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

Authors:

Makhosazane Nomhle Ndimande-Khoza, Jennifer Velloza, Hlukelo Chauke, Lisa Mills, Nicole Poovan, Nontokozo Ndlovu, Tessa Concepcion, Sybil Hosek, Connie Celum, & Sinead Delany-Moretlwe

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2026

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

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**

✪ Increasing access without compromising quality: optimizing telemedicine care in pediatric rheumatology

Authors:

S Jones, M Toth, A B Liu, E M Morgan, J Leal, Y I Goh & K Hayward

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2025

Read the full text in the open access journal Frontiers in Pediatrics

Abstract:

Juvenile idiopathic arthritis (JIA) is a chronic immune-mediated condition affecting approximately 1 in 1,000 children in the United States. Without appropriate treatment, JIA can lead to permanent disability, chronic pain, and impaired quality of life. Targeted treatment strategies have enabled some patients to achieve sustained inactive disease and improved outcomes. However, the ongoing workforce shortage of pediatric rheumatologists poses a barrier to accessing effective care for many patients and families. Telemedicine is a potential solution to improving access to care for patients who travel significant distances to obtain pediatric rheumatology healthcare. During the COVID-19 pandemic, telemedicine saw rapid adoption with exponential uptake in use during unprecedented circumstances and resulted in inconsistent implementation of this emerging healthcare modality. While virtual visits offer many benefits, they often fail in gathering critical data elements required for measuring and tracking health outcomes, engaging in data-driven shared decision making, population health management and secondary research. In response to these challenges, the Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN) Digital Health Workgroup conducted a needs assessment among its members to identify opportunities and barriers for optimizing telemedicine visits for patients with JIA. Based on this assessment, potential interventions and instructional materials were developed and compiled into a “change package” to assist rheumatology teams in planning, implementing and evaluating improvements to telemedicine visits at their centers. This change package is publicly available on the PR-COIN website for adoption and use (https://www.pr-coin.org/center-tools-resources). Continuous evaluation and adaptation of these tools are essential as telemedicine practices continue to evolve.

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

✪ Finding the balance between rigour and relevance: implementing adaptations to the implementation of a pragmatic randomised controlled trial of a two-way texting intervention for voluntary medical male circumcision in South Africa

Authors:

Geoffrey Setswe, Sarah Day, Felex Ndebele, Jacqueline Pienaar, Vuyolwethu Ncube, & Caryl Feldacker

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2025

Read the full text in the open access journal BMJ Open

Abstract:

Objectives

To document adaptations that were made to the implementation of the two-way texting (2wT) randomised controlled trial (RCT) for voluntary medical male circumcision (VMMC) in South Africa and to provide a nuanced discussion on the differences between adaptations and fidelity in this context.

Design

We conducted a qualitative study using the Framework for Reporting Adaptations and Modifications in Evidence-based Implementation Strategies (FRAME-IS) to examine 2wT adaptations. We reported adaptations to the 2wT intervention using two steps. First, we categorised adaptations in a shared study-specific Google Docs that documented participant engagement with the 2wT system, tracked daily RCT implementation notes, reported software bugs and noted reminder emails about adaptations for the research team. Second, we conducted a qualitative assessment of the influence of adaptations on project outcomes via 10 periodic reflection meetings with VMMC implementers. Reflection documentation included notes from field observations, meeting minutes and informal partner check-ins to complete adaptation documentation. Using the FRAME-IS as a codebook, adaptations were categorised.

Settings

The RCT was conducted in rural and urban VMMC clinics in the North West and Gauteng districts of South Africa.

Participants

Implementation scientists and VMMC implementers who implemented the 2wT pragmatic randomised controlled trial (pRCT) were participants for the adaptation study.

Primary and secondary outcome measures

The primary outcome measure was the adaptations that were made during the implementation of the 2wT pRCT. The secondary outcome measures were fidelity and rigour of implementing adaptations to the 2wT pRCT.

Results

Between June 2021 and February 2022, 13 adaptations were identified in three phases during the implementation of the 2wT pRCT. The first phase of adaptations aimed to augment study recruitment, including conducting weekend VMMC recruitment camps, using mobile outreach services in the rural site, adding two urban sites to increase recruitment, using weekly WhatsApp calls for updates with all implementing teams, using virtual meetings to implement the 2wT strategy remotely during COVID-19 restrictions and allocating one clinician to work outside of normal working hours. The second phase of adaptations further enhanced enrolments, including adding two local language translations in the usability survey for 2wT men and contributing a portion towards the salary of the implementing staff by the research partner. The third phase included the exclusion of two rural clinics as recruitment sites due to inconsistent mobile phone networks, adding another layer of data quality checks to ensure data quality, training non-clinical counsellors to help with enrolling clients, retraining of staff in the rural site with high staff turnover and using both primary and alternative phone numbers for enrolment to reduce loss to follow-up.

Conclusions

This study made adaptations to the 2wT pRCT without compromising the fidelity of the study. The 2wT pRCT balances rigour (fidelity) and relevance (adaptation). Adaptations should not be confined by rigour but should also not go unchallenged or unverified. We conclude that fidelity can be maintained with adaptations that are implemented to close the gap between research in the laboratory and practice.

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

✪ School-Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: Development and Usability Study of a Virtual Intervention With Multisystem Community Partners

Authors:

Christine A March, Elissa Naame, Ingrid Libman, Chelsea N Proulx, Linda Siminerio, Elizabeth Miller, & Aaron R Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2025

Read the full text in the open access journal JMIR Diabetes

Abstract:

Background

School-partnered interventions may improve health outcomes for children with type 1 diabetes, though there is limited evidence to support their effectiveness and sustainability. Family, school, or health system factors may interfere with intervention usability and implementation.

Objective

To identify and address potential implementation barriers during intervention development, we combined methods in user-centered design and implementation science to adapt an evidence-based psychosocial intervention, the collaborative care model, to a virtual school-partnered collaborative care (SPACE) model for type 1 diabetes between schools and diabetes medical teams.

Methods

We recruited patient, family, school, and health system partners (n=20) to cocreate SPACE through iterative, web-based design sessions using a digital whiteboard (phase 1). User-centered design methods included independent and group activities for idea generation, visual voting, and structured critique of the evolving SPACE prototype. In phase 2, the prototype was evaluated with the usability evaluation for evidence-based psychosocial interventions methods. School nurses reviewed the prototype and tasks in cognitive walkthroughs and completed the Intervention Usability Scale (IUS). Two members of the research team independently identified and prioritized (1-3 rating) discrete usability concerns. We evaluated the relationship between prioritization and the percentage of nurses reporting each usability issue with Spearman correlation. Differences in IUS scores by school nurse characteristics were assessed with ANOVA.

Results

In the design phase, the partners generated over 90 unique ideas for SPACE, prioritizing elements pertaining to intervention adaptability, team-based communication, and multidimensional outcome tracking. Following three iterations of prototype development, cognitive walkthroughs were completed with 10 school nurses (n=10, 100% female; mean age 48.5, SD 9.5 years) representing different districts and years of experience. Nurses identified 16 discrete usability issues (each reported by 10%-60% of participants). Two issues receiving the highest priority (3.0): ability to access a virtual platform (n=3, 30% of participants) and data-sharing mechanisms between nurses and providers (n=6, 60% of participants). There was a moderate correlation between priority rating and the percentage of nurses reporting each issue (ρ=0.63; P=.01). Average IUS ratings (77.8, SD 11.1; 100-point scale) indicated appropriate usability. There was no difference in IUS ratings by school nurse experience (P=.54), student caseload (P=.12), number of schools covered (P=.90), or prior experience with type 1 diabetes (P=.83), suggesting that other factors may influence usability. The design team recommended strategies for SPACE implementation to overcome high-priority issues, including training users on videoconferencing applications, establishing secure forms for school data reporting, and sharing glucose data in real-time during SPACE meetings.

Conclusions

Cross-sector interventions are complex, and perceived usability is a potential barrier to implementation. Using web-based cocreation methods with community partners promoted high-quality intervention design that is aligned with end-user priorities. Quantitative and qualitative assessments indicated appropriate degree of usability to move forward with pilot-testing.

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

How to integrate and leverage digital health modalities for health promotion in early childhood education: Opportunities to improve intervention access and engagement

Authors:

Chelsea L Kracht, Alison Tovar, Kim M Gans, Rebecca E Lee, Pooja S Tandon, Tayla von Ash, & Lucine Francis

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: March 2025

Read the full text in the subscription access journal Translational Behavioral Medicine

✪ A framework for designing hybrid effectiveness-implementation trials for digital health interventions

Authors:

Theresa E. Matson, Eric D.A. Hermes, Aaron R. Lyon, Andrew Quanbeck, Stephen M. Schueller, Sarah M. Wilson, and Joseph E. Glass

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2025

Read the full text open access in the journal Annals of Epidemiology

Abstract:

This article proposes methods for designing randomized controlled trials studying the implementation and effectiveness of digital interventions, meaning websites or applications ("apps") that patients use in healthcare. Deploying digital interventions for behavioral health differs from implementing traditional interventions such as medications or human-delivered therapy. Prior trial design guidance has ignored the existence of international governmental evidence standards, has paid insufficient attention to implementation reporting guidelines, and has not described methods for empirically testing the approach for organizing the delivery of digital interventions.

This framework for designing hybrid effectiveness-implementation trials of digital behavioral health interventions helps researchers articulate research questions that matter to decision-makers and meaningfully contribute to implementation. The framework outlines three phases: 1) frame effectiveness and implementation questions in terms of the digital intervention components, types of clinical support for the digital intervention, and specific strategies for implementing the digital intervention; 2) define and delineate actors, activities, action targets, dose, temporality, and outcomes to maximize inference and reproducibility; and 3) specify trial design features used for hybrid classification.

We illustrate the utility of this framework with two effectiveness-implementation studies of digital interventions for substance use. This framework can help researchers decide on appropriate methodology and help decision-makers apply findings.

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

Pilot Testing a Digital Transdiagnostic Mental Health Intervention for Use Among Immigrant and Refugee Youth in the USA: A Mixed Methods Evaluation of Clinical and Implementation Outcomes

Authors:

Katrin E. Fabian, Morgan Turner, Katherine T. Foster, Lydia Chwastiak & Bradley H. Wagenaar

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: February 2025

Read the full text in the subscription access Journal of Technology in Behavioral Science

✪ Human-Centered Design of an mHealth Tool for Optimizing HIV Index Testing in Wartime Ukraine: Formative Research Case Study

Authors:

Nancy Puttkammer, Elizabeth Dunbar, Myroslava Germanovych, Mariia Rosol, Matthew Golden, Anna Hubashova, Vladyslav Fedorchenko, Larisa Hetman, Liudmyla Legkostup, Jan Flowers, and Olena Nesterova

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text in the open access journal JMIR Formative Research

Abstract:

Background

Assisted partner services (APSs; sometimes called index testing) are now being brought to scale as a high-yield HIV testing strategy in many nations. However, the success of APSs is often hampered by low levels of partner elicitation. The Computer-Assisted Self-Interview (CASI)–Plus study sought to develop and test a mobile health (mHealth) tool to increase the elicitation of sexual and needle-sharing partners among persons with newly diagnosed HIV. CASI-Plus provides client-facing information on APS methods and uses a standardized, self-guided questionnaire with nonjudgmental language for clients to list partners who would benefit from HIV testing. The tool also enables health care workers (HCWs) to see summarized data to facilitate partner tracking.

Objective

The formative research phase of the CASI-Plus study aimed to gather client and HCW input on the design of the CASI-Plus tool to ensure its acceptability, feasibility, and usability.

Methods

This study gathered input to prioritize features and tested the usability of CASI-Plus with HCWs and clients receiving HIV services in public health clinics in wartime Ukraine. The CASI-Plus study’s formative phase, carried out from May 2023 to July 2024, adapted human-centered design (HCD) methods grounded in principles of empathy, iteration, and creative ideation. The study involved 3 steps: formative HCD, including in-depth individual interviews with clients, such as men who have sex with men and people who inject drugs, and internet-based design workshops with HCWs from rural and urban HIV clinics in Chernihiv and Dnipro; software platform assessment and heuristic evaluation, including assessment of open-source mHealth platforms against CASI-Plus requirements, prototype development, and testing of the REDCap (Research Electronic Data Capture) prototype based on usability heuristics; and usability walk-throughs, including simulated cases with HCWs and clients.

Results:

The formative phase of the CASI-Plus study included in-depth individual interviews with 10 clients and 3 workshops with 22 HCWs. This study demonstrated how simplified HCD methods, adapted to the wartime context, gathered rich input on prioritized features and tool design. The CASI-Plus design reflected features that are both culturally sensitive and in alignment with the constraints of Ukraine’s wartime setting. Prioritized features included information about the benefits of HIV index testing; a nonjudgmental, self-guided questionnaire to report partners; client stories; and bright images to accompany the text. Two-way SMS text messaging between clients and HCWs was deemed impractical based on risks of privacy breaches, national patient privacy regulations, and HCW workload./p>

Conclusions

It was feasible to conduct HCD research in Ukraine in a wartime setting. The CASI-Plus mHealth tool was acceptable to both HCWs and clients. The next step for this research is a randomized clinical trial of the effect of the REDCap-based CASI-Plus tool on the number of partners named and the rate of partners completing HIV testing.

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

✪ Implementation research logic model in the design and execution of eHealth innovations for maternal and newborn healthcare in Ethiopia

Authors:

Dabere Nigatu, Muluken Azage, Eyaya Misgan, Daniel A. Enquobahrie, Tegegn Kebebaw, Enyew Abate, Esubalew Alemneh, Mirkuzie Woldie & Tsinuel Girma

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2025

Read the full text open access in the journal Health Research Policy and Systems

Abstract:

Background

The use of eHealth innovations is becoming increasingly important in improving health outcomes, especially for maternal and newborn health. However, planning and executing these innovations can be challenging due to their complex nature. To provide guidance and clarity on implementation approaches, researchers need to use implementation research (IR) tools. We conducted IR to recognize the challenges in implementing eHealth innovations in the context of maternal and newborn healthcare using the implementation research logic model (IRLM). Therefore, this paper aims to describe the practical application of IRLM to design, execute and evaluate eHealth innovations that improve maternal and newborn care in public facilities in Ethiopia.

Methods

We employed rapid review, formative assessment and process evaluation of an eHealth innovation in selected healthcare facilities serving maternal and newborn care. The eHealth innovation we developed and deployed was named ‘ADHERE’ (Antenatal Care, ChilDbirtH CarE and Postnatal CaRE), representing the continuum of maternal care. The rapid review was conducted as an initial step using the Consolidated Framework for Implementation Research (CFIR). We employed a mix of data collection methods: interview/discussion, eHealth system or document review and direct observation. Furthermore, we executed various stakeholder engagement activities: two co-creation workshops and on-site iterative discussions. We applied the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) to capture ongoing implementation learnings.

Results

We developed IRLM of the eHealth innovation implementation for three contexts: urban, peri-urban and remote public healthcare facilities. The model depicted the mechanism of interaction between implementation determinants and implementation strategies to produce the intended implementation outcomes. The IRLM helped to identify more than 35 implementation barriers or facilitators for eHealth interventions and to develop over 17 mitigation strategies for the study contexts. The initial IRLM was refined through ongoing implementation learnings and the mitigation strategies that were executed.

Conclusions

The IRLM is a comprehensive and effective guiding tool for the development, implementation and evaluation of innovations in various low- and middle-income contexts. Researchers and implementing partners should adapt and use it.

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

✪ WhatsApp Versus SMS for 2-Way, Text-Based Follow-Up After Voluntary Medical Male Circumcision in South Africa: Exploration of Messaging Platform Choice

Authors:

Isabella Fabens, Calsile Makhele, Nelson Kibiribiri Igaba, Sizwe Hlongwane, Motshana Phohole, Evelyn Waweru, Femi Oni, Madalitso Khwepeya, Maria Sardini, Khumbulani Moyo, Hannock Tweya, Mourice Barasa Wafula, Jacqueline Pienaar, Felex Ndebele, Geoffrey Setswe, Tracy Qi Dong, & Caryl Feldacker

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2024

Read the full text in the open access journal JMIR Formative Research

Abstract:

Background

Telehealth is growing, especially in areas where access to health facilities is difficult. We previously used 2-way texting (2wT) via SMS to improve the quality of postoperative care after voluntary medical male circumcision in South Africa. In this study, we offered males aged 15 years and older WhatsApp or SMS as their message delivery and interaction platform to explore user preferences and behaviors.

Objective

The objectives of this process evaluation embedded within a larger 2wT expansion trial were to (1) explore 2wT client preferences, including client satisfaction, with WhatsApp or SMS; (2) examine response rates (participation) by SMS and WhatsApp; and (3) gather feedback from the 2wT implementation team on the WhatsApp approach.

Methods

Males aged 15 years and older undergoing voluntary medical male circumcision in program sites could choose their follow-up approach, selecting 2wT via SMS or WhatsApp or routine care (in-person postoperative visits). The 2wT system provided 1-way educational messages and an open 2-way communication channel between providers and clients. We analyzed quantitative data from the 2wT database on message delivery platforms (WhatsApp vs SMS), response rates, and user behaviors using chi-square tests, z tests, and t tests. The team conducted short phone calls with WhatsApp and SMS clients about their perceptions of this 2wT platform using a short, structured interview guide. We consider informal reflections from the technical team members on the use of WhatsApp. We applied an implementation science lens using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to focus results on practice and policy improvement.

Results

Over a 2-month period—from August to October, 2023—337 males enrolled in 2wT and were offered WhatsApp or SMS and were included in the analysis. For 2wT reach, 177 (53%) participants chose WhatsApp as their platform (P=.38). Mean client age was 30 years, and 253 (75%) participants chose English for automated messages. From quality assurance calls, almost all respondents (87/89, 98%) were happy with the way they were followed up. For effectiveness, on average for the days on which responses were requested, 58 (33%) WhatsApp clients and 44 (28%) SMS clients responded (P=.50). All 2wT team members believed WhatsApp limited the automated message content, language choices, and inclusivity as compared with the SMS-based 2wT approach.

Conclusions

When presented with a choice of 2wT communication platform, clients appear evenly split between SMS and WhatsApp. However, WhatsApp requires a smartphone and data plan, potentially reducing reach at scale. Clients using both platforms responded to 2wT interactive prompts, demonstrating similar effectiveness in engaging clients in follow-up. For telehealth interventions, digital health designers should maintain an SMS-based platform and carefully consider adding WhatsApp as an option for clients, using an implementation science approach to present evidence that guides the best implementation approach for their setting.

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