Feasibility Archives - Implementation Science at UW

✪ Acceptability and Feasibility of Remote PrEP Visits for Adolescent Girls and Young Women in South Africa

Abstract:

The World Health Organization recommends differentiated service delivery (DSD) models for HIV prevention, including alternatives to clinic-based PrEP services. This study assessed the acceptability and feasibility of remote PrEP delivery—including HIV and pregnancy self-testing, and phone-based adherence counselling—among adolescent girls and young women (AGYW) in Johannesburg. The research was nested within the PrEP SMART trial (2019–2022), which evaluated scalable adherence support strategies for AGYW aged 18–25. During COVID-19 lockdowns, PrEP refills and testing kits were delivered to participants’ homes, and counselling was provided by phone. Using a phenomenological qualitative method, we conducted in-depth interviews with AGYW (n = 14) who had the option to complete remote PrEP visits (accepting or declining), study staff (n = 12), and key informants (n = 10) involved in PrEP programming. Thematic analysis explored experiences of remote delivery, focusing on acceptability and feasibility.

AGYW found remote PrEP visits convenient, empowering, and time-saving. Procedures such as self-testing and phone counselling were generally acceptable, though some expressed anxiety about performing tests incorrectly and concerns over privacy, stigma, and unintentional disclosure of PrEP use at home. About half still preferred clinic-based visits. Staff and key informants recognized benefits, but highlighted challenges related to cost, sustainability, and provider workload. Suggestions for improvement included integrating contraception and partnering with community organizations. In conclusion, remote PrEP delivery is acceptable and feasible for many AGYW but not universally suitable. These findings support the inclusion of remote PrEP options in DSD models, with attention to privacy concerns and support for self-testing in this age group.

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

✪ Targeted social and behavior change communication (SBCC) in a high adolescent pregnancy setting of Bangladesh: a cluster-randomized study protocol engaging key family members

Abstract:

Background

Maternal health service utilization remains low in Bangladesh, while maternal health outcomes are poor and adolescent pregnancy rates are high. In this context, targeted social and behavior change communication (SBCC) can be an effective approach. This targeted SBCC research was participatorily designed in collaboration with Bangladesh local partners and was funded as part of the 2023–27 KOICA Strategic Partnership Program (SPP)- Strengthening Maternal and Neonatal Health System in Rangpur, Bangladesh (No. 2023–0515). The study was informed by implementation and behavior change theories, engaging key family members in the intervention.

Methods

A hybrid effectiveness-implementation type II cluster-randomized study was designed to measure key maternal health service utilization outcomes as well as implementation outcomes. A total of 750 participants classified into four targeted groups-1) adolescent pregnant women, 2) adult pregnant women, 3) husbands and 4) mothers-in-law, will be invited to participate in group-based interactive community courtyard sessions. These 5-month curriculum targeted SBCC sessions cover maternal and newborn health topics such as antenatal care (ANC), safe delivery, postnatal care (PNC), and neonatal care. The primary outcomes include four or more ANC visits, facility delivery, Postnatal Care (PNC) and neonatal care within 48 h after delivery. Secondary outcomes are perceptions on early marriage, maternal health-seeking behaviors, family support, decision making, and satisfaction with the information gained from the targeted SBCC sessions. To assess the effectiveness, baseline and endline surveys, along with endline focus group discussions (FGDs) will be conducted before and after the 5-month curriculum. Additionally, implementation outcomes such as adoption, penetration, acceptability, coverage, feasibility, fidelity, and sustainability will be measured.

Discussion

This study engages key decision-makers such as pregnant women, their husbands, and mothers-in-law, to enhance maternal health service utilization. As Bangladesh is a patriarchal society, men within households are often the primary decision-makers regarding marriage and reproductive matters. Moreover, the child marriage and adolescent pregnancy rates remain high, contributing to persistently elevated maternal and neonatal mortality. By applying implementation science frameworks and behavior change theories, this study aims to generate evidence to inform future scale-up efforts in similar contexts.

Trial registration

The protocol was registered with ISRCTN registry under registration ISRCTN12515877.

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

✪ Feasibility and Implementation of INTERVAL-GAP4: A Global Randomised Controlled Trial of Intense Hybrid-supervised/Self-managed Versus Self-directed Exercise for Metastatic Prostate Cancer

Authors:

Stacey A Kenfield, Nicolas H Hart, Kerry S Courneya, Rosemary Greenwood , June M Chan, Jennette Sison, Li Zhang, Sarah RudmaN, Leah Ung, Moritz Schumann, Erin L Van Blarigan, Sam McKeown, Charles J Ryan, James Catto, Daniel A Galvão, Robert U Newton, Fred Saad; INTERVAL-GAP4 Site Investigators and INTERVAL-GAP4 Steering and Management Committees (Stephen R. Plymate, Committee Member

^{University of Washington affiliated authors are displayed in bold.}

✪ Open Access

Published: December 2025

Read the full text in the open access journal European Urology Open Science

Abstract:

Background and objective

Physical activity is associated with a lower risk of mortality in men with prostate cancer (PC); yet, randomised controlled trials with survival endpoints are nonexistent. INTense ExeRcise for surviVAL-Global Action Plan 4 (INTERVAL-GAP4) was a global phase 3 trial designed to test whether structured, hybrid-supervised/self-managed exercise improves survival in men with metastatic PC. The trial was stopped early due to poor accrual. This paper reports feasibility and implementation outcomes.

Methods

Men with metastatic PC were randomised (1:1) to a supervised/self-managed moderate- to high-intensity resistance and aerobic programme (three sessions per week for 2 yr) or to self-directed exercise. We evaluated site activation, recruitment, year 1 adherence, adverse events, and barriers to global trial feasibility. Efficacy outcomes—including survival, physical fitness, and biomarker results—will be reported separately.

Key findings and limitations

Of 21 activated sites across seven countries, 13 (62%) randomised patients. Of 938 patients approached, 232 (25%) consented and 145 (15%) were randomised (75 in the intervention and 70 in the control group) between April 2016 and February 2023. The median age was 70 yr (range: 44–89 yr). The study closed early after reaching 17% of the intended target. The median adherence in the intervention arm was 84% (interquartile range: 61–95%), with no difference between metastatic castrate-resistant and hormone-sensitive PC. At 12 mo, 58% of intervention participants met exercise guidelines versus 24% of controls. In year 1, 162 adverse events occurred in the intervention group and 109 in the control group; 19 adverse events were study related, all in the intervention arm. The major feasibility challenges included administrative burden, infrastructure limitations, logistics of supervised exercise delivery, and coronavirus disease 2019 disruptions.

Conclusions and clinical implications

While high adherence to a demanding exercise programme was achieved in selected metastatic PC patients, global recruitment proved difficult. Future large-scale exercise-oncology trials require streamlined protocols, realistic timelines, and greater alignment with site resources. Implementation science research is needed to support integration of exercise into routine advanced cancer care. A forthcoming paper will present the trial’s survival and physical fitness efficacy outcomes.

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

✪ Strategies to improve healthcare team communication structure and quality in resource-variable childhood cancer hospitals (TeamTalk): a study protocol

Abstract:

Background

Healthcare team communication is essential to high-quality childhood cancer care, especially during high-acuity events such as clinical deterioration and in resource-variable settings, where supportive interventions to resolve deterioration are less available. Communication quality has traditionally been understudied in these settings, and there is a notable lack of communication interventions that are appropriate and feasible in settings across resource levels. We propose addressing this challenge in this study protocol, which will co-develop and pilot a multi-level intervention to improve communication and outcomes for children receiving cancer treatment.

Methods/design

This study leverages systems and implementation science methodologies to evaluate and improve communication quality in the care of hospitalized children with cancer. We will use a newly developed reliable and multilingual measure of communication quality during clinical deterioration (CritCom). In this study, we will: 1) evaluate the relationship between healthcare team communication structures (using social network analysis) and quality (using CritCom) in the care of children with cancer, with a specific focus on the impact of hierarchy and modifiable communication determinants. We will then: 2) co-develop a multilevel intervention to address challenges in communication quality across variably resourced settings, using semi-structured interviews among clinicians working in these settings and intervention mapping with a global expert panel. Finally, we will 3) test the feasibility, acceptability, appropriateness, and preliminary efficacy of this novel intervention using a cluster-randomized wait list control pilot trial in eight resource-variable hospitals providing childhood cancer care with poor team communication quality.

Discussion

This project identifies modifiable determinants of communication before co-developing and testing interventions with clinicians. When completed, this study will produce an evidence-informed, multilevel intervention to improve healthcare team communication during clinical deterioration, advancing the science of team communication during cancer care, and ultimately improving survival for children with cancer.

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

From Tanzania to Washington, DC: Application of the Consolidated Framework for Implementation Research and ADAPT-ITT Model to Guide the Development of a Community-Based PrEP Intervention for Black Adults

Authors:

Waimar Tun, Jennifer Gomez-Berrospi, Samuel Janson, Demarc Hickson, Christian Morris, Julie Pulerwitz, Mamaswatsi Kopeka, Jesse Yao, Rikiyah Mixson, Amanda McHale, Rachel Macey, Christian Buchanan, Bukola Rinola, Naana Koranteng-Yorke, Deanna Kerrigan, Oluwaseun Adebayo Bamodu, Donaldson F. Conserve & BRIDGE Research Team

^{University of Washington affiliated authors are displayed in bold.}

Subscription Required for Full Text Access

Published: October 2025

Read the full text in the subscription access journal AIDS and Behavior

✪ Optimizing healthcare for blood donors at risk of transfusion-transmissible infections: pre-implementation mixed methods protocol

Abstract:

In the Peruvian Amazon, a significant proportion of replacement blood donors test reactive for HIV, HTLV-1/2, and other transfusion-transmissible infections but often receive no subsequent care. Optimizing healthcare for these individuals can mitigate adverse outcomes by enabling early diagnosis and management. Effective coordination between Blood Bank and Infectious Diseases services is essential to provide comprehensive care. To address this challenge, this study applies an Implementation Science approach to design and assess an innovation that enhances healthcare for blood donors affected by transfusion-transmissible infections. A pre-implementation mixed methods study will be conducted at two hospitals in the Peruvian Amazon, employing the Consolidated Framework for Implementation Research (CFIR) and a systems engineering tool (mapping). The study will focus on the inner setting domain of CFIR and map the care continuum to identify contextual determinants that may influence implementation. It has three specific aims planned for the future: first, to use a convergent mixed methods approach to examine the care continuum of blood donors and the inner settings; second, to co-design an innovation through qualitative and participatory methods, integrating Blood Bank and Infectious Diseases services via the hospital information management system; and third, to evaluate the feasibility, appropriateness, and acceptability of the co-designed innovation through a pilot. Replacement blood donation and fragmented healthcare systems are common challenges in other low- and middle-income countries. The findings of this study can inform future implementation research and policy in similar settings.

Paper context

Main findings: This study will co-design and pilot an innovation to improve how blood donors at risk of transfusion-transmissible infections receive screening results, confirmatory testing, and care, by integrating Blood Bank and Infectious Diseases services through digital tools.

Added knowledge: This study employs a participatory, mixed-methods implementation science approach to systematically assess and address gaps in blood donor healthcare, providing a scalable methodology while ensuring context-specific, actionable interventions for resource-limited settings.

Global health impact for policy and action: This study will drive digital innovations in blood donor healthcare to strengthen blood safety and infectious disease control, while framing a pragmatic, adaptable approach for integrating fragmented healthcare systems in resource-limited settings.

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

✪ High acceptability, feasibility and sustainability of a direct-to-pharmacy differentiated PrEP delivery model in public health HIV clinics in Kenya: perspectives of PrEP clients and healthcare providers

Abstract:

Introduction

High client opportunity costs and a burdened healthcare system limit oral pre-exposure prophylaxis (PrEP) delivery in Kenyan public HIV clinics. We conducted a qualitative study among PrEP clients and providers to understand the acceptability, feasibility and willingness to implement a client-centred, differentiated direct-to-pharmacy (DTP) PrEP refill visits intervention aimed at improving the efficiency of PrEP implementation in real-world clinics.

Methods

From March 2021 to March 2022, we conducted in-depth interviews with clients and healthcare providers participating in an individual facility pharmacy-based PrEP delivery model for PrEP refills among clients in the continuation phase at two public HIV clinics in central Kenya. The core components of the DTP model included directed-to-PrEP pharmacy refill visits conducted by facility pharmacy staff and client HIV self-testing (HIVST) while waiting for services at the pharmacy. We used semi-structured interview guides informed by the Consolidated Framework for Implementation Research (CFIR). We analysed data using thematic content analysis and organised findings by CFIR constructs.

Results

We interviewed 20 PrEP clients and 20 healthcare providers. PrEP clients included 15 females and had a median age of 39 years (interquartile range [IQR]: 33–48). Providers included 13 females, had a median age of 32 years (IQR: 30–41), and included 10 HIV counsellors, 5 pharmacy and 3 clinical providers. Both providers and clients reported high satisfaction with DTP PrEP refill visits derived from improved clinic flow and quality of service. Among clients, shorter waiting times and less movement between multiple clinic rooms reduced delays, improved privacy and reduced stigma associated with visiting HIV clinics. Furthermore, shorter waiting times and infrequent clinic visits reduced loss of working hours and income among clients, motivating PrEP continuation. Providers reported improved clinic flow, reduced work burden among non-pharmacy providers, improved knowledge and ease of implementing DTP refill visits. However, providers expressed concerns about the potential loss of roles among HIV counsellors and the shifting of workload burden to pharmacy providers.

Conclusions

Differentiated DTP refill visits with HIVST were highly acceptable and feasible among PrEP clients and providers. Context-specific modifications and scale-up of the intervention could improve the efficiency of PrEP delivery within public HIV clinics in Kenya and similar settings.

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

✪ Evaluating behavioral intervention technologies: Integrating human-centered design and implementation science outcomes

Abstract:

Background

Behavioral intervention technologies (BITs) offer scalable, cost-effective healthcare solutions but often show reduced impacts in community settings and are rarely sustained. Human-centered design (HCD) enhances usability by tailoring BITs to stakeholder needs, while implementation science (IS) identifies contextual barriers and strategies to promote uptake and sustainability. Both HCD and IS aim to improve BIT usability and implementation through iterative, user-focused processes but are rarely integrated.

Objective

We introduced the user-centered and sustainable implementation science (USIS) model, a novel and systematic framework that combines HCD and IS principles to enhance BIT effectiveness and sustainability. We aimed to (1) synthesize the HCD and IS outcomes and integrate them into a USIS framework; (2) apply USIS to a case study: the sleep shared-management intervention for children with juvenile idiopathic arthritis and their parents (SLEEPSMART).

Methods

We conducted a narrative literature review on HCD and IS outcomes for BITs from the PubMed, CINAHL, and Web of Science databases. Articles were selected based on their focus on usability, implementation outcomes, and evidence-based healthcare practices. This synthesis informed the development of the USIS model.

Results

The USIS model incorporates five domains: (1) user-centeredness (empathy, engagement, and equity), (2) efficiency (cost, timeliness, and rapidity), (3) feasibility (learnability, memorability, error reduction, and low cognitive load), (4) satisfaction (acceptability and appropriateness), and (5) fidelity (adoption, penetration, and sustainability). We applied the USIS model to evaluate the SLEEPSMART project to demonstrate the application of the USIS model in guiding BIT design and refinement. Insights from the review informed the design principles applied during the development and testing stages of SLEEPSMART.

Conclusion

The USIS model serves as a practical and theoretical guide to improve BIT design and evaluation. By emphasizing implementation considerations early and centering user needs, USIS provides a pathway to bridge HCD and IS approaches to enhance the real-world impact and sustainability of digital health innovations.

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

✪ Acceptability, feasibility, and factors affecting implementation of a gender-sensitivity training for HIV providers and staff in Uganda: a mixed methods, quasi-experimental controlled pilot trial

Abstract:

Background

Health workers play a critical role in providing gender-sensitive HIV care. However, without adequate training, they may inadvertently reinforce negative gender norms that hinder engagement in care. To improve ART services in sub-Saharan Africa, effective implementation strategies, including trainings, are essential.

Methods

This study evaluated the feasibility and acceptability of a novel 4-session, gender-sensitivity training for HIV health and lay workers in rural and peri-urban Uganda. We conducted a pilot quasi-experimental controlled trial in 2022–23, utilizing data from three sources: process data from 144 providers and 238 clients, qualitative post-intervention focus groups and interviews with 53 training attendees, and stakeholder interviews with 12 community leaders and facilitators. We employed thematic analysis guided by the Consolidated Framework for Implementation Research (CFIR).

Results

The training was highly rated by attendees via brief post-session surveys, with 99% of sessions deemed satisfactory. Qualitative feedback indicated that the sessions were perceived as appropriate for addressing providers’ gaps in delivering gender-sensitive care and as beneficial for participants. High feasibility was evidenced by 100% of intervention steps delivered (fidelity checklists), 86% attendance (attendance logs), and 98.6% and 94.8% recruitment of eligible providers and clients (study records), respectively. Through qualitative exit focus groups, factors that positively affected acceptability and feasibility included tactics to gain support from supervisors, the use of experienced facilitators and active learning approaches, and the consideration of the health system context in delivery (e.g., cadre mix, location). Suggested improvements encompassed addressing interpersonal and structural barriers to client-centered care, incorporating community sensitization, streamlining content, and enhancing mentorship follow-ups. Stakeholders recognized the training’s alignment with national health priorities and emphasized the need for clarity regarding its integration with existing training curricula and ongoing stakeholder engagement.

Conclusions

This study underscores the acceptability and feasibility of a gender-sensitivity training program for HIV providers; further evaluation of the program is warranted. Identified factors influencing implementation can inform enhancements to gender-focused training initiatives to improve the quality of HIV services and enhance client engagement and health outcomes.

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

✪ Integrating behavioral health care into a low-barrier HIV clinic using the Collaborative Care Model: a mixed methods evaluation of patient care cascade outcomes and determinants

Abstract:

Background

Low-barrier HIV care is an evidence-based intervention to improve HIV outcomes among those who have complex barriers to care, but the walk-in model poses challenges to integrating behavioral health services. We evaluated the acceptability and feasibility of a Collaborative Care Model (CoCM) for treatment of depression and opioid use disorder in a low-barrier clinic.

Methods

In a sequential explanatory mixed methods pilot study, we accessed data from patient records to generate a care cascade for the number of patients enrolled in the first six months of the program and conducted individual interviews with patients and staff to interpret the care cascade findings.

Results

Among 175 patients who visited the clinic, 36% were screened for, 24% were referred to, 15% completed an intake for, and 9% engaged in CoCM. The interviews revealed that screening was limited by a lack of clarity among staff about services offered in CoCM, staff forgetting the screening process, and limited time during patent visits. Referrals were limited by low buy-in among staff and patient complexity. Intakes were limited by time and space constraints in the care setting and competing acute patient needs. The care manager’s ability to embody the clinic’s culture facilitated engagement among patients who completed intakes.

Conclusions

Staff perceived CoCM to be acceptable and feasible to implement, but only in the context of multiple barriers to implementation and challenges to systematic screening and measurement-based care.

Trial registration

Not applicable.

Contributions to the literature

We evaluated implementation of the Collaborative Care Model, an evidence-based model for integrating behavioral healthcare into primary care settings, for treating depression and opioid-use disorder in a low-barrier HIV clinic. To our knowledge, this is the first implementation of the Collaborative Care Model in a low-barrier HIV clinic.
By specifying a multi-component implementation strategy, our evaluation provides a foundation for selecting and tailoring implementation strategies for use with integrated behavioral healthcare interventions.
Through use of a joint visual display showing a care cascade with illustrative quotes, our evaluation demonstrates a novel approach to using explanatory mixed methods in implementation science.

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

Authors:

✪ Open Access

Read the full text in the open access journal AIDS and Behavior

Abstract:

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration

Authors:

✪ Open Access

Read the full text in the open access journal European Urology Open Science

Abstract:

Background and objective

Methods

Key findings and limitations

Conclusions and clinical implications

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science Communication

Abstract:

Background

Methods/design

Discussion

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal AIDS and Behavior

Authors:

✪ Open Access

Read the full text in the open access journal Global Health Action

Abstract:

Paper context

Authors:

✪ Open Access

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

Abstract:

Introduction

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal Digital Health

Abstract:

Background

Objective

Methods

Results

Conclusion

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Contributions to the literature