SAFER CONCEPTION: Training for health care providers

Transcription

1 SAFER CONCEPTION: Training for health care providers

2 Overview of the Training Lecture Define and provide raconale for safer concepcon ObjecCves of the research and the training Safer concepcon strategies described Adjunct risk reduccon strategies, ferclity monitoring PreconcepCon/Safer concepcon counseling Resources: Counseling Guide and Brochures QuesCons & Answers Role Play & Case- studies Post- training QuesConnaire & EvaluaCon Next steps: Mock counseling session and In- depth Interviews

3 HIV- infected women and men desire children 20-50% of HIV- infected men and women desire children (1-3) Childbearing desires can lead to unprotected sex and/or non- disclosure of HIV status (4-6) ContribuCon of intended concepcon to incident HIV infeccon is unknown, but likely represents a significant proporcon given high ferclity rates and the importance of having children in most HIV endemic areas (7-9) 1. Chen Family Planning Perspective 2001; 2. Ogilvie AIDS 2007; Frodsham Fertil Steril 2006; 4. Brubaker HIV Medicine 2011; 5. Chen Family Planning Perspective 2011; 6. Ujiji BMC Women s Health 2010; 7. Preston-Whyte South African J Demog 1988; 8. Beyeza-Kahsesya Afrcian Health Sci 2009; 9. Cooper Soc Sci Med 2007

4 HIV serodiscordant couples are common, and HIV transmission is high In sub- Saharan Africa, up to half of those living with HIV report a serodiscordant partnership (10-11) Up to 60% of new infeccons occur between stable, heterosexual, discordant couples in countries in sub- Saharan Africa, including Kenya (12-13) HIV transmission risk is up to 2x greater among discordant couples who conceive, compared to those who do not (14) 10. Chemaitelly STI 2012; 11. Guthrie Curr HIV Res 2007; 12. Dunkle Lancet 2008; 13. Coburn Lancet Infect Dis Brubaker HIV Medicince 2011.

5 HIV- discordance and childbearing Nyanza (15, 16): in Kenya HIV prevalence = 15.1% Home to approximately 30% of the country s HIV- infected populacon FerClity average: 4.6 children per woman Antenatal HIV prevalence: 16% Improving reproduccve health is a public health priority in Kenya (17) 15. National AIDS and STI control programmer Kenya Demographic Health Survey Kenya Global Health Initiative Strategy ( )

6 ReproducCve rights and counseling With treatment, men and women with HIV are living longer, healthier lives, and can expect to see their children grow into adulthood. Safer concepcon counseling for HIV- discordant couples is a reproduccve right and should be included as a public health strategy to reduce HIV incidence among men, women, and their children (18-19) 18. WHO Guidance on Couples HIV testing and counseling 2012; 19. Matthews AIDS Behavior 2011

7 What are reproduccve rights? The basic right of all couples and individuals to decide freely and responsibly the number, spacing and Cming of their children and to have the informacon and means to do so, and the right to aiain the highest standard of sexual and reproduccve health. - World Health OrganizaCon

8 ReproducCve rights in Kenya Every person has the right to the highest aiainable standard of health, which includes the right to health care services, including reproduccve health care - Kenya ConsCtuCon, ArCcle 43 (1)

9 Guidelines on Safer ConcepCon InternaConal guidelines have shijed from recommending avoidance of pregnancy among HIV- affected populacons to recognizing concepcon as a realiscc opcon for HIV- affected couples. Evidence- based Safer ConcepCon Guidelines developed in 2012 by the South African Clinicians Society for selngs in sub- Saharan Africa (Bekker et al 2012) Training and materials Safer ConcepCon Guidelines, South African Clinicians Society Francois- Xavier Bagnoud Center, University of New Jersey University of California Bay Area Perinatal AIDS Center

10 Safer ConcepCon defined Use of HIV prevencon strategies that allow a couple to conceive while limicng the risk of HIV transmission to partner and baby Type of HIV transmission Method Es6mated risk reduc6on Mother + Goal: perinatal transmission) F+ M- (goal: female to male sexual transmission) M+ F- (goal: male to female sexual transmission) AnCretroviral therapy in the mother AnCretroviral therapy in child ajer birth Non- intercourse vaginal inseminacon Voluntary medical male circumcision 95% Unknown (theoreccally 100%) 66% Sperm washing + IUI or IVF (+/- ICSI) 100% Either partner infected Goal: sexual transmission) Sex without condoms limited to peak ferclity ART for infected partner PrEP (oral, daily FTC/TDF) Treatment of STIs Unknown 96% 63-73% 40%

11 Ethical implicacons of providing safer concepcon to HIV- affected couples With the majority of those living with HIV infeccon being of reproduccve age, it is criccal they are given opcons to conceive without transmilng HIV to their partner or baby. The ethical dilemma in providing safer concepcon strategies to HIV affected couples includes the possibility of mother- to- child HIV transmission and the risk of HIV transmission to an uninfected partner. However, consider that HIV discordant couples who aiempt to conceive currently put themselves at considerable risk of HIV transmission Even though safer concepcon strategies may not eliminate risk, they offer a vast improvement over the status quo. Some have argued that it would be unethical to withhold proven HIV prevencon strategies to HIV- affected couples who desire pregnancy (25) 25. Mantel Journal Public health Policy 2009

12 And one more word about ethics If we do not broaden our discussions around reproduccve health among HIV posicve people (leaving it at use condoms ), many individuals will do what they will do at home in order to achieve pregnancy It is much beier that they conceive with support and knowledge of safe opcons. We do not want clients to feel they have to hide their desire to have children

13 ObjecCves of the Research (i) Develop a pracccal, concise, interaccve Safer ConcepCon Counseling Toolkit for healthcare providers (HCP) 1. HCP training session 2. Counseling guide for HCP 3. Methods brochures for pacents (ii) Evaluate the feasibility, acceptability, and comprehension of the safer concepcon counseling messages amongst HCPs and HIV- discordant couples

14 ObjecCves of Provider training Upon complecon of training, providers will be able to: 1. Define and explain the raconale for Safer ConcepCon 2. Explain three safer concepcon strategies for M+F- couples, and three for M- F+ couples 3. Competently and confidently counsel pacents on HIV prevencon strategies that can be used whilst allowing pregnancy to occur 4. Competently and confidently counsel pacents on preconcepcon care 5. Understand and uclize the Counselling Guide and Brochures

15 HIV PREVENTION STRATEGIES FOR SAFER CONCEPTION

16 Overview of Safer ConcepCon Strategies (reduccon in HIV risk) Baby PMTCT (95%) Female Male ART (96%) PrEP (63-73%) Vaginal insemination (~100%) Male Female ART (96%) PrEP (63-73%) Sperm washing (~100%) Adjunct risk reduction strategies: MMC (66%), STI screening and treatment (40%), Unprotected sex timed to peak fertility in conjunction with ART and/or PrEP

17 PrevenCon of mother- to- child- transmission (PMTCT) Goal DescripCon Prevent perinatal transmission from Mother+ to baby These are intervencons to prevent transmission of HIV from a mother living with HIV to her infant during pregnancy, labor and delivery, or during breasteeding. EffecCveness in HIV prevencon with the success and increasing availability of drug regimens for prevent mother- to- child HIV transmission (PMTCT) (concurrent with safer childbirth and breasteeding praccces), the risk of mother- to- child transmission has been lowered from more than 30% to less than 1% in industrialized countries Approx. cost per pregnancy 11,560/=

18 PMTCT: Step by step 2. Prevention of unwanted Pregnancies in HIV+ women 3. Core PMTCT: - Use of ARV, - Safe Obstetrical practices - Safe infant feeding 1. Primary prevention 4. Long term follow-up of mother-infant pair

19 AnCretroviral treatment as prevencon Goal DescripCon EffecCveness in HIV prevencon Pregnancy rate Approx. cost per cycle Prevent sexual transmission from M- F+ and M+F- TreaCng the HIV posicve partner with ancretrovirals and monitoring their viral load (the amount of HIV in his blood) to make sure the HIV viral load is very low or undetectable before aiempcng unprotected sex during the fercle period Barreiro: 62 serodiscordant couples (M- F+ & M+F- ), AnCretroviral in HIV posicve parccipant, and viral load<500, no HIV transmission, 68 children over 2 years of follow- up. HPTN 052: 96% reduccon in transmission of HIV among serodiscordant couples (ARVs started if CD ). No measured reduccon in pregnancy incidence with use of ART HAART cost=300/= Viral Load cost=4500/=

20 AnCretroviral: Step by step Ensure viral load is suppressed Safer ConcepCon guidelines recommend monthly viral loads for up to 6 months Counsel on adherence to ARVs Counsel on 100% condom use Determine the fercle period Counsel on idencfying the fercle day Unprotected intercourse during the fercle days 100% condom use at all other Cmes

21 Pre- exposure Prophylaxis (PrEP) Goal DescripCon EffecCveness in HIV prevencon Prevent sexual transmission from M- F+ and M+F- TreaCng the HIV- negacve partner with ancretrovirals called pre- exposure prophylaxis, or PrEP, during the Cme they are trying to get pregnant. Switzerland study: 46 M+F- discordant couples; ARVs in man, periconcepcon PrEP in woman, no HIV transmission; 14 babies ajer 1 aiempt, 25 babies ajer up to 5 aiempts; 40 babies ajer up to 12 aiempts. Partners Prep: 4,758 discordant couples in Kenya and Uganda, daily oral Truvada, 73% reduccon in HIV transmission Pregnancy rate Approx. cost per cycle TDF PrEP: 1,219 men and women, daily oral Truvada, 63% reduccon in HIV transmission No measured reduccon in pregnancy incidence with use of PrEP 1650/=Per cycle.

22 PrEP: Step by step Counsel on adherence to ARVs Counsel on daily, oral use of PrEP Counsel on 100% condom use Determine the fercle period Counsel on idencfying fercle period Unprotected intercourse during the fercle period 100% condom use at all other Cmes Ideally in combinacon with HIV posicve partner on ARVs and virally suppressed

23 Vaginal inseminacon (VI) without intercourse Goal DescripCon EffecCveness in HIV prevencon Pregnancy rate Approx. cost per cycle Prevent sexual transmission from M- F+ This is when sperm is collected from the man into a condom or a cup, and then using a needless syringe, the sperm is taken from the condom or cup and gently placed inside the woman s vagina by the woman, or by the man. This is usually done at home, and is somecmes refferred to as home inseminacon. Not yet established through research, though theoreccally 100% No measured reduccon in pregnancy incidence Ajer 6 months, 75% will aiain pregnancy ~100KSH per cycle for materials (non- lubricated condoms, cups, syringe)

24 VI Procedure: Step by step 1. Determine the fercle period 2. Perform the procedure 3 Cmes per cycle i.e. for a 28- day cycle on Day 11, 13, Steps i. Man ejaculates into a condom or a cup ii. iii. iv. Semen is aspirated using a needleless syringe Push out air bubbles while being careful to not spill semen Insert syringe in vagina uncl the base of the syringe reaches the opening of the vagina and gently deposit the semen within one hour of colleccon v. Advise woman to lay on her back for 20 minutes with hips slightly elevated 4. Counsel to use condoms 100% during intercourse

25 Sperm washing removing HIV from sperm Goal DescripCon EffecCveness in HIV prevencon Pregnancy rate Prevent sexual transmission from M+F- This is when semen is collected from the man and then processed or washed to remove the HIV (HIV lives in seminal fluid, not on the sperm). The washed sperm will then be placed inside the woman either through intrauterine inseminacon (IUI) or in vitro inseminacon (IVF). Sperm washing with IUI/IVF is available in Nairobi, but not yet widely available in Kenya. CREAThe Network*: 967 discordant couples having 2840 IUI cycles and 107 IVF cycles; no HIV transmission; 463 live births CREAThe: Delivery per couple: 36% (IUI); 26% (IVF) Approx. cost per cycle Sperm washing + IUI: 5,000-10,000 KSH *CREAThe = Centre for Reproductive Assisted Technologies for HIV in Europe, see Bujan et al 2008

26 Sperm washing: step by step Collect semen sample In laboratory, separate sperm from semen Two methods: i) centrifuge or ii) swim up Test sperm to confirm absence of HIV Sperm is maintained in laboratory while waicng for HIV results

27 What is then done with the washed sperm? Intrauterine insemination (IUI) Using a thin catheter, sperm is transfered through vagina and cervix directly into the uterus where fertilization occurs In vitro insemination (IVF) Eggs are removed from the woman s ovary, fertilized outside the body using the sperm. Using a thin catheter the embryo is transferred through the vagina and cervix directly into the uterus.

28 Unprotected sex limited to fercle days Goal DescripCon EffecCveness in HIV prevencon Pregnancy rate Approx cost per cycle Prevent sexual transmission from M- F+ and M+F- This is when the woman and man have sex without a condom during the woman s fercle days. Condoms are used 100% of the Cme, except around the Cme of ovulacon to allow pregnancy to occur. Strongly recommended to combine this strategy with ART and PrEP as treatment as preven@on. Unknown Would mimic natural concepcon rates (20% chance per cycle) Calendar method: negligible Cervical mucus monitoring: negligible LH tescng: 85KSH per test strip BBT monitoring: thermometer, negligible Ultrasound assessment of follicles: 2500KSH per ultrasound

29 Unprotected sex limited to fercle days: Step by step 1. Determine peak fercle days 1. Calendar method (ferclity beads) 2. Monitoring cervical mucus (Billings method) 3. TesCng for Luteinizing hormone (LH) in urine 4. Monitoring basal body temperature 5. Ultrasound monitoring of the follicles % condom use at all other Cmes

30 Adjunct HIV risk reduccon strategies 1. Voluntary Medical Male Circumcision (VMMC) 66% reduccon in sexual M- F+ HIV transmission 2. Screening and treatment of STIs 40% reduccon in HIV acquisicon M- F+ & M+F-

31 DETERMINATION OF FERTILE DAYS i) Calendar method (ferclity beads) ii) Cervical mucus monitoring (Billings method) iii) TesCng for LH urinary metabolite iv) Tracking basal body temperature v) Ultrasound monitoring for follicle development

32 Quick Refresher on the Menstrual Cycle A menstrual cycle starts on Day 1 of bleeding (first day of full blood flow) and concnues uncl the next Day 1 of bleeding. The average menstrual cycle is 28 days long Cycles can range anywhere from 21 to 35 days OvulaCon occurs midway through the menstrual cycle. For a 28 day cycle, ovulacon is expected around Day 14. For a 32 day cycle, ovulacon is expected around Day 16.

33 Calendar Method: IdenCfy fercle days Predicts ovulacon trends based on past menstrual paierns It is more accurate when the woman has a regular cycle Key to calendar colors and CD = Condom symbols day FD = Fertile Days (most likely to get pregnant) Perceiving ovulacon paierns becomes easier ajer a couple months of maintaining the calendar records

34 Cervical mucus monitoring (Billings method): IdenCfy fercle days Ajer menses ends the external cervical os is blocked by mucus that is thick and acidic This mucus blocks sperm from entering the uterus Around the Cme of ovulacon (Day 14) another type of mucus is produced which is: higher in water content, less acidic, higher in electrolyte Involves escmacng a woman's fercle days by observing changes in her body Quality of cervical mucus ElasCcity (Spinbarkeit) Transparency Ferning paiern (under magnificacon)

35 LH tescng: IdenCfy fercle days Measuring the amounts of luteinizing hormone (LH) and estrogen in urine to idencfy the peak fercle days of a woman s menstrual cycle The most fercle days are the day prior to ovulacon and the day that ovulacon takes place

36 Basal body temperature (BBT): IdenCfy fercle days for a future cycle DefiniCon: BBT is the lowest temperature aiained by the body during rest (usually during sleep) Why track: OvulaCon causes an increase of quarter to half degree Celsius in BBT; biphasic paiern: women have lower temp before ovulacon and higher temp ajer. When to track: Measured immediately ajer awakening and before any physical accvity How to track: The temperature is normally taken orally with a regular fever thermometer

37 Ultrasound Assessment for OvulaCon Definition: Serial transvaginal ultrasound evaluations can demonstrate the development of a mature follicle prior to ovulation. Mature follicle is approximately 20-25mm before ovulation Ovulation: the follicle ruptures and the egg is released Monitoring Disadvantage: time consuming, costly, not readily available Developing ovarian follicles

38 FerClity evaluacon WHO definicon of inferclity: 12 cycles of unprotected sex without concepcon HIV and FerClity: Some evidence of decreased ferclity among HIV+ men and women, and menstrual cycle abnormalices, but data are inconclusive, confounded by STIs FerClity assessment prior to offering safer concepcon: Self- reported history of 12 months of concepcon aiempts that result in no concepcon FerClity evaluacons: South African Guidelines suggest ferclity evaluacons ajer 6-12 months of safer concepcon aiempts Hysterosalpinogram & sperm analysis available in Kenya

39 AlternaCves to having biological children (available in Kenya) AdopCon Sperm DonaCon, Egg donacon Surrogacy

40 PreconcepCon counseling and resources

41 Pre- concepcon care and counseling WHO DefiniCon: IntervenCons that aim to idencfy and modify biomedical, behavioral and socials risks to a women s health or pregnancy outcomes through prevencon and management Reasons for: Ensure maternal and fetal health during and ajer pregnancy Prevent unintended pregnancies Prevent HIV transmission to uninfected partner Prevent perinatal HIV transmission

42 Pre- concepcon care and counseling (cont.) When to offer: Nonuse/inadequate use of effeccve contracepcon, or at risk for unintended pregnancy Expressed interest in conceiving Change in relaconship or personal circumstances Woman taking medicacons with reproduccve toxicity (examples), or interact with contracepcon There is new informacon about pregnancy, or HIV

43 Pre- concepcon care and counseling (cont.) What to discuss with pacents considering pregnancy: OpCmizaCon of HIV care and treatment, CD4 count, viral load suppression, HIV counseling and tescng in partner Safer concepcon strategies Using contracepcon to delay pregnancy uncl healthy Assess and manage underlying medical condicon (e.g. Hypertension, Diabetes) MulCvitamins with 400 mcg of folic acid daily Avoid over- the- counter medicines...

44 Pre- concepcon care and counseling (cont.) What to discuss (concnued): Healthy accvity level and weight Ways to improve nutricon Resources to stop smoking and to avoid second- hand smoke Screening, treatment for sexually transmiied diseases ImmunizaCons for HepaCCs B, Tetanus & Whooping cough, Rubella, Varicella WAIT 4 WEEKS AFTER RUBELLA AND VARICELLA LIVE VACCINE TO ATTEMPT PREGNANCY Partner involvement AND Provide referrals to support services as appropriate

45 Pre- concepcon care and counseling (cont.) Emphasize importance of opcmizing HIV care and treatment: Assessment of clinical and immunologic status e.g. CD4 count, viral load, regular HIV tescng of the negacve partner in a discordant relaconship IniCate or modify HIV treatment Adjust ARV regimens to exclude efavirenz or other drugs with teratogenic potencal during the preconcepcon period Treat and provide prophylaxis for any opportuniscc infeccons

46 Pre- concepcon care and counseling (cont.) Emphasize delaying pregnancy uncl health issues are addressed, couple in opcmal health: Most forms of birth control are safe and effeccve for women living with HIV Encourage dual proteccon uncl pregnancy is desired and couple is healthy Prescribe hormonal contracepcon, if medically appropriate

47 Resources for counseling sessions Counseling Guide Brochures for men and women

48 QuesCons and Answers

49 Role plays è Use the Patient Brochures and the Preconception Counseling guide for Providers during your role play.

50 Role Play De- brief How did you feel in your role? What was the most difficult part of the role? Which part did you enjoy most in your role? What addiconal informacon could have been provided to enhance your ability to counsel HIV- affected women or couples?

51 Case Studies CASE 1: Rebecca is 28 years old; she has been in HIV care for six years. She is currently married and living with her husband who is HIV-negative. They have one child who is seven years old. She is using condoms to prevent HIV transmission to her uninfected partner and is not on any other contraceptive method. CASE 2: Jirus and Prisca have come for their clinic follow up. Jirus is HIV-infected and has been in care for two years. Jirus is on HAART and his CD4 count which was done nine months ago was 659. Prisca last tested HIV negative about 6 months ago. They are no longer using condoms because they want to have a baby. è Using the Preconception Counseling Guide for Providers and the Patient Brochures, discuss within your group and write out your preconception/safer conception plan for the patient (s). You will present this plan to the rest of the participants in the training.

52 Case Study 1 De- brief - Rebecca Assessment of reproduccve desires (safer concepcon versus contracepcon) Partner involvement Basic ferclity evaluacon through self- reported history of aiempcng concepcon Repeat HIV tescng as indicated in the male partner OpCmizaCon of ART care with CD4/HIV viral load monitoring according to naconal or WHO guidelines Adherence to ARVs switching of ARVs (no EFV in first trimester, if possible) Dual contracepcve proteccon uncl ready to aiempt pregnancy Consistent condom use Reversible contracepcve Safer concepcon opcons (i.e. ARVs, PrEP, vaginal inseminacon) IdenCfying peak fercle days/monitoring the menstrual cycle Adjunct strategies: VMMC, STI Screening and Treatment Once pregnant 100% condom use ARV inicacon for Rebecca, if she is not already on ARVs

53 Case Study 2 De- brief Jarius & Prisca Assessment of reproduccve desires (safer concepcon versus contracepcon) Basic ferclity evaluacon through self- reported history of aiempcng concepcon Repeat HIV tescng as indicated in the female partner (Prisca) OpCmizaCon of ART care with CD4/HIV viral load monitoring according to naconal or WHO guidelines Adherence to ARVs switching of ARVs (no EFV in first trimester, if possible) Dual contracepcve proteccon uncl healthy enough to aiempt pregnancy Consistent condom use Reversible contracepcve Safer concepcon opcons (i.e. ARVs, PrEP, sperm washing) IdenCfying peak fercle days/monitoring the menstrual cycle Adjunct strategies: STI Screening and Treatment Once pregnant - 100% condom use

54 EvaluaCons today Post- training QuesConnaire Training EvaluaCon Content, duracon, facilitacon

55 Next steps Mock counseling sessions (in 1-2 weeks) Each provider to counsel 1 HIV discordant couple, and 2 HIV- affected women who have agreed to parccipate in this research study Direct observacon and support by a member of the research staff In- depth interviews Immediately following mock counseling sessions

56 Thank you! We will communicate with you the findings of this research study. We will inform you when Safer ConcepCon resources have been developed and become available/approved for use in Kenya.