Swiss Aids Federation Advice Manual: Doing without condoms during potent ART

Approved by the Executive Board of Swiss Aids Federation, 30 January 2008

Counselling about infectiousness during ART with completely suppressed viremia (potent ART)1 and about doing without condoms as protection against HIV transmission ideally comprises two parts: - medical counselling by a physician and - psychosocial and legal counselling by a qualified person at a Regional Advice Centre. The physician counselling contained in this Advice Manual is presented only as core information for general guidance. This counselling is based on the Swiss National AIDS Commission (EKAF) recommendations of 30.01.2008 (see Swiss Medical Weekly [Schweizerische rztezeitung]) and the corresponding Recommendations for Action for Physicians and Counsellors). The Manual comprises three parts: A: B: The core contents of the new message and guiderails for prevention recommendations Counsellors at the Regional Advice Centres Counselling content in medical know what knowledge physicians should consultations communicate to their clients and can ask them whether they have received this information, explain it again if they have difficulty understanding and resolve any misunderstandings. Detailed guidance for holding this Counselling content in consultations with Regional Advice consultation, what topics should be addressed and what relevant information Centre employees content should be provided. Principles of counselling

C:

Potent ART is the name given to combination therapy against HIV which reduces the viral load below the limit of detection. This condition was confirmed by regular monitoring over a period of six months.

A: Principles of counselling
This part of the Manual contains the core content of the new message and the guiderails for prevention recommendations according to serostatus based target groups. An HIV-infected person with potent ART is not sexually infectious, i.e. does not transmit the virus via sexual contacts as long as - the therapy is practised consistently and monitored regularly by the treating physician; - the viral load on ART has been below the limit of detection for at least 6 months; - no infections with other STI are present. Under these circumstances, potent ART therefore definitely prevents HIV transmission as safely as condoms. Serodifferent and seroconcordant couples are recommended to obtain information on this topic together from a physician and at a Regional Advice Centre. The decision to do without condoms on potent ART must be taken by the couple together in full knowledge of all the facts. Subjects which should be addressed are: - at the physician: preconditions for potent ART, medical check-up frequencies, residual risk (adherence, resistances), superinfection, STI, contraception (and ART) - at the Regional Advice Centre: legal situation, adherence, rules for the couple (negotiated safety). Without this counselling and the decision taken jointly as a couple, serodifferent and seroconcordant couples are recommended to keep using a condom. For HIV-negative persons or persons of unknown serostatus the recommendation to practice safer sex (condoms) in casual contacts, anonymous sex or in new partnerships remains valid. They are responsible for their own protection in such circumstances and cannot rely on the credibility of information they receive from their sexual partners regarding serostatus, therapy and its success. HIV-positive persons should be informed about the protective effect of potent therapy. At the same time, however, their attention must be drawn to the risk of superinfections and other STI and also to the legal situation. It should also be explained why the general recommendation to use condoms remains applicable outside the relationship of the steady couple who decide otherwise in the informed consent. If HIV-positive persons do not use condoms despite this recommendation, they should be persuaded of the importance of potent ART. They should also be encouraged to have regular STI check-ups. (For the check-up frequencies, see Sexually transmissible infections. Information for counsellors, AHS/PLANeS 2007)

B. Counselling content in medical consultations

This part of the Manual outlines the contents of the medical consultation, so that - counsellors at the Regional Advice Centres know what information physicians should communicate to their clients; - they can ask their clients whether they have received this information, explain it again if they have difficulty understanding and resolve any misunderstandings.

Situational history What is potent ART ?

The viral load remains stable below the limit of detection over time. Successful ART which succeeds in lowering the viral load below the limit of detection at all check-ups over a period of six months generally remains stably successful assuming good adherence by the patient. Declining effectiveness of the therapy in subjects with good adherence will at most lead to a slow increase in the viral load - somewhat more rapidly in NNRTI. Since regular medical check-ups at least every three months are the rule for HIV therapy, this will be noticed at the latest on these occasions. Until then, the values will not reach levels relevant for transmission. Nevertheless, a therapy can only be regarded as stably effective if, after the therapy adjustment the viral load was again below the limit of detection over a six month period.

Information: infectiousness with stably suppressed viral load

The Swiss National AIDS Commission (EKAF), Swiss Federal Office of Public Health (BAG) and Responsibilities of the Swiss Aids Federation (AHS) consider the evidential situation to be sufficient to state that no HIV transmission occurs during ART provided that adherence is assured and no STI is present.

Risk of superinfection

Overall, superinfections with clinical consequences are observed extremely rarely, if at all. It is nevertheless possible that some of these rare events are not recognised, and the recommendations are therefore worded to remain on the cautious side. The only theoretically possible consequence is the transmission of a resistant virus. Resistant viruses are generally transmitted less often. The following applies for the likelihood of clinically relevant superinfections: a) Superinfections represent no risk to public health. b) An individual risk exists: o Superinfection of a person with HIV receiving therapy is possible if the partner has a resistant virus and the viral concentration is sufficiently high (HIV-RNA at least several thousand copies/ml). o Superinfection of a person with HIV who is untreated is theoretically possible if he/she has a very benign virus (long-term slow progressor; e.g. CD4> 500, HIV-RNA < 1000) and the partner does not have completely suppressive therapy. o Both partners are untreated and have viruses of differing origin showing resistances.

c) Negligible individual risk (magnitude of normal life risks): o Both partners are receiving effective therapy with completely suppressed viral load o One partner is receiving effective therapy with completely suppressed viral load and the other is untreated and has no known therapy resistances o Both partners are infected with the same virus (infection within the partnership) and have so far had no therapies o Both partners are untreated and have viruses of differing origins showing no resistances In these situations, all sexual practices are to be classified as risk-free To estimate the risk of superinfection it is necessary to know the viruses of both partners. An effective risk for one or the other of the partners arises especially when one of the partners is carrying a therapy resistant virus. Concordant couples require counselling by a health care professional to assess the risk of a superinfection in the partnership. With casual partners and in anonymous sexual contacts, this knowledge is absent. A person with HIV thus has the individual risk of acquiring a superinfection during unprotected contacts - whether or not potent ART is being practised. Acquiring a superinfection through a therapy resistant HI virus can worsen the available therapeutic options and is to be avoided. Even with unprotected sexual intercourse, superinfections that jeopardise clinical success are extremely rare.

Medical check-up frequencies for HIV/ART and STI

Three-monthly check-ups for HIV/ART. Check-ups for STI depending on sexual behaviour and social group affiliation (see Sexually transmissible infections. Information for counsellors ).

Adherence

The importance of adherence with ART (also compared to other therapies) / required degree of adherence / offers to support adherence

Conclusions

ART and contraception

For HIV-positive, heterosexual women and in steady heterosexual serodifferent or concordantly positive couples, contraception or the wish to have children must be discussed. Particular attention should focus on - possible interactions between hormonal contraceptives and ART - their possibly reduced effectiveness - teratogenic properties of the active agents used (potential to harm the unborn child) Reference to topics to be additionally addressed and suitable counselling by C Legal situation / adherence / negotiating rules within the couple

C. Counselling content in consultations with Regional Advice Centre employees

This part of the Manual gives a detailed description of which topics should be addressed by employees at Regional Advice Centres and what relevant information content should be provided.

Defining the counselling session Structured and targeted counselling is only possible if the counselling situation is defined in advance. The optimal effect of these recommendations lies in the complementary counselling of the medical and psychosocial setting. 1) What is the clients concern? => Counselling on potent ART and infectiousness.

2) What information is already available? Where has advice already been sought? Has counselling by a physician Part B already taken place? Comments Usually a visit to a physician comes first. This person advises the client in accordance with the recommendations outlined above. If an HIV-positive client first seeks counselling at a Regional Advice Centre, he/she is counselled in accordance with the recommendations given below. He/she is also referred to a medical unit.

3) What exactly is the concern? a) General information about potent ART and infectiousness? b) Safer sex will not be practised in a steady partnership? => Insist on counselling as a couple, either already in the initial talk, but definitely later. c) Changes in protective behaviour outside a steady partnership?

4) Is successful therapy already in progress? a) If so: conduct the session as outlined below. b) If not: wider-ranging discussion of therapy decision, see Ready for therapy?

5) In what phase of behavioural adjustment is the client in terms of protection?2 6) Define the goal of the planned session: provision of information and discussion, so that the client (and his/her partner) can take a decision on their own responsibility. But: disclose the principles of counselling 7) Explain the structure of the scheduled session: see Capital headings

Situational history Depending on the relationship situation and previous protective strategies, counselling on potent ART and infectiousness requires different recommendations and information. 1) Talk about the structure of lived sexuality Is there a steady partner? If so: partners serostatus? If steady couple: Are there other sexual relationships? With casual partners (serostatus known?)? With anonymous partners? Paid contacts? Heterosexual homosexual bisexual? - Who is informed about the serostatus and how? => Insist on couple counselling as the basis for making a decision about doing without condoms on potent ART If not within the couple relationship: are there other sexual relations? With casual partners (serostatus known?)? If so: has client previously/to date practised unprotected sex with the casual partner? With anonymous partners? Paid contacts? Heterosexual homosexual bisexual? Who is informed about the serostatus and how? -

2) Talk about active protective behaviour. a) Intention, b) Implementation and c) Problems - With the steady partner - With casual partners - With anonymous or paid partners
2

Stage Pre-contemplation

Characteristics Denying or ignoring the problem Ambivalence, conflicted feelings

Helpful strategies Encourage the individual to reconsider his/her behaviour. Propose self-reflection and introspection. Explain the risks of the present behaviour. Weigh the advantages and disadvantages of a change in behaviour against each other. Reinforce readiness for change and support confidence in his/her own abilities (for action). Identify obstacles to changing behaviour Define goals in writing Prepare a plan of action Compile a list of supportive statements Consciously percieve and reward the success Seek social support Compile a list of supportive statements Develop strategies to cope with temptations Continue rewarding oneself for success

Contemplation

Preparation

Experiment with small changes Gather information about the change Direct activities for achieving the goal Maintain a new behaviour Avoid temptations

Action

Maintenance

With seroconcordant persons Which strategies? Condom, disclosure, sexual behaviour (active/passive dipping...)

If condom: - When was the last condom failure? When was the last time no condom was used? And vice versa: What protection the last three times? - What difficulties? => Assess how urgently preventive measures are needed and in what direction they should aim. See principles of counselling.

Medical topics Assurance should be obtained that all aspects that have to be clarified in the counselling session with the physician have been clarified and understood. If the consultation with the physician has already taken place: Clarify whether all points have been addressed: Information: infectiousness with stable suppressed viral load Risk of superinfection Medical check-up frequencies for HIV/ART and STI Adherence Conclusions ART and contraception Clarify unresolved aspects, check understanding if necessary, refer back to B If the consultation has not yet taken place: address the items to be clarified and record them in writing for this consultation.

Adherence Adherence is a central topic in counselling because it is an important precondition for achieving a stable reduction of the viral load below the limit of detection over time.3 It is also the factor that is determined by the client in relation to efficacy of the ART. 1) Definition and importance of adherence - Does the client understand what adherence means? - Can the client assess the importance of adherence for potent ART?

The medications only exert their desired actions if they are continuously present in sufficient concentrations in the blood. Only with good adherence will HIV positive persons succeed in reducing the viral load below the limit of detection for a prolonged period and thereby minimise the probability of transmitting HIV to other persons. If the drug level is too low, the viruses multiply again and resistance to HIV medications can develop. One possible consequence of this is that the number of viruses starts increasing again and the subjects state of health deteriorates. The probability of transmitting HIV to other persons then also increases again.

2) Current status of adherence - Are there problems with conscientious adherence? - When was the last time a dose was forgotten? Last month, last week? - Has the client assistive means for ensuring adherence? o What assistive means does the person use in everyday situations? o What assistive means or strategies does the person use in unusual situations?

3) Assessment of adherence: sufficient for potent ART? If not: - Initiate process of change to enhance adherence and draw attention to the risks, especially with regard to infectiousness. - Clarify importance of regular medical check-ups. - Clarify what support is required and can be offered including in the medical setting.

4) To what extent the steady partner is informed - Is the HIV-negative partner involved in maintaining adherence in steady partnerships? How? - Does he/she know about forgotten doses? - If not: is there need for action in this respect?

Comments Lifelong HIV therapy with its requirement for regular intake of medications at the right time intervals, in the correct dose and depending on the drug with or without food requires high and constant discipline. An exacting requirement in everyday life. The motivation to comply with therapy is not a once-only commitment. It has to be constantly renewed by the patient and tips and tricks must be found to remind the person to take the medication for example if the person has a hectic daily round of activities or in the light of possible adverse reactions of HIV medications. Specific tips and tricks can be found in the booklet Ready for the therapy?.

Current legislative situation The clients must be clear that in the current legal situation, doing without protection from condoms can have consequences under criminal law regardless of whether potent ART is practised or not. 1) Does the HIV-positive person (and the steady partner, if any) understand the legal situation in terms of HIV transmission? - Is the person aware that the transmission of HIV in unprotected sexual intercourse is punishable with a prison sentence? - Is the person aware that even if no HIV transmission occurs due to unprotected sexual intercourse, under current legislation they are still committing an offence because of attempted HIV transmission? - Is the person aware that they are still liable to prosecution even if (a) they have informed their HIV negative partner that they are HIV positive before having unprotected sex, (b) the HIV negative partner has consented to unprotected sex and (c) no HIV transmission may even have occurred? - That in fact only sex with a condom is free from prosecution under current legislation; that potent ART does not (yet) change anything as regards the current legislation?

2) For a steady couple: written agreement on this point or at least a memorandum from the counselling person. See next point

Comments Based on recent rulings of the Swiss Federal Court, persons with HIV can be convicted under criminal law if they transmit HIV to other persons. A conviction is even possible if no HIV transmission has taken place: this is then attempted HIV transmission. The sentences range from several months to several years. A distinction is to be made between the sanctions intended to protect the general public public health and the articles relating the protection of the individual. Protection of the general public: transmission of a dangerous human disease According to Article 231 of the Swiss Criminal Code, anyone who deliberately spreads a dangerous transmissible human disease is liable to prosecution. The partners prior informed consent to unprotected sexual contact does not nullify the offence pursuant to Art. 231 because Article 231 is not designed to protect individual persons but the general public. The attempt to spread a human disease, i.e. even if transmission of the HI virus has not taken place, is also an offence. The offence is a public offence and therefore does not require notification by the affected person: the procedure is instituted ex officio by the police. Protection of the individual: grievous bodily harm According the Swiss Federal Court, the transmission of HIV is the infliction of grievous bodily harm (Art. 122 Swiss Federal Criminal Code) because the virus within the body represents a deterioration of the state of health. The fact that the symptoms of disease do not develop until a later stage is without importance. Anyone who transmits HIV (possibly) deliberately through unprotected sexual contact with other persons I.e. anyone who to a great extent must assume that HIV can be transmitted by unprotected sexual contact and accepts this possibility must expect to be convicted of causing grievous bodily harm. The HIV-positive person is also liable to prosecution even if no HIV infection of the other person occurs but if the situation was such that transmission could have occurred the prosecution then relates to attempted HIV transmission. In contrast to the legal rulings pursuant to Art. 231 Swiss Criminal Code, situations are excluded in which (a) the HIV-positive person has informed their partner about their HIV status before the sexual contact and (b) the partner consents to the risk. Grievous bodily harm is also a public offence, i.e. is subject to public prosecution. In practice, it is not a rare occurrence that in the event of separations or in casual partnerships the victim reports the HIV-positive person from disappointment over the end of the relationship or because they are seeking revenge on the HIV-positive partner. Under these circumstances it may be difficult to prove that the HIV-positive person disclosed their HIV status to the partner before the sexual contact and that he/she consented to the unprotected sexual contact.

Conclusion In principle every HIV-positive person engaging in unprotected sexual contact is committing an offence. This principle applies because in unprotected sexual contact practised by an HIV-positive person both criminal offences grievous bodily harm and/or spreading a dangerous transmissible human disease are committed simultaneously and it is therefore irrelevant (in the light of Art. 231 Swiss Criminal Code) whether the HIV-negative partner freely consented to the risk of HIV transmission or not. The attention of HIV-positive persons must be drawn to these facts during the counselling. In steady partnerships these circumstances may be discussed with both partners in this case at least a memorandum and even a written statement by both partners may be recommended. In casual partnerships, a mutual discussion is not always possible and in anonymous sexual contacts it is never possible. Nevertheless, considerations of criminal liability should be included in all counselling. The clients attention can be drawn to the fact that the AHS consistently rejects the application of Article 231 Swiss Criminal Code and in agreement with the EKAF is calling for a change in the legislation in regard to grievous bodily harm if potent ART is being practised.

Why the Swiss Aids Federation (AHS), Swiss Federal Office of Public Health (BAG) and Swiss National AIDS Commission (EKAF) do not recommend doing without condoms outside the steady couple situation even with potent ART HIV-positive persons must understand why we recommend using a condom in casual and anonymous contacts despite the unequivocal comments on the absent risk of infection when practising potent ART. 1) Information about personal residual risks - superinfections - STI - criminal liability

2) Communication situation in casual and anonymous contacts - The HIV-positive person is aware of potent ART, but the HIV-negative person takes the residual risk - There is no basis of trust or informed situation

3) If HIV-positive persons do not use condoms despite this recommendation, they should be convinced of the importance of potent ART. They should also be encouraged to have regular STI check-ups. For the recommended frequencies, see Sexually transmissible infections. Information for counsellors.

The steady couple: negotiating the rules Doing without the protection of condoms in a steady couple situation requires clear decisions taken by mutual agreement and negotiated rules. Serodifferent couple 1) Both partners are familiar with the general conditions - Potent ART and adherence (see above) - Residual risks (Counselling B) - Resistances (Counselling B) - With heterosexual couples the desire to have a child (Counselling B) - Legal situation Only if the general conditions are also clear for the seronegative partner can he/she develop materially justified trust.

2) Address wishes and fears relating to shared sexuality - Despite objective safety with potent ART, fears surrounding the possibility of transmitting infection are possible.

3) Relationship and contacts to outside - Address the stability of the relationship - How is the HIV-negative person kept informed about the success of therapy? - The fact possibility of external contacts is explicitly discussed. - It is clarified how both partners behave towards other sexual partners outside the relationship. In casual and anonymous sexual contacts the use of a condom, i.e. safer sex, continues to be recommended for both parties: a superinfection could jeopardise the success of therapy and increase the infectiousness and both could introduce an STI into the relationship. In addition, no trusting, mutual decision can be taken in the event of casual and anonymous contacts. - What happens if a crisis develops or the relationship breaks up? - For heterosexuals: what about contraception?

4) Establishing rules - Both partners establish binding rules of conduct for themself and the other. If these cannot be adhered to, there is an obligation to inform the other party. This means that adhering to rules creates trust, and if they are not adhered to and this is not disclosed, this trust is being abused and destroyed. - Record rules in writing: for persons in love, trust is immeasurably great. The experience of disappointment is absent and it is legitimate to wish that it should remain so forever. A discussion about rules of behaviour or even a written agreement is likely to be most difficult during this phase, because there is the feeling of destroying the state of being in love. What dominates, however, is the care and concern for the other and this includes bringing fears, wishes and how to deal with them out into the open.

An explicit agreement in which all the above points are addressed and rules are established is the minimum requirement. If there is a greater need for security or if the trust is not great enough, this must also be addressed. A written agreement is then recommended. Because if the seronegative partner should nevertheless become infected, a completely new partnership dynamic could develop which could subsequently lead to accusations and legal steps. In such cases a written agreement means protection for both partners (except aspects covered by Art. 231 Swiss Criminal Code, see above).

Supplement: seroconcordant couple The additional topic for the seroconcordant couple is superinfections and other STI. Acquiring a superinfection especially with a resistant HI virus significantly worsens the persons own therapeutic options and is to be avoided (see Counselling B). For concordant couples, counselling by a health care professional is mandatory to clarify the risk of superinfection within the partnership. With casual partners and in anonymous sexual contacts this knowledge is not present. There is thus an individual risk for a person with HIV of acquiring a superinfection through unprotected contact whether potent ART is practised or not.