from fusing with the CD4 cell
membrane.
Others
18
™ The entry inhibitors prevent the virus from gaining access into the cytoplasm
of the CD4 cells. There are 3 categories of these inhibitors:
™ The chemokine receptors antagonists which bind to CCR5 and CXCR4 and
thereby prevent fusion of viral gp41 to these receptors
™ Attachment inhibitors which inhibit interaction between gp120 and CD4
molecule
™ Nucleoside- and Non Nucleoside-Reverse Transcriptase Inhibitors and
Protease Inhibitors are however the most widely used.
The following drugs and Fixed Drug Combinations have been licensed for use in Nigeria.
Table 4.2: ARTs currently registered with NAFDAC
Nucleoside/
[Nucleotide] Reverse
Transcriptase
Inhibitors (NsRTIs)
Zidovudine
(AZT,
ZDV)
Didanosine (ddl)
Stavudine (d4T)
Lamivudine (3TC)
Abacavir (ABC)
[Tenofovir(TDF)]
Non-Nucleoside
Reverse
Transcriptase
Inhibitors (NNRTIs)
Nevirapine (NVP)
Efavirenz (EFV)
Fixed
dose
Protease Inhibitors combinations*
(PIs)
Saquinavir (SQV)
Ritonavir
(RTV)
Indinavir (IDV)
Nelfinavir (NFV)
Amprenavir (APV)
Lopinavir/Ritonavir
d4T+3TC+NVP
d4T+3TC
ZDV+3TC+NVP
ZDV+3TC
ABC+ZDV+3TC
LPV/r
* Fixed dose combinations (FDC) are based on the principle of inclusion of two or more
active pharmacological products in the same tablet, capsule or solution.
The first line drugs being used in Nigeria are Zidovudine, Tenofovir , Lamivudine,
Stavudine , Efavirenz and Nevirapine .
4.3.2 ART Regimens and Doses
The preferred ART regimen for TB/HIV co-infected patients are:
• For Rifampicin-containing regimen [(ZDV ,ABC)] +[3TC or FTC] + EFV
• For non Rifampicin-containing continuation phase regimen [(ZDV ] +[3TC or
FTC] + [EFV or NVP]
• For pregnant women,(ZDV + 3TC + ABC or SQV/r
• For patients who are poorly tolerant of EFV, ZDV + 3TC + ABC or SQV/r or
NVP
• For those with hepatitis (B or Alcoholic) , ZDV+3TC+TDF
The table below shows the first line ART regimens and doses. In managing patients who
are dually infected with TB, Efavirenz is substituted for Nevirapine because Rifampicin,
a first line drug in the management of TB, lowers the serum concentration of Nevirapine.
19
Table 4.3: ARVs and Dosages
Drug
Strength/Prepar
ation for adults
Lamivudine 100mg,
150mg
(3TC)
tablets
Emtrcitabine 200mg
(FTC)
Stavudine
30mg tablets
(d4T)
40mg capsules
Zidovudine
(ZDV)
Abacavir
(ABC)
Tenofovir
TDF
Efavirenz
(EFV)
Nevirapine
(NVP)
Adult dosing
150 mg BD or
300mg OD
200mg OD
30 mg BD,
consider 40 mg
BD if weight is
> 60 kg
Comments
May be taken taken 300mg OD as
prescribed by physician
Closely related to 3TC and should
not be co-administered with it
Not to be used with ZDV. Needs
to be refrigerated and shaken well
before use.
100mg capsule, 250 – 300 mg Use with caution in the setting of
300mg tablets
BD
anaemia.
Increased toxicity possible when
used with other drugs that are
associated with bone marrow
suppression.
Should not be administered in
combination with d4T.
Store at 15-25oC
300 mg tabs
300 mg BD or Causes hypersensitivity reaction
600mg OD
(HSR), which can be fatal; never
re-challenge the patient. Educate
patient on HSR
300 mg tab
300mg OD
Caution should be taken in renal
impairment and renal function in
particular.
Plasma
creatinine
should be monitored.
200mg,
600mg 600mg OD *
Contraindicated below 3 years of
capsule
age and in early pregnancy
200mg tablet
200mg
BD,
always initiate
200mg OD for
2 weeks before
giving full dose.
Increase incidence of severe
hepatotoxity in women with CD4
count > 250/ml and men with CD4
count > 400 /ml. Other common
reactions include skin rash. Should
not be used with Rifampicin.
Saquinavir
200mg gel filled 1000mg + RTV Administer with or after food
(SQV)
capsule
100mg BD
Dose adjustments may be necessary with renal impairment.
*(information on benefits of 800mg EFV still awaited for patients >60kg
4.3.3 When to start Antiretroviral Therapy
For patients with active TB in whom HIV infection is diagnosed and ART is required the
first priority is to initiate standard antituberculosis treatment (in accordance with National
20
TB policy and Guidelines). The optimal time to initiate ART is not known. See table 4.4
for recommendations.
Table 4.4: Recommendations for initiating ARTs in co–infected Adults and
Adolescents
CD4 CELL COUNT
ART RECOMMENDATIONS
CD4≤ 200 cells/mm3
Recommend ARTa
CD4between
200 Recommend ART
3
and
350
cells/mm
cells/mm3
CD4≥ 350 cells/mm3
Defer ARTc
TIMING OF ART IN
RELATION TO START
OF TB TREATMENT
Between two and eight
weeksb
After eight weeks
Re-evaluate patient at eight
weeks and at the end of TB
treatment
Not available
Recommend ARTd
Between two and eight
weeks
a An EFV-containing regimen is the preferred first-line regimen. Alternative first-line
treatment regimens include NVP and triple NRTI (based ABC) regimens. For NVPcontaining regimens, ALT should be checked at 4, 8 and 12 weeks; treatment should be
decided on the basis of symptoms thereafter.
b ART should start as soon as TB treatment is tolerated, particularly in patients with
severe immunosuppression.
c ART should be started if other non-TB stage 3 or 4 events are present.
d For some TB diagnoses that generally respond well to anti-TB theraphy (i.e lymph
node TB, uncomplicated pleural effusion), deferral of ART should be considered.
Note:
1. Refer patients to ART sites for commencement of ART
2. Refer children to pediatricians for commencement of ART
4.3.4 Tuberculosis in patients already receiving ART
There are two issues to consider in patients who are diagnosed with TB while on ART.
The first concerns the modifications of ART, if any, which should be recommended for
patients developing active TB within six months of initiating first-line or second-line
ART. These recommendations are summarized in Table 4.5.
21
Table 4.5 ART recommendations for patients who develop TB within six months of
starting a first-line or second-line ART regimen
FIRST-LINE
OR ART REGIMEN AT THE OPTIONS
SECOND-LINE ART
TIME TB OCCURS
Two NRTIs + EFV
Continue with two NRTIs +
EFV
Two NRTIs + NVP
• Substitute to EFVab or
• Substitute
to
triple
First-line ART
NRTI regimena or
• Continue with two
NRTIs + NVPa
Triple NRTI regimen
Continue
triple
NRTI
regimen
Second-line ART
Two NRTIs + PI
Substitute to or continue (if
already being taken) LPV/ror
SQV/r-containing
regimen and adjust dose of
RTVa
a Substituting back to the original regimens once the rifampicin-containing regimen is
completed can be considered. When switching back from EFV to NVP, no lead-in dose is
required.
b The use of EFV-containing regimens is not recommended in women of childbearing
potential, if adequate contraception cannot be ensured, and during the first trimester of
pregnancy.
c Careful clinical and laboratory monitoring (ALT) is advised when NVP or boosted PIs
are administered concurrently with rifampicin
The second issue is whether the presentation of active TB on ART constitutes ART
failure. An episode of TB can occur across a wide range of CD4 cell counts and does not
necessarily herald ART failure and the need to switch to second-line regimens. In
addition, sub clinical or undiagnosed TB often presents within the
first six months after the initiation of ART, frequently as part of IRIS.
WHO recommendations:
• If an episode of TB occurs during the first six months following the initiation of
ART, this should not be considered a treatment failure event and the ART
regimen should be adjusted for co-administration with Rifampicin-containing
regimens
• If an episode of TB develops more than six months after the initiation of ART and
data on the CD4 cell count and viral load are available, the decision about
whether the TB diagnosis represents ART failure is based on the CD4 cell count
and, if available, the viral load.
22
•
If a CD4 cell count is not available the decision on whether the TB diagnosis
constitutes ART failure depends on whether the TB is pulmonary or extra
pulmonary and whether there are other non-TB stage 3 or 4 events.
•
WHO recommends that the development of an episode of pulmonary TB after six
months of ART, without other clinical and immunological evidence of disease
progression, should not be regarded as representing ART failure.
Extra pulmonary TB should be considered as indicating ART failure, although
simple lymph node TB or uncomplicated pleural disease may be less significant
than disseminated TB.
o If there is a good response to TB therapy, the decision to switch to a
second-line regimen can be delayed until short-course TB therapy has
been completed.
•
4.3.5 Side-effects of Antiretroviral Therapy
Monitoring of patients receiving ART is of utmost importance due to the interactions and
adverse drug reactions produced by some of the drugs. Table 4.6 shows some common
complaints to be expected from patients on ART, the possible offending drug and the
recommended action to be taken.
Table 4.6: Drug interactions / side-effects and recommended actions
Symptoms/ signs
Possible offending drug
Headache, anaemia, sepsis, low Zidovudine
white blood cell count
Numbness of hands or feet, Stavudine
muscular weakness, jaundice,
abdominal pain
Headache, fatigue, abdominal Lamivudine
upset, numbness of hands and feet
Abnormal liver function tests, Nevirapine
severe hypersensitivity reactions,
rash
Dizziness,
sleeplessness
or Efavirenz
somnolescence,
headache,
depression
Action to be taken
Refer for specialist care:
Monitoring FBC
Monitor, withdraw drug if
symptoms are severe; if
neuromuscular
weakness
discontinue and do not re-start
Monitor, withdraw drug if
symptoms are severe
If LFT is suggestive of hepatitis
or if jaundice is present
discontinue; if rash is severe
discontinue. Note- Rifampicin,
Isoniazid, Pyrazinamide can
cause abnormal liver function
tests. There may be need to
replace
Nevirapine
with
Efavirenz.
Monitor, withdraw
symptoms are severe
23
drug
if
4.4
OPPORTUNISTIC INFECTIONS
4.4.1 Introduction
Opportunistic infections (OIs) are infections or disease conditions that take advantage of
the depressed immunity of HIV-infected persons. In Nigeria, TB is the most important OI
in terms of morbidity and mortality in PLWHAs. Care givers at the PHC facility level
are expected to be familiar with some of these OIs, and be able to give treatment to
alleviate the symptoms using the syndromic management approach or refer cases as
required.
4.4.2 List of common Opportunistic Infections (OI) in Nigeria
The common OIs are due mainly to: viral, fungal, bacterial and parasitic/ protozoal
organisms, which include tuberculosis, diarrhoeal diseases (infectious),oral and vaginal
candidiasis, respiratory tract infections, herpes zoster, scabies, Kaposi’s sarcoma, etc.
Viral
•
•
•
•
•
Herpes Simplex
Herpes Zooster
Multiple bluish nodules (Kaposi sarcoma)
Human papilloma virus (vaginal warts)
Viral upper respiratory tract infection
Fungal
• Ringworm
• Nail infections
• Candida infections
Bacterial
• Papulo-pruritic eruptions
• Pneumonia
• Diarrhoeal diseases
• Urinary tract infection
Protozoal / Parasitic
• Scabies
• Diarrhoeal diseases
• Toxoplasma encephalitis
See Annex 1: for table of management of OIs in Nigeria.
5.
DUAL INFECTION OF TB AND HIV
Management of the dual infection of TB and HIV is aimed at reducing the morbidity and
mortality arising from both diseases in the patients. This entails preventive and
therapeutic strategies which healthcare workers managing such patients need to be
familiar with.
24
5.1
ISONIAZID PREVENTIVE THERAPY (IPT)
Isoniazid Preventive therapy (IPT) is the use of Isoniazid in HIV Positive individuals
with latent TB infection and under five contacts of PTB index cases in order to prevent
the development of active TB disease. Available evidence shows that TB is the
commonest opportunistic infection and the leading cause of death among PLWHA and
also that IPT is effective in preventing it.
IPT is not the treatment for active TB. It is therefore necessary to exclude active TB
before commencing a patient on IPT. This therapy should be left at the discretion of
a medical officer experienced in management of Tuberculosis and HIV/AIDS
5.1.1 Target groups for Preventive Treatment
• Infants of mothers with either Smear Negative or Positive PTB
• Children under 5 years of age
• HIV-infected individuals
• Health care workers who are HIV positive
• HIV positive prison inmates
5.1.2 Eligibility for IPT
For a patient to benefit from IPT, he/she must:
• Asymptomatic HIV Positive patients
• Not have active TB.
• Be motivated to adhere to treatment.
5.1.3 Services needed before setting up a preventive therapy service
Before a preventive therapy service is considered, the following prerequisites should
be in place:
• Adequate capacity for HIV counseling, which should include IEC about TB;
• Sufficient trained health care staff;
• Linkage between HIV care and TB control services;
5.1.4 Steps in Commencing IPT
The following steps should be followed before a patient is placed on IPT
• Verify/Confirm HIV Status
• Counsel on TB/HIV interactions
• Exclude active TB
o Ask the patient about cough, chest pain, fever, night sweats and weight loss
etc
o Check for lymph node enlargement
o Those with the above symptoms/signs should not be considered for IPT
o Do sputum smear examination for AFB
o Refer/commence short course chemotherapy for TB (DOTS) if smearpositive
o Refer those with negative sputum smear results to medical officers for
excluding active TB by chest X-ray or culture where available
25
ƒ
Commence IPT, if no active TB is confirmed
5.1.5. Dosage of INH for IPT
5mg/kg/day to a maximum of 300mg/day for six months. INH should be dispensed
monthly to enhance compliance.
ƒ
ƒ
Counsel patient on:
o Treatment adherence
o Side-effects of INH
o Immediate recognition and reporting of signs and symptoms of active TB
Complete necessary INH Prophylaxis Register and complete INH Appointment
Card. (See INH prophylaxis Treatment register for PLWHA and INH
Prophylaxis card in the annex.)
ƒ Monitor
During monthly drug refills, monitor patient
o For development of active TB (clinical assessment of signs and symptoms
of active TB )
o Ask for side-effects; the commonest side-effect is peripheral neuropathy
(numbness/tingling sensation of extremities). If present give Pyridoxine
50-75 mg daily
o Check for jaundice. If present stop IPT and refer to medical officer for
assessment
o Check for allergic skin eruptions
•
5.2
Note: If patient develops signs and symptoms suggestive of active TB during
the course of IPT:
• Discontinue IPT,
• Assess for active TB,
• Commence DOTS if confirmed or refer to medical officer.
Assess for ART
COTRIMOXAZOLE PREVENTIVE THERAPY (CPT)
Cotrimoxazole preventive therapy (CPT) is use of cotrimoxazole for the prevention of
several secondary bacterial and parasitic infections in HIV-infected individuals. It helps
to improve the quality of life and reduce the rate of death among HIV-infected patients
and those that are dually infected.
5.2.1 Eligibility
For a patient to benefit from CPT, he/she must be:
•
•
•
•
A PLWHA with symptomatic HIV
Asymptomatic PLWHA with total lymphocyte count < 1,200/mm3 or CD4 count of
<350/mm3
Motivated to adhere to treatment
A PLWHA with active TB
26
•
•
•
A pregnant PLWHA after the first trimester
A child born to an HIV-infected woman (offer CPT from six weeks of age)
A child identified as HIV-positive within the first year of life
5.2.2 Steps for CPT
• Verify HIV status
• Take medical history and screen for contraindications to CPT
o Known allergy to sulphur containing drugs (which includes cotrimoxazole
and sulphadoxine-pyrimethamine
o First trimester pregnancy
o Kidney or Liver disease
o Seriously ill patient
• Conduct physical examination
• Counsel patient on
o OI’s in HIV infection
o Drug adherence
o Side-effects of cotrimoxazole
1. Skin eruptions, which may be severe (Stevens Johnson syndrome)
2. Kidney or Liver failure
3. Anaemia
• Treat pre-existing OI’s
• Commence CPT
Dosage of Co-trimoxazole for CPT
Adults:
960mg daily (two single strength tablets)
Children:
4mg/kg body weight once daily. Cotrimoxazole syrup is
preferable, in its absence, the tablets can be crushed.
•
•
•
•
Monitor patients
o Adult should be reviewed monthly initially, and then three monthly
thereafter if the medications are tolerated
o Laboratory monitoring of adults should take place every six months or when
clinically indicated. This should include hemoglobin and white cell count
o Children should be reviewed monthly
o Replenish patient’s drug during review
Discontinue CPT
o If side-effects occur
o If children test HIV-negative when older than 18 months (where CPT was
commenced in infancy)
o When CD4 count rises above 500 or total lymphocyte count above
2000/mm3
Complete necessary CPT Prophylaxis Register and Treatment Appointment Card
Assess for ART
27
5.3
TREATMENT
TUBERCULOSIS
OF
HIV-POSITIVE
PERSONS
WITH
ACTIVE
Dually infected TB/HIV patients should benefit from both DOTS and ART in a
coordinated manner to ensure maximum clinical response.
5.4
IMMUNE RECONSTITUTION SYNDROME
When monitoring a patient on ART who starts anti-TB drugs, care givers should be on
the look out for a worsening of symptoms, signs and radiological manifestations of TB.
This paradoxical reaction in HIV-infected patients with TB occurs 2–3 weeks and
sometimes up to 8 weeks after commencement of therapy. It is thought to be the result of
immune reconstitution.
Instead of the expected improvement after commencing anti-TB drugs, the patient may
present with high fever, lymphadenopathy, expanding central nervous system lesions and
worsening chest X-ray findings. Such patients should be referred to a medical officer
experienced in the management of TB and HIV/AIDS for thorough evaluation to rule out
other causes of the paradoxical reaction before confirming the diagnosis and commencing
treatment.
6. PREVENTION OF TB/HIV IN HEALTH CARE
SETTINGS
INTRODUCTION
From the public health point of view, the best way to prevent TB is to provide effective treatment
for people with infectious TB.This interrupts the chain of transmission. Good treatment
programmes are the best prevention programmes. HIV-infected individuals are particularly
susceptible to infection with M. tuberculosis and the development of TB.
6.1
PREVENTION OF HIV-INFECTED PERSONS AGAINST EXPOSURE
•
•
•
•
•
•
HIV-positive patients and staff in health units face daily exposure to TB
The risk of exposure is greatest in adult medical wards and TB wards
where there are many PTB cases
Often the wards are crowded and badly ventilated
Prompt diagnosis and treatment of patients with sputum smear-positive PTB helps to
reduce exposure to TB. Prompt outpatient diagnosis and treatment of PTB patients avoids
hospital admission. This is an advantage in decreasing exposure to TB in hospital wards
In-patient management of intensive phase TB patients should as much as possible be
avoided
Known HIV-positive health workers should not work with PTB patients. They should
therefore not work in TB wards or adult medical wards
Good ventilation helps reduce TB transmission indoors.
• Sunlight is a source of ultraviolet light, which can kill TB bacilli. So, ideally, wards
should have large windows.
28
•
•
Laboratories that process sputum specimens for AFB should follow standard operating
procedures involved in good laboratory practice (GLP).
• In wards, outpatient clinics, sputum collection rooms, microbiology laboratories,
surgical and autopsy suites, keep the doors closed and the windows open.
• Health workers should teach TB suspects and TB patients simple measures to decrease
the risk of transmitting TB. These include
o
Covering the mouth with a clean handkerchief/cloth when coughing/sneezing,
and using sputum pots with lids.
o
When examining TB patients or suspects, ask them to turn their
head away, to avoid coughing directly at the health worker.
Mop floor before sweeping
6.2
PULMONARY TB CASES
•
•
•
•
•
•
•
•
6.3
If possible admit them to a separate ward from other patients.
If there are no facilities to separate PTB suspects from other patients, at least try to keep
PTB suspects in a part of the ward away from other patients.
Staff should also encourage PTB suspects to spend daylight hours outside the ward if the
weather is good.
Sputum for smear examination should be collected as rapidly as possible.
The laboratory should process and examine sputum smears rapidly and efficiently.
Hospitals should ensure a minimum of delay in delivering smear examination results
back to the wards.
Well children should be discouraged from accompanying infected adults for DOTS
follow-up
Children should be discouraged from entering TB inpatient wards/clinics for social visits
PREVENTION OF HIV TRANSMISSION IN HEALTH CARE SETTINGS
Less than 0.5 % of health workers exposed to a needle-stick injury from the blood of an
HIV-positive patient have acquired HIV infection.
The following are recommended precautions for healthcare workers
• Assume that all blood and body fluids are potentially infectious
• Handle all “sharps” (needles and syringes) carefully and discard used ones into a
disposable container, then burn them.
• If you have a needle-stick injury, squeeze the wound to encourage blood flow and
wash well with soap and water and follow the steps outlined below under PEP.
The table below gives some guidance on prevention of transmission to health workers.
Table 6.1: Precautions for Healthcare Workers against Occupational Risks
29
Exposure to risk
Venepuncture
Precaution for prevention of transmission of HIV
• Wear gloves
• Use a closed vacuum system if available
• Discard needle and syringe into sharps box
• Discard gloves and swabs into leak-proof plastic bag for
incineration (burning)
• Label blood bottle and request form “inoculation risk”
Invasive
procedure, • Wear gloves and apron
surgery or delivery of a • Protect your eyes (glasses or protective goggles)
baby
• Discard sharps into sharps box
Spilled blood
• Clean up as soon as possible using available disinfectant (e.g.
Dettol, Purit, Savlon, Izal)
Resuscitation
• Avoid mouth-to-mouth resuscitation (use Ambu-bag)
7.
GUIDELINES FOR POST EXPOSURE PROPHYLAXIS (PEP) HIV
INTRODUCTION AND RATIONALE OF PEP
Information about primary HIV infection indicates that systemic infection does not occur
immediately after exposure, leaving a brief window of opportunity during which
administration of PEP might prevent viral transmission and replication. Commencement
of PEP within two hours after exposure might inhibit or prevent systemic infection. After
an exposure the following steps should be pursued:
7.1
FIRST AID
Following any occupational exposure, the following are recommended before reporting:
1.
Wash percutaneous injuries with soap under running water (tap or stored water) and
allow the wound to bleed freely; do not compress to stop bleeding.
2.
Use water to flush out nose, mouth or areas of the skin (broken) that have been
splashed with blood.
3.
Irrigate eyes when exposed with saline or clean water
4. Report and document incident immediately through supervising officer.
5.
Index worker and supervisor should consult an expert or the designated persons
listed immediately or be immediately referred to an ART treatment center for PEP.
7.2
EVALUATE EXPOSURE RISK ASSESSMENT
Low risk
• Solid needle injury
• Superficial sharps injuries
• Exposure to blood/fluid from asymptomatic HIV patient with low viral load or
suppressed viral load on therapy
• Exposure to a small amount of infected blood/fluid
• Splash of blood on intact skin
High risk
• Deep injury with hollow especially large bore needle
30
• Exposure to blood/fluids of patient with AIDS or advanced HIV infection or acute
sero-conversion illness
• Extensive and deep sharp injury
• Exposure to large volume of infected blood / fluid
• Splash of blood on broken skin
7.3
EVALUATION OF EXPOSURE SOURCE
Known Source
• Enquire whether patient is known to be infected with HIV
• Evaluate HIV infected patients’ stage, performance status, CD4 cell count (or
lymphocyte counts) and clinical condition
• If status unknown, test for HBsAg, HCV and HIV antibodies using rapid HIV
testing technique with informed consent. [Screening for HIV should not be
delayed or deferred to await HBV and HCV screening]
• If source is not infected with any of the above viruses, baseline testing or
further follow-up is not necessary (unless strong suspicion or possibility that
he / she is in the window period – should especially suspect sexually active
individuals).
• If source person refuses testing, consider clinical presentation, diagnoses and
history of risk behaviors; consider source infected if sexually active.
Unknown Source
• Evaluate the likelihood of exposure to a source at high risk for infection
• Consider the likelihood of infection among patients in the exposure setting
8.
TB Infection Control (TB-IC) I Health care settings.
Health care workers and other staff are at particularly high risk of infection with TB
because of frequent exposure to patients with infectious TB disease. They may also be
immune-suppressed due to HIV infection and be at higher risk of developing TB disease
once infected.
Persons with HIV-associated immune-suppression may become infected or re-infected
with TB if they are exposed to someone with infectious TB disease. They can progress
rapidly from TB infection to disease – over a period of months rather than a period of
years as is common for persons with a normal immune system.
Long waiting hours as well as overcrowding and poor ventilation of health facilities
increase the risk of TB transmission among clients receiving care and portraying danger
to health workers delivering care. This section highlight steps to reduce TB-IC in health
care settings, refer to National Guidelines on TB infection control for detail information.
8.1 How TB is spread
TB is caused by Mycobacterium tuberculosis (M. tb). People who have TB disease in
their lungs or larynx (throat) can release tiny particles containing M. tb into the air by
coughing or sneezing. These particles are called droplet nuclei. They are invisible to the
naked eye because they are only about one-millionth of a meter long. Droplet nuclei can
remain airborne in room air for many hours, until they are removed by natural or
mechanical ventilation.
31
For TB to spread, there must be a source that produces M. tb (person with TB disease)
and others to inhale droplet nuclei containing M. tb. Anyone who shares air with a person
with TB disease of the lungs or larynx in an infectious stage is at risk. When another
person inhales one or more of the droplet nuclei he or she can become infected with TB,
or, in other words, develop TB infection.
8.2
When is TB disease infectious?
TB can be infectious when it occurs in the lungs or larynx.
In general, a person with TB disease of the lungs or larynx should be considered
infectious until the person:
has had three consecutive negative acid-fast bacilli (AFB) sputum smears on two
different days; or
has completed at least two weeks of anti-TB therapy, preferably with direct observation
by a TB program-appointed treatment supervisor; and
has improvement in symptoms.
A TB suspect should be considered infectious until a diagnostic evaluation is completed.
8.3
INTERVENTIONS TO REDUCE RISK OF INFECTION
There are three main ways in which the risk of Tuberculosis infection can be reduced.
• Work practice and administrative control measures
• Environmental control measures
• Personal protective measures
In all, work practice and administration control measures have the greatest impact on
preventing TB transmission. Environmental control measures provide further steps to
reduce/eliminate risk of exposure.
8.4
Work Practice and Administrative Control Measures
These serve as the first line of defence for preventing the spread of TB in HIV settings.
The aims are :
• To prevent TB exposure to staff and patients
• To reduce the spread of infection by ensuring rapid and recommended diagnostic
investigation and treatment for patients and staff known to have TB.
These can best be accomplished through the prompt recognition, separation, provision of
services, and referral of persons with potentially infectious TB disease.
8.5
Recommended TB-IC procedures at General Out-patient Departments
HIV-positive patients and staff in health units face daily exposure to TB. The following
procedures are suggested:
•
Ensure prompt diagnosis and treatment of patients with sputum smear-positive
PTB
32
•
•
•
•
•
•
•
•
•
•
8.6
•
•
•
•
•
•
•
Ensure prompt outpatient diagnosis and treatment of PTB patients to prevent
hospital admission.
In-patient management of intensive phase TB patients should as much as possible
be avoided.
Known HIV-positive health workers should not work with PTB patients (they
should therefore not work in TB wards or adult medical wards)
Ensure good ventilation to help reduce TB transmission indoors.
Wards should have large windows as sunlight is a source of ultraviolet light,
which can kill TB bacilli.
Laboratories that process sputum specimens for AFB should follow should follow
standard operating procedures involved in good laboratory practice (GLP).
In wards, outpatient clinics, sputum collection rooms, microbiology laboratories,
surgical and autopsy suites, keep the doors closed and the windows open.
Educating the TB suspects and TB patients on Dangers of Exposure and
Prevention covering the mouth with a clean handkerchief/cloth when
coughing/sneezing, and using sputum pots with lids.
When examining TB patients or suspects, ask them to turn their head away, to
avoid coughing directly at the health worker.
Wet floor before sweeping (bleach should be used rather than disinfectants like
Izal, Dettol etc.)
Recommended procedures for TB-IC in the Medical Wards
If possible admit them to a separate ward from other patients.
If there are no facilities to separate PTB suspects from other patients, at least try
to keep PTB suspects in a part of the ward away from other patients.
Staff should also encourage PTB suspects to spend daylight hours outside the
ward if the weather is good.
Sputum for smear examination should be collected as rapidly as possible.
The laboratory should process and examine sputum smears rapidly and
efficiently.
Hospitals should ensure a minimum of delay in delivering smear examination
results back to the wards.
Children should be discouraged to accompany infected adults for DOTS followup and from entering TB inpatient wards/clinics for social visits
8.7
TB Infection Control (TB-IC) Procedures at the Health Facilities
Ideally, each facility should have a written TB infection control plan which outlines a
protocol for the prompt recognition, separation, provision of services, investigation for
TB and referral of patients with suspected or confirmed TB disease.
8.8
The TB infection control plan for all health facilities should include:
Screen all clients to identify persons with cough > 2 weeks as soon as possible after
arrival at the facility
Ask patients to cover their mouths when they cough if possible
Place TB suspects in a separate well-ventilated waiting area or outside
33
Suggested clinic operating procedure: A staff person should direct or escort the TB
suspect to a separate waiting area. Clients need to be assured of their place in the
queue for registration and/or services. (This special waiting area should have the
highest natural ventilation possible.)
Expedite TB suspects’ receipt of services in the facility
Suggested clinic operating procedure: TB suspects should be moved to the front of
the queue for whatever services they are accessing, e.g., HIV testing and counseling
or VCT, medication refills, medical evaluation. This reduces the duration of potential
exposure in the facility and may be an incentive to disclose information during
screening.
Ensure rapid investigation of TB suspects or referring TB suspects to TB diagnostic
services if not available on site.
Use and maintain environmental control measures (see next section)
Screen staff for symptoms of TB disease (see Section A)
Provide voluntary, confidential HIV counseling and testing for staff with appropriate
access to treatment
Train and educate all staff on TB, TB control and the TB infection control plan.
Monitor the implementation of the TB infection control plan
8.9 Environmental control measures
Environmental controls are the second line of defense for preventing the spread of TB in
HIV care settings. If the work practice controls are inadequate, environmental controls
will not eliminate the risk of spread of TB.
Environmental control measures include:
8.10 Ventilation (natural and mechanical)
Controlled natural ventilation can reduce the risk of spreading TB. Ventilation is the
movement of air in a building and replacement of air in a building with air from
outside. When fresh air enters a room it dilutes the concentration of particles, such as
droplet nuclei containing M.tb, in room air.
•
Open doors and windows to bring in air from the outside; ‘controlled’ implies
that checks are in place to make sure that doors and windows are maintained in the
position that enhances ventilation. Design waiting areas and examination rooms so
that they have maximum natural ventilation can help reduce the spread of TB.
•
Always collect sputum for TB outside (open environment) and away from
other people, not in small rooms such as toilets or other enclosed areas.
.
8.11 Protection of health workers
34
The primary way to prevent transmission of TB to health workers and others at the
health facility is for TB patients to take their drugs regularly. They will then become
non-infectious in a week or two. Good ventilation of the place where treatment is
provided is also very important.
Personal respiratory protection (respirators) are not a priority intervention. Respirators
can protect health care workers from inhaling M. tb only if appropriate work practice and
environmental controls are in place; i.e., they are a last line of defense. They are
expensive to purchase and require specialized equipment to determine the appropriate fit.
Frequently, they are unavailable in resource-limited settings. Their use should be
restricted to specific high risk areas in hospitals and referral centers, such as rooms where
spirometry or bronchoscopy are performed or specialized treatment centers for persons
with multi-drug resistant TB.
Respirators are different from face masks, such as surgical masks made of cloth or paper.
Face masks do not protect those wearing them from inhaling M. tb. In fact, the use of
these masks may contribute to a false sense of security. There is no role for health care
workers or staff to use face masks for protection from TB.
35
Annex 1 : Algorithm for the diagnosis of TB in ambulatory patients
36
Annex 2:
Organ
Involvement
Table 7.2
Management of Common OIs in Nigeria
Complaints
Itchy Rash
SKIN
Examination
Clinical
Judgment
• Papular
rash
and Papulopustules
located pruritic
mainly on the extensor eruptions
surfaces of the arms,
back of the hands, and
trunk; there is sparing
of the palms and soles.
The
condition
is
chronic and tends to
wax
and
wanes.
Scratch marks may or
not be present
• Papular rash more
on the webs of the
fingers and toes often
with scratch marks
Scabies
Painful rash
• Painful fluid filled Herpes
skin rash with a Zoster
reddish base on one
side of the body not
crossing the midline
• Painful rash/ blisters
on the lips and tips of
the penis or vulva
• Multiple bluish purple
rashes
commonly
found at the back of
the hand and at the
dorsum of the foot.
Itchy scaly lesions Ring worm
spreading at the edges
on any part of the body
Action
• Reassure
• Treat
with
antihistamines
e.g.
Antisan
cream
• Tab piriton 1 tds
x 1 week
• If no improvement refer
Benzyl
benzoic
acid
solution,
apply topically bd
from
neck
downwards x 4
days.
• Reassure
the
patient.
• Paracetamol
1000mg qds x
3days
• Ascorbic
acid
100mg daily x 7
days
• Zovira
cream
topically.
• Tab
acyclovir
200mg tds x 2
weeks
Refer
if
no
improvement.
• Apply Whitfield
or
Miconazole
ointment twice
daily.
37
ORAL
PHARNGEA
L
LESIONS.
•
•
•
•
GASTRO
INTESTINAL
SYSTEM
UROGENIT
•
Pain in
the throat
Fever
Pain on
swallowi
ng
Altered
taste.
Frequent
watery
stools
more
than 5
times
daily
• Abdomi
nal
cramps
weakness
Continue for one
month extra after
disappearance of
lesions
Refer
if
no
improvement.
• White patches in Oral
• Reassure
pharyngeal
the mouth cavity
patient
thrush
• Palpable enlarged
• Nystatine oral
lymph nodes
suspension (
to
confirm
dosage) and
Gentian violet
paint for 14
days
• Paracetamol 2
tabs. tds. x
3days.
• Tab.
Clotrimazole
10mg 5 times
x 2 weeks.
bacterial
/
• watery stools
• fluid
parasitic
replacement
• dehydration
infections
(ORS)
• Tab.
Cotrimoxazol
e 960mg bd x
5 days and /
or
• Tab.
Metronidazol
e 400mg tds
x 5 days
• Refer
if
symptoms
persist
Persistent
• Evidence
of
diarrhoea for
weight loss.
14 days with Dehydration
weight loss
Recurrent or Marked weight loss
persistent
diarrhoea for
more
than
one month.
to
the
• Abnorma Refer
Unexplaine
d diarrhoea
Give ORS in sips
and refer.
Unexplaine
d diarrhoea
Refer immediately
to medical officer.
Treat as in the
38
AL SYSTEM
•
•
•
•
•
SYSTEMIC
INFECTION
S
•
•
•
•
•
•
•
RESPIRATO
RY
TRACT
INFECTION
•
•
•
•
•
•
•
l vaginal Guidelines on STI on
discharge syndromic
management of STI
Male
uretheral
discharge
Genital
ulcers
Groin
swelling
Female
lower
abdomin
al pain
Scrotal
swelling.
• Febrile
Fever,
• Parlour
Malaria
Weaknes
s
Chills
Rigours
Headach
e
Joint
pains
Clear
nasal
discharge
Headach
e
Malaise
Slight
Fever
Upper
respirator
y
tract
infection
Cough
• cough productive
sputum
Chest
In
drawing
of
pain
• Difficult intercostals space
y
in
breathing
malaise
Guidelines
syndromic
management
STI.
for
of
Screen for malaria
and Enteric fever
and
treat
accordingly.
Viral upper
respiratory
tract
infection.
•
•
•
•
Severe
lower
respiratory
tract
infection
?Pneumonia
Paracetamol 2
tabs. bd x 3
days
Piriton 1 bd x
3 days
Multivitamins
tabs 1 tds x 2
weeks.
Vitamin C 2
tds x 2 weeks
• Bed rest
• Good diet
Give paracetamol
and
consider
referral
if
condition persists
39