Patient actor training improves PrEP delivery for adolescent girls and young women in Kenya: a cluster randomized trial.

OBJECTIVE: To evaluate effectiveness of a standardized patient actor (SP) training intervention to improve quality of PrEP services for adolescent girls and young women (AGYW) in Kenya. DESIGN: Cluster randomized trial and mystery shopper evaluation. METHODS: Twelve of 24 maternal child health and family planning facilities were randomized to SP training. Providers at intervention facilities participated in 2-day training in adolescent health, PrEP guidelines, values clarification, and communication skills, followed by role-playing and de-briefing with trained actors. Control facilities received standard national training. The primary outcome was quality of care, assessed by unannounced SPs (USPs) or "mystery shoppers" blinded to intervention arm. Quality was measured in two domains: guideline adherence and communication skills. Intent to treat analysis compared post-intervention quality scores by randomization arm, clustering on facility, and adjusting for baseline scores and USP. RESULTS: Overall, 232 providers consented to USP visits, and 94 providers completed the training. Following training, USPs posed as AGYW seeking PrEP in 142 encounters (5-6 encounters per site). The mean quality score was 73.6% at intervention sites and 58.4% at control sites [adjusted mean difference=15.3, 95% Confidence interval (CI): 9.4-21.1, p < 0.001]. Mean guideline adherence scores were 57.2% at intervention sites and 36.2% at control sites (adjusted mean difference=21.0, 95% CI: 12.5-29.4, p < 0.001). Mean communication scores were 90.0% at intervention sites and 80.5% at control sites (adjusted mean difference=9.5, 95% CI: 5.5-13.6, p < 0.001). CONCLUSIONS: SP training significantly improved quality of PrEP care for AGYW in Kenya. Incorporating SP training and unannounced SP evaluation could improve PrEP uptake among AGYW.

Higher rates of mental health screening of adolescents recorded after provider training using simulated patients in a Kenyan HIV clinic: results of a pilot study.

Background: Kenyan adolescent girls and young women (AGYW) experience a dual burden of HIV and common mental disorders (CMD). HIV clinics are a key entry point for AGYW in need of integrated CMD and HIV care; however, rates of screening and referral for CMDs are low. Our objective was to test an evidence-based provider training strategy, simulated patient encounters (SPEs), on CMD service delivery for AGYW in a Kenyan HIV clinic. Methods: This pilot study was conducted in a public HIV clinic in Thika, Kenya from January to November 2021. The simulated patient encounter (SPE) implementation strategy included case script development from prior qualitative work, patient actor training, and a three-day SPE training including four standardized mock clinical encounters followed by quantitative surveys assessing provider competencies for each encounter. We abstracted medical record data related to HIV and CMDs such as HIV status, reason for visit, CMD screening test performed, and counselling or referral information. We conducted an interrupted time series analysis using abstracted HIV and CMD screening rates from AGYW ages 16-25 years visiting the clinic 7 months before and 3 months after SPE training. We used generalized linear models to assess changes in CMD screening rates after training. Results: A total of 10 providers participated in the training. Competency ratings improved across four mock encounters (mean score from 8.1 to 13.7) between first and fourth encounters. We abstracted all medical records (n = 1,154) including from 888 (76%) AGYW seeking HIV treatment, 243 (21%) seeking prevention services, and 34 (3%) seeking other services. CMD screening rates increased immediately following training from 8 to 21% [relative risk (RR) = 2.57, 95% confidence interval (CI) = 1.34-4.90, p < 0.01]. The 3 months following the SPE training resulted in an 11% relative increase in CMD screening proportion compared to the 7 months pre-SPE (RR: 1.11, 95% CI: 1.04-1.17, p < 0.01). Finally, 1% of all pre-SPE screens resulted in referral versus 5% of post-SPE screens (p = 0.07). Conclusion: The SPE model is a promising implementation strategy for improving HIV provider competencies and CMD service delivery for adolescents in HIV clinics. Future research is needed to explore effects on adolescent clinical outcomes in larger trials.

The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) delivery at private pharmacies is a promising new differentiated service delivery model that may address barriers to PrEP delivery at public health care facilities. We measured the fidelity of this model (ie, delivery as intended) in a pilot study in Kenya. SETTING: Five private, retail pharmacies in Kisumu and Thika Counties. METHODS: Trained pharmacy providers delivered PrEP services, including identifying eligible clients, counseling on HIV risk, assessing PrEP safety, testing for HIV, and dispensing PrEP. Pharmacy clients completed surveys that assessed the fidelity of the services received after each visit. Standardized client actors (ie, mystery shoppers) were trained on 4 different case scripts, then made unannounced pharmacy visits, and then completed a 40-item checklist that assessed the fidelity and quality of service delivery components. RESULTS: From November 2020 to December 2021, 287 clients initiated and 159 (55%) refilled PrEP. At initiation, most clients were counseled on PrEP adherence (99%, 284 of 287) and potential side effects (97%, 279 of 287) and all received provider-assisted HIV self-testing before PrEP dispensing (findings consistent across refill visits). Nine standardized client actors completed 15 pharmacy visits. At each visit, most actors were asked about their behaviors associated with HIV risk (80%, 12/15) and all were counseled on PrEP safety and side effects. All actors reported that pharmacy providers treated them with respect. CONCLUSIONS: In this first pilot study of pharmacy-delivered PrEP services in Africa, the fidelity of service delivery was high, suggesting that trained providers at private pharmacies can deliver quality PrEP services.

Simulated patient training to improve youth engagement in HIV care in Kenya: A stepped wedge cluster randomized controlled trial.

Youth living with HIV (YLHIV) report that negative interactions with health care workers (HCWs) affects willingness to return to care. This stepped wedge randomized trial evaluated effectiveness of a standardized patient actor (SP) HCW training intervention on adolescent engagement in care in Kenya. HCWs caring for YLHIV at 24 clinics received training on adolescent care, values clarification, communication, and motivational interviewing, with 7 SP encounters followed by facilitated feedback of videotaped interactions. Facilities were randomized to timing of the intervention. The primary outcome was defined as return within 3 months after first visit (engagement) among YLHIV who were either newly enrolled or who returned to care after >3 months out of care. Visit data was abstracted from electronic medical records. Generalized linear mixed models adjusted for time, being newly enrolled, and clustering by facility. YLHIV were surveyed regarding satisfaction with care. Overall, 139 HCWs were trained, and medical records were abstracted for 4,595 YLHIV. Median YLHIV age was 21 (IQR 19-23); 82% were female, 77% were newly enrolled in care, and 75% returned within 3 months. Half (54%) of trained HCWs remained at their clinics 9 months post-training. YLHIV engagement improved over time (global Wald test, p = 0.10). In adjusted models, the intervention showed no significant effect on engagement [adjusted Prevalence Ratio (aPR) = 0.95, 95% Confidence Interval (CI): 0.88-1.02]. Newly enrolled YLHIV had significantly higher engagement than those with prior lapses in care (aPR = 1.18, 95%CI: 1.05-1.33). Continuous satisfaction with care scores were significantly higher by wave 3 compared to baseline (coefficient = 0.38, 95%CI: 0.19-0.58). Despite provider skill improvement, there was no effect of SP training on YLHIV engagement in care. This may be due to temporal improvements or turnover of trained HCWs. Strategies to retain SP-training benefits need to address HCW turnover. YLHIV with prior gaps in care may need more intensive support. Registration CT #: NCT02928900. https://clinicaltrials.gov/ct2/show/NCT02928900.

Mystery Shopper Assessment of PrEP Service Delivery Quality for Adolescent Girls and Young Women in Kenya: A Cross-sectional Study.

ABSTRACT: Pre-exposure prophylaxis (PrEP) uptake and adherence among adolescent girls and young women (AGYW) may be negatively influenced by poor interactions with health care providers. We assessed PrEP counseling using unannounced standardized patient actors (USPs) at routine care clinics in Kenya. Trained actors posed as AGYW seeking PrEP services following case scripts and completed a checklist of provider adherence to national guidelines and communication skills. Scores were converted into a percentage and compared using linear regression. The overall mean quality score was 52.1 and varied across case scripts: a married new initiator yielded higher scores than portrayals of adherence/stigma challenges, transactional sex, and a minor adolescent. Mean guideline scores (31.4) were lower than communication scores (72.8), although in 36.5% of encounters, USPs stated they would not seek help from that provider again. Unannounced standardized patients reported provider reluctance to offer PrEP to AGYW. Interventions to strengthen provider counseling skills are needed.

"I Have Actually not Lost any Adolescent Since I Started Engaging Them one on one:" Training Satisfaction and Subsequent Practice among Health Providers Participating in a Standardized Patient Actor Training to Improve Adolescent Engagement in HIV Care.

BACKGROUND: Poor health care worker (HCW) interactions with adolescents negatively influence engagement in HIV care. We assessed the impact of standardized patient actor training on HCW competence in providing adolescent HIV care in Kenya. METHODS: We conducted pre-post cross-sectional surveys and qualitative exit interviews during a stepped wedge randomized trial. Cross-sectional surveys assessed self-rated competence in providing adolescent services before and after the intervention, and training satisfaction. In-depth interviews with a subset of HCW participants one year after training. RESULTS: Over 90% of HCWs reported satisfaction with the training and there was significant improvement in self-rated competence scores (mean = 4.63 [highest possible score of 5] post-training vs 3.86 pre-training, p < 0.001). One-year following training, HCWs reported using skills in patient-centered communication and structuring an adolescent clinical encounter. CONCLUSIONS: This SP training intervention improved self-rated competence and showed sustained perceived impact on HCW skills in adolescent HIV service provision one year later.

Improving Quality of PrEP Counseling for Adolescent Girls and Young Women in Kenya With Standardized Patient Actors: A Dose-Response Analysis.

BACKGROUND: Health care worker (HCW) training using standardized patient actors (SPs) is an evidence-based approach for improving patient-provider interactions. We evaluated whether SP training among HCWs in Western Kenya improved the quality of pre-exposure prophylaxis (PrEP) counseling for adolescent girls and young women (AGYW). METHODS: We conducted a 2-day SP training intervention among HCWs providing PrEP counseling for AGYW. Six trained SPs role played one encounter each with HCWs following scripts depicting common PrEP-seeking scenarios. SPs used checklists to report and discuss domains of adherence to national PrEP guidelines, communication, and interpersonal skills using validated scales after each encounter. HCWs presented to each case in a random order. Overall and domain-specific mean score percentages were compared between the first and subsequent case encounters using generalized linear models, clustering by HCWs. RESULTS: During 564 training cases among 94 HCWs, the overall mean quality of PrEP counseling score was 83.1 (SD: 10.1); scores improved over the course of the 6 encounters (P < 0.001). Compared with the first case encounter, the mean scores for the fourth were significantly higher (79.1 vs. 85.9, P < 0.001). The mean scores plateaued from the fourth to the sixth case (85.2). Although HCWs demonstrated high baseline communication (95.3) and interpersonal skills (83.7), adherence to PrEP guidelines at baseline was suboptimal (57.6). By the fourth case, scores increased significantly (P < 0.001) for all domains. CONCLUSIONS: SP training improved PrEP counseling overall and in domains of interpersonal skills, use of guidelines, and communication with AGYW and could be useful in efforts to improve the quality of PrEP counseling for AGYW.

SP safety, autonomy and healthcare simulation practice in the COVID-19 era.

This letter expands upon the three tenets of the Healthcare Simulation Manifesto-comprehensive safety, collaborative advocacy, and ethical leadership. To do this, we will discuss two key terms: 'essential' and 'autonomy' in relation to safety for standardized/simulated patients (SPs). In this time of crisis, simulationists must move the boundary of skills training previously accepted as safe for human beings, and leverage technology to ensure the highest level of safety achievable for our SPs.

Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial.

INTRODUCTION: Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies. METHODS AND ANALYSIS: PrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP 'mystery shoppers' present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group. ETHICS AND DISSEMINATION: The protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT03875950.

Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial.

BACKGROUND: Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10-24 years (AYA) to promote health outcomes and improve retention in HIV care and treatment. However, few interventions focus on improving healthcare worker (HCW) competencies and skills for provision of high-quality adolescent care. Standardized patients (SPs) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment, communication, and empathy skills. This stepped-wedge randomized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA, resulting in increased retention in care. METHODS/DESIGN: The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment, communication, and empathy skills for AYA HIV care. We will recruit 24 clinics in Kenya with an active electronic medical record (EMR) system and at least 40 adolescents enrolled in HIV care per site. Stratified randomization by county will be used to assign clinics to one of four waves - time periods when they receive the intervention - with each wave including six clinics. From each clinic, up to 10 HCWs will participate in the training intervention. SP training includes didactic sessions in adolescent health, current guidelines, communication skills, and motivational interviewing techniques. HCW participants will rotate through seven standardized SP scenarios, followed by SP feedback, group debriefing, and remote expert evaluation. AYA outcomes will be assessed using routine clinic data. The primary outcome is AYA retention in HIV care, defined as returning for first follow-up visit within 6 months of presenting to care, or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up. Secondary outcomes include HCW competency scores, AYA satisfaction with care, and AYA clinical outcomes including CD4 and viral load. Additional analyses will determine cost-effectiveness of the intervention. DISCUSSION: This trial will contribute valuable information to HIV programs in Kenya and other low-resource settings, providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02928900. Registered 26 August 2016.

Three methods of delivering clinic-based training on syndromic management of sexually transmitted diseases in South Africa: a pilot study.

INTRODUCTION: The South African National Department of Health sought to improve syndromic management of sexually transmitted infections (STIs). Continuing medical education on STIs was delivered at primary healthcare (PHC) clinics using one of three training methods: (1) lecture, (2) computer and (3) paper-based. Clinics with training were compared with control clinics. METHODS: Ten PHC clinics were randomly assigned to control and 10 to each training method arm. Clinicians participated in on-site training on six modules; two per week for three weeks. Each clinic was visited by three or four unannounced standardised patient (SP) actors pre-training and post-training. Male SPs reported symptoms of male urethritis syndrome and female SPs reported symptoms of vaginal discharge syndrome. Quality of healthcare was measured by whether or not clinicians completed five tasks: HIV test, genital exam, correct medications, condoms and partner notification. RESULTS: An average of 31% of clinicians from each PHC attended each module. Quality of STI care was low. Pre-training (n=128) clinicians completed an average of 1.63 tasks. Post-training (n=114) they completed 1.73. There was no change in the number of STI tasks completed in the control arm and an 11% increase overall in the training arms relative to the control (ratio of relative risk (RRR)=1.11, 95% CI 0.67 to 1.84). Across training arms, there was a 26% increase (RRR=1.26, 95% CI 0.77 to 2.06) associated with lecture, 17% increase (RRR=1.17, 95% CI 0.59 to 2.28) with paper-based and 13% decrease (RRR=0.87, 95% CI 0.40 to 1.90) with computer arm relative to the control. CONCLUSIONS: Future interventions should address increasing training attendance and computer-based training effectiveness. TRIAL REGISTRATION NUMBER: AEARCTR-0000668.

Standardized patient assessment of medical student empathy: ethnicity and gender effects in a multi-institutional study.

PURPOSE: To examine, primarily, the effects of ethnicity and gender, which could introduce bias into scoring, on standardized patient (SP) assessments of medical students and, secondarily, to examine medical students' self-reported empathy for ethnicity and gender effects so as to compare self-perception with the perceptions of SPs. METHOD: Participants were 577 students from four medical schools in 2012: 373 (65%) were white, 79 (14%) black/African American, and 125 (22%) Asian/Pacific Islander. These students were assessed by 84 SPs: 62 (74%) were white and 22 (26%) were black/African American. SPs completed the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE) and the Global Ratings of Empathy tool. Students completed the Jefferson Scale of Empathy and two Interpersonal Reactivity Index subscales. The investigators used 2,882 student-SP encounters in their analyses. RESULTS: Analyses of SPs' assessments of students' empathy indicated significant interaction effects of gender and ethnicity. Female students, regardless of ethnicity, obtained significantly higher mean JSPPPE scores than men. Female black/African American, female white, and female Asian/Pacific Islander students scored significantly higher on the JSPPPE than their respective male counterparts. Male black/African American students obtained the lowest SP assessment scores of empathy regardless of SP ethnicity. Black/African American students obtained the highest mean scores on self-reported empathy. CONCLUSIONS: The significant interaction effects of ethnicity and gender in clinical encounters, plus the inconsistencies observed between SPs' assessments of students' empathy and students' self-reported empathy, raise questions about possible ethnicity and gender biases in the SPs' assessments of medical students' clinical skills.

Characteristics of simulation activities at North American medical schools and teaching hospitals: an AAMC-SSH-ASPE-AACN collaboration.

SUMMARY STATEMENT: In September 2011, the Association of American Medical Colleges released the results of a survey conducted in 2010 on simulation activities at its member medical schools and teaching hospitals. In this commentary, we offer a synthesis of data and conclude that (1) simulation is used broadly at Association of American Medical Colleges member institutions, for many types of learners, including other health care professionals; (2) it addresses core training competencies and has many educational purposes; (3) its use in learner assessment is more prevalent at medical schools but is still significant at teaching hospitals; and (4) it requires a considerable investment of money, space, personnel, and time. These data confirm general perceptions about the state of simulation in North America for physician training. Future endeavors should include a more granular examination of how simulation is integrated into curricula, a similar survey of other health care-related institutions and professions, and a periodic assessment to characterize trends over time.