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Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program.Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128.From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses.Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV.National Institute of Mental Health (R01MH110296).

Background: Adolescent girls and young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including provision of pre-exposure prophylaxis (PrEP). Anchoring PrEP delivery to care settings like family planning (FP) services that women already access routinely may offer an efficient platform to reach HIV at-risk women. However, context-specific implementation science evaluation is needed.Methods: The Family Planning Plus Project is a prospective, pragmatic implementation evaluation, designed as a stepped wedge, cluster randomized trial, at 12 clinics in Kenya. In collaboration with the Kenya Ministry of Health and Kisumu County Department of Health, we will introduce integration of HIV risk screening and PrEP delivery in public health FP clinics. The core multifaceted implementation strategies to integrate PrEP in FP clinics will include: 1) PrEP delivery by existing FP clinic staff; 2) health provider training; 3) PrEP technical assistance to coach and mentor providers; 4) joint supervision with Kisumu County health officials; and 5) stakeholder engagement. All core components of PrEP delivery– including screening for HIV risk, HIV testing, dispensing, adherence and risk reduction counseling, assessment of side effects, and provision of refills, or safety assessment– will be conducted by existing FP clinic staff as part of a standard care service package. The goal is to catalyze sustainable scale-up within existing infrastructures beyond the project. We will rigorously evaluate implementation outcomes and impact, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and we will use Organizational Readiness for Implementing Change (ORIC) and the Consolidated Framework for Implementation Science Research (CFIR) to assess readiness to implement and contextual enablers and barriers of implementation, including how clinics innovate efficient delivery systems.Discussion: Anchoring PrEP delivery to existing FP systems and staffing has tremendous potential to address barriers that women face in accessing HIV prevention and PrEP care, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. The FP Plus Project will initiate preparation for full-scale and sustainable model of integration of comprehensive HIV prevention services, including PrEP implementation, in public health FP clinics in low-income settings. Trial registration: Registered with ClinicalTrials.gov on December 14, 2020: NCT04666792.

Introduction Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy and is recommended for populations at risk of HIV, including adolescent girls and young women (AGYW) in HIV endemic settings. However, PrEP continuation and high adherence remain challenges to its impact. Existing PrEP adherence interventions can be time- and cost-intensive. Widescale PrEP delivery will require the identification of layered PrEP support strategies for AGYW with diverse prevention needs. We describe the design of a sequential multiple assignment randomized trial (SMART) to evaluate a PrEP adherence support model using scalable, stepped interventions in AGYW in South Africa. Methods “PrEP SMART” is a randomized trial in Johannesburg, South Africa, enrolling AGYW who are between 18 and 25 years of age, sexually active, newly initiating PrEP, and have regular access to a mobile phone. Participants are randomized 1:1 to standard-of-care PrEP counseling with either two-way SMS or WhatsApp group adherence support. Adherence is assessed at three months using tenofovir diphosphate (TFV-DP) levels from dried blood spots collected at month 2 to categorize participants as “responders” (TFV-DP ≥500 fmol/punch) or “non-responders” (TFV-DP Trial registration ClinicalTrials.gov, NCT04038060. Registered on 30 July 2019.

Background Reduction of healthcare-associated infections (HAIs) is critical to improve patient safety and hospital quality. However, not all HAI-associated outcomes are well studied. We examined several of these—the financial and length of stay (LOS) burden of HAIs and patient experience of care. Methods National Healthcare Safety Network-reported catheter-associated urinary tract infections (CAUTI), C. difficile infections (CDI), central line-associated bloodstream infections (CLABSI), MRSA bacteremia, and colon surgery surgical site infections (SSI-COLO) were queried for the first 9 months of 2016 from 43 hospitals. Patients with an HAI were matched to controls on hospital and primary diagnosis to create a retrospective case–control study. CAUTI and CLABSI patients were matched to controls with associated device codes. LOS and total direct variable cost (TDVC) were collected for all HAI and control patients. If patients returned a Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, their likelihood to recommend (LTR) response was additionally analyzed. Results Data were analyzed for 123 CAUTI, 1,116 CDI, 166 CLABSI, 58 MRSA, and 127 SSI-COLO case–control pairs across 43 hospitals. TDVC per case was significantly higher among HAI cases than controls for CDI ($6,484), CLABSI ($14,646), and SSI-COLO ($9,770; figure 1). LOS was significantly higher for cases across all HAI groups, with attributable differences of 7.6 days for CAUTI, 6.4 for CDI, 9.7 for CLABSI, 7.4 for MRSA, and 4.5 for SSI-COLO (Figure 2). Of 3,180 subjects, 198 returned HCAHPS surveys. Response rate of “Yes, definitely” to LTR for 85 HAI patients was 63.5% compared with 72.6% for 113 control patients (Figure 3). Conclusion This is the first investigation to our knowledge pairing patient experience of care data with TDVC and LOS for HAI patients. HAIs have a significant impact on patient experience, cost, and length of stay―further supporting the importance of preventing HAIs. Disclosures R. Olmsted, Ethicon, Inc.: Speaker’s Bureau, Speaker honorarium; APIC: External faculty HRET/CDC STRIVE project, Speaker honorarium.