Antiretroviral Therapy Delivery Research Articles

Performance of patient-collected dried blood spot specimens for HIV-1 viral load testing: evidence from the DO ART Study in South Africa.

Evaluate the clinical utility of patient-collected dried blood spots (DBS) in measuring HIV-1 viral load (VL) for monitoring antiretroviral therapy (ART) compared to provider-collected DBS and blood plasma. In a randomized trial of community-based delivery of ART in South Africa, we assessed performance of: (1) DBS specimens compared to plasma, and (2) participant-collected versus staff-collected DBS specimens, to measure HIV-1 VL. The bioMérieux NucliSENS EasyQ HIV-1 v2.0 assay was used for VL measurement. From October 2017 to November 2019, we collected 996 pairs of plasma/DBS specimens from 760 participants and 315 pairs of staff-/participant-collected DBS cards from 261 participants. We assessed DBS test sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using the WHO failure threshold of 1000 copies/mL. Log-transformed VL was compared using concordance correlation coefficients (CCC) and mean differences from linear mixed models. In a population with 13% detectable VL, DBS VL compared with plasma VL had 91% (95% CI: 86-95) sensitivity, 99% (98-100) specificity, 94% (90-98) PPV, and 99% (98-99) NPV. We observed high agreement between staff-collected DBS VL and plasma VL (CCC: 0.94), and between participant-collected DBS VL and plasma VL (CCC: 0.92). Correlation between participant- and staff-collected DBS was very high (CCC: 0.97; mean difference for those with a detectable result: -0.10 log 10 copies/mL [-0.21-0.02]). VL results from participant-collected DBS are clinically comparable with those collected by clinical staff and using blood plasma. Self-collected DBS has potential for use for ART monitoring outside the clinic.

Courier delivery of antiretroviral therapy: a cohort study of a South African private-sector HIV programme.

Courier delivery has become a popular antiretroviral therapy (ART) distribution method in some HIV care settings, yet data on ART courier delivery and how it relates to ART outcomes are scarce. We studied the differences in viral suppression rates between individuals from a South African private sector HIV programme receiving ART by courier delivery and those receiving ART through traditional retail dispensing. Individuals aged 15 years or older who were actively enrolled in the Aid for AIDS programme between January 2011 and July 2022 were eligible for the analysis. The outcome of interest was viral suppression defined as a viral load (VL) <400 copies per ml. We calculated adjusted odds ratios (OR) for the association between the ART distribution method and viral suppression, comparing those receiving refills through courier pharmacies versus retail dispensing at the time of the VL testing. We used generalized estimating equations to account for repeated VL testing of the same individual. The models were adjusted for age, sex, calendar year, ART regimen, history of mental illness and medical insurance scheme. We computed adjusted ORs for the calendar periods 2011-2013, 2014-2016, 2017-2019, 2020-2022 and overall. We extracted 442,619 VL measurements from 68,720 eligible individuals, 39,406 (57.3%) were women. The median number of VL measurements per individual was 6 (IQR 3-10). VL suppression was detected in 398,901 (90.1%) tests, and 185,701 (42.0%) of the tests were taken while the individual was receiving ART by courier delivery. Overall, courier delivery was associated with 5% higher odds of viral suppression than retail dispensing (adjusted OR 1.05, 95% CI 1.02-1.08). The strength and direction of this association varied by calendar period, with an adjusted OR of 1.37 (95% CI 1.27-1.48) in 2011-2013 and 1.02 (95% CI 0.97-1.07) in 2020-2022. Courier delivery of ART is a viable alternative to retail dispensing in the South African private sector, as it was associated with higher viral suppression until 2016 and similar suppression rates in recent years. Further research is needed to investigate the potential benefits and drawbacks of courier delivery of ART in both private and public healthcare settings.

Barriers to enrolment of clients into community client led anti-retroviral therapy delivery (CCLAD) in selected health facilities in Kasese district, Uganda.

Community Client Led Anti-retroviral therapy Delivery (CCLAD) Model has been associated with increased community participation and ownership, which leads to better treatment outcomes with reduced workload and increased client satisfaction of health services. To explore the barriers to enrolment of eligible clients into CCLAD in selected health facilities in Kasese District, Uganda. Analytical cross-sectional study utilizing mixed method approach was conducted among 384 PLWHIV attending public health facilities of Kasese District. Sampling was done by simple random sampling method. Data was collected using researcher-administered questionnaire method and interview guide. Most of the respondents 253(65.9%) had not yet enrolled into CCLAD. This was due to some client-related factors such as non-disclosure of HIV sero-status (p=0.040), person to whom HIV sero-status was disclosed to (p=0.009), not having ever heard about CCLAD (p=0.000), incorrect description of CCLAD (p=0.000), limited knowledge of advantages of CCLAD (p=0.000) or disadvantages of CCLAD (p=0.003). Other barriers were; failure to have access to organizations or groups that support PLWHIV to get treatment (p=0.025) and duration of ART refills [AOR=1.637, 95% CI (0.820 - 3.270)]. Adoption of CCLAD model among PLWHIV in Kasese District is still low.

Patient Education and Decision Support for Long-Acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing with Ryan White HIV/AIDS Program Medical Case Management Programs in New York.

Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people living with HIV and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence and thus can clinically benefit from alternative treatment modalities. Ryan White HIV/AIDS Program Part A medical case management (MCM) programs provide an array of services to address barriers to HIV care and treatment among economically and socially marginalized people living with HIV. These programs have demonstrated effectiveness in improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence. This study aims to adapt and expand Ryan White MCM service strategies to integrate LAI ART regimen options, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens. In 3 phases of work involving patient and provider participants, this study uses role-specific focus groups to elicit perceptions of LAI versus daily oral ART; discrete choice experiment (DCE) surveys to quantify preferences for different ART delivery options and related supports; and a nonrandomized trial to assess the implementation and utility of newly developed tools at 6 partnering Ryan White HIV/AIDS Program Part A MCM programs based in urban, suburban, and semirural areas of New York. Findings from the focus groups and DCEs, as well as feedback from advisory board meetings, informed the design and selection of the tools: a patient-facing, 2-page fact sheet, including frequently asked questions and a side-by-side comparison of LAI with daily oral ART; a patient-facing informational video available on YouTube (Google Inc); and a patient-provider decision aid. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide further specification of strategies to integrate LAI ART options into MCM program workflows. The study was funded in late April 2021 and received approval from the institutional review board in May 2021 under protocol 20-096. Focus groups were conducted in late 2021 (n=21), DCEs ran from June 2022 to January 2023 (n=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024) has enrolled >200 patients. This study is designed to provide evidence regarding the acceptability, feasibility, appropriateness, and utility of a package of patient-oriented tools for comparing and deciding between LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed methods approach, and the testing of tools in real-world safety-net service settings. Clinicaltrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542. DERR1-10.2196/56892.

Differentiated care for youth in Zimbabwe: Outcomes across the HIV care cascade.

Youth living with HIV are at higher risk than adults of disengaging from HIV care. Differentiated models of care such as community delivery of antiretroviral therapy (ART) may improve treatment outcomes. We investigated outcomes across the HIV cascade among youth accessing HIV services in a community-based setting. This study was nested in a cluster-randomised controlled trial (CHIEDZA: Clinicaltrials.gov, Registration Number: NCT03719521) conducted in three provinces in Zimbabwe and aimed to investigate the impact of a youth-friendly community-based package of HIV services, integrated with sexual and reproductive health services for youth (16-24 years), on population-level HIV viral load (VL). HIV services included HIV testing, ART initiation and continuous care, VL testing, and adherence support. Overall 377 clients were newly diagnosed with HIV at CHIEDZA, and linkage to HIV care was confirmed for 265 (70.7%, 234 accessed care at CHIEDZA and 31 with other providers); of these 250 (94.3%) started ART. Among those starting ART at CHIEDZA who did not transfer out and had enough follow up time (>6 months), 38% (68/177) were lost-to-follow-up within six months. Viral suppression (HIV Viral Load <1000 copies/ml) among those who had a test at 6 months was 90% (96/107). In addition 1162 clients previously diagnosed with HIV accessed CHIEDZA; 714 (61.4%) had a VL test, of whom 565 (79.1%) were virally suppressed. This study shows that provision of differentiated services for youth in the community is feasible. Linkage to care and retention during the initial months of ART was the main challenge and needs concerted attention to achieve the ambitious 95-95-95 UNAIDS targets.

Virological and care outcomes of community ART distribution: Experience with the PODI+ model in Kinshasa, Democratic Republic of the Congo.

Differentiated service delivery models for HIV treatment can minimize unnecessary burdens on health systems and promote efficient delivery of antiretroviral therapy (ART). Under the PODI+ (poste de distribution communautaire) model, ART multi-month dispensation (MMD) was provided by lay workers (peers) in communities. We compared outcomes among clinically stable adults living with HIV receiving MMD via PODI+ or health facility (HF). Clients receiving MMD at nine HFs and two PODI+ sites in Kinshasa were followed prospectively for one year (2018-2020). Medication possession ratio (MPR) was measured as proportion of total days with medication during the study through record abstraction at 3-month intervals. Viral load was assessed at enrollment and 12 months. We compared MPR and viral load suppression by arm and examined associations and potential confounders using unadjusted and adjusted odds ratios (AOR). Likert-style client satisfaction was collected during 12-month interviews and described by arm. Odds of maintaining viral load suppression at 12 months for PODI+ participants were two times that for HF participants. In adjusted models, PODI+ participants had 1.89 times the odds of being suppressed at 12 months compared to HF participants (95% CI: 1.10, 3.27). No significant differences in MPR were found between groups (OR: 0.86, 0.38-1.99). Older participants had significantly higher odds of MPR (AOR: 1.02, 95% CI: 1.01, 1.03) and viral suppression (AOR: 1.03, 95% CI: 1.00, 1.07). Satisfaction with services was ≥87% overall, but PODI+ participants rated time spent at site, provider attributes and other care aspects more favorably. Participants receiving MMD via peer-run community distribution points had similar MPR, but better virological outcomes and greater satisfaction with care than clinically similar participants receiving MMD through facilities. PODI+ could be a useful model for expansion to serve larger clinic populations from overburdened health facilities, particularly as policy shifts towards more inclusive MMD eligibility requirements.

Perceptions and attitudes towards unmanned aerial vehicles (drones) use for delivery of HIV medication among fisher folk communities on the Islands of Kalangala, Uganda.

The study aimed to assess the attitudes of stakeholders towards the use of unmanned aerial vehicles (medical drones) for delivering antiretroviral therapy (ART) in the Kalangala district of Uganda, which is comprised of 84 islands and has approximately 18,500 People Living with HIV (PLHIV). A qualitative baseline study was conducted to assess the acceptability and feasibility of using a medical drone for ART delivery in the island settlements of Kalangala Islands. The data revealed four emerging themes: knowledge about the drones, perceived benefits of medical drone delivery, perceived risks of medical drone use, and recommendations for future use. The study found that most participants, especially healthcare workers and key opinion leaders, were aware of the medical drones, which could reduce transport costs, deliver medication on time, and reduce healthcare workers' workload. However, there were also perceived risks related to the use of medical drones, such as stigma, reduced contact with healthcare providers, and maintenance and security issues. The study provided evidence that medical drones would be acceptable and have support from various stakeholders in the island settlements for ART delivery. However, concerns were raised about potential stigma and less health worker interaction. This qualitative work allowed the team to address these concerns during the pilot phase.

Advances in the transdermal delivery of antiretroviral drugs.

Antiretroviral therapy regimens are successful in stopping the advancement of human immunodeficiency virus infection to acquired immunodeficiency syndrome, and other opportunistic infections. However, they do have significant disadvantages, including long-term treatment, limited oral bioavailability, inaccessibility to organs, non-adherence by patients, and the development of medication resistance. Because of the listed drawbacks of available routes and the availability of curative medicines for human immunodeficiency virus/acquired immunodeficiency syndrome, advanced solutions are required. Antiretroviral therapy transdermal delivery is one of the current strategies that have attracted much attention from many researchers. In this narrative review, various in vitro, in vivo, and ex vivo transdermal antiretroviral therapy delivery strategies were reviewed, such as transdermal patches and films, lipid-based nano-delivery systems, microneedles, chemical penetration enhancers, and iontophoresis, which showed promising results. Although the majority of studies on Antiretroviral transdermal delivery have produced hopeful findings, additional in-depth research on passive and physical enhancement techniques, both existing and new, is necessary to fully understand the potential of this route and to make it accessible to human immunodeficiency virus patients.

EE180 Comparing the Environmental Costs of Differentiated Service Delivery of Antiretroviral Therapy for People Living with HIV in Rural South Africa

EE180 Comparing the Environmental Costs of Differentiated Service Delivery of Antiretroviral Therapy for People Living with HIV in Rural South Africa

HIV viral suppression at different thresholds and duration of treatment in the dolutegravir treatment era in Sierra Leone: a nationwide survey

IntroductionViral load assessment for people living with HIV is key for monitoring treatment and achieving the 95-95-95. In this study, we aimed to assess the degree of viral suppression at different thresholds and treatment duration after the introduction of dolutegravir-based therapy in ten public hospitals in Sierra Leone.MethodsWe used a cross-sectional study design to recruits patients aged 18 years or older between August 2022 and January 2023. Statistical analyses were performed using R-software. Logistic regression was used to assess factors independently associated with viral suppression. The level of significance was set at P < 0.05.ResultsOf the 2,253 patients recruited, 1,720 (76%) were women and 1,705 (76%) were receiving a fixed dose combination of tenofovir, lamivudine and dolutegravir. The median age and duration of anti-retroviral therapy (ART) was 36.0 (IQR, 28.0–45.0) years and 40.9 (IQR, 14.4–79.6) months, respectively. Using a threshold of HIV RNA < 1000 copies/mL, 1,715 (88.4%) patients on ART for more than 6 months were virally suppressed. Viral suppression rates were higher with dolutegravir-based (1,277, 89.5%) than efavirenz-based (418, 86.2%) ART. HIV RNA was < 200 copies/mL in 1,643 (84.6%) patients or < 50 copies/mL in 1,487 (76.6%) patients or between 50 and 999 copies/mL in 228 (11.7%) patients. Viral suppression rates at different ART durations (months) were as follows: 84.2% (≤ 3), 88.8% (4–6), 90.9% (6–12), and 88.1% (> 12). Viral suppression rates were higher for patients aged 40 or older (40–50 years: aOR 2.05, 95%CI 1.41–3.04, P < 0.01; 50–60 years: aOR 2.51, 95%CI 1.53–4.35, P < 0.01; >60 years: aOR 2.69, 95%CI 1.28–6.63, P = 0.02). Men had 49% lower odds of viral suppression than women (aOR 0.50, 95% CI 0.38–0.67, P < 0.01).ConclusionWe report a viral suppression rate of 88.4% among patients on treatment for at least 6 months, with higher rate of suppression with dolutegravir than efavirenz. Factors associated with virological suppression were age and gender, emphasizing the need for innovative differentiated ART delivery models to optimize viral suppression and achieve the 95% target.

Antiretroviral Therapy and Adverse Pregnancy Outcomes in People Living with HIV

(N Engl J Med. 2023;388:344–356) Human immunodeficiency virus (HIV) is detected in about 1.3 million pregnant individuals every year. The use of antiretroviral therapy (ART) is common in about 1.1 million (85%) of these cases. When ART is not prescribed, 15% to 30% of individuals born to those with HIV will develop HIV. Maternal zidovudine (ZDV), a 3-drug ART regimen, has been proven to reduce the number of infants who contract HIV from their mothers. ZDV decreases the rate of vertical transmission of HIV from 25.5% to 8.3%. This study aimed to show the key evidence in support of ART and to evaluate both contemporary and legacy methods of ART delivery to see how they compare.

Strategies to improve the care of older adults 50 years and above living with HIV in Uganda

IntroductionWith effective antiretroviral therapy (ART), many persons living with HIV (PLHIV) live to old age. Caring for aged PLHIV necessitates the engagement of caregivers and patients to establish agreed-upon goals of treatment. However, there is limited literature on friendly and centered models of care for elderly PLHIV. We explored strategies to improve care in HIV clinics among PLHIV aged 50 years and above in Uganda.MethodsWe conducted 40 in-depth interviews in two hospitals with elderly PLHIV aged 50 years and above who had lived with HIV for more than ten years. We explored strategies for improving care of elderly PLHIV at both health facility and community levels. The in-depth interviews were audio-recorded and transcribed verbatim. The thematic approach guided data analysis.ResultsThe elderly PLHIV suggested the following strategies to improve their care: creating geriatric clinics; increasing screening tests for non-communicable diseases in the ART clinics; community and home-based ART delivery; workshops at health facilities to provide health education on aging effectively; creating community support groups; financial assistance for the elderly PLHIV and advances in science.ConclusionsThere is need to improve community HIV care especially for the elderly and social and economic support in the community. Involving the elderly PLHIV in developing strategies to improve their health goes a long way to improve the patients' quality of care. There is a need to incorporate the raised strategies in HIV care or older adults.

Perceptions and factors associated with the uptake of the community client-led antiretroviral therapy delivery model (CCLAD) at a large urban clinic in Uganda: a mixed methods study

IntroductionCommunity Client-Led ART Delivery (CCLAD) is a community HIV care model. In this model, a group of persons living with HIV (PLHIV) in a specific location, take turns going to the HIV clinic to pick up Antiretroviral Treatment refills for members. The uptake of this model, however, remains low despite its improvements in patient retention. In this study, we explored PLHIV’s perceptions of this model and identified the factors associated with its low uptake.MethodsThis was a mixed methods study based on a retrospective review of records of PLHIV and in-depth interviews. We reviewed the medical records of people receiving ART to determine their current model of ART delivery and conducted in-depth interviews with 30 participants who were eligible to be enrolled in the CCLAD model at the Mulago ISS clinic. We performed logistic regression to identify factors associated with the uptake of the CCLAD model and inductive thematic analysis to explore PLHIV’s perceptions of the CCLAD model.ResultsA total of 776 PLHIV were sampled for the study, 545 (70.2%) of whom were female. The mean age (standard deviation) was 42 (± 9.3) years. Overall, 55 (7.1%) received ART using the CCLAD model. Compared to other ART-delivery models, CCLAD was associated with being on ART for at least eight years (AOR 3.72; 95% CI: 1.35–10.25) and having no prior missed clinic appointments (AOR 10.68; 95% CI: 3.31–34.55). Mixed perceptions were expressed about the CCLAD model. Participants interviewed appreciated CCLAD for its convenience and the opportunities it offered members to talk and support each other. Others however, expressed concerns about the process of group formation, and feeling detached from the health facility with consequences of lack of confidentiality.ConclusionThe current uptake of the CCLAD model is lower than the national recommended percentage of 15%. Its uptake was associated with those who had been in care for a longer period and who did not miss appointments. Despite CCLAD being perceived as convenient and as promoting support among members, several challenges were expressed. These included complexities of group formation, fear of stigma and feelings of detachment from health facilities among others. So, while CCLAD presents a promising alternative ART delivery model, more attention needs to be paid to the processes of group formation and improved patient monitoring to address the feelings of detachment from the facility and facility staff.

Assessment of knowledge of differentiated service delivery among HIV-positive patients receiving care in a Southeastern Nigerian State

Background: Since the adoption of the differentiated service delivery (DSD) as a programmatic strategy in the delivery of antiretroviral therapy (ART) in Imo state, no research has assessed the level of knowledge of DSD among HIV-positive patients receiving ART in the state, a research gap which this study aimed to fill.&#x0D; Methods: This was a cross sectional study carried out among the adult patients receiving ART in three DSD models and the usual care group at one tertiary and three secondary hospitals using a structured questionnaire validated by the researcher. Descriptive and inferential analyses were performed using the statistical product and service solutions (SPSS) version 24. All the analysis was performed at p≤0.05.&#x0D; Results: Of the 542 questionnaires retrieved, the female gender was predominant in all the groups. Up to 57.3% and 55.5% of the patients had good knowledge and perception towards differentiated care respectively. A significant difference was found in the mean perception among the groups (F (3.538)=9.309, p&lt;0.05). While education and participation in HIV activities were found to be significant predators of knowledge of DSD, (F (10.466)=3.082, R2 of 0.062, p&lt;0.05), only education was found to be determinant of perception.&#x0D; Conclusions: This study has shown that the patients had fair knowledge of the DSD in all the models examined, as well as the usual group; and this did not differ significantly across the groups. However, there is need to improve on patients' enlightenment of the initiative, especially for those in the usual care group.

Clinical outcomes after extended 12-month antiretroviral therapy prescriptions in a community-based differentiated HIV service delivery programme in South Africa: a retrospective cohort study.

There is an urgent need for more efficient models of differentiated antiretroviral therapy (ART) delivery for people living with HIV (PLHIV), with the World Health Organization calling for evidence to guide whether annual ART prescriptions and consultations (12M scripts) should be recommended in global guidelines. We assessed the association between 12M scripts (allowed temporarily during the COVID-19 pandemic) versus standard 6-month prescriptions and consultations (6M scripts) and clinical outcomes. We performed a retrospective cohort study using routine, de-identified data from 59 public clinics in KwaZulu-Natal, South Africa. We included PLHIV aged ≥18 years with a recent suppressed viral load (VL) who had been referred for community ART delivery with 6M or 12M scripts. We used modified Poisson regression to compare 12-month retention-in-care (≤90 days late for all visits) and viral suppression (<50 copies/ml) between prescription groups. Among 27,148 PLHIV referred for community ART during Jun-Dec 2020, 57.4% received 12M scripts. The median age was 39 years and 69.4% were women. Age, sex, prior community ART use and time on ART were similar across groups. However, more of the 12M script group had dolutegravir-based regimens (60.0% vs. 46.3%). The median (interquartile range) number of clinic visits in the year of follow-up was 1(1-1) in the 12M group and 2(2-3) in the 6M group. Retention was 94.6% (95% confidence interval [CI]: 94.2%-94.9%) among those receiving 12M scripts and 91.8% (95% CI: 91.3%-92.3%) among those with 6M scripts. 17.1% and 16.9% of clients in the 12M and 6M groups were missing follow-up VL data, respectively. Among those with VLs, 92.4% (95% CI: 92.0%-92.9%) in the 12M group and 91.4% (95% CI: 90.8%-92.0%) in the 6M group were suppressed. After adjusting for age, sex, ART regimen, time on ART, prior community ART use and calendar month, retention (adjusted risk ratio [aRR]: 1.03, 95% CI: 1.01-1.05) and suppression (aRR: 1.00, 95% CI: 0.99-1.01) were similar across groups. Among PLHIV referred for community ART with a recent suppressed VL, the use of 12M scripts reduced clinic visits without impacting short-term clinical outcomes. 12M scripts should be considered for differentiated service delivery programmes.

The SENTINEL study of differentiated service delivery models for HIV treatment in Malawi, South Africa, and Zambia: research protocol for a prospective cohort study

BackgroundMany countries in sub-Saharan Africa are rapidly scaling up “differentiated service delivery” (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers’ job satisfaction, patients’ quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level.MethodsSENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include four or more approximately annual rounds of data collection between 2021 and 2026.DiscussionAs national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.

Long‐term usage patterns and clinical outcomes in a community‐based differentiated antiretroviral therapy delivery programme in South Africa

AbstractIntroductionThere is little data on long‐term implementation and outcomes for people living with HIV (PLHIV) in differentiated antiretroviral therapy (ART) delivery programmes. We aimed to analyse usage patterns of and associated treatment outcomes in a community ART programme, within the Centralized Chronic Medicines Dispensing and Distribution programme, in South Africa over 3.5 years.MethodsWe performed a retrospective cohort study among PLHIV on first‐line ART who were eligible for community ART delivery between October 2016 and March 2019, from 56 urban clinics in KwaZulu‐Natal, South Africa. Follow‐up ended in March 2020. We measured referral rates and, among those referred, we characterized patterns of community ART usage using group‐based trajectory modelling following referral. We used survival analysis to measure the association between community ART usage and loss‐to‐care (no visit for ≥365 days) and logistic regression to measure the association between community ART usage and viraemia (≥50 copies/ml).ResultsAmong the 80,801 patients eligible for community ART, the median age was 36 years, 69.8% were female and the median (interquartile range [IQR]) follow‐up time was 22 (13–31) months. In total, 49,961 (61.8%) were referred after a median of 6 (IQR 2–13) months from first eligibility. After referral, time spent in community ART varied; 42% remained consistently in community ART, 15% returned to consistent clinic‐based care and the remaining 43% oscillated between community ART and clinic‐based care. Following referral, the incidence of loss‐to‐care was 3.93 (95% confidence interval [CI]: 3.71–4.15) per 100 person‐years during periods of community ART usage compared to 5.75 (95% CI: 5.28–6.25) during clinic‐based care. In multivariable models, community ART usage was associated with a 36% reduction in the hazards of loss‐to‐care (adjusted hazard ratio: 0.64 [95% CI: 0.57–0.72]). The proportion of patients who became viraemic after first community ART referral was 5.2% and a 10% increase in time in community ART was associated with a 3% reduction in odds of viraemia (adjusted odds ratio: 0.97 [95% CI: 0.95–0.99]).ConclusionsCommunity ART usage patterns vary considerably, while clinical outcomes were good. Promoting consistent community ART usage may reduce clinic burden and the likelihood of patients being lost to care, while sustaining viral suppression.

Unexpected effects of COVID-19 outbreak: adaption of Anti-Retroviral Therapy (ART) delivery policies improved adherence in a population of People Living With HIV (PLWH).

Adherence to Anti-Retroviral Therapy (ART) is crucial for People Living With HIV (PLWH). In Italy, ART is delivered by Hospital Pharmacies, on a renewable prescription from the hospital physician. The measurement of package-refill (the rate of ART packages actually collected out of those to be collected in order to comply with therapy) is an effective tool to evaluate the adherence.During COVID-19 outbreak, at "D. Cotugno" hospital in Naples, Italy, the ART delivery policies have been adapted, in order to reduce the number of patients' access. We analysed the impact of these changes on the pill-refill of ART in January-August 2020, compared with 2018-2019. "D. Cotugno" hospital is a mono-specialistic Infectious Diseases hospital, caring for about 2500 PLWH. Since February 2020, the hospital was almost entirely dedicated to COVID-19 patients. All out-patient activities were interrupted, except for those dedicated to HIV/AIDS patients.In this preliminary study we included all patients assigned to one of the three Medical Divisions dedicated to HIV, who were already under treatment since at least 2017. Rate of package-refill was obtained by the Hospital Pharmacy registry, demographic and clinical data were derived from clinical database.During COVID-19, many measures were adopted in order to increase safety of PLWH attending to hospital. Among these, medical prescription validity increased from 4 to 6 months, and number of packages to be collected increased from 2 to 4, adopting a multi-month dispensing strategy.Package-refill is adequate if at least 95% of ART have been actually collected; partial and inadequate if 75%-94% or less than 75% of ART, respectively, have been collected. Package-refill was measured during the first year of COVID-19 (March 2020 - February 2021), compared to the same period in the two years before. A total of 594 PLWH were included. PLWH with optimal pill-refill significantly increased in 2020-21 compared to 2018-2020 (62% vs 55%, p 0.013). Due to COVID-19, we would have expected a reduction in ART deliveries. Surprisingly, the opposite occurred. The increase of pill-refill rates may be due to different reasons, but we hypothesized that the adaption of delivery policies, with a higher number of packages allowed to be collected, strongly contributed to this result. This study suggests that multi-month dispensing policies may contribute to the improvement of adherence among PLWH.

Retention in care among people living with HIV in the national antiretroviral therapy programme in Guinea: A retrospective cohort analysis.

Few studies have investigated retention in HIV care in West Africa. We measured retention in antiretroviral therapy (ART) programmes among people living with HIV and re-engagement in care among those lost to follow up (LTFU) in Guinea and identified associated risk factors using survival analysis. Patient-level data were analysed from 73 ART sites. Treatment interruptions and LTFU were defined as missing a ART refill appointment by over 30 days and by over 90 days respectively. A total of 26,290 patients initiating ART between January 2018 and September 2020 were included in the analysis. The mean age at ART initiation was of 36.2 years, with women accounting for 67% of the cohort. Retention 12 months after ART initiation was 48.7% (95%CI 48.1-49.4%). The LTFU rate was 54.5 per 1000 person-months (95% CI 53.6-55.4), with the peak hazards of LTFU occurring after the first visit and decreasing steadily over time. In an adjusted analysis, the hazards of LTFU were higher among men compared to women (aHR = 1.10; 95%CI 1.08-1.12), being aged 13-25 years old versus older patients (aHR = 1.07; 95%CI = 1.03-1.13), and among those initating ART in smaller health facilities (aHR = 1.52; 95%CI 1.45-1.60). Among 14,683 patients with an LTFU event, 4,896 (33.3%) re-engaged in care, of whom 76% did so within six months from LTFU. The re-engagement rate was 27.1 per 1000 person-months (95%CI 26.3-27.9). Treatment interruptions were correlated with rainfall patterns and end of year mobility patterns. Rates of retention and re-engagement in care are very low in Guinea, undermining the effectiveness and durability of first-line ART regimens. Tracing interventions and differentiated service delivery of ART, including multi-month dispensing may improve care engagement, especially in rural areas. Further research should investigate social and health systems barriers to retention in care.

Initial programme theory for community-based ART delivery for key populations in Benue State, Nigeria: a realist evaluation study

BackgroundThe community-based antiretroviral therapy delivery (CBART) model was implemented in Benue State in Nigeria to increase access of key populations living with HIV (KPLHIV) to antiretroviral treatment. Key populations (KP) are female sex workers, men who have sex with men, persons who inject drugs, and transgender people. Evidence shows that the CBART model for KP (KP-CBART) can improve HIV outcomes along the cascade of HIV care and treatment in sub-Saharan Africa. However, how KP-CBART works, for whom, why, and under what circumstances it generates specific outcomes are not yet clear. Therefore, the aim of this study is to identify the initial programme theory (IPT) of the KP-CBART in Benue State using a realist approach.MethodThe study design is exploratory and qualitative, exploring the implementation of KP-CBART. We reviewed the intervention logic framework & guidelines for the KP-CBART in Nigeria, conducted a desk review of KP-CBART in Sub-Saharan Africa (SSA) and interviewed programme managers in the Benue HIV programme between November 2021 and April 2022. Findings were synthesized using the Context-Mechanism-Outcome (CMO) heuristic tool to explain the relationship between the different types of CBART models, contextual factors, actors, mechanisms and outcomes. Using a generative causality logic (retroduction and abduction), we developed, following a realist approach, CMO configurations (CMOc), summarized as an empirically testable IPT.ResultWe developed 7 CMOc and an IPT of the KP-CBART. Where KPLHIV receive ART in a safe place while living in a setting of punitive laws, harassment, stigma and discrimination, KP will adhere to treatment and be retained in care because they feel safe and trust the healthcare providers. Where KPLHIV are involved in the design, planning and implementation of HIV services; medication adherence and retention in care will improve because KP clients perceive HIV services to be KP-friendly and participate in KP-CBART.ConclusionImplementation of CBART model where KPLHIV feel safe, trust healthcare providers, and participate in HIV service delivery can improve medication adherence and retention in care. This programme hypothesis will be tested and refined in the next phase of the realist evaluation of KP-CBART.