Study Design
This study sought to assess the effects of the CDD intervention on key health outcomes, conducted at intervals of twelve months over a span of four years from January 2018 to September 2021. To do this, we conducted a retrospective cohort study using programmatic data pertaining to a cohort of 17,155 stable patients who enrolled to receive chronic antiretroviral therapy (ART) within the framework of the CDD intervention. For complete and transparent reporting of a study on this intervention, we followed the StaRI and TIDieR guidelines [10,11].
Study Setting and Sample
The study was conducted within the framework of the CDD program, which operated across nine high-volume treatment facilities situated in the Ndola district. Ndola, a significant urban hub in Zambia's Copperbelt province, grapples with healthcare facility overcrowding. The district has 37 public health facilities [12], with approximately 32 accredited to provide comprehensive ART services to a population of approximately 624,579 [13]. Ndola's urban landscape attracts migrant laborers from diverse regions of Zambia and beyond, resulting in a densely populated area. Ndola is the home for approximately 64,765 PLHIV, with approximately 89% (equivalent to 57,925 PLHIV) of them actively enrolled in chronic ART [14].
Our study primarily focused on the CDD program, engaging a carefully selected cohort of patients from 9 high-volume treatment facilities. This cohort represented approximately 30% of individuals actively receiving ART in Ndola, amounting to 17,157 individuals out of the total 57,925 PLHIV on ART. Notably, Zambia's guidelines mandate ART initiation for all PLHIV, with participants initially receiving the fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and efavirenz (TLE) regimen and subsequently transitioning to the tenofovir, lamivudine, and dolutegravir (TLD) regimen in line with updated guidelines.
Key to the program's success were viral load measurements at 6 and 12 months post ART initiation, which were repeated every 12 months thereafter. The CDD program beneficiaries had 6-month clinical reviews at the treatment facility and 3-month ART refills from the central pharmacy, consistent with the country's multiple-month scripting and dispensing (MMSD) guidelines. The eligibility criteria that governed inclusion in the program included viral load results below 1000 copies/mL within the past 12 months, a minimum of 6 months on ART, age above 10 years with adherence to adult ART regimens, absence of AIDS-defining illnesses, and controlled comorbidities. Exclusion from the program included pregnant individuals, those with active tuberculosis (TB) symptoms, and those with uncontrolled conditions requiring frequent clinical consultations.
Beneficiaries of the CDD program underwent regular 6-month clinical reviews, and those consistently eligible had their ART prescriptions renewed for sustained participation.
Intervention Description: Centralized Dispensing and Distribution
A concise description of the CDD program was done using (TIDieR) [11] guidelines, we present. The CDD program was designed to address the needs of stable individuals with chronic conditions such as HIV, with the specific objective of alleviating the strain in the 9 high-volume treatment facilities. This objective included enrolling up to 70% (23,216/33,397) of eligible individuals currently receiving ART in those facilities while enhancing primary health outcomes such as treatment adherence, retention, and viral load suppression. This program embodies a structured triad consisting of originating treatment facilities, a central dispensing pharmacy, and a network of community-based medicine collection points. These components are seamlessly connected through an end-to-end information technology (IT) platform, orchestrating a well-defined set of processes, such as patient registration, prescription acquisition, centralized prescription processing, dispensing, medicine logistics, personalized collection, reverse logistics, and comprehensive data reporting.
Program Workflow
Potential beneficiaries receive program information through sessions led by healthcare professionals, including nurses and counselors. Informative pamphlets and prominently displayed posters at healthcare facilities provide additional insights. Eligibility criteria were established for precise targeting, followed by screening by qualified clinicians such as medical doctors, clinical officers, or nurses, ensuring enrolment of appropriate individuals. Clinicians validate eligibility, and upon confirmation, beneficiaries give informed consent and choose a preferred medicine Pickup Point (PuP). A clinician completes a prescription form, and beneficiaries receive an appointment card detailing dates and program specifics. Quality-assured prescription forms are digitally transmitted to the central pharmacy, ensuring accuracy and efficiency. Initial refills occurred at the treatment facility and are managed by pharmacists, pharmacy technicians, or dispensing nurses. Subsequent refills are overseen by the central pharmacy, involving validation, packing, and distribution to designated PuPs. Medicine parcels are stored securely at PuPs until beneficiaries receive them, adhering to strict identification protocols and tracked using a dedicated mobile application. Scheduled SMS notifications provide support, reminding beneficiaries of collection, upcoming reviews, and program updates. The CDD program introduces a comprehensive, technologically advanced approach to healthcare in Ndola, harmonizing diverse entities and logistical complexities. Through its integrated system, the program elevates patient care, ensuring improved treatment adherence, retention, and overall health outcomes.
Health Outcomes in the CDD Program
The quantification of the effects of the CDD program included the measurement and estimation of several key health outcomes, providing a comprehensive measure of its effectiveness. These outcomes were evaluated over the course of the program's implementation, offering insights into utilization, adherence, retention, and state of viral suppression rates.
Utilization Rate
The utilization rate of the CDD program was quantified as the proportion of eligible patients who successfully enrolled, thereby participating in the program at 12-month intervals. This metric was tracked throughout the program's implementation, offering a dynamic snapshot of patient engagement and program access while decongesting high-volume sites. The predefined utilization rate of the intervention included the achievement of enrolments up to 70% (23,216/33,397) of eligible individuals currently receiving ART from high-volume facilities.
Medicine Collection Rates
As a crucial proxy measurement of program adherence, medicine collection rates were defined as the proportion of medicine parcels collected by beneficiaries at their chosen PuPs in adherence to the prescribed collection schedule upon enrollment and with every encounter during prescription renewal. This rate was computed by dividing the number of successfully collected medicine parcels by the total count of prepared and scheduled parcels, presenting a quantified snapshot of patient commitment to timely medicine retrieval. Through this program, the standard from which to assess the success of scheduled medicine collection rates was preset at 90%, measured annually.
Beneficiary Retention Rates
Retention rates, a vital feature of program success, reflected the proportion of beneficiaries who maintained active engagement in the CDD program at successive 12-month intervals from their initial enrollment [15]. Computation of this rate involved subtracting the newly engaged beneficiaries within the current period from those remaining engaged at the period's conclusion, divided by the number of beneficiaries continuing from the preceding period. For this computation, we assumed uniform beneficiary engagement at the onset of each 12-month cycle. The resulting proportion represented beneficiaries continuously enrolled in the CDD program since 2018, sustaining engagement over successive 12-month spans until the program's conclusion in September 2021. This calculation excluded beneficiaries that were either reported as deceased or transferred out from their treatment facilities. The observed net retention rates were benchmarked against the targeted threshold of 95% and above, following WHO and UNAIDS benchmarks.
Sustained viral suppression rates
This pivotal metric gauged the proportion of patients persistently maintaining viral suppression throughout each viral load assessment post-enrollment while receiving ART through the DDD program. This critical indicator signified the program's impact on sustained positive health outcomes among participants, reflecting effective viral load management and treatment adherence. The standard for this outcome was based on the proportion of active participants remaining virally suppressed (i.e., < 1000 copies/ml) while on the intervention as defined by WHO.
Data Collection and Sources
Routine program data management included an integration of clinical, dispensing, and medicine logistics information obtained throughout the active prescription cycles. This array of information was drawn from several distinct sources, which included the electronic health records management system within the treatment facilities, known as SMARTCARE. Furthermore, the central pharmacy database, eRX, played a pivotal role in integrating and sourcing pertinent data from various sources. Complementing these sources was the mobile logistics application database, which augmented the comprehensive repository of information essential for this study.
Data Analysis
The examination of program effects was determined through a systematic quantification process. This involved the calculation of annual rates pertaining to program utilization as measured by the number of beneficiaries enrolling against the preset target, medicine collection, beneficiary retention, and the maintained status of viral load suppression while on the program over the period of program implementation. We determined net program effects, presented as the mean effects observed per annum. The outcomes were further summarized into presentation formats, encompassing two-way tables and visually informative charts using Microsoft Excel. We used descriptive analysis to describe participant characteristics upon enrollment in the CDD program.