3.1. PRE-TEST INFORMATION AND INFORMED CONSENT
Pre-test information may be provided in a number of ways:
One-to-one, face-to-face, etc.
group information + brief individual risk assessment
group information only
couples + individual
couples together
de-linked community counselling (in PWID settings, encouraging self-referral), or
phone link/hotline pre-test counselling in the community linked to a testing laboratory.
Providers of HIV testing and counselling typically conduct an education session and a risk assessment, with a primary focus on prevention counselling for clients both prior to and after receiving their test results. This approach to testing and counselling in PWID settings attempts to find a balance between complicated and overdrawn counselling sessions and rapid, intense education/information transfer. While it is accepted that detailed counselling is vital in certain circ*mstances, it is felt that in most settings attended by PWID it can be substantially shortened.
Because the objective of HIV testing and counselling in PWID settings is the timely detection of HIV and access to health-care services, pre-test information in particular can be simplified. For example, individual risk assessment and risk reduction plans can be covered during post-test sessions, rather than in the pre-test information session, and tailored to the patient’s HIV status.
Depending on local conditions, pre-test information can be provided in the form of individual information sessions, as couples or in group health information talks, with provision of appropriate printed materials. Informed consent should always be given individually, in private, in the presence of a care provider.
When recommending HIV testing and counselling to a client attending services for PWID, the care provider should, at a minimum, provide the client with the following information:
The reason(s) the test is being recommended (symptoms or the presence of risk behaviour)
The clinical benefits of testing (access to ART, OI prophylaxis) and the potential risks (discrimination or abandonment)
The services available in the case of negative and positive results (including the availability of ART)
That the result will be treated confidentially and shared only with involved care providers
That the person has the right to decline the test
That declining an HIV test will not affect the person’s access to other services
That, if the test result is positive, disclosure to the person’s contacts who may be at risk is encouraged.
An opportunity should then be provided for the client to ask the care provider questions and the client given time to make a decision about consenting to the test. Clients should also be made aware of any relevant laws in jurisdictions that mandate the disclosure of HIV status to sexual and/or drug-injecting partners.
Drug and alcohol use are commonly underreported and can be missed if the client is not directly asked about their use. The HIV counsellor should become aware of the pattern of a client’s drug use so that appropriate information and advice can be provided on reducing any associated risks. It is important that a drug use assessment be carried out during HIV test counselling as part of the risk assessment and reviewed in any behaviour change counselling session or supportive post-diagnosis counselling sessions.
Verbal communication is normally adequate for the purpose of obtaining informed consent. Those institutions or jurisdictions that require consent for testing to be given in writing are encouraged to review their policy.
Some populations, such as those at higher risk of HIV transmission and women, may be more susceptible to being coerced for testing and to the previously discussed adverse outcomes, such as discrimination, violence, abandonment or incarceration. Alternatively, individuals may be subjected to pressure to be tested in environments where treatment for OIs or HIV is not available. In such situations, additional measures to ensure informed consent may be appropriate, beyond the minimum requirements defined in this document. The care provider may need to particularly emphasize the voluntary nature of the test and the client’s right to decline it.
Summary of core content of pre-test counselling session
Reason for testing
Imparting basic information on HIV, including on HIV transmission
Personal risk assessment
Feedback of possible results in relation to individual risk assessment
Assessment and discussion regarding capacity to cope with potential positive result
Assessment of potential support requirements
Development of a personal risk reduction plan
Provision of HIV test information
Informed consent
Follow-up arrangements for collection of results and other referrals, e.g. STI treatment
3.1.1. Pre-test individual risk assessment
The risk assessment is undertaken to understand the nature and time course of behavioural risks. It is important for clients to understand that the HIV test only screens for HIV and not the other pathogens associated with the risks of injecting drug use or unprotected sex, such as hepatitis B, C or syphilis. Clients should be advised of the routine blood and other tests that are offered and informed consent obtained for them. Often, care providers focus only on HIV transmission associated with unsafe injecting practices and neglect the other transmission risks, such as unprotected intercourse, tattooing and the additional risks for female drug users, including MTCT.
3.1.2. Pre-HIV test information in a group
Individual pre-test counselling is considered to be the most effective pre-test counselling strategy. However, this may not be possible where routine testing and counselling results in large numbers of individuals requiring pre-test information. In many settings the demand for VCT is high and resources are limited. Often, clients are kept waiting in busy waiting rooms for long periods of time. The information components of pre-test counselling could be provided in a group setting, while issues specific to the individual could be discussed on an individual level in a briefer, individual session. Informed consent for testing should be always taken on an individual basis.
| SUITABLE FOR GROUP INFORMATION |
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| INDIVIDUAL COUNSELLING (PRE- OR POST-TEST) |
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3.1.3. Additional information for women who are or may become pregnant
In addition to the information given above, pre-test information for women who are or may become pregnant should include:
the risks of transmitting HIV to the infant;
the special risks associated with acquiring HIV during pregnancy;
measures that can be taken to reduce MTCT, including ARV prophylaxis and infant-feeding counselling; and
the benefits to infants of an early diagnosis of HIV
advice on contraception if they do not want to become pregnant.
3.1.4. Addressing the special needs of sex workers, MSM and transgender PWID
In addition to the recommendations above, it must be recognized that clients from these populations are vulnerable to additional stigma and discrimination, and may have lifestyles that complicate their access to HIV or other health services during normal working hours. Testing and counselling services wishing to provide comprehensive or quality services to these subpopulations of PWID must therefore consider service adjustments (in place and service hours) to facilitate access and provide a welcoming environment, and meet any special needs.
The development of rapid HIV testing technologies will decrease the waiting times for HIV results and may thereby improve the rate of return for results among these clients. Additional support from peer outreach workers and innovative reminder strategies (e.g. mobile phone SMS) may also increase the chances of completing testing and counselling.
Referral of high-need drug users to specialist drug treatment services and OST should be a high priority to provide the opportunity to substantially improve their quality of life and contribute to the additional stability required to undertake appropriate testing and counselling, and subsequent HIV treatment.
3.1.5. Special considerations for adolescents
In most countries, the median age for the onset of sexual activity is earlier than the age of legal majority. Many adolescents do not have independent access to HIV prevention services. With regard to information on sexual and reproductive health, including that on family planning, the Committee on the Rights of the Child has stated in General Comment “4” (Adolescent Health and Development) that governments “should ensure that adolescents have access to appropriate information regardless of their marital status and whether their parents or guardians consent”, and should remove all barriers to health services, including those relating to HIV prevention (such as condoms).16 For these reasons, WHO and UNAIDS encourage countries to provide adolescents with independent access to HIV prevention, treatment, care and support services.2
Adolescents are not easy to engage in mainstream or even PWID services, as they have additional reasons for attempting to avoid detection of their risk behaviours. Health services need to pay special attention to orienting HIV prevention and care programmes to their needs and adjusting programmes to the behavioural issues generated by adolescents.
National and local laws may not stipulate precisely the age of majority for independent access to health services. The age at which adolescents are allowed to give their own consent may vary for different procedures. Many countries make allowances for adolescents designated as “mature” or “emancipated minors” (e.g. those who are married, pregnant, sexually active, living independently or who are themselves parents), which will enable them to provide consent by themselves for some services.
Governments should be encouraged to develop and implement clear legal and policy frameworks that stipulate: (i) the specific age and/or circ*mstances in which minors may consent to HIV testing for themselves or for others (as in the case of child-headed households); and (ii) how the assent of and consent for adolescents should best be assessed and obtained. Efforts to expand HIV testing and counselling in PWID settings should include training and supervision for care providers on laws and policies governing consent for minors to access clinical services, including when they can and cannot recommend an HIV test to an adolescent independent of the consent of the adolescent’s parent or legal guardian.
Where the law does not allow a sufficiently mature adolescent to give his or her own informed consent to an HIV test, the care provider should provide the adolescent with the opportunity to assent to HIV testing and counselling in private, without the presence or knowledge of his or her parents or legal guardians. Pre-test information should be adapted to the patient’s age, developmental stage and literacy level. If the adolescent provides assent, indicating that he or she understands the risks and benefits of HIV testing and would like to receive the test, then the care provider should seek the informed consent of the parent or legal guardian.
In some situations, a parent or legal guardian may not be available to give consent on the adolescent’s behalf, and the care provider may need to assess whether an adolescent can request and consent to testing alone. The provider must always work within the framework of local or national laws and regulations, be assisted by consultation with professional colleagues and be guided by the best interests of the patient.
3.1.6. Seriously ill patients
Many individuals undergoing HIV testing in PWID settings have been ill for some time and, for a variety of reasons, delayed seeking definitive health care. Many have their own expectation of the outcome of a positive test result. HIV testing services in PWID settings should build strong support services for these individuals to complete the testing process, rapidly establish an extended support network, and facilitate referral to appropriate health services for the investigation and treatment of OIs and initiation of ART. Any delay in or failure of the referral process at this advanced stage of HIV infection can markedly shorten the patient’s life.
Critically ill or unconscious patients may not be able to provide informed consent for HIV testing and counselling. In such circ*mstances, consent should be sought from the patient’s next-of-kin, guardian or other caregiver. In the absence of such a person, care providers should act according to the best interests of the patient.
3.1.7. Follow up where a test is declined
Declining an HIV test following counselling should not result in reduced quality or denial of services, coercive treatment or breach of confidentiality, nor should it affect a person’s access to health services that do not depend on knowledge of their HIV status. Individuals declining the test should be offered assistance to access HIV testing and counselling in the future.
The individual’s decision to decline the HIV test should be noted in the medical record so that, at subsequent visits to the health facility, a discussion about HIV testing and counselling can be re-initiated.
3.1.8. Preparation to return for results
Clients should be advised in advance that they will not be provided with their results if they present to the facility under the influence of drugs or alcohol, or experiencing the effects of withdrawal from such substances. Counsellors should explain the rationale for this policy and advise clients to control their drug or alcohol use before returning for their results.
Where there are concerns about an individual’s ability to fully participate in counselling, informed consent for testing or receiving the results, it should be discussed with him or her in a supportive and non-threatening way. It is important to acknowledge that the stress of the situation is understandable, but that it is not possible to proceed if the person is unable to participate fully. This may simply mean allowing the person to wait in a supervised area or come back later in the day.
3.2. POST-TEST COUNSELLING
Post-test counselling is an integral component of the HIV testing process. All clients undergoing HIV testing must be counselled when their test results are given, regardless of the test result. Given that many inpatient and outpatient facilities are crowded, care should be taken to discuss results and follow-up care in a confidential manner. The results should be given to clients in person by care providers or trained lay personnel. Ideally, post-test counselling should be provided by the same care provider who initiated the HIV testing and counselling. Results should not be given in group settings.
PWID who are regular drug users will be at additional risk for recreational or self-harming drug overdose after receiving their HIV test results. This additional component should be specifically addressed during counselling in an attempt to identify those at high risk for suicide if the risk of positive or recreational overdose is negative. Coping strategies are particularly limited in such clients and peer support mechanisms may be helpful.
It is not acceptable practice for health-care providers to recommend HIV testing and counselling to clients and to subsequently withhold or fail to convey the test results. Although clients can refuse to receive or accept the results of any test or investigation, health-care providers should make every reasonable attempt to ensure that clients receive and understand their test results in a confidential and sympathetic manner.
Counselling for those whose test result is HIV-negative should include the following minimum information:
an explanation of the test result, including information about the window period for the appearance of HIV antibodies and a recommendation to re-test in case of a recent exposure;
basic advice on methods to prevent HIV transmission, including avoiding the use of non-sterile needles, syringes or other injecting equipment;
access to drug dependence treatment and its effectiveness, particularly OST where it is available;
guidance on the use of condoms, safe injecting advice (if possible, an appropriate supply of condoms, sterile needles/syringes and other commodities should be provided); and
the appropriate time for a follow-up test, based on the risk assessment and ongoing risk behaviour.
The care provider and the client should jointly assess whether there is a need to be referred for more extensive post-test counselling or additional prevention support including OST.
Counsellors need to assist all clients in preventing unplanned pregnancies by providing adequate information on barrier contraception such as the use of condoms, especially during periods of potential exposure to HIV or suspected acute infection. It is also important that partners of pregnant women are screened and that they are aware of the risk of transmission to unborn children and the heightened risk of transmission during seroconversion.
For those clients whose test result is HIV-positive, the care provider should:
inform the client of the result simply and clearly, and give time to consider it;
ensure that the client understands the result;
allow the client to ask questions;
See AlsoPre-HIV test counselling | Lifeassist the client in coping with the emotions arising from the test result;
discuss immediate concerns and assist the client in determining what social network may be acceptable and available to offer immediate support;
describe follow-up services that are available in the health facility and in the community, paying special attention to OI/HIV treatment, PMTCT, and care and support services;
provide information on how to prevent the transmission of HIV, including provision of sterile needles, syringes and condoms, and guidance on their use;
provide information on other relevant preventive measures, such as good nutrition, use of co-trimoxazole prophylaxis and, if appropriate, insecticide-treated bednets, and OST;
discuss disclosure of the result – when and how this may happen, and to whom (see below);
encourage testing and counselling of partners and children;
provide advice on other pathological tests that may be appropriate (such as for liver function, hepatitis B and C serology, pregnancy, X-ray, sputum for acid-fast bacilli [AFB]);
assess the risk of violence, drug overdose or suicide, and discuss possible measures to ensure the physical safety of clients, particularly women, who are diagnosed HIV-positive;
arrange a specific date and time for follow-up visits or referrals to treatment, care, counselling, support and other services, as appropriate (e.g. screening for and treatment of TB, prophylaxis for OIs, STI treatment, contraception, antenatal care, OST, hepatitis B and C screening, and access to supplies of condoms and sterile needles/syringes); and
consider introducing the client to relevant team members who may be involved in future care.
Post-test counselling for pregnant women whose test results are HIV-positive should also address the following routine measures:
childbirth plans;
the use of ARV drugs for the client’s own health when indicated, and for PMTCT;
maternal nutrition, including iron and folic acid supplements;
infant-feeding options and support options to facilitate the mother’s infant-feeding choice;
HIV testing for the infant and the follow up that will be necessary; and
partner testing (see below).
There is a need for counsellors to increase client awareness of the impact of continued substance use on the unborn or breastfed child and to consider referral to drug treatment services, particularly those providing OST.
When pregnant women or their partners are identified as HIV-positive, it is essential that that they are referred to specialist PMTCT programmes and that good communication is facilitated between the counselling and testing service, drug treatment services and the PMTCT programme. Counsellors can facilitate this process by getting client consent for information-sharing between service providers.
For those clients whose test result is HIV-indeterminate, the care provider should:
explain to the client what this means;
specifically enquire about recent symptoms suggestive of a seroconversion illness;
ask the patient to return for re-testing in three months; and
reaffirm the necessity for safer sexual practices with all partners in the absence of a negative result.
3.2.1. Disclosure of positive HIV test results to partners
Disclosure of a positive result to sexual or injecting partners is a complex and sensitive issue, with a variety of options available to clients for its successful completion. Counsellors should support the client’s decision-making process by providing a list of potential disclosure mechanisms and facilitating a discussion of the advantages and disadvantages of each. The client and counsellor can even rehearse the act of disclosure to develop the client’s skills in managing his or her partner’s potential response. Options include:
The client discloses the status.
The client brings the partner to the clinic for self-disclosure in the presence and with the support of the counsellor.
The client brings the partner to the clinic and the counsellor discloses in the presence of the client.
The client authorizes the counsellor to disclose to the partner in the absence of the client.
The client discloses to a key trusted family member who discloses to the partner.
The client hands out referral cards for testing and counselling to sexual/injecting partners.
3.3. REFERRAL SYSTEMS
HIV test results should be communicated with an explanation of the prevention, treatment, care and support services available to the client. Linkages between programmes for other chronic illnesses (such as TB, hepatitis C) and community-based HIV prevention, care, support and treatment services are especially important, as is establishing and maintaining collaborative referral and communication mechanisms with them. Care providers should undertake a formal or informal screening for comorbid physical and mental illness to facilitate all appropriate referrals as early as possible in the care cycle.
At a minimum, referral should include providing the client with information about whom to contact as well as where, when and how to contact them. Client referral works best if the care provider makes the contact and schedules an appointment in the presence of the client, making a note of the contact and the organization in the client’s file.
Effective referral involves:
communicating with the client about the referral process;
consent for information transfer to referral services (shared confidentiality);
supporting the client in getting to the referral services (strategies, treatment “buddies”, etc.); and
tracking referrals (following up – did the client get there?).
As stated above, services relevant to the management of HIV illness should be integrated into a local network of care providers who meet regularly to discuss problems, referrals and mechanisms to strengthen HIV care. Relevant services include those for harm reduction, diagnosis and treatment of TB and STI, reproductive health, PMTCT, palliative care and HIV home care/support. Staff within the referral network need to routinely inform each other of changes in personnel or processes which could impact on the referral of clients. In settings attended by PWID, the intrinsic stigma displayed toward or perceived by PWID presents a significant barrier to normal referral processes and hence access to services.
Useful strategies employed in PWID settings to overcome these barriers include:
the provision of “buddies” or navigators to negotiate the referral process with the referred individual;
identified peers based at the referral site to welcome and familiarize new clients with the services at the referral site; and
specialist or treatment service visits to the PWID setting to provide personal “bridges” across the services.
3.4. FREQUENCY OF TESTING
Care providers should subsequently recommend testing and counselling to all HIV-negative patients likely to be at high risk for HIV, based on individual risk assessment. This should be conducted at least annually for:
PWID and their sex partners;
persons who exchange sex for money or drugs;
sex partners of HIV-infected persons; and
MSM or heterosexual persons who themselves or whose sex partners have had more than one sex partner since their most recent HIV test.
Re-testing every six months may be beneficial for individuals at a particularly high risk for HIV exposure, such as sex workers, men who have unprotected sex with men, PWID who report using unsterile injecting equipment, and sex partners of PLHIV. This more frequent testing provides an added opportunity to emphasize the need for such individuals to practise safe behaviours. It is important that regular HIV testing does not become a substitute for prevention behaviours, and care providers should use the post-test counselling session to emphasize safer behaviours.
Health-care providers should encourage individuals and their prospective sex partners to be tested before initiating a new sexual relationship.
Repeat screening of persons not likely to be at high risk for HIV should be performed on the basis of clinical judgement.
Unless recent HIV test results are immediately available, any person whose blood or body fluid is the source of an occupational exposure for a care provider should be informed of the incident and asked to consent to testing for HIV infection at the time the exposure occurs.
Additional research is needed in diverse settings with varying HIV epidemiology to determine the optimum interval between HIV tests for specific populations.
Risks of HIV transmission to an infant are very high if the mother acquires HIV during pregnancy or while breastfeeding. HIV-negative women should be tested as early as possible in each new pregnancy, particularly in the case of women who are at high risk for HIV exposure. Repeat testing late in pregnancy is recommended to HIV-negative women exposed to ongoing risk through their own behaviour or that of their partner who injects drugs.
3.5. HIV TESTING TECHNOLOGIES
3.5.1. Factors to consider
The advantages of using rapid tests for HIV testing and counselling in PWID settings, particularly for health facilities where laboratory services are weak or in peripheral and rural settings where traditional laboratory infrastructure does not exist, include the visibility of the test and the quick turnaround time, which increases confidence in the results and helps to avoid clerical errors. Rapid HIV testing can occur outside laboratory settings, does not require specialized equipment and can be carried out in primary health-care facilities by appropriately trained non-laboratory personnel, including counsellors. However, trained laboratory supervisors are required for supervision and provision of quality assurance measures, including external quality assessment, regular quality control for testing and biosafety. The tests selected should be of assured quality.2
Enzyme-linked immunosorbent assay (ELISA) may be preferable in settings where large numbers of tests need to be performed, where immediate provision of test results is less important (such as for hospital inpatients) and in reference laboratories. ELISA tests require specialized laboratory equipment and staff. Decisions on whether to use HIV rapid tests or ELISA for HIV testing and counselling in PWID settings should take into account such factors as:2
the setting in which testing is proposed;
cost and availability of the test kits, reagents and equipment;
available staff;
the available resources and infrastructure;
the laboratory expertise and personnel available;
the number of specimens to be tested;
specimen collection and transport mechanisms;
the ability and likelihood of individuals to return for the results.
In the environment of services for PWID, the use of rapid HIV tests provides a particular advantage for those clients with high mobility experiencing a “brief window of opportunity” for access to testing or a widely fluctuating enthusiasm for HIV diagnosis and treatment.
3.5.2. Diagnostic testing strategies
HIV testing should follow strategies recommended by WHO and the Centers for Disease Control and Prevention (CDC).17 A testing strategy refers to a generic testing approach for specific needs (for example, transfusion and transplant safety, surveillance or diagnosis of HIV infection) and a testing algorithm refers to the combination in sequence of specific HIV testing assays used within a given HIV testing strategy. Both the selection of test kits and the order in which the assays are used are of the utmost importance for the final outcome of the testing algorithm.
The number of algorithms should be limited in order to streamline procurement procedures and facilitate standardization and ease of training. It is of the utmost importance that assay combinations should always be validated in the context in which they will be used before widescale implementation. All HIV assays used in a particular HIV testing algorithm should have at least a sensitivity and specificity of 99% and 99%, respectively.18 The current recommended HIV testing strategies are in the process of being reviewed and so this document will not go into detail except to emphasize that testing strategies should only be applied to validated testing algorithms.19
A testing algorithm must be nationally validated for its intended use. At the country level, the choice of testing strategy and the choice of HIV assays for use in a particular testing algorithm should be determined by:18
the objective of the testing to be performed and the type of HIV epidemic;
the performance characteristics of the tests (i.e. sensitivity and specificity), the positive predictive value of the testing algorithm and costs;
the availability of the assays, reagents and equipment including considerations of shelf-life and storage conditions;
aspects related to implementation such as resources and infrastructure, existing laboratory expertise and personnel, daily specimen throughput, specimen collection and transport methods, the setting in which testing will take place, how they work together as a system, and the convenience and ability of individuals to return for results.
1 Gold standard of HIV testing
2 Dependent on risk assessment
