Safer conception intervention to reduce HIV risk for Kenyan HIV serodiscordant couples with immediate fertility needs (preliminary findings)

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1 Safer conception intervention to reduce HIV risk for Kenyan HIV serodiscordant couples with immediate fertility needs (preliminary findings) Kenneth Ngure, Catherine Kiptinness, Justice Quame-Amaglo, Lawrence Mwaniki, Jennifer Velloza, Nicholas Thuo, Lynda Oluoch, Nelly Mugo, Renee Heffron

2 Why safer conception We know that HIV discordant couples get pregnant and the pregnancy rates is similar to the general population 1 We know that very often they make an intentional decision to risk HIV transmission because having children is such an important desire 2 We have opportunities to discuss fertility planning with couples and help them reduce HIV transmission risk when they try to conceive 1 Homsy (2009), 2 Ngure (2011)

3 HIV serodiscordant couples desire fertility we had planned earlier before knowing we had the virus. We did not stop our plan; we just said even if we have the virus, we will still get the baby. I went and had the coil removed and we stopped using condoms 23 yr old female HIV negative Ngure et al. AIDS Care 2014

4 Safer conception strategies HIV prevention Pre-exposure prophylaxis (PrEP) used by HIV- partner Antiretroviral therapy (ART) used by HIV+ partner Condomless sex timed to peak fertility Additional strategies include medical male circumcision, vaginal selfinsemination, and treatment of genital infections Pregnancy optimization Identification of ovulation through fertility awareness methods Simple fertility screening Fertility workup and fertility services

5 SCIP Safer Conception Intervention for Partners SCIP is a pilot project to demonstrate use of a client-centered, comprehensive safer conception strategy for HIV serodiscordant couples in Thika, Kenya Pre-exposure prophylaxis (PrEP) used by HIV- partner Antiretroviral therapy (ART) used by HIV+ partner Condomless sex timed to peak fertility including teaching women to use fertility awareness methods to predict upcoming peak fertility Planned enrollment of 80 couples for prospective follow up through pregnancy (or 12 months) Other services provided through referral (for male circumcision, fertility workup etc.)

6 Eligibility criteria HIV serodiscordant couples Immediate fertility intention Neither partner has a clear indication of infertility or subfertility, as determined by medical history Both partners must have their own mobile phones Other usual things important for PrEP use, being sexually active etc.

7 Key Intervention Components Preparatory Peri-conception Pregnancy Monthly clinic visits Focus on ART and PrEP initiation and adherence with quarterly viral load measurements Consistent condom use except during periconception period (and then focus on timed condomless sex) Other interventions as desired SMS daily diary to track fertility data In-clinic tablet app to examine data on fertility, PrEP and ART use and assist with participant-provider communication Quarterly visits Continued discussion about ART and PrEP use and adherence Resumption of consistent condom use Other interventions as desired

8 Quantitative data collection Paper-based CRFs to collect demographic, medical, and behavioral data Data entry into REDCap

9 Qualitative data collection During follow up, we are conducting in depth interviews With couples To understand how participants perceive our integrated safer conception intervention, including the mhealth components With Thika staff providers To understand how clinicians and counselors perceive the use of the tablet application during counseling sessions

10 Even not many women understand it [fertility], someone just finds they are pregnant. -HIV+ woman Ngure et al. AIDS Care 2014

11 mhealth tools Assist women with tracking fertility indicators Improve couple-provider communication about readiness to practice timed condomless sex Assist couples to remember days with peak fertility

12 SMS surveys Menses Waking temperature Cervical mucus Results from home ovulation test Sex Condom use

13 Clinic-based tablet app: SCIP-App Fertility data - SMS survey Female participant Viral load data results returned from lab HIV+ participant msurvey API Web-based data entry Data downloaded to clinic server during study visit PrEP adherence - MEMSCap HIV- participant

14 Clinic-based tablet app: SCIP-App

15 Calendar view

16 ART view

17 Preliminary results

18 Participant characteristics at enrollment Demographic characteristics Age (female) years 32.8 ( ) Education, years 10.0 ( ) Couple characteristics Married 73(98.7) Partnership duration, years 3.2 ( ) No. children with study partner 0.0 ( ) Time known discordant, years 1.0 ( ) Sexual behavior and medical characteristics Circumcised (men only) 70 (94.6) HIV-1 characteristics HIV-1 infected 74 (50.0) Plasma HIV-1 RNA (log 10 copies per ml) 1.6 ( ) CD4 count (cells per µl) ( ) >3 mo ART use (HIV-1 infected partner only) 52 (70.3) Accepted PrEP (HIV-1 uninfected partner only) 1 73 (98.6) Data are number (%),or median (IQR). ART=antiretroviral therapy. PrEP= pre-exposure prophylaxis. 1 Participants were marked as not accepting PrEP at enrollment if the PDR CRF is incomplete in REDCap by the data lock date.

19 Pregnancies 28 Pregnancies 2 Live Birth No HIV transmission Female Index Female Partner

20 Summary SMS COMPLETION RATE Partially Missed 6% Fully Missed 16% Completed 78%

21 Opportunity At the end of the study we will demonstrate whether: HIV serodiscordant couples can become pregnant without HIV transmission use of mhealth tools and understand whether they facilitate provider-couple communication and women s ability to track daily fertility indicators Capture experiences of couples and providers with safer conception

22 Acknowledgements University of Washington Department of Global Health: Renee Heffron (protocol chair), Justice Quame-Amaglo, Harald Haugen, Jennifer Velloza, Susan Morrison University of Washington Department of Human Centered Design & Engineering: Kristin Dew, Beth Kolko Kenya Medical Research Institute/Thika Partners in Health & Research Development: Nelly Mugo, Kenneth Ngure, Elizabeth Irungu, Lawrence Mwaniki, Steve Gakuo, Simon Mburu, Grace Thuku, Catherine Kiptinness, Nicholas Thuo, Lynda Oluoch msurvey: Vivian Akinyi, Aimee Leidich, Laura Farren Funding is provided through the Eunice K. Shriver National Institute for Child Health & Human Development (K99/R00HD and the Fogarty International Center (R21TW009908) SCIP Safer Conception Intervention for Partners

23 Thank you