A youth-centred approach to improving engagement in HIV services: human-centred design methods and outcomes in a research trial in Kisumu County, Kenya.

IntroductionInnovative interventions are needed to improve HIV outcomes among adolescents and young adults (AYAs) living with HIV. Engaging AYAs in intervention development could increase effectiveness and youth acceptance, yet research is limited. We applied human-centred design (HCD) to refine adherence-support interventions pretrial and assessed HCD workshop acceptability. METHODS: We applied an iterative, four-phased HCD process in Kenya that included: (1) systematic review of extant knowledge, (2) prioritisation of design challenges, (3) a co-creation workshop and (4) translation tables to pair insights with trial intervention adaptations. The co-creation workshop was co-led by youth facilitators employing participatory activities to inform intervention adaptations. Iterative data analysis included rapid thematic analysis of visualised workshop outputs and notes using affinity mapping and dialogue to identify key themes. We conducted a survey to assess workshop acceptability among participants. RESULTS: Twenty-two participants engaged in the 4-day workshop. Co-creation activities yielded recommendations for improving planned interventions (eg, message frequency and content; strategies to engage hard-to-reach participants), critical principles to employ across interventions (eg, personalisation, AYA empowerment) and identification of unanticipated AYA HIV treatment priorities (eg, drug holidays, transition from adolescent to adult services). We revised intervention content, peer navigator training materials and study inclusion criteria in response to findings. The youth-led HCD workshop was highly acceptable to participants. CONCLUSIONS: Research employing HCD among youth can improve interventions preimplementation through empathy, youth-led inquiry and real-time problem solving. Peer navigation may be most influential in improving retention when engagement with young people is based on mutual trust, respect, privacy and extends beyond HIV-specific support. Identifying opportunities for personalisation and adaptation within intervention delivery is important for AYAs. Patient engagement interventions that target young people should prioritise improved transition between youth and adult services, youth HIV status disclosure, AYA empowerment and healthcare worker responsiveness in interactions and episodic adherence interruptions.

Oral HIV pre-exposure prophylaxis use among pregnant and postpartum women: results from real-world implementation in Lesotho.

Introduction: Lesotho has reached epidemic control, PrEP is an important component in maintaining that and in reaching the goal of eliminating mother-to-child transmission. Methods: We conducted a retrospective review of existing, routine PrEP health records in 26 health facilities in Lesotho. PrEP visit data were collected for pregnant and postpartum women screened for PrEP and/or enrolled in PrEP programs from 1 January 2019 through 30 June 2021 with follow-up data collected up to the date of data abstraction per site between October 2021 and May 2022. Poisson regression with robust variance was used to evaluate the association between patient characteristics and continuation of PrEP. Results: Indications for starting PrEP were significantly associated with continuation in PrEP use. Women starting PrEP due to having a partner known to be living with HIV were the most likely to return for follow-up. In all age groups, the most common reason for starting PrEP was being in a serodiscordant relationship, though the proportion varies by age. Conclusion: As Lesotho is now in the process of optimizing PrEP use among pregnant and postpartum women, it is critical to revise data sources to capture information that will link PrEP records and ANC/PNC records and document pregnancy/postpartum status in order to better understand PrEP use and gaps in this population.

Patterns of person-centred communications in public HIV clinics: a latent class analysis using the Roter interaction analysis system.

INTRODUCTION: Poor client-provider communication is a critical barrier to long-term retention in care among people living with HIV. However, standardized assessments of this key metric are limited in Africa. We used the Roter Interaction Analysis System (RIAS) to quantitatively characterize patterns of person-centred communication (PCC) behaviours in Zambia. METHODS: We enrolled pairs of people living with HIV making routine HIV follow-up visit and their providers at 24 Ministry of Health-facilities supported by the Centre for Infectious Disease Research in Zambia in Lusaka province between August 2019 and November 2021. Client-provider encounters were audio-recorded and coded using RIAS by trained research staff. We performed latent class analysis to identify interactions with distinctive patterns of provider PCC behaviours (i.e. rapport building, person-centred counselling, PCC micropractices [e.g. brief empathy statements], assessing barriers to care, shared decision-making and leveraging discretionary power) and compared their distribution across client, provider, interaction and facility characteristics. RESULTS: We enrolled 478 people living with HIV and 139 providers (14% nurses, 73.6% clinical officers, 12.3% were medical officers). We identified four distinct profiles: (1) "Medically Oriented Interaction, Minimal PCC Behaviours" (47.6% of interactions) was characterized by medical discussion, minimal psychosocial/non-medical talk and low use of PCC behaviours; (2) "Balanced Medical/Non-medical Interaction, Low PCC Behaviours" (21.0%) was characterized by medical and non-medical discussion but limited use of other PCC behaviours; (3) "Medically Oriented Interaction, Good PCC Behaviours" (23.9%) was characterized by medically oriented discussion, more information-giving and increased use of PCC behaviours; and (4) "Highly person-centred Interaction" (7.5%) was characterized by both balanced medical/non-medical focus and the highest use of PCC behaviours. Nurse interactions were more likely to be characterized by more PCC behaviours (i.e. Class 3 or 4) (44.8%), followed by medical officers (33.9%) and clinical officers (27.3%) (p = 0.031). Longer interactions were also more likely to integrate more PCC behaviours (p < 0.001). CONCLUSIONS: PCC behaviours are relatively uncommon in HIV care in Zambia, and often limited to brief rapport-building statements and PCC micropractices. Strengthening PCC, such as shared decision-making and leveraging discretionary power to better accommodate client needs and preferences, may be an important strategy for improving the quality in HIV treatment programmes.

Provider perspectives on patient-centredness: participatory formative research and rapid analysis methods to inform the design and implementation of a facility-based HIV care improvement intervention in Zambia.

INTRODUCTION: Implementation of patient-centred care (PCC) practices in HIV treatment depends on healthcare workers' (HCWs) perceptions of the acceptability, appropriateness and feasibility of such practices (e.g. use of intentional, metric-driven activities to improve patient experiences). METHODS: We applied rapid, rigorous formative research methods to refine a PCC intervention for future trial. In 2018, we conducted focus group discussions (FGDs) with 46 HCWs purposefully selected from two pilot sites. We elicited HCW perceptions of HIV service delivery, HCW motivation and perceived value of patient experience measures intended to improve PCC. FGDs utilized participatory methods to understand HCW responses to patient-reported care engagement challenges and Scholl's PCC Framework principles (e.g. seeing a patient as a unique person), enablers (e.g. care coordination) and activities (e.g. patient involvement). Our rapid analysis used analytic memos, thematic analysis, research team debriefs and HCW feedback to inform time-sensitive trial implementation. RESULTS: While HCWs nearly universally identified with and supported principles of PCC in both facilities, they raised practical barriers given the practice environment. HCWs described motivation to help patients, attached value to seeing positive health outcomes and the importance of teamwork. However, HCWs reported challenges with enablers needed to deliver PCC. HCWs cited a work culture characterized by differential power dynamics between cadres and departments restricting HCW autonomy and resource access. Barriers included inflexibility in accommodating individual patient needs due to high patient volumes, limited human resources, laboratory capacity, infrastructure and skills translating patient perspectives into practice. HCW motivation was negatively influenced by encounters with "difficult patients," and feeling "unappreciated" by management, resulting in cognitive dissonance between HCW beliefs and behaviours. However, the enactment of PCC values also occurred. Results suggested that PCC interventions should reduce practice barriers, highlighting the value of mentors who could help HCWs dynamically engage with health system constraints, to facilitate PCC. CONCLUSIONS: While HCWs perceived PCC principles as acceptable, they did not think it universally appropriate or feasible given the practice environment. Participatory and rapid methods provided timely insight that PCC interventions must provide clear and effective systems enabling PCC activities by measuring and mitigating relational and organizational constraints amenable to change such as inter-cadre coordination.

Comparison of patient exit interviews with unannounced standardised patients for assessing HIV service delivery in Zambia: a study nested within a cluster randomised trial.

OBJECTIVES: To compare unannounced standardised patient approach (eg, mystery clients) with typical exit interviews for assessing patient experiences in HIV care (eg, unfriendly providers, long waiting times). We hypothesise standardised patients would report more negative experiences than typical exit interviews affected by social desirability bias. SETTING: Cross-sectional surveys in 16 government-operated HIV primary care clinics in Lusaka, Zambia providing antiretroviral therapy (ART). PARTICIPANTS: 3526 participants aged ≥18 years receiving ART participated in the exit surveys between August 2019 and November 2021. INTERVENTION: Systematic sample (every nth file) of patients in clinic waiting area willing to be trained received pre-visit training and post-visit interviews. Providers were unaware of trained patients. OUTCOME MEASURES: We compared patient experience among patients who received brief training prior to their care visit (explaining each patient experience construct in the exit survey, being anonymous, without manipulating behaviour) with those who did not undergo training on the survey prior to their visit. RESULTS: Among 3526 participants who participated in exit surveys, 2415 were untrained (56% female, median age 40 (IQR: 32-47)) and 1111 were trained (50% female, median age 37 (IQR: 31-45)). Compared with untrained, trained patients were more likely to report a negative care experience overall (adjusted prevalence ratio (aPR) for aggregate sum score: 1.64 (95% CI: 1.39 to 1.94)), with a greater proportion reporting feeling unwelcome by providers (aPR: 1.71 (95% CI: 1.20 to 2.44)) and witnessing providers behaving rude (aPR: 2.28 (95% CI: 1.63 to 3.19)). CONCLUSION: Trained patients were more likely to identify suboptimal care. They may have understood the items solicited better or felt empowered to be more critical. We trained existing patients, unlike studies that use 'standardised patients' drawn from outside the patient population. This low-cost strategy could improve patient-centred service delivery elsewhere. TRIAL REGISTRATION NUMBER: Assessment was nested within a parent study; www.pactr.org registered the parent study (PACTR202101847907585).

Mixed Methods, Implementation Science Evaluation of a Community Health Worker Strategy for HIV Service Engagement in Uganda.

BACKGROUND: A trial found that a community health worker (CHW) strategy using "Health Scouts" improved HIV care uptake and ART coverage. To better understand outcomes and areas for improvement, we conducted an implementation science evaluation. METHODS: Using the RE-AIM framework, quantitative methods included analyses of a community-wide survey (n = 1903), CHW log books, and phone application data. Qualitative methods included in-depth interviews (n = 72) with CHWs, clients, staff, and community leaders. RESULTS: Thirteen Health Scouts logged 11,221 counseling sessions; 2532 unique clients were counseled. 95.7% (1789 of 1891) of residents reported awareness of the Health Scouts. Overall, reach (self-reported receipt of counseling) was 30.7% (580 of 1891). Unreached residents were more likely to be male and HIV seronegative ( P < 0.05). Qualitative themes included the following: (1) reach was promoted by perceived usefulness but deterred by busy client lifestyles and stigma, (2) effectiveness was enabled through good acceptability and consistency with the conceptual framework, (3) adoption was facilitated by positive impacts on HIV service engagement, and (4) implementation fidelity was initially promoted by the CHW phone application but deterred by mobility. Maintenance showed consistent counseling sessions over time. The findings suggested the strategy was fundamentally sound but had suboptimal reach. Future iterations could consider adaptations to improve reach to priority populations, testing the need for mobile health support, and additional community sensitization to reduce stigma. CONCLUSIONS: A CHW strategy to promote HIV services was implemented with moderate success in an HIV hyperendemic setting and should be considered for adoption and scale-up in other communities as part of comprehensive HIV epidemic control efforts. TRIAL REGISTRATION: ClinicalTrials.gov Trial Number NCT02556957.

Cross-sectional study to assess depression among healthcare workers in Lusaka, Zambia during the COVID-19 pandemic.

OBJECTIVES: We sought to assess depression among healthcare workers (HCWs) in the context of COVID-19 in Lusaka Province, Zambia. DESIGN: This cross-sectional study is nested within a larger study, the Person-Centred Public Health for HIV Treatment in Zambia (PCPH), a cluster-randomised trial to assess HIV care and outcomes. SETTING: The research was conducted in 24 government-run health facilities from 11 August to 15 October 2020 during the first wave of the COVID-19 pandemic in Lusaka, Zambia. PARTICIPANTS: We used convenience sampling to recruit HCW participants who were previously enrolled in the PCPH study, had more than 6 months' experience working at the facility and were voluntarily willing to participate. PRIMARY OUTCOME MEASURES: We implemented the well-validated 9-question Patient Health Questionnaire (PHQ-9) to assess HCW depression. We used mixed-effects, adjusted Poisson regression to estimate the marginal probability of HCWs experiencing depression that may warrant intervention (PHQ-9 score ≥5) by healthcare facility. RESULTS: We collected PHQ-9 survey responses from 713 professional and lay HCWs. Overall, 334 (46.8%, 95% CI 43.1%, 50.6%) HCWs recorded a PHQ-9 score ≥5, indicating the need for further assessment and potential intervention for depression. We identified significant heterogeneity across facilities and observed a greater proportion of HCWs with symptoms of depression in facilities providing COVID-19 testing and treatment services. CONCLUSIONS: Depression may be a concern for a large proportion of HCWs in Zambia. Further work to understand the magnitude and aetiologies of depression among HCWs in the public sector is needed to design effective prevention and treatment interventions to meet the needs for mental health support and to minimise poor health outcomes.

Patient interpretations vary for questions in the Patient-Reported Outcomes Measurement Information System Upper Extremity.

The Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS-UE) is frequently used in research/clinical care, but how it is understood by patients is unknown. We conducted a qualitative study including 12 cognitive interviews with patients with hand/upper extremity conditions and those purposively sampled for mixed literacy. Using framework analysis, we identified six themes total: difficulty answering questions due to insufficient information; uncertainty about whether to respond with the ability to perform the task with the injured extremity alone, either the injured or healthy extremity, or both; lack of experience doing certain tasks; uncertainty about whether to answer questions based on ability to perform the task with or without adaptive techniques; answering questions based on limitations not related to upper extremity function; and uncertainty regarding whether to answer questions on the basis of ability or pain. This study demonstrates the challenges in completing questionnaires and that variability may limit the reliability, validity and responsiveness of the PROMIS-UE.

Trajectories of re-engagement: factors and mechanisms enabling patient return to HIV care in Zambia.

INTRODUCTION: While disengagement from HIV care threatens the health of persons living with HIV (PLWH) and incidence-reduction targets, re-engagement is a critical step towards positive outcomes. Studies that establish a deeper understanding of successful return to clinical care among previously disengaged PLWH and the factors supporting re-engagement are essential to facilitate long-term care continuity. METHODS: We conducted narrative, patient-centred, in-depth interviews between January and June 2019 with 20 PLWH in Lusaka, Zambia, who had disengaged and then re-engaged in HIV care, identified through electronic medical records (EMRs). We applied narrative analysis techniques, and deductive and inductive thematic analysis to identify engagement patterns and enablers of return. RESULTS: We inductively identified five trajectories of care engagement, suggesting patterns in patient characteristics, experienced barriers and return facilitators that may aid intervention targeting including: (1) intermittent engagement;(2) mostly engaged; (3) delayed linkage after testing; (4) needs time to initiate antiretroviral therapy (ART); and (5) re-engagement with ART initiation. Patient-identified periods of disengagement from care did not always align with care gaps indicated in the EMR. Key, interactive re-engagement facilitators experienced by participants, with varied importance across trajectories, included a desire for physical wellness and social support manifested through verbal encouragement, facility outreach or personal facility connections and family instrumental support. The mechanisms through which facilitators led to return were: (1) the promising of living out one's life priorities; (2) feeling valued; (3) fostering interpersonal accountability; (4) re-entry navigation support; (5) facilitated care and treatment access; and (6) management of significant barriers, such as depression. CONCLUSIONS: While preliminary, the identified trajectories may guide interventions to support re-engagement, such as offering flexible ART access to patients with intermittent engagement patterns instead of stable patients only. Further, for re-engagement interventions to achieve impact, they must activate mechanisms underlying re-engagement behaviours. For example, facility outreach that reminds a patient to return to care but does not affirm a patient's value or navigate re-entry is unlikely to be effective. The demonstrated importance of positive health facility connections reinforces a growing call for patient-centred care. Additionally, interventions should consider the important role communities play in fostering treatment motivation and overcoming practical barriers.

Adapt for Adolescents: Protocol for a sequential multiple assignment randomized trial to improve retention and viral suppression among adolescents and young adults living with HIV in Kenya.

BACKGROUND: Adolescents and young adults living with HIV (AYAH) aged 14-24 years in Africa experience substantially higher rates of virological failure and HIV-related mortality than adults. We propose to utilize developmentally appropriate interventions with high potential for effectiveness, tailored by AYAH pre-implementation, in a sequential multiple assignment randomized trial (SMART) aimed at improving viral suppression for AYAH in Kenya. METHODS: Using a SMART design, we will randomize 880 AYAH in Kisumu, Kenya to either youth-centered education and counseling (standard of care) or electronic peer navigation in which a peer provides support, information, and counseling via phone and automated monthly text messages. Those with a lapse in engagement (defined as either a missed clinic visit by ≥14 days or HIV viral load ≥1000 copies/ml) will be randomized a second time to one of three higher-intensity re-engagement interventions: This study will evaluate which interventions and which dynamic sequence of interventions improve sustained viral suppression and HIV care engagement in AYAH at 24 months post-enrollment and assess the cost-effectiveness of successful strategies. DISCUSSION: The study utilizes promising interventions tailored to AYAH while optimizing resources by intensifying services only for those AYAH who need more support. Findings from this innovative study will offer evidence for public health programming to end the HIV epidemic as a public health threat for AYAH in Africa. TRIAL REGISTRATION: Clinicaltrials.govNCT04432571, registered June 16, 2020.

HIV care experiences and health priorities during the first wave of COVID-19: clients' perspectives - a qualitative study in Lusaka, Zambia.

BACKGROUND: The novel COVID-19 pandemic threatened to disrupt access to human immunodeficiency (HIV) treatment for persons living with HIV (PLHIV), two-thirds of whom live in sub-Saharan Africa. To inform a health system response supportive of continuity of care, we sought to understand clients' HIV care experiences and health priorities during the first wave of COVID-19 outbreak in Lusaka, Zambia. METHODS: Leveraging a study cohort of those who completed periodic SMS surveys on HIV care, we purposefully sampled 25 PLHIV after first confirmed COVID-19 case was reported in Zambia on 18th March 2020. We phone-interviewed participants, iteratively refining interview guide to capture emergent themes on COVID-19 awareness, health facility interactions, and social circumstances, which we analyzed using matrix analysis. RESULTS: All participants were aware of COVID-19, and HIV care experiences and health priorities of clients were affected by associated changes at health system, household, and individual level. The health system instituted early clinic visits to provide 6-months of antiretroviral therapy (ART) for stable patients and 3-months for unstable patients to reduce clinic visits and wait times. Most patients welcomed this long-desired extended appointment spacing. Some reported feeling respected and engaged when health care workers telephoned requesting their early clinic visit. However, others felt discouraged by an absence of physical distancing during their clinic visit due to 'severe acute respiratory syndrome coronavirus 2' (SARS-CoV-2) infection concerns. Several expressed a lack of clarity regarding next viral load monitoring date and means for receiving results. Patients suggested regular patient-facility communication by telephone and SMS. Patients emphasized that COVID-19 restrictions led to loss of employment and household income, exacerbating poverty and difficulties in taking ART. At individual level, most participants felt motivated to stay healthy during COVID-19 by ART adherence and regular laboratory monitoring. CONCLUSIONS: Clients' HIV care and health priorities during the first wave of COVID-19 in Lusaka province were varied with a combination of positive and negative experiences that occurred especially at health system and individual levels, while at household level, the experiences were all negative. More research is needed to understand how patients practice resiliency in the widespread context of socio-economic instability. Governments and patients must work together to find local, health systems solutions to support ART adherence and monitoring. Additionally, the health system should consider how to build on changes for long-term HIV management and service delivery.

Acceptability and feasibility of mobile phone-based ecological momentary assessment and intervention in Uganda: A pilot randomized controlled trial.

Valid, reliable behavioral data and contextually meaningful interventions are necessary for improved health outcomes. Ecological Momentary Assessment and Intervention (EMAI), which collects data as behaviors occur to deliver real-time interventions, may be more accurate and reliable than retrospective methods. The rapid expansion of mobile technologies in low-and-middle-income countries allows for unprecedented remote data collection and intervention opportunities. However, no previous studies have trialed EMAI in sub-Saharan Africa. We assessed EMAI acceptability and feasibility, including participant retention and response rate, in a prospective, parallel group, randomized pilot trial in Rakai, Uganda comparing behavioral outcomes among adults submitting ecological momentary assessments (EMA) versus EMAI. After training, participants submitted EMA data on five nutrition and health risk behaviors over a 90-day period using a smartphone-based application utilizing prompt-based, participant-initiated, and geospatial coordinate data collection, with study coordinator support and incentives for >50% completion. Included behaviors and associated EMAI-arm intervention messages were selected to pilot a range of EMAI applications. Acceptability was measured on questionnaires. We estimated the association between high response rate and participant characteristics and conducted thematic analysis characterizing participant experiences. Study completion was 48/50 participants. Median prompt response rate was 66.5% (IQR: 60.0%-78.6%). Prior smartphone app use at baseline (aPR 3.76, 95%CI: 1.16-12.17, p = 0.03) and being in the intervention arm (aPR 2.55, 95% CI: 1.01-6.44, p = 0.05) were significantly associated with the top response rate quartile (response to >78.6% of prompts). All participants submitted self-initiated reports, covering all behaviors of interest, including potentially sensitive behaviors. Inconsistent phone charging was the most reported feasibility challenge. In this pilot, EMAI was acceptable and feasible. Response rates were good; additional strategies to improve compliance should be investigated. EMAI using mobile technologies may support improved behavioral data collection and intervention approaches in low and middle-income settings. This approach should be tested in larger studies.

Data Velocity in HIV-Related Implementation Research: Estimating Time From Funding to Publication.

BACKGROUND: Given available effective biomedical and behavioral prevention and treatment interventions, HIV-related implementation research (IR) is expanding. The rapid generation and dissemination of IR to inform guidelines and practice has the potential to optimize the impact of the Ending the Epidemic Initiative and the HIV pandemic response more broadly. METHODS: We leveraged a prior mapping review of NIH-funded awards in HIV and IR from January 2013 to March 2018 and identified all publications linked to those grants in NIH RePORTER through January 1, 2021 (n = 1509). Deduplication and screening of nonoriginal research reduced the count to 1032 articles, of which 952 were eligible and included in this review. Publication volume and timing were summarized; Kaplan-Meier plots estimated time to publication. RESULTS: Among the 215 NIH-funded IR-related awards, 127 of 215 (59%) published original research directly related to the grant, averaging 2.0 articles (SD: 3.3) per award, largely in the early IR phases. Many articles (521 of 952, 55%) attributed to grants did not report grant-related data. Time from article submission to publication averaged 205 days (SD: 107). The median time-to-first publication from funding start was 4 years. Data dissemination velocity varied by award type, trending toward faster publication in recent years. Delays in data velocity included (1) time from funding to enrollment, (2) enrollment length, and (3) time from data collection completion to publication. CONCLUSION: Research publication was high overall, and time-to-publication is accelerating; however, over 40% of grants have yet to publish findings from grant-related data. Addressing bottlenecks in the production and dissemination of HIV-related IR would reinforce its programmatic and policy relevance in the HIV response.

Five Common Myths Limiting Engagement in HIV-Related Implementation Research.

ABSTRACT: HIV-related implementation research holds great promise in achieving the potential of efficacious prevention and treatment tools in reducing the incidence of HIV and improving HIV treatment outcomes among people living with HIV. From the perspectives of HIV-related implementation research training and academia and through consultations with funders and investigators new to implementation research, we identified 5 myths that act as barriers to engagement in implementation research among new investigators. Prevailing myths broadly include (1) one must rigidly apply all aspects of an implementation framework for it to be valid, (2) implementation research limits the type of designs available to researchers, (3) implementation strategies cannot be patient-level or client-level approaches, (4) only studies prioritizing implementation outcomes are "true" implementation research, and (5) if not explicitly labeled implementation research, it may have limited impact on implementation. We offer pragmatic approaches to negotiate these myths with the goal of encouraging dialog, ensuring high-quality research, and fostering a more inclusive and dynamic field of implementation research. Ultimately, the goal of dispelling these myths was to lower the perceived bar to engagement in HIV-related implementation research while still ensuring quality in the methods and measures used.

'I need time to start antiretroviral therapy': understanding reasons for delayed ART initiation among people diagnosed with HIV in Lusaka, Zambia'.

INTRODUCTION: Rapid antiretroviral therapy (ART) initiation can improve patient outcomes such as viral suppression and prevent new infections. However, not everyone who can start ART does so immediately. METHODS: We conducted a qualitative study to inform interventions supporting rapid initiation in the 'Test and Start' era. We purposively sampled 20 adult patients living with HIV and a previous gap in care from ten health facilities in Lusaka, Zambia for interviews. We inductively analysed transcripts using a thematic, narrative approach. In their narratives, seven participants discussed delaying ART initiation. RESULTS: Drawing on messages gleaned from facility-based counselling and community information, many cited greater fear of rapid sickness or death due to imperfect adherence or treatment side effects than negative health consequences due to delayed initiation. Participants described needing time to 'prepare' their minds for a lifetime treatment commitment. Concerns about inadvertent HIV status disclosure during drug collection discouraged immediate initiation, as did feeling healthy, and worries about the impact of ART initiation on relationship dynamics. CONCLUSION: Findings suggest that counselling messages should accurately communicate treatment risks, without perpetuating fear-based narratives about HIV. Identifying and managing patient-specific concerns and reasons for the 'need for time' may be important for supporting individuals to rapidly accept lifelong treatment.Key messagesFear-based adherence messaging in health facilities about the dangers of missing a treatment dose or changing the time when ART is taken contributes to Zambian patients' refusals of immediate ART initiationResponsive health systems that balance a stated need for time to accept one's diagnosis and prepare to embark on a lifelong treatment plan with interventions to identify and manage patient-specific treatment related fears and concerns may support more rapid ART initiationPerceived social stigma around HIV continues to be a significant challenge for treatment initiation.

"Provider discretionary power practices to support implementation of patient-centered HIV care in Lusaka, Zambia".

Introduction: Traditional patient-provider relationships privilege the providers, as they possess the formal authority and clinical knowledge applied to address illness, but providers also have discretion over how they exercise their power to influence patients' services, benefits, and sanctions. In this study, we assessed providers' exercise of discretionary power in implementing patient-centered care (PCC) practices in Lusaka, Zambia. Methods: HIV clinical encounters between patients on antiretroviral therapy (ART) and providers across 24 public health facilities in Lusaka Province were audio recorded and transcribed verbatim. Using qualitative content analysis, we identified practices of discretionary power (DP) employed in the implementation of PCC and instances of withholding DP. A codebook of DP practices was inductively and iteratively developed. We compared outcomes across provider cadres and within sites over time. Results: We captured 194 patient-provider interactions at 24 study sites involving 11 Medical Officers, 58 Clinical Officers and 10 Nurses between August 2019 to May 2021. Median interaction length was 7.5 min. In a hierarchy where providers dominate patients and interactions are rapid, some providers invited patients to ask questions and responded at length with information that could increase patient understanding and agency. Others used inclusive language, welcomed patients, conducted introductions, and apologized for delayed services, narrowing the hierarchical distance between patient and provider, and facilitating recognition of the patient as a partner in care. Although less common, providers shared their decision-making powers, allowing patients to choose appointment dates and influence regimens. They also facilitated resource access, including access to services and providers outside of scheduled appointment times. Application of DP was not universal and missed opportunities were identified. Conclusion: Supporting providers to recognize their power and intentionally share it is both inherent to the practice of PCC (e.g., making a patient a partner), and a way to implement improved patient support. More research is needed to understand the application of DP practices in improving the patient-centeredness of care in non-ART settings.

Patient-level barriers and facilitators to completion of patient-reported outcomes measures.

PURPOSE: To identify patient-level barriers and facilitators to completion of patient-reported outcomes measures (PROMs) in a hand and upper extremity clinic in Baltimore, Maryland. METHODS: We conducted 12 h of direct observation of PROM completion (October-November, 2020). Ethnographic observation memos were qualitatively analyzed for barriers and facilitators using rapid thematic analysis. Informed by observation findings, we conducted 17 semi-structured interviews with mixed-literacy patients, caregivers, and clinic staff to understand the patient experience when completing PROMs (November 2020-March 2021). We identified initial themes through inductive and deductive framework analysis and validated findings through subsequent interviews with member-checking. RESULTS: We identified nine patient-level factors that influence PROM completion: platform design, print literacy, health literacy, technology literacy, language proficiency, physical functioning, vision, cognitive functioning, and time. CONCLUSIONS: There are multiple distinct patient-level factors that affect PROM completion. Failure to consider these factors in PROM design and implementation may lower completion rates or prevent accurate completion, undermining PROM validity. Because certain factors affect minority populations at disproportionate rates, this may also contribute to existing health disparities.

The effect of tracer contact on return to care among adult, "lost to follow-up" patients living with HIV in Zambia: an instrumental variable analysis.

INTRODUCTION: Tracing patients lost to follow-up (LTFU) from HIV care is widely practiced, yet we have little knowledge of its causal effect on care engagement. In a prospective, Zambian cohort, we examined the effect of tracing on return to care within 2 years of LTFU. METHODS: We traced a stratified, random sample of LTFU patients who had received HIV care between August 2013 and July 2015. LTFU was defined as a gap of >90 days from last scheduled appointment in the routine electronic medical record. Extracting 2 years of follow-up visit data through 2017, we identified patients who returned. Using random selection for tracing as an instrumental variable (IV), we used conditional two-stage least squares regression to estimate the local average treatment effect of tracer contact on return. We examined the observational association between tracer contact and return among patient sub-groups self-confirmed as disengaged from care. RESULTS: Of the 24,164 LTFU patients enumerated, 4380 were randomly selected for tracing and 1158 were contacted by a tracer within a median of 14.8 months post-loss. IV analysis found that patients contacted by a tracer because they were randomized to tracing were no more likely to return than those not contacted (adjusted risk difference [aRD]: 3%, 95% CI: -2%, 8%, p = 0.23). Observational data showed that among contacted, disengaged patients, the rate of return was higher in the week following tracer contact (IR 5.74, 95% CI: 3.78-8.71) than in the 2 weeks to 1-month post-contact (IR 2.28, 95% CI: 1.40-3.72). There was a greater effect of tracing among patients lost for >6 months compared to those contacted within 3 months of loss. CONCLUSIONS: Overall, tracer contact did not causally increase LTFU patient return to HIV care, demonstrating the limited impact of tracing in this program, where contact occurred months after patients were LTFU. However, observational data suggest that tracing may speed return among some LTFU patients genuinely out-of-care. Further studies may improve tracing effectiveness by examining the mechanisms underlying the impact of tracing on return to care, the effect of tracing at different times-since-loss and using more accurate identification of patients who are truly disengaged to target tracing.

Effects of implementing universal and rapid HIV treatment on initiation of antiretroviral therapy and retention in care in Zambia: a natural experiment using regression discontinuity.

BACKGROUND: Universal testing and treatment (UTT) for all people living with HIV has only been assessed under experimental conditions in cluster-randomised trials. The public health effectiveness of UTT policies on the HIV care cascade under real-world conditions is not known. We assessed the real-world effectiveness of universal HIV treatment policies that were implemented in Zambia on Jan 1, 2017. METHODS: We used data from Zambia's routine electronic health record system to analyse antiretroviral therapy (ART)-naive adults who newly enrolled in HIV care up to 1 year before and after the implementation of universal treatment (ie, Jan 1, 2016, to Jan 1, 2018) at 117 clinics supported by the Centre for Infectious Disease Research in Zambia. We used a regression discontinuity design to estimate the effects of implementing UTT on same-day ART initiation, ART initiation within 1 month, and retention on ART at 12 months (defined as clinic attendance 9-15 months after enrolment and at least 6 months on ART), under the assumption that patients presenting immediately before and after UTT implementation were balanced on both measured and unmeasured characteristics. We did an instrumental variable analysis to estimate the effect of same-day ART initiation under routine conditions on 12-month retention on ART. FINDINGS: 65 673 newly enrolled patients with HIV (40 858 [62·2%] female, median age 32 years [IQR 26-39], median CD4 count 287 cells per µL [IQR 147-466]) were eligible for inclusion in the analyses; 31 145 enrolled before implementation of UTT, and 34 528 enrolled after UTT. Implementation of universal treatment increased same-day ART initiation from 41·7% to 74·8% (risk difference [RD] 33·1%, 95% CI 30·5-35·7), ART initiation by 1 month from 69·6% to 87·0% (RD 17·4%, 15·5-19·3), and 12-month retention on ART from 56·2% to 63·3% (RD 7·1%, 4·3-9·9). ART initiation rates became more uniform across patient subgroups after implementation of universal treatment, but heterogeneity in 12-month retention on ART between subgroups was unchanged. Instrumental variable analyses indicated that same-day ART initiation in routine settings led to a 15·8% increase (95% CI 12·1-19·5) in 12-month retention on ART. INTERPRETATION: UTT policies implemented in Zambia increased the rapidity and uptake of ART, as well as retention on ART at 12 months, although overall retention on ART remained suboptimal. UTT policies reduced disparities in treatment initiation, but not 12-month retention on ART. Natural experiments reveal both the anticipated and unanticipated effects of real-world implementation and indicate the need for new strategies leveraging the short-term effects of UTT to cultivate long-term treatment success. FUNDING: National Institutes of Health.

Mobile Ecological Momentary Assessment and Intervention and Health Behavior Change Among Adults in Rakai, Uganda: Pilot Randomized Controlled Trial.

BACKGROUND: An extraordinary increase in mobile phone ownership has revolutionized the opportunities to use mobile health approaches in lower- and middle-income countries (LMICs). Ecological momentary assessment and intervention (EMAI) uses mobile technology to gather data and deliver timely, personalized behavior change interventions in an individual's natural setting. To our knowledge, there have been no previous trials of EMAI in sub-Saharan Africa. OBJECTIVE: To advance the evidence base for mobile health (mHealth) interventions in LMICs, we conduct a pilot randomized trial to assess the feasibility of EMAI and establish estimates of the potential effect of EMAI on a range of health-related behaviors in Rakai, Uganda. METHODS: This prospective, parallel-group, randomized pilot trial compared health behaviors between adult participants submitting ecological momentary assessment (EMA) data and receiving behaviorally responsive interventional health messaging (EMAI) with those submitting EMA data alone. Using a fully automated mobile phone app, participants submitted daily reports on 5 different health behaviors (fruit consumption, vegetable consumption, alcohol intake, cigarette smoking, and condomless sex with a non-long-term partner) during a 30-day period before randomization (P1). Participants were then block randomized to the control arm, continuing EMA reporting through exit, or the intervention arm, EMA reporting and behavioral health messaging receipt. Participants exited after 90 days of follow-up, divided into study periods 2 (P2: randomization + 29 days) and 3 (P3: 30 days postrandomization to exit). We used descriptive statistics to assess the feasibility of EMAI through the completeness of data and differences in reported behaviors between periods and study arms. RESULTS: The study included 48 participants (24 per arm; 23/48, 48% women; median age 31 years). EMA data collection was feasible, with 85.5% (3777/4418) of the combined days reporting behavioral data. There was a decrease in the mean proportion of days when alcohol was consumed in both arms over time (control: P1, 9.6% of days to P2, 4.3% of days; intervention: P1, 7.2% of days to P3, 2.4% of days). Decreases in sex with a non-long-term partner without a condom were also reported in both arms (P1 to P3 control: 1.9% of days to 1% of days; intervention: 6.6% of days to 1.3% of days). An increase in vegetable consumption was found in the intervention (vegetable: 65.6% of days to 76.6% of days) but not in the control arm. Between arms, there was a significant difference in the change in reported vegetable consumption between P1 and P3 (control: 8% decrease in the mean proportion of days vegetables consumed; intervention: 11.1% increase; P=.01). CONCLUSIONS: Preliminary estimates suggest that EMAI may be a promising strategy for promoting behavior change across a range of behaviors. Larger trials examining the effectiveness of EMAI in LMICs are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04375423; https://www.clinicaltrials.gov/ct2/show/NCT04375423.