Introduction Safer conception strategies minimize HIV risk during condomless sex to become pregnant. Gaps remain in understanding the acceptability, feasibility and choices HIV ‐serodiscordant couples make when multiple safer conception options are available. Methods We conducted a pilot study of a comprehensive safer conception package for HIV ‐serodiscordant couples with immediate fertility desires in Kenya from March 2016 to April 2018. The intervention package included antiretroviral therapy ( ART ) for HIV ‐positive partners, oral pre‐exposure prophylaxis (Pr EP ) for HIV ‐negative partners, daily fertility and sexual behaviour tracking via short message service ( SMS ) surveys, counselling on self‐insemination, and referrals for voluntary medical male circumcision and fertility care. Couples attended monthly visits until pregnancy with HIV testing for negative partners at each visit. We estimated the number of expected HIV seroconversions using a counterfactual cohort simulated from gender‐matched couples in the placebo arm of a previous Pr EP clinical trial. We used bootstrap methods to compare expected and observed seroconversions. Results Of the 74 enrolled couples, 54% were HIV ‐negative female/ HIV ‐positive male couples. The 6 and 12‐month cumulative pregnancy rates were 45.3% and 61.9% respectively. In the month preceding pregnancy, 80.9% of HIV ‐positive partners were virally suppressed, 81.4% of HIV ‐negative partners were highly adherent to Pr EP , and SMS surveys indicated potential timing of condomless sex to peak fertility (median of sex acts = 10, interquartile range ( IQR ) 7 to 12; median condomless sex acts = 3.5, IQR 1 to 7). Most (95.7%) pregnancies were protected by ≥2 strategies: 57.4% were protected by high Pr EP and ART adherence, male circumcision with or without timed condomless sex; 10 (21.3%) were protected by viral suppression in the HIV ‐positive partner and male circumcision with or without timed condomless sex; 8 (17.0%) were protected by high Pr EP adherence and male circumcision with or without timed condomless sex. We observed 0 HIV seroconversions (95% CI 0.0 to 6.0 per 100 person years), indicating a 100% reduction in HIV risk ( p = 0.04). Conclus...

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BACKGROUND For HIV-serodiscordant couples, integrated delivery of antiretroviral therapy (ART) for HIV-positive partners and time-limited pre-exposure prophylaxis (PrEP) for negative partners virtually eliminates HIV transmission. Standardized messaging, sensitive to the barriers and motivators to HIV treatment and prevention, is needed for widespread scale-up of this approach. METHODS Within the Partners Demonstration Project, a prospective interventional project among 1,013 serodiscordant couples in Kenya and Uganda, we offered ART to eligible HIV-positive partners and PrEP to HIV-negative partners prior to ART initiation and through the HIV-positive partner’s first six months of ART use. We conducted individual and group discussions with counseling staff to elicit the health communication framework and key messages about ART and PrEP that were delivered to couples. RESULTS Counseling sessions for serodiscordant couples about PrEP and ART included discussions of HIV serodiscordance, PrEP and ART initiation and integrated use, and PrEP discontinuation. ART messages emphasized daily, lifelong use for treatment and prevention, adherence, viral suppression, resistance, side effects, and safety of ART during pregnancy. PrEP messages emphasized daily dosing, time-limited PrEP use until the HIV-positive partner sustained six months of high adherence to ART, adherence, safety during conception, side effects, and other risks for HIV. CONCLUSION Counseling messages for HIV-serodiscordant couples are integral to the delivery of time-limited PrEP as a ‘bridge’ to ART-driven viral suppression. Their incorporation into programmatic scale-up will maximize intervention impact on the global epidemic.

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