Introduction Sustained HIV viral suppression resulting from antiretroviral therapy (ART) eliminates the risk of HIV transmission, a concept popularly framed as Undetectable = Untransmittable (U = U). We explored knowledge and acceptance of information around the elimination of HIV transmission risk with ART (U = U) in Kenya. Methods Our qualitative study was conducted within a project evaluating the use of pre‐exposure prophylaxis (PrEP) integrated into ART care for HIV serodiscordant couples in public clinics in Kenya (the Partners Scale Up Project). From February 2017 to April 2019, we conducted semi‐structured key informant interviews with 83 health providers and in‐depth interviews with 61 HIV‐negative people in serodiscordant relationships receiving PrEP services. Transcripts were coded using thematic analysis. Results Health providers reported being aware of reduced risk of HIV transmission as a result of consistent ART use and used words such as “very low,” “minimal” and “like zero” to describe HIV transmission risk after viral suppression. Providers reported finding viral load results helpful when counselling clients about the risk of HIV transmission. Many lacked confidence in U = U and counselled on consistent condom use even after viral suppression while some expressed concerns that communicating this message to people living with HIV (PLHIV) would lead them to engage in multiple sexual relationships. Other providers reported that they did not counsel about the reduced risk of HIV transmission after viral suppression for fear of being blamed if HIV transmission occurred. HIV‐negative partners reported being informed about U = U by providers but they did not believe nor trust the message. Even after their partners achieved viral suppression, some HIV‐negative partners were unwilling to stop PrEP, while others indicated that they would use condoms if they stopped PrEP to be sure that they were protected from HIV. Conclusions Despite awareness that effective ART use eliminates HIV transmission risk, there is both a lack of in‐depth knowledge and conviction about the strategy among health providers and HIV‐negative partners in serodiscordant relationships. New strategies that go beyond communicating the science of U = U to consider the local social and clinical environments could maximize the effectiveness of U = U.

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BackgroundAntiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.MethodsThe Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods.DiscussionCost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration.Trial registrationRegistered with ClinicalTrials.gov on February 14, 2017:NCT03052010.

Background: Preexposure prophylaxis (PrEP) discontinuation rates in clinical trials and demonstration projects have been well characterized; however, little is known about discontinuation in routine public health settings in sub-Saharan Africa. Understanding discontinuation in nonstudy settings is important for establishing expectations for PrEP continuation in national programs and for facilitating effective PrEP scale-up. Methods:We conducted in-depth interviews with 46 individuals who had initiated PrEP at 25 HIV comprehensive care clinics (CCCs) in central and western Kenya and whose clinic records indicated they had discontinued.Results: Many of our study participants discontinued PrEP when their perceived risk decreased (eg, hiatus or end of a sexual relationship or partner known to be living with HIV became virally suppressed). Others reported discontinuation due to side effects, daily pill burden, preference for condoms, or their partner's insistence. Participant narratives frequently described facility level factors such as stigma-related discomforts with accessing PrEP at CCCs, inconvenient clinic location or operating hours, long wait times, and short refill dates as discouraging factors, suggesting actionable areas for improving PrEP access and continuation. Conclusion:Clients frequently make intentional decisions to discontinue PrEP as they weigh different prevention options within the context of complex lives. Many clients will decide to discontinue PrEP when perceiving themselves to be at reduced risk and PrEP counseling must include provisions for addressing seasons of risk. PrEP will not be the right prevention method for everyone, or forever. Expanding PrEP access points and increasing sex-positive messaging may facilitate PrEP being a better option for many.

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