Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study.

BACKGROUND: Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs). OBJECTIVE: ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services. METHODS: This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively. RESULTS: During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023. CONCLUSIONS: ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South. TRIAL REGISTRATION: Clinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44961.

Comparing COVID-19 physical distancing policies: results from a physical distancing intensity coding framework for Botswana, India, Jamaica, Mozambique, Namibia, Ukraine, and the United States.

BACKGROUND: Understanding the differences in timing and composition of physical distancing policies is important to evaluate the early global response to COVID-19. A physical distancing intensity monitoring framework comprising 16 domains was recently published to compare physical distancing approaches across 12 U.S. States. We applied this framework to a diverse set of low and middle-income countries (LMICs) (Botswana, India, Jamaica, Mozambique, Namibia, and Ukraine) to test the appropriateness of this framework in the global context and to compare the policy responses in these LMICs with a sample of U.S. States during the first 100-days of the pandemic. RESULTS: The LMICs in our sample adopted wide ranging physical distancing policies. The highest peak daily physical distancing intensity during this period was: Botswana (4.60); India (4.40); Ukraine (4.40); Namibia (4.20); Mozambique (3.87), and Jamaica (3.80). The number of days each country stayed at peak policy intensity ranged from 12-days (Jamaica) to more than 67-days (Mozambique). We found some key similarities and differences, including substantial differences in whether and how countries expressly required certain groups to stay at home. Despite the much higher number of cases in the US, the physical distancing responses in our LMIC sample were generally more intense than in the U.S. States, but results vary depending on the U.S. State. The peak policy intensity for the U.S. 12-state average was 3.84, which would place it lower than every LMIC in this sample except Jamaica. The LMIC sample countries also reached peak physical distancing intensity earlier in outbreak progression compared to the U.S. states sample. The easing of physical distancing policies in the LMIC sample did not discernably correlate with change in COVID-19 incidence. CONCLUSIONS: This physical distancing intensity framework was appropriate for the LMIC context with only minor adaptations. This framework may be useful for ongoing monitoring of physical distancing policy approaches and for use in effectiveness analyses. This analysis helps to highlight the differing paths taken by the countries in this sample and may provide lessons to other countries regarding options for structuring physical distancing policies in response to COVID-19 and future outbreaks.

Implementation and expansion of an electronic medical record for HIV care and treatment in Haiti: an assessment of system use and the impact of large-scale disruptions.

PURPOSE: System use is a key criterion of success in an electronic medical record (EMR) implementation, and there is little research on long-term use of systems following implementation. The aim of the paper was to describe the development, implementation and use of iSanté, Haiti's national HIV care and treatment EMR. METHODS: To build a picture of the history of iSanté, we interviewed 11 staff involved with the development and implementation of the EMR, and reviewed organization records. Data entry and report use were ascertained by querying the central patient database. RESULTS: By the end of 2010 there were 67 sites with iSanté installed, and the scope of the system had been expanded to include primary care and obstetrics and gynecology. New functionality includes data forms specific to subpopulations, the ability to transfer patient records among clinics, and integration with an electronic laboratory system. We observed fluctuations in use over time, with substantial reductions in the number of active sites during times of large-scale disruptions in Haiti. A surge in report use following the January 2010 earthquake suggests that clinics found the EMR to be a valuable source of data during the recovery phase. CONCLUSION: There is real potential for EMRs in developing countries to improve clinical practice and make data available for efficient reporting, quality improvement and other population health uses. An approach of continuous system improvement, combined with regular assessments of use, is necessary for achieving an effective, national implementation of a standardized EMR. We have achieved successes in terms of rolling out new functionality and expanding to new sites, but more work remains to be done to improve perceptions of data quality and increase use of population data for accurate and timely reporting.