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✪ Real-world impact of integrating HIV assisted partner services into 31 facilities in Kenya: a single-arm, hybrid type 2 implementation-effectiveness study

Authors:

Monisha Sharma, Brienna Naughton, Harison Lagat, George Otieno, David A Katz, Beatrice M Wamuti, Sarah Masyuko, Rose Bosire, Mary Mugambi, Unmesha Roy Paladhi, Bryan J Weiner, Edward Kariithi & Carey Farquhar

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2023

Read the full text in the open access journal The Lancet Global Health

Abstract:

Background

Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of individuals diagnosed with HIV (index clients), have been shown to be safe and effective in clinical trials. We assessed the real-world effectiveness of APS when integrated into HIV clinics in western Kenya.

Methods

In this single-arm, hybrid type 2 implementation science study, we facilitated APS implementation in 31 health facilities in Kenya by training existing health-care staff. We focused on male partner outcomes to assess the impact of APS in reaching male individuals in sub-Saharan Africa, who have lower rates of HIV testing than female individuals. Female individuals (aged ≥18 years or emancipated minor) who tested positive for HIV at participating facilities in Kenya were offered APS; consenting female participants provided contact information for all male sexual partners in the past 3 years. Male partners were notified of their potential HIV exposure and offered a choice of community-based or facility-based HIV testing services (HTS). Female index clients and male partners with HIV were followed up at 6 weeks, 6 months, and 12 months after enrolment, to assess linkage to antiretroviral treatment. Viral load was assessed at 12 months.

Findings

Between May 1, 2018, and March 31, 2020, 32 722 female individuals received HTS; 1910 (6%) tested positive for HIV, of whom 1724 (90%) received APS. Female index clients named 5137 male partners (median 3 per index [IQR 2–4]), of whom 4422 (86%) were reached with exposure notification and HTS. 524 (12%) of the male partners tested were newly diagnosed with HIV and 1292 (29%) reported a previous HIV diagnosis. At 12 months follow-up, 1512 (88%) female index clients and 1621 (89%) male partners with HIV were taking ART, with few adverse events: 25 (2%) female index clients and seven (<1%) male partners reported intimate partner violence, and 60 (3%) female index clients and ten (<1%) male partners reported relationship dissolution.

Interpretation

Evidence from this real-world APS scale-up project shows that APS is a safe, acceptable, and effective strategy to identify males with HIV and retain them in care.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Advancing Adolescent HIV Prevention and Care Through Implementation Science: An Agenda for Combating the Global AIDS Epidemic in Sub-Saharan Africa

Authors:

Eric Goosby, Judith N Wasserheit, Roger Glass & Peter Kilmarx

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal Prevention Science

Abstract:

AIDS continues to be a major driver of adolescent mortality in Sub-Saharan Africa. Despite evidence of efficacy in this population, many efforts to address adolescent HIV have had limited impact across the region because of difficulty with implementation. The field of implementation science holds promise for addressing these challenges. The Fogarty-led Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) creates a platform for bidirectional learning between researchers and the users of research evidence that promotes the use of implementation science to strengthen adolescent HIV prevention and care across Africa. The unique contributions of AHISA are reflected in this supplement’s articles which represent the collective learning of the Alliance; illustrate the value of implementation science in the context of adolescent HIV; and identify critical research gaps that should be addressed by implementation science in the future.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Implementing Mailed Colorectal Cancer Fecal Screening Tests in Real-World Primary Care Settings: Promising Implementation Practices and Opportunities for Improvement

Authors:

Sarah D. Hohl, Annette E. Maxwell, Krishna P. Sharma, Juzhong Sun, Thuy T. Vu, Amy DeGroff, Cam Escoffery, Dara Schlueter & Peggy A. Hannon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal Prevention Science

Abstract:

Colorectal cancer (CRC) screening reduces morbidity and mortality, but screening rates in the USA remain suboptimal. The Colorectal Cancer Control Program (CRCCP) was established in 2009 to increase screening among groups disproportionately affected. The CRCCP utilizes implementation science to support health system change as a strategy to reduce disparities in CRC screening by directing resources to primary care clinics to implement evidence-based interventions (EBIs) proven to increase CRC screening. As COVID-19 continues to impede in-person healthcare visits and compel the unpredictable redirection of clinic priorities, understanding clinics’ adoption and implementation of EBIs into routine care is crucial. Mailed fecal testing is an evidence-based screening approach that offers an alternative to in-person screening tests and represents a promising approach to reduce CRC screening disparities. However, little is known about how mailed fecal testing is implemented in real-world settings. In this retrospective, cross-sectional analysis, we assessed practices around mailed fecal testing implementation in 185 clinics across 62 US health systems. We sought to (1) determine whether clinics that do and do not implement mailed fecal testing differ with respect to characteristics (e.g., type, location, and proportion of uninsured patients) and (2) identify implementation practices among clinics that offer mailed fecal testing. Our findings revealed that over half (58%) of clinics implemented mailed fecal testing. These clinics were more likely to have a CRC screening policy than clinics that did not implement mailed fecal testing (p = 0.007) and to serve a larger patient population (p = 0.004), but less likely to have a large proportion of uninsured patients (p = 0.01). Clinics that implemented mailed fecal testing offered it in combination with EBIs, including patient reminders (92%), provider reminders (94%), and other activities to reduce structural barriers (95%). However, fewer clinics reported having the leadership support (58%) or funding stability (29%) to sustain mailed fecal testing. Mailed fecal testing was widely implemented alongside other EBIs in primary care clinics participating in the CRCCP, but multiple opportunities for enhancing its implementation exist. These include increasing the proportion of community health centers/federally qualified health centers offering mailed screening; increasing the proportion that provide pre-paid return mail supplies with the screening kit; increasing the proportion of clinics monitoring both screening kit distribution and return; ensuring patients with abnormal tests can obtain colonoscopy; and increasing sustainability planning and support.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Optimizing naloxone distribution to prevent opioid overdose fatalities: results from piloting the Systems Analysis and Improvement Approach within syringe service programs

Authors:

Sheila V. Patel, Lynn D. Wenger, Alex H. Kral, Kenneth Sherr, Anjuli D. Wagner, Peter J. Davidson & Barrot H. Lambdin

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

Opioid overdose fatalities are preventable with timely administration of naloxone, an opioid antagonist, during an opioid overdose event. Syringe service programs have pioneered naloxone distribution for potential bystanders of opioid overdose. The objective of this study was to pilot test a multi-component implementation strategy—the systems analysis and improvement approach for naloxone (SAIA-Naloxone)—with the goal of improving naloxone distribution by syringe service programs.

Methods

Two syringe service programs participated in a 6-month pilot of SAIA-Naloxone, which included (1) analyzing program data to identify gaps in the naloxone delivery cascade, (2) flow mapping to identify causes of attrition and brainstorm programmatic changes for improvement, and (3) conducting continuous quality improvement to test and assess whether modifications improve the cascade. We conducted an interrupted time series analysis using 52 weeks of data before and 26 weeks of data after initiating SAIA-Naloxone. Poisson regression was used to evaluate the association between SAIA-Naloxone and the weekly number of participants receiving naloxone and number of naloxone doses distributed.

Results

Over the course of the study, 11,107 doses of naloxone were distributed to 6,071 participants. Through SAIA-Naloxone, syringe service programs prioritized testing programmatic modifications to improve data collection procedures, proactively screen and identify naloxone-naïve participants, streamline naloxone refill systems, and allow for secondary naloxone distribution. SAIA-Naloxone was associated with statistically significant increases in the average number of people receiving naloxone per week (37% more SPP participants; 95% CI, 12% to 67%) and average number of naloxone doses distributed per week (105% more naloxone doses; 95% CI, 79% to 136%) beyond the underlying pre-SAIA-Naloxone levels. These initial increases were extended by ongoing positive changes over time (1.6% more SSP participants received naloxone and 0.3% more naloxone doses were distributed in each subsequent week compared to the weekly trend in the pre-SAIA Naloxone period).

Conclusions

SAIA-Naloxone has strong potential for improving naloxone distribution from syringe service programs. These findings are encouraging in the face of the worsening opioid overdose crisis in the United States and support testing SAIA-Naloxone in a large-scale randomized trial within syringe service programs.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Applying and reporting relevance, richness and rigour in realist evidence appraisals: Advancing key concepts in realist reviews

Authors:

Sara Dada, Sonia Dalkin, Brynne Gilmore, Rebecca Hunter & Ferdinand C Mukumbang

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal Research Synthesis Methods

Abstract:

The realist review/synthesis has become an increasingly prominent methodological approach to evidence synthesis that can inform policy and practice. While there are publication standards and guidelines for the conduct of realist reviews, published reviews often provide minimal detail regarding how they have conducted some methodological steps. This includes selecting and appraising evidence sources, which are often considered for their ‘relevance, richness and rigour.’ In contrast to other review approaches, for example, narrative reviews and meta-analyses, the inclusion criteria and appraisal of evidence within realist reviews depend less on the study's methodological quality and more on its contribution to our understanding of generative causation, uncovered through the process of retroductive theorising. This research brief aims to discuss the current challenges and practices for appraising documents' relevance, richness and rigour and to provide pragmatic suggestions for how realist reviewers can put this into practice.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study

Authors:

Catherine Kiptinness, Paulami Naik, Nicholas Thuo, Rachel C. Malen, Julia C. Dettinger, Jillian Pintye, Maeve Rafferty, Edwin Jomo, Nicky Nyamasyo, Tony Wood, Paul Isabelli, Sarah Morris, David Hattery, Andy Stergachis, Daniel Were, Monisha Sharma, Kenneth Ngure, Melissa Latigo Mugambi, and Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

Read the full text in the open access journal Frontiers in Public Health

Abstract:

Background

Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model.

Methods

The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs).

Discussion

Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data

Authors:

Hilma N. Nakambale, Stephanie D. Roche, Peter Mogere, Victor Omollo, Alexandra P. Kuo, Andy Stergachis, Jared M. Baeten, Elizabeth Bukusi, Kenneth Ngure, Melissa Latigo Mugambi & Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

Read the full text in the open access journal Frontiers in Reproductive Health

Abstract:

Background

For individuals who face challenges accessing clinic-based HIV pre-exposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers.

Methods

We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR).

Results

From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacy-delivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff.

Conclusion

Our study provides insight into early barriers to implementing pharmacy-delivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Risk-based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019

Authors:

John Kinuthia, Julia C. Dettinger, Joshua Stern, Nancy Ngumbau, Ben Ochieng, Laurén Gómez, Felix Abuna, Salphine Watoyi, Mary Marwa, Daniel Odinga, Anjuli D. Wagner, Barbra A. Richardson, Jillian Pintye, Jared M. Baeten & Grace John-Stewart

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

Read the full text in the open access journal Journal of the International AIDS Society

Abstract:

Introduction

Integrating pre-exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk-guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP.

Methods

The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self-selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk-scoring tool and an offer of HIV self-tests for at-home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention-to-treat analyses, adjusting for baseline HIV risk and marital status.

Results

Among 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person-years (p-yr) of follow-up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p-yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p-yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]).

Conclusions

Given comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Phased Implementation of COVID-19 Vaccination: Rapid Assessment of Policy Adoption, Reach and Effectiveness to Protect the Most Vulnerable in the US

Authors:

Yun Li, Moming Li, Megan Rice, Yanfang Su, and Chaowei Yang

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2021

Read the full text in the open access International Journal of Environmental Research and Public Health

Abstract:

The US and the rest of the world have suffered from the COVID-19 pandemic for over a year. The high transmissibility and severity of this virus have provoked governments to adopt a variety of mitigation strategies. Some of these previous measures, such as social distancing and mask mandates, were effective in reducing the case growth rate yet became economically and administratively difficult to enforce as the pandemic continued. In late December 2020, COVID-19 vaccines were first approved in the US and states began a phased implementation of COVID-19 vaccination. However, there is limited quantitative evidence regarding the effectiveness of the phased COVID-19 vaccination. This study aims to provide a rapid assessment of the adoption, reach, and effectiveness of the phased implementation of COVID-19 vaccination. We utilize an event-study analysis to evaluate the effect of vaccination on the state-level daily COVID-19 case growth rate. Through this analysis, we assert that vaccination was effective in reducing the spread of COVID-19 shortly after the first shots were given. Specifically, the case growth rate declined by 0.124, 0.347, 0.345, 0.464, 0.490, and 0.756 percentage points corresponding to the 1–5, 6–10, 11–15, 16–20, 21–25, and 26 or more day periods after the initial shots. The findings could be insightful for policymakers as they work to optimize vaccine distribution in later phases, and also for the public as the COVID-19 related health risk is a contentious issue.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study

Authors:

Craig S. Rosen
C. Adrian Davis, David Riggs, Jeffery Cook, Alan L. Peterson, Stacey Young-McCaughan, Katherine Anne Comtois, Christopher K. Haddock, Elisa V. Borah, Katherine A. Dondanville, Erin P. Finley, Sara A. Jahnke, Walker S.C. Poston, Shannon Wiltsey-Stirman, Andrea Neitzer, Capt Rachel Broussard, MAJ Amy Brzuchalski, Maj Spencer P. Clayton, LT Allison M. Conforte, Araceli Flores, Jessica Hein, Capt Felicia Keith, Capt Jeremy Jinkerson, Margaret Letendre, Debra Nofziger, Kirsten Pollick, Capt Kyra Santiago, Lt Col John Waggoner, Craig Woodworth, and Carmen P. McLean for the STRONG STAR Consortium andthe TACTICS Research Group

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: April 2020

Read the full text in the subscription access journal Contemporary Clinical Trials