Global Consensus Guidelines on Safer Conception Research - PowerPoint Presentation

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Global Consensus Guidelines on Safer Conception Research & Programming Priorities for HIV-affected Individuals and Couples

Dr. Nelly Rwamba Mugo Kenya Medical Research Institute (KEMRI), Center for Clinical ResearchUniversity of Washington-ICRC, Department of Global HealthPartners in Health Research and Development (PHRD)-Thika

Implementation of Safer Conception Programs

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OUTLINERationale for delivery of safer conception servicesGoal for safer conception programsRoutine care

User values & preferencesFeasibility of implementationHuman rightsSafer conception toolkitRecommendations

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Rationale

Risk of HIV Acquisition during Pregnancy and

Lactation; systematic review

(Drake AL et al. PLosMed 2014;11

)Pregnancy 4.7 (3.3, 6.1)Post partum 2.9 (1.8, 4.0) Overall 3.8 (2.0,4.6)

Pregnancy is a high risk state for both sexual partner HIV acquisition and transmission

Without intervention, couples will risk infection to achieve fertility

Increases risk for maternal and perinatal HIV infection

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Incident HIV Infection During Pregnancy and Risk of Transmission (Courtesy Heather Watts) Range 10.7%-30.5%

Summary: 105/578 18.2%Excluded: *Taha et al (Malawi) - BED assay; only discussed IU tx; 17.8% IU with acute vs 6.7% IU with chronic infection * Marinda et al (Zimbabwe) - BED assay; denominator not provided; 13.4% IU acute vs 9.1% IU chronic; 7.5% IP acute vs 10.5% IP chronic = 20.9% acute vs 19.6% chronic

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Peri-conception safety is importantSedgh G, et al. Intended

and unintended pregnancies worldwide in 2012 and recent trends.Stud Fam Plann. 2014 Sep;45(3):301-14.Pregnancy rate per 1000 births among women age 15-44 years

Continent

All pregnancies (million)

intendedUnintended % unintended

Globally

213

80

53

40%

Africa

53.8

145

80

35%

Europe

14.1

524345%Asia119.7754638%

Globally, 40% of pregnancies are unplanned, any exposure to product often unintended. Intervention products should be safe for early gestation.

Global pregnancy rates

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Goal for Safer Conception ProgramsIntegration of safer conception practices into routine clinical care practice offering services to persons infected and affected by HIV/AIDS

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Fertility desires is globalIn the US, approx 50% of persons living with HIV/AIDS express desire for child bearingPeri-conception safety studies on going

Finocchario-Kessler, et al. AIDS Behav. 2010, Oladapo OT et al. J Natl Med Assoc. 2005Okeomo Mmeje et al. Inf Dis O/G 2012Guillaume M. CROI 2016, abstract 1122 Procreation in HIV-Serodiscordant Couples: TasP, PrEP, or Assisted Reproduction?

Peri-conception safety study: Heffron R. on-going in Kenya

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Fertility desiresHIV infected and affected individuals, like all others individuals, have reproductive health desires

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Fertility desires outstrip fear of HIV infectionFertility decisions are complex among HIV-serodiscordant couples (Pintye J. AIDS Patient Care STDS 2015, Ngure

AIDS Care 2015)

“We became motivated to have a baby because we preferred to conceive now [after learning] that I am HIV positive

. We thought I am supposed to get a child before I get so weak

.” (HIV-infected female, age 25)“…I am the one [in our marriage] who felt that I should have another child

now because I was growing old and my peers, all of them, had children and I was the only one left

[without multiple children]. (HIV-uninfected male)

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Fertility Decision Making:Fertility Desires over rides fear of HIV infection

There are multiple and complex personal, social and cultural factors that motivate women to conceive naturally even when the risk of HIV acquisition is high

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Fear Amidst RiskNgure K. AlDS

Care 2015“I would say in my heart ..telling God to look after the baby, it is not the wish for the baby who is in the stomach to get disease.. I just pray to God she is not infected “ HIV 24 year old negative female

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Stigma:HIV infected & affected persons desire children“We have our desires of having children, yet we fear that we will give birth in unsafe way and infect the child. But now the fear will be reduced that you can conceive and give birth to a healthy child.” (FGD, HIV-affected couples, age 29) Mmeje

et al. AIDS 2016StigmaThe general public “HIV infected people should not have children” often assumption the children will be infected (Consensus Statement, pregnancy experencies of HIV –affected men and women)Perspectives of healthcare providers and HIV-affected individuals and couples Mmeje O. et al. AIDS Care 2016

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Health Care Providers‘prerequisite to service delivery’HIV-affected persons desire to receive safer conception counseling and assessment during routine HIV care and treatment visits (Mmeje et al. AIDS Care 2016)

HCP often do not initiate conversations on fertility intentions with HIV-affected men and women (West N et al. AIDS Care 2016); the conversation is often client initiated

“Yes. I think when it comes to safer conception I think the healthcare provider or the nurse or a doctor should do so. Yeah not just anyone around.” (FGD, HIV-affected male, age

25)

““I can only add that there is no problem when the provider reminds or talks to me about it every time I visit the clinic just like they always ask about condom use. They will also advice on when to conceive and discuss with you what you should do to give birth to a healthy baby.” (FGD, HIV-affected women, age 31

)

“

Mostly women ask if it is possible to have a child if they are HIV-positive.

They ask “how [can I conceive] the natural way?” They are scared of infection.” [M, doctor]

(

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Provider challengesAcross countries HCP interviews expose Ambivalence towards supporting HIV-infected persons get childrenReservations about condomless sex and/or child bearing among PLWHLack of comprehensive knowledge on safer conception interventions Misconceptions that HIV uninfected partners in HIV serodiscordant partnerships are in ‘latency

’ (West N.AIDS Care 2016)Challenges dealing with couples, & HIV disclosure within partnershipsMathews LT JAID 2014 (SA), Kawale P, Reprod. Health 2015 (Malawi), Mmeje O. AIDS Care 2015; (Kenya) Heffron R. J Int AIDS Soc

2015.

“

You should tackle it as a couple and not as one individual. Counseling becomes easier if it involves both.” (IDI, HCP, age 31)

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Reducing HIV-1 risk among HIV-1 serodiscordant couples with immediate fertility goals: formative research to guide intervention developmentDevelopment of a Safer Conception Intervention

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What we have learnt about delivering safer conception services to HIV SDC in Kenya: Interviews with HCP and HIV SDCCouples preference for timed condomless sex, Couples & providers experienced with ART (VS) & PrEP

expressed comfort with use of ART for safer conceptionEasy access in majority of health care servicesLow costK.; Heffron

R. J Int AIDS Soc; 2017.

“I have seen the strategy of using drugs, that is

ART to …......Truvada to the negative partner, work. Then now you counsel them about fertility period so that

they know how

they can go about

condomless

sex during the per-

iod

that the peak fertility

is high

.”

(Health provider

,

KII)

“…and he takes Truvada and I take ARV and you can see his health is good, it is hard for me to infection and our health is okay, so I think ARVs they help me, they are even my best friend..(HIV-Infected female, FGD)

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What we have learnt about delivering safer conception services to HIV SDC in Kenya: Interviews with HCP and HIV SDCCouples inaccurate in calculating peak fertility periodInadequate provider expertise with safer conception interventions

K.; Heffron R. J Int AIDS Soc; 2017.

“well I am aware of the new PEP and PrEP studies… I think the safest way is really if it is the man it s the sperm wash” (Health care provider, private fertility clinic, KII)

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Safer Conception services is a ‘human right’All persons have the basic reproductive right to information and ability to decide and control their reproductive decision-making (UNFPA 1994)“decide freely and responsibly the number, spacing and timing of their children, access information, education and means to do so”

Safer conception services promote reproductive autonomy and reduce risk of HIV infectionAccess to information on safer methods of conception should be part of routine servicesLegal and ethical challenge is the disclosure to partners

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Service delivery, is it feasible?Is implementation of safer conception services feasible?Will the population of end users who need them, use the interventions?

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EXPECTEDThe degree of effect was similar for men (97%) and women (93%)

All four seroconverters were not using PrEP and none had resistance to PrEP medicationsN=83.3 infectionsincidence = 4.9 (95% CI 3.9-6.0)

OBSERVED

N=4 infections

incidence = 0.2 (95% CI 0.1-0.6)

IRR observed vs. expected =

0.05

(95% CI 0.02-0.13)

or a

95% reduction

(95% CI 87-98%)

P<0.0001

Partners

Demonstration Project

:

PrEP

as Bridge to ART (

Kenya, Uganda)Enrolled 1013 high risk HIV serodiscordant couples; 24 month follow up80% expressed desire for fertility156 pregnancies (HIV infected & un-infected women)Pregnancy incidence: 18.5/100 pyrs (HIV-uninfected); 18.7/100 pyrs (HIV infected)83% used PrEP & ART, 13.7% sperm wash; 21.8% self insemination

One HIV acquisition event in pregnancy (no evidence of tenofovir in plasma)Baeten

et al.

PLoS

Med. 2016;

Heffron

R. in print

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Safer Conception Demonstration Project, Inner-city Johannesburg, South Africa

Slides courtesy of Lynn Mathews

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Client Uptake (June 2015 – April 2017)

676 individualshave accessed the service

449 females, 227 males

215 couples,

235 unaccompanied females, 11 unaccompanied males

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Conception Before Clinically Ready

Pregnancies & Challenges

32%

(21/98) conceived before given the green light

Reasons not considered ready included: only attended baseline visit, male partner not yet engaged, viral

suppression not confirmed

, not

on

ART for 3 months, or peak fertility timing

not established

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HIV transmission outcomesNo partner to partner HIV transmissionsNo mother to baby HIV transmissions

Horizontal Transmission

Vertical Transmission

98 pregnancies

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Experiences from Sakh’umndeni Safer Conception Service at Witkoppen Health and Welfare Centre, Johannesburg, South Africa

With thanks from Sheree Schwartz (Witkoppen, South Africa)

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80% used at least one strategy15% none (93% had HIV pos partner with VS)5% undecided

Uptake of safer conception interventions%ART90%PrEP23%Home self insemination

39%Timed condomless

sex48%

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Safer conception strategy uptake according to HIV status of the couple

Results from interim analysis (Schwartz, Bassett, Holmes, et al. JIAS 2017)

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Follow-up pregnancies & infections>3100 follow-up visits complete93 pregnancies to date (93/334 women=28%)0 horizontal transmissions observed0 vertical transmission observedSafer conception services get men into clinic and engaged in treatment and prevention

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Safer Conception ToolkitSafer conception toolkitDelivery of options

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Safer conception strategiesART use by HIV infected partner with viral suppressionPrEP use by HIV uninfected partnerTiming unprotected sex to most fertile days (1-2 days per month)Condom use on days when fertility is unlikely and after conceptionSelf inseminationAssisted reproductive technologies (high tech)

Intra uterine insemination, in vitro fertilizationSperm washing may be added if the man is HIV infectedSTI treatment, male circumcision (if man is HIV uninfected)

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Biomedical InterventionsART use by HIV infected partner with viral suppressionPrEP use by HIV uninfected partner

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Peak fertility = during ovulation

Counting days

(since LMP began)

Measuring basal body temperature

(temperature immediately upon waking)

Monitoring cervical mucous

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Timing OvulationTiming unprotected sex to most fertile days (1-2 days per month)Condom use on days when fertility is unlikely and after conceptionSelf inseminationAssisted reproductive technologies (high tech) Intra uterine insemination, in vitro fertilization

Sperm washing may be added if the man is HIV infectedSTI treatment, male circumcision (if man is HIV uninfected)

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InseminationSelf inseminationis a low tech method that can be used when the woman is HIV-infected and the man is HIV-uninfectedDone at homeAssisted reproductive technologiesIntra uterine insemination, in vitro

fertilizationSperm washing may be added if the man is HIV infected

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Renee Heffron,et al. J Int AIDS Soc. 2015; 18(6Suppl 5): 20272. Key values to inform the design and delivery of services for HIV-affected women and couples attempting pregnancy in resource-constrained settings

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SummaryRoutine provision of safer conception interventions promotes maternal and child health and should be integrated in routine services with frequent screening for fertility desiresHealth care providers, when well informed and couples support safer conception interventions when availedUptake is high when services are availedLow cost easily accessible interventions are accessible in low resource settings

HIV infected and affected individuals use interventions with high fidelity & effectively reduce both maternal and perinatal incident HIV infectionsImportant to eMTCT and should be part of PMTCT programIncrease access to reproductive health services is a human rightProvider education and stigma mitigation is required

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Symposium organizersAll research participants and investigatorsFunding institutionsEach one of you for listeningWorking towards improving maternal and neonatal health

Acknowledgements