Acceptability and Feasibility of a Mobile Phone Application to Support HIV Pre-exposure Prophylaxis Among Women with Opioid Use Disorder.

Despite evidence supporting HIV pre-exposure prophylaxis (PrEP) effectiveness, very few women with opioid use disorder (OUD) take PrEP. Interventions that improve medication assisted treatment (MAT) uptake and adherence may also be beneficial for PrEP. The reSET-O mobile phone app is a component of the evidence-based Therapeutic Education System, which improves retention and abstinence for people with OUD. To better understand use of this mobile health tool as a support for PrEP among women with OUD, pre-implementation contextual inquiry is needed. Therefore, we set out to assess target user characteristics, implementation barriers, feasibility, and acceptability of reSET-O. We recruited women with OUD receiving care from a community-based organization in Philadelphia to complete semi-structured interviews. All participants were prescribed reSET-O. We interviewed 20 participants (average age 37 years; 70% white, 15% Hispanic, 5% Black) from 5/2021 to 2/2022. We used an integrated analysis approach combining modified grounded theory and implementation science constructs. Half reported recent injection drug use, and 6 were taking buprenorphine. Mental health symptoms were common, and half described engaging in transactional sex. The majority expressed strong interest in PrEP. Participants reported the app would be highly acceptable for PrEP and MAT adherence support, but only two redeemed the prescription. The most common barriers included phone and internet access. Our findings highlight potential implementation challenges for the use of such an app to support PrEP use in this population. Poor uptake of the app at follow-up indicates that initial prescription redemption is a major barrier to reSET-O implementation.

Predictive Validity of a Computerized Battery for Identifying Neurocognitive Impairments Among Children Living with HIV in Botswana.

Children living with HIV (HIV+) experience increased risk of neurocognitive deficits, but standardized cognitive testing is limited in low-resource, high-prevalence settings. The Penn Computerized Neurocognitive Battery (PennCNB) was adapted for use in Botswana. This study evaluated the criterion validity of a locally adapted version of the PennCNB among a cohort of HIV+ individuals aged 10-17 years in Botswana. Participants completed the PennCNB and a comprehensive professional consensus assessment consisting of pencil-and-paper psychological assessments, clinical interview, and review of academic performance. Seventy-two participants were classified as cases (i.e., with cognitive impairment; N = 48) or controls (i.e., without cognitive impairment; N = 24). Sensitivity, specificity, positive predictive value, negative predictive value, and the area under receiver operating characteristic curves were calculated. Discrimination was acceptable, and prediction improved as the threshold for PennCNB impairment was less conservative. This research contributes to the validation of the PennCNB for use among children affected by HIV in Botswana.

Medical stakeholder perspectives on implementing a computerized battery to identify neurocognitive impairments among youth in Botswana.

HIV infection and in utero exposure, common in Sub-Saharan Africa, are associated with pediatric neurocognitive impairment. Cognitive screening can identify impairments, but it is rarely used in this setting. The Penn Computerized Neurocognitive Battery (PennCNB), an evidence-based cognitive screening tool, was adapted for use in Botswana. To facilitate future implementation, 20 semi-structured interviews were conducted to elicit key stakeholders' perspectives on factors likely to be related to successful uptake of the PennCNB in clinical settings. An integrated analytic approach combining constructs from the Consolidated Framework for Implementation Research and modified grounded theory was used. Results underscore the need for cognitive screening in Botswana and the acceptability of the PennCNB. Implementation barriers include limited time and resources, whereas facilitators include standard procedures for introducing new tools into medical settings and for training implementers. Recommended implementation strategies include integrating screening into the existing workflow, implementing the tool in the medical and educational sectors, and targeting selection of children for assessment. This research addresses the research-to-practice gap by engaging in pre-implementation inquiry and designing for implementation. Results will inform the development of strategies to maximize the likelihood of successful implementation of the PennCNB to identify neurocognitive impairment in children in this high-need setting.

Interventions for Children with Neurocognitive Impairments in Resource-Limited Settings: A Systematic Review.

Many children and adolescents around the world suffer from neurocognitive deficits due to chronic disorders, such as Human Immunodeficiency Virus (HIV) and malaria. Resource-limited settings exacerbate the risk of negative cognitive outcomes due to high prevalence of associated disorders, poverty, and limited access to interventions. Current literature does not provide consensus regarding the efficacy of interventions to support children with cognitive impairments in low-resource settings. This research aimed to identify and evaluate interventions for youth with neurocognitive deficits in resource-limited settings. A systematic review of peer-reviewed literature was conducted within five databases (PubMed, Web of Science, CINAHL, PsycInfo, and WHO Index Medicus). Cognitive impairment was broadly defined to be inclusive of aspects of intellectual and cognitive functioning (e.g., working memory, attention, executive function). The income status of the country or countries in which each study was located was determined according to World Bank Income Status. Studies conducted in countries classified as low- or middle-income were included. Since low-resource areas exist within high-income countries, the resource availability within study settings in high-income countries was systematically evaluated for inclusion. The search yielded 19 articles that met all inclusion criteria. Interventions included strategies involving caregiver training, computerized and non-computerized cognitive training, physical activity, and nutritional supplementation. Interventions were administered in medical facilities, educational facilities, or the home. The majority of the interventions targeted the domains of memory and attention. Overall, the efficacy of interventions was inconsistent. Further, results indicated that the relationship between cognitive improvement and intervention types was not consistent across cognitive domains. However, when evaluating studies on an individual basis, some strategies demonstrated clinically- and statistically-significant improvement in cognitive function among specific groups of children. The low article yield highlights that few researchers have evaluated pediatric cognitive support interventions in low-resource contexts. This review suggests support strategies that should be considered for future studies as neurocognitive screening capacity improves in resource-limited settings.

Co-designing strategies to implement long-acting injectable PrEP for sexual minority men in Chicago: a study protocol for an innovation tournament and implementation mapping.

BACKGROUND: Participatory design approaches can improve successful selection and tailoring of implementation strategies by centering the voices of key constituents. To reduce incidence of the human immunodeficiency virus (HIV) in the USA, co-design of implementation strategies is needed for long-acting injectable cabotegravir (CAB-LA), a new form of HIV pre-exposure prophylaxis, among the disproportionately impacted population of sexual minority men (SMM). This manuscript describes the protocol for participatory design approaches (i.e., innovation tournament and implementation mapping) to inform implementation of CAB-LA among SMM (≥ 12 years), particularly Black and Latino populations, in Chicago. METHODS: This research incorporates innovative methods to accomplish two objectives: (1) to crowdsource ideas for the design of implementation strategies for CAB-LA through a virtual innovation tournament and (2) to leverage the ideas from the innovation tournament to operationalize implementation strategies for CAB-LA thorough the systematic process of implementation mapping. A committee of constituents with diverse expertise and perspectives (e.g., SMM, implementation scientists, HIV clinicians, public health leadership, and community partners) will provide input throughout the design process. DISCUSSION: This research will produce a menu of co-designed implementation strategies, which can guide plans for CAB-LA integration in Chicago and provide insights for other EHE regions. Further, as the first innovation tournament focused on HIV prevention, this research can provide a framework for participatory approaches across the care continuum. Given that the co-design of implementation strategies often does not involve the participation of individuals with lived experiences, this work will center the voices of those who will benefit most.

Spanish translation of the Expert Recommendations for Implementing Change (ERIC) compilation.

BACKGROUND: Most implementation science resources (e.g., taxonomies) are published in English. Linguistic inaccessibility creates a barrier to the conduct of implementation research among non-English-speaking populations, so translation of resources is needed. Translation into Spanish can facilitate widespread reach, given the large proportion of Spanish speakers around the world. This research aimed to systematically translate the Expert Recommendations for Implementation Change (ERIC) compilation into Spanish as an exemplar for the linguistic translation process. METHODS: Using the World Health Organization guidelines, this work translated the ERIC compilation strategy names, short definitions, and thematic clusters through a three-step process: 1) forward translation into Spanish by a native Spanish-speaking implementation scientist, 2) back-translation into English by a bilingual global health researcher, and 3) piloting via virtual focus group discussions with bilingual researchers not conducting implementation research. To achieve a generalizable translation, recruitment targeted a multicultural group of Spanish-speaking researchers. At the conclusion of each step, the transdisciplinary research team (N = 7) met to discuss discrepancies and refine translations. The Spanish version of the ERIC compilation was finalized through group consensus. Reflections from research team meetings and focus group discussions were synthesized qualitatively. RESULTS: Given that dialectical nuances exist between Spanish-speaking regions, efforts prioritized universally accepted terminology. Team discussions focused on difficult translations, word choice, and clarity of concepts. Seven researchers participated in two focus groups, where discussion surrounded clarity of concepts, alternative word choice for Spanish translations, linguistic formality, grammar, and conciseness. Translation difficulties highlighted lack of precision in implementation science terminology, and the lack of conceptual clarity of words underscored limitations in the application of the compilation. CONCLUSIONS: The work demonstrated the feasibility of translating implementation science resources. As one of the first systematic efforts to translate implementation resources, this study can serve as a model for additional efforts, including translation into other languages and the expansion to conceptual modifications. Further, this work yielded insights into the need to provide conceptual clarity in implementation science terminology. Importantly, the development of Spanish resources will increase access to conduct implementation research among Spanish-speaking populations.

A mixed methods approach identifying facilitators and barriers to guide adaptations to InterCARE strategies: an integrated HIV and hypertension care model in Botswana.

BACKGROUND: Botswana serves as a model of success for HIV with 95% of people living with HIV (PLWH) virally suppressed. Yet, only 19% of PLWH and hypertension have controlled blood pressure. To address this gap, InterCARE, a care model that integrates HIV and hypertension care through a) provider training; b) adapted electronic health record; and c) treatment partners (peer support), was designed. This study presents results from our baseline assessment of the determinants and factors used to guide adaptations to InterCARE implementation strategies prior to a hybrid type 2 effectiveness-implementation study. METHODS: This study employed a convergent mixed methods design across two clinics (one rural, one urban) to collect quantitative and qualitative data through facility assessments, 100 stakeholder surveys (20 each PLWH and hypertension, existing HIV treatment partners, clinical healthcare providers (HCPs), and 40 community leaders) and ten stakeholder key informative interviews (KIIs). Data were analyzed using descriptive statistics and deductive qualitative analysis organized by the Consolidated Framework for Implementation Research (CFIR) and compared to identify areas of convergence and divergence. RESULTS: Although 90.3% of 290 PLWH and hypertension at the clinics were taking antihypertensive medications, 52.8% had uncontrolled blood pressure. Results from facility assessments, surveys, and KIIs identified key determinants in the CFIR innovation and inner setting domains. Most stakeholders (> 85%) agreed that InterCARE was adaptable, compatible and would be successful at improving blood pressure control in PLWH and hypertension. HCPs agreed that there were insufficient resources (40%), consistent with facility assessments and KIIs which identified limited staffing, inconsistent electricity, and a lack of supplies as key barriers. Adaptations to InterCARE included a task-sharing strategy and expanded treatment partner training and support. CONCLUSIONS: Integrating hypertension services into HIV clinics was perceived as more advantageous for PLWH than the current model of hypertension care delivered outside of HIV clinics. Identified barriers were used to adapt InterCARE implementation strategies for more effective intervention delivery. TRIAL REGISTRATION: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT05414526 . Registered 18 May 2022 - Retrospectively registered.

Quantitative outcomes of a type 2 single arm hybrid effectiveness implementation pilot study for hypertension-HIV integration in Botswana.

BACKGROUND: Successful HIV treatment programs have turned HIV into a chronic condition, but noncommunicable diseases such as hypertension jeopardize this progress. Hypertension control rates among people with HIV (PWH) are low owing to gaps in patient awareness, diagnosis, effective treatment, and management of both conditions at separate clinic visits. Integrated management, such as in our study, InterCARE, can enhance HIV-hypertension integration and blood pressure (BP) control. METHODS: Our pilot study was conducted in two Botswana HIV clinics between October 2021 and November 2022. Based on our formative work, we adopted three main strategies; Health worker training on HTN/cardiovascular disease (CVD) management, adaptation of HIV Electronic Health Record (EHR) for HTN/CVD care, and use of treatment partners to support PWH with hypertension for implementation. We employed the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to assess implementation effectiveness and outcomes for BP control at baseline, 6 and 12 months. HIV viral load (VL) suppression was also measured to assess impact of integration on HIV care. RESULTS: We enrolled 290 participants; 35 (12.1%) were lost to follow-up, leaving 255 (87.9%) at 12-months. Median age was 54 years (IQR 46-62), and 77.2% were females. Our interventions significantly improved BP control to < 140/90 mmHg (or < 130/80 mmHg if diagnosis of diabetes or chronic kidney disease), from 137/290 participants, 47.2% at baseline to 206/290 participants, 71.0%, at 12 months (p < 0.001). Among targeted providers, 94.7% received training, with an associated significant increase in counseling on exercise, diet, and medication (all p < 0.001) but EHR use for BP medication prescribing and cardiovascular risk factor evaluation showed no adoption. In the intention-to-treat analysis, HIV VL suppression at 12 months decreased (85.5% vs 93.8%, p = 0.002) due to loss to follow-up but the per protocol analysis showed no difference in VL suppression between baseline and 12 months (97.3% vs 93.3%, p = 0.060). CONCLUSION: The InterCARE pilot study demonstrated that low-cost practical support measures involving the integration of HIV and hypertension/CVD management could lead to improvements in BP control. These results support the need for a large implementation and effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05414526. Registered 18th May 2022.

Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE).

BACKGROUND: Despite success in HIV treatment, diagnosis and management of hypertension (HTN) and cardiovascular disease (CVD) remains suboptimal among people living with HIV (PLWH) in Botswana, with an overall HTN control of only 19% compared to 98% HIV viral suppressed. These gaps persist despite CVD primary care national guidelines and availability of free healthcare including antihypertensive medications. Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care, leveraging the successful national HIV care and treatment program and strategies. METHODS: The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial at 14 sites designed to enroll 4652 adults living with HIV and HTN plus up to 2326 treatment partners. Primary outcomes included effectiveness (HTN control) and implementation outcomes using the Reach Effectiveness Adoption Implementation and Maintenance framework, with explanatory mixed methods used to understand variability in outcomes. InterCARE trial's main strategies include healthcare worker HTN and CVD care training plus long-term practice facilitation, electronic health record (EHR) documentation of key indicators and use of reminders, and use of treatment partners to provide social support to people living with HIV and HTN. InterCARE started with formative research to identify contextual factors influencing care gaps using the Consolidated Framework for Implementation Research. Results were used to adapt initial and develop additional implementation strategies to address barriers and leverage facilitators. The package was pilot tested in two clinics, with findings used to further adapt or add strategies for the clinical trial. DISCUSSION: If successful, the InterCARE model can be scaled up to HIV clinics nationwide to improve diagnosis, management, and support in Botswana. The trial will provide insights for scale-up of HTN integration into HIV care in the region. TRIAL REGISTRATION: ClinicalTrials.gov reference NCT05414526. Registered 18 May 2022, https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526.&rank=1 .

Evaluation of a brief virtual implementation science training program: the Penn Implementation Science Institute.

BACKGROUND: To meet the growing demand for implementation science expertise, building capacity is a priority. Various training opportunities have emerged to meet this need. To ensure rigor and achievement of specific implementation science competencies, it is critical to systematically evaluate training programs. METHODS: The Penn Implementation Science Institute (PennISI) offers 4 days (20 h) of virtual synchronous training on foundational and advanced topics in implementation science. Through a pre-post design, this study evaluated the sixth PennISI, delivered in 2022. Surveys measures included 43 implementation science training evaluation competencies grouped into four thematic domains (e.g., items related to implementation science study design grouped into the "design, background, and rationale" competency category), course-specific evaluation criteria, and open-ended questions to evaluate change in knowledge and suggestions for improving future institutes. Mean composite scores were created for each of the competency themes. Descriptive statistics and thematic analysis were completed. RESULTS: One hundred four (95.41% response rate) and 55 (50.46% response rate) participants completed the pre-survey and post-survey, respectively. Participants included a diverse cohort of individuals primarily affiliated with US-based academic institutions and self-reported as having novice or beginner-level knowledge of implementation science at baseline (81.73%). In the pre-survey, all mean composite scores for implementation science competencies were below one (i.e., beginner-level). Participants reported high value from the PennISI across standard course evaluation criteria (e.g., mean score of 3.77/4.00 for overall quality of course). Scores for all competency domains increased to a score between beginner-level and intermediate-level following training. In both the pre-survey and post-survey, competencies related to "definition, background, and rationale" had the highest mean composite score, whereas competencies related to "design and analysis" received the lowest score. Qualitative themes offered impressions of the PennISI, didactic content, PennISI structure, and suggestions for improvement. Prior experience with or knowledge of implementation science influenced many themes. CONCLUSIONS: This evaluation highlights the strengths of an established implementation science institute, which can serve as a model for brief, virtual training programs. Findings provide insight for improving future program efforts to meet the needs of the heterogenous implementation science community (e.g., different disciplines and levels of implementation science knowledge). This study contributes to ensuring rigorous implementation science capacity building through the evaluation of programs.