Counseling Tools on Dolutegravir Transition [Draft]

National HIV, AIDS, STI Prevention and Control Program

COUNSELING TOOLS ON DOLUTEGRAVIR TRANSITION December 2020

National HIV, AIDS, STI Prevention and Control Program

COUNSELING TOOLS ON DOLUTEGRAVIR TRANSITION December 2020

Table of Contents Tools A. General Tools B. Counseling Tool for Females in Childbearing Age

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References

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Overview This is a consolidated document that includes counseling tools adopted and contextualized for: 1. Patients on TLD/DTG-containing regimen, and 2. Females in childbearing age

A. General Tool

This tool provides holistic and comprehensive advice to patients undergoing TLD transition. This tool was adopted from the Clinton Health Access Initiative counseling job aid for TLD transition published in 2018.

Key DTG Counselling Messages What is TLD?

TLD is a pill that contains three medicines: tenofovir (TDF), lamivudine (3TC), and a new medicine – dolutegravir (DTG). It has several benefits. It is very effective for treating HIV, has fewer side effects than other medicines.

Take it upon waking up.

Take your TLD pill in the morning because DTG sometimes causes insomnia. This usually gets better after 1–2 months of taking the medicine. If it persists, please discuss this side effect with your clinician.

TLD can be taken with or without food

TLD can also be safely taken with or without food. However, taking DTG with food may increase absorption and this may impact side effects. Calcium (milk, dairy, green leafy vegetables) and iron (red meat, chicken, pork) can reduce absorption of your TLD medicine. This can be avoided by taking calcium or iron supplements 2 hours before or 6 hours after you take your TLD.

No interactions with birth TLD has no interaction with hormonal birth control methods. It is safe to take TLD control with any hormonal birth control method. Patients using a hormonal birth control method should also use condoms to protect against STIs.

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Key DTG Counselling Messages Report any symptoms of IRIS

This medication works faster than other ARVs. This is good, because it means your immune system will recover more quickly. However, one possible effect of your immune system recovering quickly is something called Immune Reconstitution Inflammatory Syndrome (IRIS). Common symptoms can vary and include fever, swollen lymph nodes, rashes, pneumonia, and eye inflammation. These symptoms usually start after 2–12 weeks on treatment. If you develop these symptoms, you should come back to the ART clinic as soon as possible. This information is to ensure you are prepared in case they appear, but you shouldn’t be discouraged by it, as they might or not happen. You should not stop taking your medications unless we suggest it to you. There may be additional treatments that are necessary to control these symptoms.

Side effects

IRIS is different from other ART medication side effects. Rashes, diarrhea, headache, and sleep changes are side effects that usually go away after 1–2 months of taking ART. These may be due to the medication, not due to a hidden infection or IRIS. Again, you should not stop your medications on your own, and should discuss any symptoms with your doctor even if outside of your normal appointment date.

Tuberculosis

If you experience a cough for 2 weeks, have weight loss, a fever, or night sweats, these may be symptoms of TB. Please come back to the facility to be screened. A key TB medication called rifampicin causes lower levels of DTG in the body. If you need to be treated for TB with rifampicin, your doctor may change your ART regimen.

Once you have completed your TB treatment, you may discuss with your doctor if you want to switch back to TLD. Patients whose TB regimen does not contain rifampicin should stay on TLD.

Pregnancy

Note: Please see attached in Counselling Tool for Women in Childbearing Age

Questions

This is a good opportunity to ask any questions about your treatment.

Adopted from: Clinton Health Access Initiative (2018). Key DTG Counseling Messages. Retrieved November 18, 2020, from https://clintonhealth.app.box.com/s/gkwkxsbass9i6sf82n4k0bhsdw2sjuu3

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B. Counseling Tool for Females in Childbearing Age This tool can be used by the HIV and AIDS Core Team when counseling a female patient of childbearing age. This tool is adopted from a decision tool created by FHI 360 and USAID.

Safe Use of Dolutegravir (DTG) by Women and Girls of Child-bearing Potential: A Decision-making Tool Assess life stage and fertility intentions of client* Actively trying to get pregnant

EFV-based regimen is preferred Explain the risks associated with the use of DTG at conception and early in pregnancy; facilitate informed choice of ART. If woman wants to use DTG, support informed decision.

Currently pregnant in Currently pregnant in 1st trimester ‡ 2nd–3rd trimester

EFV-based regimen is preferred Explain the risks associated with the use of DTG early in pregnancy; facilitate informed choice of ART. If woman wants to use DTG, support informed decision.

DTG-based regimen is preferred Counsel about safety of use of DTG during this part of the pregnancy.

Help woman decide on postpartum contraceptive method.

Postpartum (breastfeeding or not), want to avoid pregnancy

Wants to space pregnancies

Perimenopausal (≥40 years old), wants to limit childbearing

Assess for current use of contraception YES DTG-based regimen is preferred Support consistent use of reliable contraception.

Ask clients about changes in fertility desires every time they come for regular follow-up (about once every 3 months); track their FP method use; and refer for any FP methods not available on site. ‡ The concern over birth defects with DTG use applies to the first 8 weeks of pregnancy only; however, because it is not always possible to accurately establish the date of conception, avoiding use during the entire first trimester is recommended. *

Adolescent or young woman wants to delay pregnancy

NO

Screen for pregnancy using checklist and/or test Early pregnancy ruled out with reasonable certainty Counsel about and help woman choose a reliable FP option. Emphasize importance of consistent use.

DTG-based regimen is preferred If woman opts not to use any form of contraception, explain the risks of using DTG at conception and early in pregnancy; facilitate and support informed choice of ART. Once fully and thoroughly counseled, the woman still can choose to use DTG without concurrent use of a contraceptive method.

Early pregnancy cannot be ruled out with reasonable certainty EFV-based regimen is preferred Explain the risks of using DTG early in pregnancy; facilitate informed choice of ART. If woman opts to use DTG, support informed decision.

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All individuals, regardless of their HIV status, have the right to choose the number, timing, and spacing of their children; and make an informed choice about the use of FP methods. Providers can offer informed choice counseling, confirm medical eligibility and provide FP methods, or refer.

General messages for all women about dolutegravir (DTG)

DTG is a new ARV drug with many advantages including fewer side effects, lower risk of HIV drug resistance, more rapid viral suppression, and fewer drug interactions (e.g., unlike EFV, it does not interact with hormonal contraceptives).

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Benefits / advantages

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It is also easier to take when given as TLD—a combination pill (one pill containing three ARVs)

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Safety to women and adolescent girls

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There are safety concerns on the use of DTG in the women and adolescent girls in the reproductive age group. Specifically, the association DTG use and the development of neural tube among infants when used in the first trimester.

For this reason, women at risk of pregnancy who use DTG should be counseled about these concerns, offered a choice of reliable contraceptive options, and advised on consistent use.

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Almost any FP method can be used safely and effectively by women with HIV and these include the following:

General messages for all women about family planning (FP)

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1. Hormonal contraceptives (whether oral, injectables, combined, or progestogen-only) are 90–97% effective in preventing pregnancy, but do not offer protection against STIs. 2. Male condoms are 98% effective effective in preventing pregnancy when used correctly and consistently, and 85% when commonly used. Condoms protect against STIs. 3. Fertility-awareness methods (temperature method, cervical mucus method, and the standard days method) are the least effective in preventing pregnancy (76–88%, perfect use). ●

Long-acting reversible contraceptives in the form of copper IUD or progestin subdermal implants are highly effective (>99%) in preventing pregnancy and has the added benefit for long-term (3–5 years) use and its use doesn’t depend on a woman’s ability to use them correctly and provides several years of protection. IUD insertion should be delayed in women with AIDS until they are clinically well on ART. However, they do not offer protection against sexually transmitted infections (STIs).

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Female sterilization is a long-lasting, highly effective (>99%) form of permanent contraception and is an option for women who have completed their childbearing.

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Only condoms (male or female) prevent STI/HIV transmission between partners; the best protection from both pregnancy and STIs/HIV can be achieved when a condom is used with another contraceptive method (dual method use).

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Emergency contraceptive pills can prevent pregnancy when taken within 5 days when contraception method of choice was not used or was used incorrectly, including in cases of rape.

For all women who want to AVOID pregnancy but are NOT USING contraception

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Offer informed choice counseling about effective contraceptive methods.

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For women who opt to use contraception ❑ help her to choose a method that suits her reproductive life stage, individual needs, and fertility intentions ❑ encourage correct and consistent use ❑ provide DTG-based regimen

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For women who choose not use any form of contraception: ❑ counsel about risk associated with DTG ❑ allow informed choice of ART regimen (DTG- or EFV-based regimen)

Additional considerations for clients in these life stages who wish to avoid pregnancy: Adolescent or young woman ❑ Age or parity alone do not restrict contraceptive method options. ❑ Emphasize dual method use—especially if multiple partners or frequent new partners.

Postpartum woman Breastfeeding ❑ The lactational amenorrhea method (LAM) offers temporary contraception for new mothers whose monthly bleeding has not returned, requires exclusive or full breastfeeding day and night of an infant less than 6 months old. It is 99% effective with correct and consistent use. ❑ Choose contraceptive method before LAM effectiveness ends or consider using EFV-based regimen to avoid exposure to DTG should unintended pregnancy occur.

Not breastfeeding ❑ Counsel about the risk of pregnancy after 4 weeks ❑ postpartum and healthy pregnancy spacing (waiting for 2 years before trying to conceive again) for mother and baby safety. ❑ Help to choose effective contraception.

Perimenopausal woman after age 40 ❑ Age alone does not restrict contraceptive method options. ❑ May be interested in a long-acting/permanent method; however, if she chooses a short-acting method, encourage correct and consistent use until she stops having periods for one year.

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Women who want to AVOID pregnancy and are currently USING contraception

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Women who are actively trying to get pregnant

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Can safely use DTG-based regimen.

Evaluate satisfaction with current method; depending on fertility intentions, discuss availability of long- acting methods (e.g., implant, IUD).

If using client-dependent method, support correct and consistent use (e.g., use condoms every time you have sex, take a pill every day, come for re- injection on time) Counsel about safe conception and pregnancy. It is recommended that an effective family planning method be used until viral load is undetectable to lessen chances of mother-to-child transmission.

EFV-based regimen recommended to avoid DTG exposure at conception and during first 8 weeks of pregnancy. Counsel about risks associated with DTG and facilitate informed choice of ARV regimen. Support woman’s informed decision.

Women currently pregnant — 1st trimester

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DTG-based regimen is not recommended until after the first trimester, where the risk of neural tube defect is absent. Counsel about risks; support informed choice of ARV regimen.

Women currently pregnant — 2nd–3rd trimester

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Can safely use DTG-based regimen.

Decide on postpartum contraceptive method. LAM can be an effective option during the first 6 months postpartum for fully breastfeeding women who have not resumed their menses.

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Excluding Pregnancy Prior to Initiation of DTG and Desired Contraceptive Method Match the client’s menstrual status with the options below and follow the instructions.

Client with amenorrhea (postpartum or other type)

Client between two regular menses (monthly bleeding) Use pregnancy checklist.

Use pregnancy checklist.

Pregnancy ruled out: provide DTG and FP method.

Pregnancy not ruled out: use a pregnancy test.

Pregnancy test is negative1 (or test is not immediately available): pregnancy cannot be ruled out until the test is repeated in 3–4 weeks. EFV-based regimen is preferred.

Counsel about DTG risks and facilitate informed choice of ART regimen. If client still wants to use DTG-based regimen, support informed decision.

Provide implant, OMPA, or COCs (but not IUD) as desired; or abstain/use condoms for 3–4 weeks, then repeat the Pregnancy test.

If second pregnancy test is negative: switch to (or continue with) OTG and use any effective FP method, including IUD. 2

Pregnancy ruled out: provide DTG and FP method.

Do not use a pregnancy test—in most cases, tests are not effective until a woman misses her menses.*

Pregnancy not ruled out: EFV-based regimen is preferred. Counsel about DTG risks and facilitate informed choice of ART regimen. If client still wants to use DTGbased regimen, support informed decision.

Provide implant, DMPA, or COCs (but not IUD} as desired. At onset of next menses, switch to (or continue with) DTG; provide IUD if desired.

Return for a pregnancy test if next menses are delayed (see instructions below*).

* If the client presents with a late/missed menses, use a pregnancy test to rule out pregnancy.

First Pregnancy Test Positive: estimate gestational age by ultrasound or pelvic exam. If more than 8 weeks, DTG use is preferred.

If using a highly sensitive pregnancy test (for example, 25 mIU/ml) and it is negative, provide DTG-based regimen and her desired FP method.

First Pregnancy Test Is Negative, second positive: gestational age is at least 5 weeks. DTG use will be preferred in 3–4 weeks. If planning to continue pregnancy, discontinue FP method.

If using a test with lower sensitivity (for example, 50 mIU/ml) and it is negative during the time of her missed period, wait until at least 10 days after expected date of menses to repeat the test. Advise the woman to use condoms or abstain in the meantime. Until pregnancy can be ruled out, EFV-based regimen is preferred. Counsel about the risks of using DTG early in pregnancy and facilitate/support informed choice.

If the test is still negative after 10 days, switch to (or continue with) DTG-based regimen and provide her desired FP method.

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If test sensitivity is not specified, assume lower sensitivity.

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PREGNANCY CHECKLIST How to be Reasonably Sure a Client is Not Pregnant: Client History Ask the client questions 1–6. As soon as the client answers YES to any question, stop, and follow the instructions.

NO

1.

Did your last menstrual period start within the past 7 days?*

YES

NO

2.

Have you abstained from sexual intercourse since your last menstrual period, delivery, abortion or miscarriage?

YES

NO

3.

Have you been using a reliable contraceptive method consistently and correctly since your last menstrual period, delivery, abortion or miscarriage?

YES

NO

4.

Have you had a baby in the last 4 weeks?

YES

NO

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Did you have a baby less than 6 months ago, are you fully or nearly-fully breastfeeding, and have you had no menstrual period since then?

YES

NO

6.

Have you had a miscarriage or abortion in the past 7 days?*

YES

* if the client is planning to use a copper IUD, the 7-day window is expanded to 12 days.

If the client answered NO to all of the questions, pregnancy cannot be ruled out using the checklist.

Rule out pregnancy by other means.

If the client answered YES to at least one of the questions, you can be reasonably sure she is not pregnant.

In cases where pregnancy cannot be rujed out, offer emergency contraception if the woman had unprotected sex within the Jost 5 days. Counsel ali women ta come back any time they have ao reason to suspect pregnancy tfor example, missed period).

Adopted from: Family Health International 360 (2019). Safe Use of Dolutegravir (DTG) by Women and Girls of Childbearing Potential: A Decision-making Tool. Retrieved November 18, 2020, from https://www.fhi360.org/sites/default/ files/media/documents/resource-dtg-job-aid.pdf

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References Clinton Health Access Initiative (2018). Key DTG Counseling Messages. Retrieved November 18, 2020, from https://clintonhealth.app.box.com/s/gkwkxsbass9i6sf82n4k0bhsdw2sjuu3 Family Health International 360 (2019). Safe Use of Dolutegravir (DTG) by Women and Girls of Childbearing Potential: A Decision-making Tool. Retrieved November 18, 2020, from https://www.fhi360. org/sites/default/files/media/documents/resource-dtg-job-aid.pdf

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