Kristin Beima-Sofie Archives - Implementation Science at UW

✪ “When he is around, I’ll take the PrEP, but when he is not, I will not take PrEP”: key influences on PrEP use decisions among women attending family planning clinics in Kenya

Abstract:

Background

Women of childbearing age in sub-Saharan Africa (SSA) face a disproportionately high risk of HIV acquisition. Although oral PrEP has been universally scaled up for individuals at significant risk of HIV, its uptake and sustained use remain suboptimal. Understanding PrEP use decisions offers insights into context-specific barriers and facilitators to its utilization.

Methods

From September to November 2023, we conducted a qualitative study nested in a larger prospective, open-label clinical trial (FP-Plus). We conducted in-depth interviews (IDIs) with younger women (ages 15–24) and older women (ages ≥25) who declined, delayed, discontinued, or restarted PrEP during the study. IDIs were conducted at two FP clinics by trained Kenyan social scientists and were audio recorded, translated, and transcribed. We analyzed data using inductive and deductive thematic analysis through the lens of the theory of planned behavior (TPB) to explore experiences, beliefs, and rationale among women who made various PrEP decisions.

Results

We interviewed 64 women, including 40 younger women and 24 older women, all of whom declined, delayed, discontinued, or restarted PrEP (n = 16 women/category). The median age of these women was 24 years (IQR, 23–30). The majority of participants (86%, 55/64) were using family planning methods, primarily injectables (42%, 23/64). PrEP discontinuation or restart was primarily influenced by changes in HIV risk dynamics. Agency and perceived HIV risk were pivotal factors in PrEP use decisions, shaping participants’ ability to practice effective prevention adherence (TPB: perceived behavioral control). Women who declined PrEP cited a lack of autonomy, partner influence, and insufficient information (TPB: social and subjective norms). Low self-efficacy influenced decisions to delay or decline PrEP (TPB: behavioral beliefs and attitudes). In addition, challenges with PrEP pill size, taste, and texture were perceived as barriers to swallowing pills among all groups of women. Participants expressed a preference for alternative PrEP formulations, such as injectable PrEP, due to perceived ease of use, privacy, and potential to support adherence.

Conclusions

PrEP discontinuation and restart cycles largely reflected changes in HIV risk. Women who decline or delay PrEP may benefit from personalized support to improve their autonomy, recognizing that HIV risk persists during periods of PrEP delay.

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

✪ Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation

Abstract:

Background

Differentiation of HIV services, a client-centered strategy, may improve care outcomes among adolescents and youth living with HIV (AYLHIV). Understanding health provider perceptions of barriers and facilitators that influence implementation can optimize adoption and sustainment of health systems interventions.

Methods

The Data-informed Stepped Care (DiSC) study was a cluster randomized controlled trial of a stepped care intervention in 24 HIV care facilities in Kenya. At each visit, providers used an assessment tool to allocate AYLHIV to services according to level of need. Stable clients were allocated to differentiated service delivery (DSD) with less frequent visits. Intensified services, including behavioral counseling, were provided for those with greater likelihood of loss to follow-up, mental health issues, or viral non-suppression. We conducted focus group discussions (FGDs) with providers across 12 intervention sites between January-February 2023. FGDs used a semi-structured interview guide, grounded in the Consolidated Framework for Implementation Research, which were audio-recorded and transcribed. Transcripts were analyzed using a team-based rapid turnaround approach to characterize key determinants influencing adoption, reach, and fidelity.

Results

Providers were enthusiastic about, and quick to adopt, the DiSC intervention. They found the DiSC tool easy to use and felt it provided a relative advantage by improving service delivery efficiency and prioritizing time with higher need AYLHIV. Providers noted the importance of tool flexibility to align with changing national guidelines. They expressed concerns about compatibility with existing workflows at facilities exclusively using electronic medical record (EMR) systems, suggesting EMR integration will be needed for intervention sustainment. AYLHIV eligible for DSD benefited from clinic visit intervals that aligned with the school calendar, which posed a challenge for reaching AYLHIV in more intensive steps. Provider collective efficacy was important in consistent implementation of DiSC and was facilitated by continuous quality improvement meetings, access to knowledge and information, and perceived intervention effectiveness. Supportive leadership was an important driver of implementation success, through availing space for mental health counseling sessions and time for client-provider interactions outside standard operating hours.

Conclusions

Consideration of alignment with national policy, integration into clinic workflows, school schedules, and leadership engagement, will be important for sustained use of differentiated care interventions.

Trial registration

ClinicalTrials.gov, NCT05007717. Registration date: July 13, 2021.

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

✪ Sustainability of an evidence-based intervention supporting transition to independent care for youth living with HIV in Kenya

Abstract:

Integrating and sustaining evidence-based interventions (EBIs) in routine care is crucial to improving HIV treatment outcomes among youth living with HIV (YLH). However, EBIs are often not sustained post clinical trial. An Adolescent Transition Package (ATP) delivered by health care workers (HCWs) and tested in Kenya in 2021 significantly improved YLH readiness to transition to independent care. Post-trial, participating clinics could continue using the ATP. We conducted 30 in-depth interviews with health care workers to evaluate determinants of continued ATP implementation one-year post-trial. Interviews used semi-structured guides, informed by the Consolidated Framework for Implementation Research version 2.0 (CFIR v2.0). Transcripts were analyzed thematically to identify key influences of ATP sustainment and fidelity post-trial. Effective training during and after the trial, and continued internal and external support for implementation, were crucial for sustained acceptability and feasibility. In contrast, staff shortages and high turnover, lack of integration into the existing electronic medical system, and maintaining staff motivation were barriers to ATP sustainment. Implementation fidelity was limited by workforce constraints and HCW beliefs about the importance of individualizing content and delivery to be responsive to individual client needs. ATP adaptability afforded optimization of delivery to overcome workforce constraints and meet client needs, increasing HCW perceptions of feasibility and motivating continued use. Alignment between observed impact and care provision goals further motivated ongoing ATP utilization. Strategies to ensure continued training and integration of tools into existing systems have the potential to further enhance ATP sustainability.

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

Formative qualitative research to guide implementation of the Collaborative Care Model in a low-barrier HIV clinic

✪ The pathway to delivering injectable CAB for HIV prevention: strategies from global PrEP leaders leveraging an adapted version of the Intervention Scalability Assessment Tool (ISAT)

Abstract:

Background

Longer-acting cabotegravir (CAB) is a novel, safe, and efficacious pre-exposure prophylaxis (PrEP) for HIV prevention. As we near a time for CAB scale-up, the experience of global leaders in PrEP research and implementation can be leveraged to identify optimal strategies for scaling and integrating CAB into existing PrEP infrastructure worldwide.

Methods

We recruited leaders of HIV prevention clinical trials and large PrEP programs through a combination of purposive and snowball sampling for participation in individual interviews. We conducted interviews using a semi-structured guide that compared CAB to oral PrEP and sought perspectives on barriers and strategies for CAB scale-up. Interviews were conducted virtually, audio recorded, and transcribed. We used thematic analysis, grounded in an adapted version of the Intervention Scalability Assessment Tool (ISAT), to identify critical elements for optimizing delivery of CAB.

Results

From October 2021 to April 2022, we interviewed 30 participants with extensive experience in PrEP research, care, and programming. Participants worked in all seven WHO regions and reported a median of 20 years working in HIV and 10 years in PrEP. Participants agreed that CAB was efficacious and discrete, therefore having the potential to address current concerns about oral PrEP adherence and stigma. Participants indicated direct and indirect costs for provider training, expansion of existing medical infrastructure, and the current medication cost of CAB as major concerns for roll out. The true cost to the end-user and health system were unknown. There were some conflicting strategies on how to best address product targeting, presentation of efficacy, and timing of product availability with scale-up. Some thought that targeting CAB for the general population could normalize PrEP and decrease stigma, while others thought that prioritizing key populations could optimize impact by targeting those with highest risk. Overall, participants emphasized that to ensure successful CAB scale-up, communities and stakeholders must be involved at every stage of planning and implementation.

Conclusions

Our evaluation found that although there is a clear and urgent need for additional HIV PrEP options beyond daily oral PrEP, CAB scale-up must be thoughtful, flexible, and based in lessons learned from oral PrEP rollout.

Contributions to the literature

We used the Intervention Scalability Assessment Tool (ISAT), a quantitative tool used to inform decision-making for the scale-up of health interventions, as a framework for a qualitative analysis.
To our knowledge, this is the first use of the ISAT to assess scalability of injectable cabotegravir (CAB) for HIV pre-exposure prophylaxis (PrEP).
Our findings offer a summary of perspectives from global HIV PrEP leaders, experts, and advocates that can be used to map the process of CAB implementation using existing HIV prevention infrastructure.

^{**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

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**}

✪ Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya

Abstract:

Background

Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery.

Methods

We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them.

Results

Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments.

Conclusions

HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

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

✪ Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach

Abstract:

Background

The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention — the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP.

Methods

We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes.

Results

We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%).

Conclusion

Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility.

Trial registration

Trial registered on ClinicalTrial.gov as NCT03574129.

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

Financial Incentives for Pediatric HIV Testing (FIT): Caregiver Insights on Incentive Mechanisms, Focus Populations, and Acceptability for Programmatic Scale Up

Use of the Consolidated Framework for Implementation Research (CFIR) to Characterize Healthcare Workers’ Perspectives on Financial Incentives to Increase Pediatric HIV Testing

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Authors:

✪ Open Access

Read the full text in the open access journal PLOS Global Public Health

Abstract:

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Read the full text in the subscription access journal AIDS Care

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✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Contributions to the literature

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 Frontiers in Reproductive Health

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusion

Trial registration

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

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Read the full text in the subscription access journal JAIDS