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

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

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

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

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

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

Improving same-day antiretroviral therapy in Botswana: effects of a multifaceted national intervention.

BACKGROUND: In 2019, the Botswana Ministry of Health and Wellness (MOHW) implemented an HIV national Reboot program, which was needed for refocusing and intensifying efforts for achieving epidemic control. The strategies deployed as part of Reboot were reviewed and evaluated for their effect on same-day and within-seven-days (fast-track initiation) antiretroviral therapy (ART) initiation among adults newly identified with HIV. METHODS: We conducted a retrospective cohort analysis of patients aged 18 years or older who were newly diagnosed with HIV from October 2018 to September 2019 across 41 health facilities. We used generalized linear mixed models, adjusting for clustering by facility, to assess the association of the Reboot with same-day or within-seven-days ART initiation (fast-track initiation). RESULTS: From October 2018 to January 2019, 28% (636/2269) of newly diagnosed HIV patients were initiated the same day of diagnosis, and 56% (1260/2269) were initiated within seven days. Following the launch of Reboot (February to September 2019), 59% (2092/3553) were initiated the same day of diagnosis, and 77% (2752/3553) were initiated within seven days. Clients were 2.08 (adjusted risk ratio 95% confidence interval 1.79-2.43) times more likely to be initiated the same day of diagnosis and 1.39 (adjusted risk ratio 95% confidence interval 1.28-1.52) times more likely to be initiated within seven days than before Reboot after adjusting for sex and age. CONCLUSION: In Botswana, a multifaceted national intervention improved timely ART initiation. Identifying and implementing different client-centered strategies to facilitate ART initiation is critical to preventing AIDS-related complications and prevent ongoing transmission.

Late registration for antenatal care by pregnant women with previous history of caesarean section.

BACKGROUND: Despite good access to antenatal care (ANC) services for most women, and regular training of healthcare workers in obstetrics and gynaecology, many pregnant women with a previous history of caesarean section (C/S) still presented late for ANC services at Letsholathebe II Memorial Hospital (LIIMH) in Maun, Botswana. This may increase morbidity and mortality in women with previous C/S delivery and neonates. Knowing why women with previous C/S present late for ANC may help in the formulation of interventions that decrease morbidity and mortality amongst these women and neonates. AIM: The aim of this study was to explore the reasons why pregnant women with a previous history of C/S registered late for ANC, at LIIMH. SETTING: This study was performed at LIIMH, a district hospital situated in Maun, Botswana. METHODS: This was a descriptive qualitative study. Consenting pregnant women with previous C/S who presented at LIIMH after the 20 weeks of pregnancy were interviewed until data saturation. The data was analysed for themes. RESULTS: The reasons for late registration at LIIMH include lack of information, misconception on the appropriate booking time and venue, dissatisfaction with the quality of ANC clinic services, use of alternative ANC providers, delayed referral, and pregnancy experience. CONCLUSION: Lack of knowledge of ANC delivery venue, using alternative ANC providers, and dissatisfaction with ANC clinic services, contributed to late registration. Pregnant women with previous history of C/S should be informed about ANC, delivery plans, and the assistance of alternative ANC providers should be explored.