A Novel Electronic Record System for Documentation and Efficient Workflow for Community Health Workers: Development and Usability Study.

BACKGROUND: The COVID-19 pandemic added to the decades of evidence that public health institutions are routinely stretched beyond their capacity. Community health workers (CHWs) can be a crucial extension of public health resources to address health inequities, but systems to document CHW efforts are often fragmented and prone to unneeded redundancy, errors, and inefficiency. OBJECTIVE: We sought to develop a more efficient data collection system for recording the wide range of community-based efforts performed by CHWs. METHODS: The Communities Organizing to Promote Equity (COPE) project is an initiative to address health disparities across Kansas, in part, through the deployment of CHWs. Our team iteratively designed and refined the features of a novel data collection system for CHWs. Pilot tests with CHWs occurred over several months to ensure that the functionality supported their daily use. Following implementation of the database, procedures were set to sustain the collection of feedback from CHWs, community partners, and organizations with similar systems to continually modify the database to meet the needs of users. A continuous quality improvement process was conducted monthly to evaluate CHW performance; feedback was exchanged at team and individual levels regarding the continuous quality improvement results and opportunities for improvement. Further, a 15-item feedback survey was distributed to all 33 COPE CHWs and supervisors for assessing the feasibility of database features, accessibility, and overall satisfaction. RESULTS: At launch, the database had 60 active users in 20 counties. Documented client interactions begin with needs assessments (modified versions of the Arizona Self-sufficiency Matrix and PRAPARE [Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences]) and continue with the longitudinal tracking of progress toward goals. A user-specific automated alerts-based dashboard displays clients needing follow-up and upcoming events. The database contains over 55,000 documented encounters across more than 5079 clients. Available resources from over 2500 community organizations have been documented. Survey data indicated that 84% (27/32) of the respondents considered the overall navigation of the database as very easy. The majority of the respondents indicated they were overall very satisfied (14/32, 44%) or satisfied (15/32, 48%) with the database. Open-ended responses indicated the database features, documentation of community organizations and visual confirmation of consent form and data storage on a Health Insurance Portability and Accountability Act-compliant record system, improved client engagement, enrollment processes, and identification of resources. CONCLUSIONS: Our database extends beyond conventional electronic medical records and provides flexibility for ever-changing needs. The COPE database provides real-world data on CHW accomplishments, thereby improving the uniformity of data collection to enhance monitoring and evaluation. This database can serve as a model for community-based documentation systems and be adapted for use in other community settings.

Challenges with pediatric antiretroviral therapy administration: Qualitative perspectives from caregivers and HIV providers in Kenya.

BACKGROUND: Current formulations of pediatric antiretroviral therapy (ART) for children with HIV present significant barriers to adherence, leading to drug resistance, ART ineffectiveness, and preventable child morbidity and mortality. Understanding these challenges and how they contribute to suboptimal adherence is an important step in improving outcomes. This qualitative study describes how regimen-related challenges create barriers to adherence and impact families. METHODS: We conducted key informant interviews (KIIs) with 30 healthcare providers and 9 focus group discussions (FGDs) with a total of 72 caregivers, across three public hospitals in Siaya and Mombasa Kenya. The KIIs and FGDs were audio recorded, translated, and transcribed verbatim. The transcripts were hand coded based on emergent and a-priori themes. RESULTS: Caregivers discussed major regimen-related challenges to adherence included poor palatability of current formulations, complex preparation, and administration (including measuring, crushing, dissolving, mixing), complex drug storage, and frequent refill appointments and how these regimen-related challenges contributed to individual and intrapersonal barriers to adherence. Caregivers discussed how poor taste led to child anxiety, refusal of medications, and the need for caregivers to use bribes or threats during administration. Complex preparation led to concerns and challenges about maintaining privacy and confidentiality, especially during times of travel. Providers corroborated this patient experience and described how these challenges with administration led to poor infant outcomes, including high viral load and preventable morbidity. Providers discussed how the frequency of refills could range from every 2 weeks to every 3 months, depending on the patient. Caregivers discussed how these refill frequencies interrupted work and school schedules, risked unwanted disclosure to peers, required use of financial resources for travel, and ultimately were a challenge to adherence. CONCLUSION: These findings highlight the need for improved formulations for pediatric ART to ease the daily burden on caregivers and children to increase adherence, improve child health, and overall quality of life of families.

Assessing COVID-related concerns and their impact on antenatal and delivery care among pregnant women living with HIV in Kenya: a brief report.

BACKGROUND: Some studies indicate that pregnant Kenyan women were concerned about Coronavirus disease 2019 (COVID-19) exposure during maternity care. We assessed concern regarding COVID-19 exposure and any impact on antenatal care (ANC) enrollment and/or hospital delivery among pregnant women living with human immunodeficiency virus (HIV) in Kenya. METHODS: Data were collected from 1,478 pregnant women living with HIV enrolled in prevention of mother to child transmission of HIV (PMTCT) care at 12 Kenyan hospitals from October 2020 to July 2022. Surveys were conducted when women first presented for PMTCT services at the study hospital and asked demographic questions as well as items related to concerns about COVID-19. A 5-point Likert scale (strongly disagree to strongly agree) assessed concerns about COVID-19 exposure and travel challenges. Gestational age at PMTCT enrollment, number of ANC appointments attended, and delivery location were compared among women who expressed COVID-19 concerns and those who did not. RESULTS: Few women reported delaying antenatal care (4.7%), attending fewer antenatal care appointments (5.0%), or having concerns about a hospital-based delivery (7.7%) because of COVID-19. More (25.8%) reported travel challenges because of COVID-19. There were no significant differences in gestational age at enrollment, number of ANC appointments, or rates of hospital-based delivery between women with concerns about COVID-19 and those without, CONCLUSION: Few pregnant women living with HIV expressed concerns about COVID-19 exposure in the context of routine ANC or delivery care. Women with and without concerns had similar care seeking behaviors. The recognized importance of routine ANC care and facility-based deliveries may have contributed to these positive pregnancy indicators, even among women who worried about COVID-19 exposure. TRIAL REGISTRATION: www. CLINICALTRIALS: gov identifier NCT04571684.

Assessing Social Needs and Engaging Community Health Workers in Underserved Kansas Counties: Insights From Primary Care Providers and Clinic Managers.

INTRODUCTION: Rural and under-resourced urban communities face unique challenges in addressing patients' social determinants of health needs (SDoH). Community health workers (CHWs) can support patients experiencing social needs, yet little is known about how rural and under-resourced primary care clinics are screening for SDoH or utilizing CHWs. METHODS: Interviews were conducted with primary care clinic providers and managers across a geographically large and predominately rural state to assess screening practices for SDoH and related community resources, and perspectives on using CHWs to address SDoH. Interviews were conducted by phone, recorded, and transcribed. Data were analyzed using thematic analysis. We completed interviews with 27 respondents (12 providers and 15 clinic managers) at 26 clinics. RESULTS: Twelve (46.1%) clinics had a standardized process for capturing SDoH, but this was primarily limited to Medicare wellness visits. Staffing and time were identified as barriers to proper SDoH screening. Lack of transportation and affordable medication were the most cited SDoH. While respondents were all aware of CHWs, only 8 (30.8%) included a CHW on their care team. Perceived barriers to engaging CHWs included cost, space, and availability of qualified CHWs. Perceived benefits of engaging CHWs in their practice were: assisting patients with navigating resources and programs, relieving clinical staff of non-medical tasks, and bridging language barriers. CONCLUSIONS: Rural and under-resourced primary care clinics need help in identifying and addressing SDoH. CHWs could play an important part in addressing social needs and promoting preventive care if financial constraints could be addressed and local CHWs could be trained.

Assessing user preferences for design characteristics of oral dissolvable strips for pediatric HIV medication: a qualitative study.

BACKGROUND: Current infant antiretroviral therapy formulations pose barriers to daily adherence due to complex weight-based dosing, conspicuous preparation, and poor palatability. These adherence barriers jeopardize adherence, making patients vulnerable to virologic failure, development of drug resistance, and preventable mortality. Our team has previously established proof-of-principle for multi-drug oral dissolvable strips as alternative pediatric antiretroviral formulations with the potential to overcome these challenges and improve pediatric ART adherence and outcomes. The objective of this study was to assess caregiver and provider preferences for oral dissolvable strips and its packaging to inform its development. METHODS: Guided by concepts of user-centered design, we conducted key informant interviews with 30 HIV care providers and focus group discussions targeting caregivers of children < 10 years of age living with HIV at 3 Kenyan hospitals. Key informant interviews and focus group discussions were audio recorded, translated/transcribed verbatim, and hand coded for a-priori and emergent themes. RESULTS: A total of 30 providers and 72 caregivers (caring for 83 children, aged 5 months to 18 years) participated in the study. Caregivers and providers expressed a strong desire for an easier way to administer medication, especially among children too young to swallow tablets whole, and expressed enthusiasm around the idea of oral dissolvable strips. Key preferences included a pleasant taste; one strip per dose; small size with rapid dissolution; clear markings and instructions; and no special storage requirements. For packaging, stakeholders preferred individually wrapped strips within a dispenser. The individual packaging should be durable, waterproof, and easy to dispose of in communal spaces. They should also be easy to open, with clear indications where to open. The packaging holding the strips should be durable, re-usable, accommodating of various refill frequencies, and easy to use for children as young as 6. DISCUSSION: The concept of oral dissolvable strips was highly acceptable to caregivers of children living with HIV and HIV care providers. By engaging stakeholders in an iterative design process starting from the early phases of design and development, we will maximize the likelihood of developing a product that is acceptable to the caregiver and infant, therefore leading to sustainable adherence.

Incorporating the HIV Infant Tracking System into standard-of-care early infant diagnosis of HIV services in Kenya: a cost-effectiveness analysis of the HITSystem randomised trial.

BACKGROUND: The HITSystem efficacy trial showed significant improvements in early infant diagnosis retention, return and notification of infant test results, and earlier antiretroviral therapy (ART) initiation compared with standard-of-care early infant diagnosis services in Kenya. This study aimed to analyse data from the HITSystem trial to assess the cost-effectiveness of the intervention in Kenya. METHODS: In this analysis, we extrapolated results from the HITSystem cluster randomised controlled trial to model early infant diagnosis outcomes and cost-effectiveness if the HITSystem was scaled up nationally in Kenya, compared with standard-of-care outcomes. We used a micro-costing method to collect cost data, which were analysed from a health-system perspective, reflecting the investment required to add HITSystem to existing early infant diagnosis services and infrastructure. The base model used to calculate cost-effectiveness was deterministic and calculated the progression of infants through early infant diagnosis. Differences in progression across study arms were used to establish efficacy outcomes. The number of life-years gained per infant successfully initiating ART were based on the Cost Effectiveness of Preventing AIDS Complications model in east Africa. HITSystem cost data were integrated into the model, and the incremental cost-effectiveness ratio was calculated in terms of cost per life-year gained. Sensitivity analyses were done using the deterministic model with triangular stochastic probability functions for key model parameters added. The number of life-years gained was discounted at 3% and costs were adjusted to 2021 values. FINDINGS: The cost per life-year gained from the HITSystem was US$82·72. Total cost for national HITSystem coverage in Kenya was estimated to be around $2·6 million; covering 82 230 infants exposed to HIV at a cost of $31·38 per infant and a yield of 1133 infants receiving timely ART, which would result in 31 189 life-years gained. With sensitivity analyses, the cost per life-year gained varied from $40·13 to $215·05. 90% of model values across iterations ranged between $55·58 (lower 5% threshold) and $132·38 (upper 95% threshold). INTERPRETATION: The HITSystem would be very cost-effective in Kenya and can optimise the return on the existing investment in the national early infant diagnosis programme. FUNDING: The US National Institute of Child Health and Human Development.

Development and evaluation of a COVID tracking system to support provision of social service in Wyandotte County, Kansas.

Background: In addition to the state-mandated case investigation and contact tracing, the Unified Government Public Health Department of Wyandotte County, Kansas implemented social support services for COVID-19 cases and contacts; however, did not have the systems in place to document the provision of these services. Our team worked with the health department to develop and implement the COVID Tracking System (CTS), an eHealth system that linked multiple involved teams. Here, we describe the development and evaluation of the CTS. The objective of this manuscript is to describe and evaluate the development and implementation process of the Covid Tracking System. Methods: Drawing from concepts of user-centered design, we took a 4-phase approach to development: understanding context, specifying needs, designing solutions, and evaluating. A mixed-methods evaluation of the development and implementation process using RE-AIM was conducted. Quantitative CTS data captured between February 1, 2021, and September 30, 2021 were exported. Descriptive statistics were calculated for categorical variables and means (SD, range) or median (IQR) for continuous variables. Qualitative discussions with key users supplemented the quantitative data. Results: There were 1,152 cases entered into the CTS, of whom 307 (26.6%) requested a letter be sent to their workplace to excuse them during their quarantine period, 817 (70.9%) requested and had food and cleaning supplies delivered, 21 (1.8%) requested guidance on applying for federal assistance, and 496 (43.1%) requested to be contacted by a community health worker. While a few technical glitches slowed down early implementation, these were quickly resolved and key users felt that the CTS streamlined client referral and simplified their workflow, allowing them to spend more time on patient care and follow up, rather than documentation. After study implementation ended, the Unified Government Public Health Department of Wyandotte County continued using the CTS for client tracing and follow up. Discussion: This project provides a roadmap of how user centered design can be applied to the development and evaluation of eHealth software to support program intervention implementation, even in situations where urgent action is needed.

Impacts, Learner Diversity, and Curricular Framework of a Virtual Global Health Elective Catalyzed by the COVID-19 Pandemic.

Background: Place-based international electives that build global health competencies have existed for decades. However, these electives require travel and are infeasible for many trainees around the world, particularly those with insufficient financial resources, logistical complexities, or visa limitations. The emergence of virtual approaches to global health electives, catalyzed by the travel pause related to the COVID-19 pandemic, necessitates the exploration of learner impacts, participant diversity, and curricular frameworks. Child Family Health International (CFHI), a non-profit global health education organization that partners with universities to expand immersive educational offerings, launched a virtual global health elective in 2021. The elective drew on faculty from Bolivia, Ecuador, Ghana, Mexico, the Philippines, Uganda, and the United States. Objective: This study aimed to describe a newly developed virtual global health elective curriculum and evaluate the demographics of and impacts on trainee participants. Methods: Eighty-two trainees who were enrolled in the virtual global health elective from January to May 2021 completed both 1) pre- and post-elective self-assessments of domains of competency mapped to the elective curriculum and 2) free text responses to standardized questions. Data were analyzed through descriptive statistical analysis, paired t-testing, and qualitative thematic analysis. Findings: The virtual global health elective had 40% of its participants hail from countries other than the United States. Self-reported competency in global health broadly, planetary health, low resource clinical reasoning, and overall composite competency significantly increased. Qualitative analysis revealed learner development in health systems, social determinants of health, critical thinking, planetary health, cultural humility, and professional practice. Conclusion: Virtual global health electives effectively develop key competencies in global health. This virtual elective had a 40-fold increase in the proportion of trainees from outside the United States, compared to pre-pandemic place-based electives. The virtual platform facilitates accessibility for learners from a variety of health professions and a wide range of geographic and socioeconomic environments. Further research is needed to confirm and expand on self-reported data, and to pursue approaches to greater diversity, equity, and inclusion in virtual frameworks.

Contraception use among individuals with substance use disorder increases tenfold with patient-centered, mobile services: a quasi-experimental study.

BACKGROUND: Individuals with substance use disorders (SUD) have disproportionately high rates of unintended pregnancy. Reducing harm associated with this risk and its biopsychosocial consequences requires evidence-based, non-coercive interventions that ensure access to contraception for individuals who choose to prevent pregnancy. We examined feasibility and impact of SexHealth Mobile, a mobile unit-based intervention that aimed to increase access to patient-centered contraceptive care for individuals in SUD recovery programs. METHODS: We conducted a quasi-experimental study (enhanced usual care [EUC] followed by intervention) at three recovery centers with participants (n = 98) at risk for unintended pregnancy. EUC participants were offered printed information on community locations where they could access contraception care. SexHealth Mobile participants were offered same-day, onsite clinical consultation on a medical mobile unit and contraception if desired. The primary outcome was use of contraception (hormonal or intrauterine device) at one-month post-enrollment. Secondary outcomes were at two-weeks and three-months. Confidence in preventing unintended pregnancy, reasons for non-use of contraception at follow-up, and intervention feasibility were also assessed. RESULTS: Participants (median age = 31, range 19-40) enrolled in the intervention period were almost 10 times more likely to be using contraception at one-month (51.5%) versus the those enrolled in the EUC period (5.4%) (unadjusted relative risk [URR] = 9.3 [95%CI: 2.3-37.1]; adjusted relative risk [ARR] = 9.8 [95%CI: 2.4-39.2]). Intervention participants were also more likely to be using contraception at 2-weeks (38.7% vs. 2.6%; URR = 14.3 [95%CI: 2.0-104.1]) and three-months (40.9% vs. 13.9%; URR = 2.9 [95% CI: 1.1-7.4]). EUC participants reported more barriers (cost, time) and less confidence in preventing unintended pregnancies. Mixed-methods feasibility data indicated high acceptability and feasible integration into recovery settings. CONCLUSIONS: Mobile contraceptive care based on principles of reproductive justice and harm reduction reduces access barriers, is feasible to implement in SUD recovery settings, and increases contraception use. Expanding interventions like SexHealth Mobile may help reduce harm from unintended pregnancies among individuals in SUD recovery. Trial Registration NCT04227145.

The Perfect Storm: Perceptions of Influencing Adults Regarding Latino Teen Pregnancy in Rural Communities.

INTRODUCTION: Recognition of the importance of adolescents' environments in influencing their sexual and reproductive health (SRH) decision-making necessitates a deeper understanding of the role that community stakeholders play in shaping Adolescent and Young Adults (AYA) access to SRH education and care. We describe community stakeholders' knowledge, beliefs, and attitudes about AYA's SRH needs in three rural Latino communities in Kansas. METHODS: Key stakeholders completed a written survey incorporating the theory of Planned Behavior to assess attitudes, norms, and intentions to support AYA's SRH education and access to care. RESULTS: Across three rural immigrant community settings, respondents (N = 55) included 8 community health workers, 9 health care providers, 7 public health officials, 19 school health officials, and 12 community members. More than half self-identified as Latino (55%). Six (11%) participants, half of whom were in the health sector, thought SRH education would increase the likelihood that teens would engage in sexual activities. In contrast, other stakeholders thought that providing condoms (17, 30.9%), contraception other than condoms (14, 25.5%), and providing HPV immunization (5, 9.6%) would increase the likelihood of engaging in sexual activity. Ambivalence regarding support for SRH education and service provision prevailed across sectors, reflected even in the endorsement of the distribution of less effective contraceptive methods. Obstacles to care include immigration status, discrimination, lack of confidential services, and transportation. CONCLUSION: Key stakeholders living in rural communities revealed misconceptions, negative attitudes, and ambivalent beliefs related to the delivery of SRH education and services, potentially creating barriers to AYA's successful access to care.

Little is known about the knowledge, beliefs and attitudes held by key stakeholders in rural immigrant Latino communities regarding their level of support for AYA's SRH needs. Key stakeholders may harbor influential and ambivalent opinions regarding AYA's sexuality considering existing cultural norms, therefore, stigmatizing access to SRH education and care. We examined key community stakeholders' attitudes and norms as measures of intentions to support AYA's SRH education and care. We identify actionable steps needed to eliminate existing barriers to AYA's access to SRH education and care among at-risk immigrant Latino communities in the rural Midwest.

Piloting a systems level intervention to improve cervical cancer screening, treatment and follow up in Kenya.

Although preventable, Cervical Cancer (CC) is the leading cause of cancer deaths among women in Sub-Saharan Africa with the highest incidence in East Africa. Kenyan guidelines recommend an immediate screen and treat approach using either Pap smear or visual screening methods. However, system (e.g., inadequate infrastructure, weak treatment, referral and tracking systems) and patient (e.g., stigma, limited accessibility, finance) barriers to comprehensive country wide screening continue to exist creating gaps in the pathways of care. These gaps result in low rates of eligible women being screened for CC and a high loss to follow up rate for treatment. The long-term goal of 70% CC screening and treatment coverage can partly be achieved by leveraging electronic health (eHealth, defined here as systems using Internet, computer, or mobile applications to support the provision of health services) to support service efficiency and client retention. To help address system level barriers to CC screening treatment and follow up, our team developed an eHealth tool-the Cancer Tracking System (CATSystem), to support CC screening, treatment, and on-site and external referrals for reproductive age women in Kenya. Preliminary data showed a higher proportion of women enrolled in the CATSystem receiving clinically adequate (patients tested positive were treated or rescreened to confirm negative within 3 months) follow up after a positive/suspicious screening, compared to women in the retrospective arm.

Evaluating the efficacy of the HITSystem 2.1 to improve PMTCT retention and maternal viral suppression in Kenya: Study protocol of a cluster-randomized trial.

BACKGROUND: Gaps in the provision of guideline-adherent prevention of mother-to-child transmission of HIV (PMTCT) services and maternal retention in care contribute to nearly 8000 Kenyan infants becoming infected with HIV annually. Interventions that routinize evidence-based PMTCT service delivery and foster consistent patient engagement are essential to eliminating mother-to-child transmission of HIV. The HITSystem 2.1 is an eHealth intervention that aims to improve retention in PMTCT services and viral load monitoring, using electronic alerts to providers and SMS to patients. This study will evaluate the impact, implementation, and cost-effectiveness of HITSystem 2.1. METHOD: This cluster randomized trial will be conducted at 12 study hospital (6 intervention, 6 control). Pregnant women living with HIV who have initiated PMTCT care ≤36 weeks gestation are eligible. Women enrolled at control hospitals will receive standard-of-care PMTCT services. Women enrolled at intervention hospitals will receive standard-of-care PMTCT services plus enhanced HITSystem 2.1 tracking. Mixed logistic regression models will compare the arms on two primary outcomes: (1) completed guideline-adherence PMTCT services and (2) viral suppression at both delivery and 6 months postpartum. We will assess associations between provider and patient characteristics (disclosure status, partner status, depression, partner support), PMTCT knowledge, and motivation with retention outcomes. Using the RE-AIM model, we will also assess implementation factors to guide sustainable scale-up. Finally, a cost-effectiveness analysis will be conducted. DISCUSSION: This study will provide insights regarding the development and adaptation of eHealth strategies to meet the global goal of eliminating new HIV infections in children and optimizing maternal health through PMTCT services. If efficacious, implementation and cost-effectiveness data gathered in this study will guide scale-up across Kenyan health facilities. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT04571684) on October 1, 2020.

Untapped Potential for Safer Conception Messaging to Transform PrEP Rollout and Promote Service Engagement Among Serodiscordant Couples.

Uptake of pre-exposure prophylaxis (PrEP) fell short of targets for Sub-Saharan Africa's initial rollout, revealing the need for more effective promotion strategies. In Uganda, we explored potential benefits and challenges of integrating safer conception messaging to promote PrEP among serodiscordant couples. In-depth interviews were conducted with clients and personnel at three clinics and analyzed thematically. Participants (n = 58) valued PrEP as a safer conception method (SCM) but described lack of integration of safer conception and PrEP services as well as inconsistent practices in prescribing PrEP to couples pursuing conception. Participants reported that the wider population remains largely unaware of PrEP and SCM or harbors misconceptions that PrEP is primarily for highly stigmatized groups like sex workers. Participants further described how heterosexual couples can still be reluctant to test for HIV, unaware of tools like PrEP and SCM that would allow them to continue their relationship and/or pursuit of childbearing. Overall, findings suggest that integrating PrEP and SCM in messaging and services targeting serodiscordant couples holds untapped benefits throughout the HIV prevention cascade.

HIV Drug Resistance in Kenyan Infants Diagnosed With HIV and Their Mothers.

The presence and type of HIV drug resistance mutations among 5 infants diagnosed with HIV were assessed and compared with their mothers' viral mutations. Mother and infant blood samples were sequenced and screened for HIV drug resistance mutations using the Stanford HIV Sequence Database. Three of 5 (60%) mother-infant pairs harbored HIV drug resistance mutations.

Provider Perspectives on Navigating Relationship Challenges in Assisting HIV-Affected Couples to Meet Their Reproductive Goals: Lessons Learned from a Safer Conception Counseling Intervention in Uganda.

In Uganda, 60% of HIV-affected couples are serodiscordant, many of whom want children. There is a need to assess their reproductive intentions and provide appropriate services that limit transmission risks while meeting reproductive goals. Our Choice intervention engaged male and female HIV-infected clients and their partners in safer conception counseling (SCC) or family planning based on their childbearing decision. We report findings of provider experiences and recommendations for engaging couples in SCC. The intervention was implemented in four clinics offering either SCC1, an intensive training and supervision arm, or SCC2, utilizing the Ministry of Health's standard approach. Qualitative interviews were conducted at 12 (N = 23) and 24 months (N = 25) after initiation of the intervention. Many partners attended at least some SCC sessions, although engaging male partners was more challenging. Providers reported partner involvement improved understanding and facilitated successful implementation of SCM, whereas confusion and challenges were common when the client participated alone. Providers shared successful strategies for engaging male partners.

"Friendly reminder: hi! It is that time again ☺": understanding PMTCT care text message design preferences amongst pre- and post-partum women and their male partners.

BACKGROUND: Prevention of mother-to-child HIV transmission (PMTCT) services in Kenya can be strengthened through the delivery of relevant and culturally appropriate SMS messages. METHODS: This study reports on the results of focus groups conducted with pre and postnatal women living with HIV (5 groups, n = 40) and their male partners (3 groups, n = 33) to elicit feedback and develop messages to support HIV+ women's adherence to ART medication, ANC appointments and a facility-based birth. The principles of message design informed message development. RESULTS: Respondents wanted ART adherence messages that were low in verbal immediacy (ambiguous), came from an anonymous source, and were customized in timing and frequency. Unlike other studies, low message immediacy was prioritized over customization of message content. For retention, participants preferred messages with high verbal immediacy-direct appointment reminders and references to the baby-sent infrequently from a clinical source. CONCLUSION: Overall, participants favored content that was brief, cheerful, and emotionally appealing.

Long-acting reversible contraceptives (LARCs) as harm reduction: a qualitative study exploring views of women with histories of opioid misuse.

BACKGROUND: The sharp rise in opioid use disorder (OUD) among women coupled with disproportionally high rates of unintended pregnancy have led to a four-fold increase in the number of pregnant women with OUD in the United States over the past decade. Supporting intentional family planning can have multiple health benefits and reduce harms related to OUD but requires a comprehensive understanding of women's perspectives of preventing unintended pregnancies. The purpose of this study was to comprehensively evaluate the knowledge, attitudes and experiences as they relate to seeking contraception, particularly LARCs, among women with active or recovered opioid misuse. METHODS: In-depth interviews and focus group discussions with 36 women with current or past opioid misuse were recorded and transcribed. Transcripts were coded by ≥ 2 investigators. Themes related to contraceptive care seeking were identified and contextualized within the Health Belief Model. RESULTS: Our analysis revealed seven interwoven themes that describe individual level factors associated with contraceptive care seeking in women with current or past opioid misuse: relationship with drugs, reproductive experiences and self-perceptions, sexual partner dynamics, access, awareness of options, healthcare attitudes/experiences, and perceptions of contraception efficacy/ side effects. Overall, perceived susceptibility and severity to unintended pregnancy varied, but most women perceived high benefits of contraception, particularly LARC. However, perceived barriers were too high for most to obtain desired contraception to support family planning intentions. CONCLUSIONS: The individual-level factors identified should inform the design of integrated services to promote patient-centered contraceptive counseling as a form of harm reduction. Interventions should reduce barriers to contraceptive access, particularly LARCs, and establish counseling strategies that use open, non-judgmental communication, acknowledge the continuum of reproductive needs, explore perceived susceptibility to pregnancy, and utilize peer educators.

Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research.

BACKGROUND: At-birth and point-of-care (POC) testing can expedite early infant diagnosis of HIV and improve infant outcomes. Guided by the Consolidated Framework for Implementation Research (CFIR), this study describes the implementation of an at-birth POC testing pilot from the perspective of implementing providers and identifies the factors that might support and hinder the scale up of these promising interventions. METHODS: We conducted 28 focus group discussions (FGDs) with 48 providers across 4 study sites throughout the course of a pilot study assessing the feasibility and impact of at-birth POC testing. FGDs were audio-recorded, transcribed, and analyzed for a priori themes related to CFIR constructs. This qualitative study was nested within a larger study to pilot and evaluate at-birth and POC HIV testing. RESULTS: Out of the 39 CFIR constructs, 30 were addressed in the FGDs. While all five domains were represented, major themes revolved around constructs related to intervention characteristics, inner setting, and outer setting. Regarding intervention characteristics, the advantages of at-birth POC (rapid turnaround time resulting in improved patient management and enhanced patient motivation) were significant enough to encourage provider uptake and enthusiasm. Challenges at the intervention level (machine breakdown, processing errors), inner settings (workload, limited leadership engagement, challenges with access to information), and outer setting (patient-level challenges, limited engagement with outer setting stakeholders) hindered implementation, frustrated providers, and resulted in missed opportunities for testing. Providers discussed how throughout the course of the study adaptations to implementation (improved channels of communication, modified implementation logistics) were made to overcome some of these challenges. To improve implementation, providers cited the need for enhanced training and for greater involvement among stakeholders outside of the implementing team (i.e., other clinicians, hospital administrators and implementing partners, county and national health officials). Despite provider enthusiasm for the intervention, providers felt that the lack of engagement from leadership within the hospital and in the outer setting would preclude sustained implementation outside of a research setting. CONCLUSION: Despite demonstrated feasibility and enthusiasm among implementing providers, the lack of outer setting support makes sustained implementation of at-birth POC testing unlikely at this time. The findings highlight the multi-dimensional aspect of implementation and the need to consider facilitators and barriers within each of the five CFIR domains. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03435887 . Retrospectively registered on 19 February 2020.

Piloting the Feasibility and Preliminary Impact of Adding Birth HIV Polymerase Chain Reaction Testing to the Early Infant Diagnosis Guidelines in Kenya.

BACKGROUND: In Kenya, standard early infant diagnosis (EID) with polymerase chain reaction (PCR) testing at 6-week postnatal achieves early treatment initiation (<12 weeks) in <20% of HIV+ infants. Kenya's new early infant diagnosis guidelines tentatively proposed adding PCR testing at birth, pending results from pilot studies. METHODS: We piloted birth testing at 4 Kenyan hospitals between November 2017 and November 2018. Eligible HIV-exposed infants were offered both point-of-care and PCR HIV testing at birth (window 0 to <4 weeks) and 6 weeks (window 4-12 weeks). We report the: proportion of infants tested at birth, 6-week, and both birth and 6-week testing; median infant age at results; seropositivity and antiretroviral therapy initiation. RESULTS: Final sample included 624 mother-infant pairs. Mean maternal age was 30.4 years, 73.2% enrolled during antenatal care and 89.9% had hospital deliveries. Among the 590 mother-infants pairs enrolled before 4 weeks postnatal, 452 (76.6%) completed birth testing before 4 weeks, with 360 (79.6%) testing within 2 weeks, and 178 (39.4%) before hospital discharge (0-2 days). Mothers were notified of birth PCR results at a median infant age of 5.4 weeks. Among all 624 enrolled infants, 575 (92.1%) were tested during the 6-week window; 417 (66.8%) received testing at both birth and 6-weeks; and 207 received incomplete testing (93.3% only 1 PCR and 6.7% no PCR). Four infants were diagnosed with HIV, and 3 infants were initiated on antiretroviral therapy early, before 12 weeks of age. CONCLUSIONS: Uptake of PCR testing at birth was high and a majority of infants received repeat testing at 6 weeks of age.

"Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches.

BACKGROUND: Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC. METHODS: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. RESULTS: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. CONCLUSIONS: More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.