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✪ The effect of proactive, interactive, two-way texting on 12-month retention in antiretroviral therapy: Findings from a quasi-experimental study in Lilongwe, Malawi

Authors:

Caryl Feldacker, Robin E. Klabbers, Jacqueline Huwa, Christine Kiruthu-Kamamia, Agness Thawani, Petros Tembo, Joseph Chintedza, Geldert Chiwaya, Aubrey Kudzala, Pachawo Bisani, Dumisani Ndhlovu, Johnnie Seyani & Hannock Tweya

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal PLOS One

Abstract:

Background

Retaining clients on antiretroviral therapy (ART) is challenging, especially during the first year on ART. Mobile health (mHealth) interventions show promise to close retention gaps. We aimed to assess reach (who received the intervention?) and effectiveness (did it work?) of a hybrid two-way texting (2wT) intervention to improve ART retention at a large public clinic in Lilongwe, Malawi.

Methods

Between August 2021—June 2023, in a quasi-experimental study, outcomes were compared between two cohorts of new ART clients: 1) those opting into 2wT who received automated, weekly motivation short messaging service (SMS) messages and response-requested appointment reminders; and 2) a matched historical cohort receiving standard of care (SoC). Reach was defined as “the proportion clients ≤6 months of ART initiation eligible for 2wT”. 2wT effectiveness was assessed in time-to-event analysis. Retention was presented in a Kaplan-Meier plot and compared between 2wT and SoC using a log-rank test. The effect of 2wT on ART dropout (lost to follow-up or stopped ART) was estimated using Fine-Gray competing risk regression models, adjusting for sex, age and WHO HIV stage at ART initiation.

Results

Of 1,146 clients screened, 501 were eligible for 2wT, a reach of 44%. Lack of phone (393/645; 61%) and illiteracy (149/645; 23%) were the most common ineligibility reasons. Among 468 participants exposed to 2wT, 12-month probability of ART retention was 91% (95% CI: 88% - 94%) compared to 76% (95% CI: 72% - 80%) among 468 SoC participants (p<0.001). Compared to SoC, 2wT participants had a 65% lower hazard of ART dropout at any timepoint (sub-distribution hazard ratio 0.35, 95% CI: 0.24–0.51; p<0.001).

Conclusions

2wT did not reach all clients. For those who opted-in, 2wT significantly increased 12-month ART retention. Expansion of 2wT as a complement to other retention interventions should be considered in other low-resource, routine ART settings.

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

✪ Are we being equitable enough? Lessons learned from sites lost in an implementation trial

Authors:

Elizabeth J Austin, Jessica Chen, Lori Ferro, Andrew J Saxon, John C Fortney, Geoffrey M Curran, Anna D Ratzliff, & Emily C Williams

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

There is a growing interest in practice-based implementation research, yet too often research prioritizes and is most successful in academic settings. During a national implementation trial to evaluate the effectiveness of Collaborative Care for co-occurring opioid use and mental health disorders, we lost three of our 11 participating implementation sites, all representing community sites.

Method

To better understand needed supports for implementation trial participation, we conducted exit interviews (n = 5) with key staff at these community sites. Interview transcripts were double-coded and analyzed using Rapid Assessment Process. Qualitative themes were iteratively reviewed by the study team.

Results

Three themes emerged characterizing challenges for community sites, including that: (1) research threatens sites’ most precious resource—staff; (2) staff lack comfort with and skills for research; and (3) research participation in its current form does not offer a clear return on investment.

Conclusions

Learnings from this work illuminate some of the barriers community sites face when trying to participate in multisite implementation research. An undercurrent of participant perspectives was the belief that community sites like theirs are just not set up to successfully participate in clinical trial research, including population-based implementation trials. Future implementation trials should consider strategies that disrupt traditional approaches, increasing the equitable inclusion of diverse practice settings in implementation research.

Plain Language Summary

There is a growing interest in research that reflects community settings. Yet too often, research is most successful in academic settings. During a national implementation trial to evaluate the effectiveness of Collaborative Care for co-occurring opioid use and mental health disorders, we lost three of our 11 participating implementation sites, all representing community sites. To better understand their perspectives, we conducted exit interviews (n = 5) with staff at these community sites. Interview transcripts were double-coded and analyzed using thematic analysis. Analysis identified three themes: (1) research threatens sites’ most precious resource—staff; (2) staff lack comfort with and skills for research, and (3) research participation in its current form does not offer a clear return on investment. Community sites face many barriers to participating in implementation research trials. Future trials should consider ways to disrupt traditional approaches and increase the equitable inclusion of community settings in implementation research.

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

✪ Implementation Science for HIV Prevention and Treatment in Indigenous Communities: a Systematic Review and Commentary

Authors:

Christopher G. Kemp (Ngāi Tahu), Abagail J. Edwards, Lauren White (Choctaw Nation of Oklahoma), Gauri Kore, Pamela Jumper Thurman (Cherokee), Tommi Gaines (Navajo, Hopi), Paula Toko King (Te Aupōuri, Te Rarawa, Ngāpuhi, Ngāti Whātua, Waikato Tainui, Ngāti Maniapoto), Marama Cole (Ngāti Kahungunu, Ngāti Porou) & E. Roberto Orellana (Maya)

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal Current HIV/AIDS Reports

Abstract:

Purpose of Review

We systematically reviewed implementation research conducted in Indigenous communities in the Americas and the Pacific that focused on improving delivery of HIV preventive or treatment services. We highlight strengths and opportunities in the literature and outline principles for Indigenous-led, HIV-related implementation science.

Recent Findings

We identified 31 studies, revealing a consistent emphasis on cultural tailoring of services to Indigenous communities. Common barriers to implementation included stigma, geographic limitations, confidentiality concerns, language barriers, and mistrust. Community involvement in intervention development and delivery emerged as a key facilitator, and nearly half of the studies used community-based participatory research methods. While behavioral HIV prevention, especially among Indigenous youth, was a major focus, there was limited research on biomedical HIV prevention and treatment. No randomized implementation trials were identified.

Summary

The findings underscore the importance of community engagement, the need for interventions developed within Indigenous communities rather than merely adapted, and the value of addressing the social determinants of implementation success. Aligned to these principles, an indigenized implementation science could enhance the acceptability and reach of critical HIV preventive and treatment services in Indigenous communities while also honoring their knowledge, wisdom, and strength.

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

✪ Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial

Authors:

David B. Bekelman, Karleen Giannitrapani, Kristin A. Linn, Paula Langner, Rebecca L. Sudore, Borsika Rabin, Karl A. Lorenz, Marybeth Foglia, Amanda Glickman, Scott Pawlikowski, Marilyn Sloan, Raziel C. Gamboa, Matthew D. McCaa, Anne Hines & Anne M. Walling

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Background

Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies are needed to improve implementation of outpatient, primary care goals of care conversations.

Methods

We plan a cluster randomized (clinician-level) sequential, multiple assignment randomized trial to evaluate the effectiveness of patient implementation strategies on the outcome of goals of care conversation documentation when delivered in combination with clinician implementation strategies. Across three VA healthcare system sites, we will enroll primary care clinicians with low rates of goals of care conversations and their patients with serious medical illness in the top 10th percentile of risk of hospitalization or death. We will compare the effectiveness of sequences of implementation strategies and explore how patient and site factors modify implementation strategy effects. Finally, we will conduct a mixed-methods evaluation to understand implementation strategy success or failure. The design includes two key innovations: (1) strategies that target both clinicians and patients and (2) sequential strategies with increased intensity for non-responders.

Conclusion

This study aims to determine the effect of different sequences and combinations of implementation strategies on primary care documentation of goals of care conversations. Study partners, including the VA National Center for Ethics in Health Care and Office of Primary Care, can consider policies based on study findings.

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

✪ Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial

Authors:

Elvira E. Jimenez, Ann-Marie Rosland, Susan E. Stockdale, Ashok Reddy, Michelle S. Wong, Natasha Torrence, Alexis Huynh & Evelyn T. Chang

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Background

Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans’ Health Administration (VHA) patients at high risk for hospitalization or death (“high-risk Veterans”) are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population’s complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown.

The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients’ cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.

Methods

We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.

Analysis

We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.

Discussion

Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.

Trial registration

ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643

Protocol version

This protocol is Version 1.0 which was created on 6/3/2020.

Contributions to the literature
  • The first study to compare the effectiveness of Evidence-Based Quality Improvement (EBQI) conducted individually with one site or conducted with a group of sites.
  • Implementation of evidence-based practices to improve care for high-risk patients in primary care.

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

✪ Relevance of learning health systems to physiatrists and its synergy with implementation science: A commentary

Authors:

Thiru M Annaswamy, Prateek Grove, Natalie F Douglas, Kathleen Poploski, Catherine A Anderson, Melissa A Clark, Ann Marie Flores, Brian J Hafner, Jeanne M Hoffman, Adam R Kinney, Kristin Ressel, Jennifer Sánchez , Margarite J Whitten, Linda Resnik, Christine M McDonough

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

Read the full text open access in The Journal of Injury, Function, and Rehabilitation

Abstract:

As health care attempts to bridge the gap between evidence and practice, the concept of the learning health system (LHS) is becoming increasingly relevant. LHS integrates evidence with health systems data, driving health care quality and outcomes through updates in policy, practice, and care delivery. In addition, LHS research is becoming critically important as there are several initiatives underway to increase research capacity, expertise, and implementation, including attempts to stimulate increasing numbers of LHS researchers. Physical Medicine & Rehabilitation (PM&R) physicians (physiatrists), nurses, therapists (physical therapists, occupational therapists, speech therapists, clinical psychologists), and scientists are affiliated with LHSs. As LHS research expands in health care systems, better awareness and understanding of LHSs and LHS research competencies are key for rehabilitation professionals including physiatrists. To address this need, the Agency of Healthcare Research and Quality (AHRQ) identified 33 core competencies, grouped into eight domains, for training LHS researchers. The domains are: (1) Systems Science; (2) Research Questions and Standards of Scientific Evidence; (3) Research Methods; (4) Informatics; (5) Ethics of Research and Implementation in Health Systems; (6) Improvement and Implementation Science; (7) Engagement, Leadership, and Research Management; and the recently added (8) Health and Healthcare Equity and Justice. The purpose of this commentary is to define LHS and its relevance to physiatrists, present the role of implementation science (IS) in LHSs and application of IS principles to design LHSs, illustrate current LHS research in rehabilitation, and discuss potential solutions to improve awareness and to stimulate interest in LHS research and IS among physiatrists in LHSs.

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

✪ Providing HIV-assisted partner services to partners of partners in western Kenya: an implementation science study

Authors:

Monisha Sharma, Barbara Wanjiku Mambo, Hanley Kingston, George Otieno, Sarah Masyuko, Harison Lagat, David A. Katz, Beatrice Wamuti, Paul Macharia, Rose Bosire , Mary Mugambi, Edward Kariithi, and Carey Farquhar

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Introduction

Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of persons diagnosed HIV positive (index clients), is recommended by the World Health Organization. Most APS literature focuses on outcomes among index clients and their partners. There is little data on the benefits of providing APS to partners of partners diagnosed with HIV.

Methods

We utilized data from a large-scale APS implementation project across 31 facilities in western Kenya from 2018 to 2022. Females testing HIV positive at facilities were offered APS; those who consented provided contact information for all male sexual partners in the last 3 years. Male partners were notified of their potential HIV exposure and offered HIV testing services (HTS). Males newly testing positive were also offered APS and asked to provide contact information for their female partners in the last 3 years. Female partners of male partners (FPPs) were provided exposure notification and HTS. All participants with HIV were followed up at 12 months post-enrolment to assess linkage-to antiretroviral treatment (ART) and viral suppression. We compared HIV positivity, demographics and linkage outcomes among female index clients and FPPs.

Results

Overall, 5708 FPPs were elicited from male partners, of whom 4951 received HTS through APS (87% coverage); 291 FPPs newly tested HIV positive (6% yield), an additional 1743 (35.2%) reported a prior HIV diagnosis, of whom 99% were on ART at baseline. At 12 months follow-up, most FPPs were taking ART (92%) with very few adverse events: <1% reported intimate partner violence or reported relationship dissolution. FPPs were more likely than female index clients to report HIV risk behaviours including no condom use at last sex (45% vs. 30%) and multiple partners (38% vs. 19%).

Conclusions

Providing HIV testing via APS to FPP is a safe and effective strategy to identify newly diagnosed females and achieve high linkage and retention to ART and can be an efficient means of identifying HIV cases in the era of declining HIV incidence. The high proportion of FPPs reporting HIV risk behaviours suggests APS may help interrupt community HIV transmission via increased knowledge of HIV status and linkage to treatment.

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

✪ Using FRAME to characterize provider-identified adaptations to a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach

Authors:

Nok Chhun, Dorothy Oketch, Kawango Agot, Dorothy I. Mangale, Jacinta Badia, James Kibugi, Wenwen Jiang, Mary Kirk, Barbra A. Richardson, Pamela K. Kohler, Grace John-Stewart & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Introduction

The Data-informed Stepped Care (DiSC) study is a cluster-randomized trial implemented in 24 HIV care clinics in Kenya, aimed at improving retention in care for adolescents and youth living with HIV (AYLHIV). DiSC is a multi-component intervention that assigns AYLHIV to different intensity (steps) of services according to risk. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to characterize provider-identified adaptations to the implementation of DiSC to optimize uptake and delivery, and determine the influence on implementation outcomes.

Methods

Between May and December 2022, we conducted continuous quality improvement (CQI) meetings with providers to optimize DiSC implementation at 12 intervention sites. The meetings were guided by plan-do-study-act processes to identify challenges during early phase implementation and propose targeted adaptations. Meetings were audio-recorded and analysed using FRAME to categorize the level, context and content of planned adaptations and determine if adaptations were fidelity consistent. Providers completed surveys to quantify perceptions of DiSC acceptability, appropriateness and feasibility. Mixed effects linear regression models were used to evaluate these implementation outcomes over time.

Results

Providers participated in eight CQI meetings per facility over a 6-month period. A total of 65 adaptations were included in the analysis. The majority focused on optimizing the integration of DiSC within the clinic (83%, n = 54), and consisted of improving documentation, addressing scheduling challenges and improving clinic workflow. Primary reasons for adaptation were to align delivery with AYLHIV needs and preferences and to increase reach among AYLHIV: with reminder calls to AYLHIV, collaborating with schools to ensure AYLHIV attended clinic appointments and addressing transportation challenges. All adaptations to optimize DiSC implementation were fidelity-consistent. Provider perceptions of implementation were consistently high throughout the process, and on average, slightly improved each month for intervention acceptability (β = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (β = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (β = 0.013, 95% CI: 0.004, 0.022, p = 0.005).

Conclusions

Provider-identified adaptations targeted improved integration into routine clinic practices and aimed to reduce barriers to service access unique to AYLHIV. Characterizing types of adaptations and adaptation rationale may enrich our understanding of the implementation context and improve abilities to tailor implementation strategies when scaling to new settings.

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

✪ Integrating a mental health intervention into PrEP services for South African young women: a human-centered implementation research approach to intervention development

Authors:

Jennifer Velloza, Nomhle Ndimande-Khoza, Lisa Mills, Tessa Concepcion, Sanele Gumede, Hlukelo Chauke, Ruth Verhey, Dixon Chibanda, Sybil Hosek, Bryan J. Weiner, Connie Celum, Sinead Delany-Moretlwe

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Introduction

Adolescent girls and young women (AGYW) who may benefit from HIV pre-exposure prophylaxis (PrEP) face high levels of common mental disorders (e.g. depression, anxiety). Common mental disorders can reduce PrEP adherence and increase HIV risk, yet mental health interventions have not been well-integrated into PrEP delivery.

Methods

We conducted a four-phase human-centered design process, from December 2020 to April 2022, to understand mental health challenges among AGYW in Johannesburg, South Africa and barriers to integrated mental health and PrEP services. In the “Discover” phase, we conducted in-depth interviews with AGYW and key informants (KIs) in Johannesburg. We conducted a rapid qualitative analysis, informed by the Consolidated Framework for Implementation Research (CFIR), to identify facilitators and barriers of integrated mental health and PrEP services and mapped barriers to potential implementation strategies. In the “Design” and “Build” phases, we conducted stakeholder workshops to iteratively adapt an evidence-based mental health intervention, the Friendship Bench, and refine implementation strategies for South African PrEP delivery settings. In the “Test” phase, we piloted our adapted Friendship Bench package.

Results

Interviews with 70 Discover phase participants (48 AGYW, 22 KIs) revealed the importance of integrated mental health and PrEP services for South African AGYW. Interviewees described barriers and implementation strategies for mental health and PrEP services around the CFIR domains: intervention characteristics (e.g. challenges with AGYW “opening up”); outer Johannesburg setting (e.g. community stigma); inner clinic setting (e.g. judgmental healthcare providers); characteristics of counsellors (e.g. training gaps); and the implementation process (e.g. need for demand creation). The Design and Build workshops included 13 AGYW and 15 KIs. Implementation barriers related to the quality and accessibility of public-sector clinic services, lay counsellor training, and community education and demand creation activities were prioritized. This led to 12 key Friendship Bench adaptations and the specification of 10 implementation strategies that were acceptable and feasible in initial pilot testing with three AGYW.

Conclusions

Using a human-centered approach, we identified determinants and potential solutions for integrating mental health interventions within PrEP services for South African AGYW. This design process centered stakeholders’ perspectives, enabling rapid development of an adapted Friendship Bench intervention implementation package.

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