Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe

Fatti, Geoffrey; Ngorima‐Mabhena, Nicoletta; Mothibi, Eula; Muzenda, Trish; Choto, Regis; Kasu, Tonderai; Tafuma, Taurayi A.; Mahachi, Nyika; Takarinda, Kudakwashe C; Apollo, Tsitsi; Mugurungi, Owen; Chasela, Charles; Hoffman, Risa M.; Grimwood, Ashraf

doi:10.1097/qai.0000000000002333

Cited by 58 publications

(86 citation statements)

References 23 publications

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“…This is the first study reporting 24-month outcomes. Our outcomes are consistent with interim 12-month outcomes in two recently published cluster randomized trials in Zimbabwe [31] and Lesotho [30] that showed non-inferior retention in community-based DSDs receiving six-monthly refills, compared to three-monthly facility controls. VL suppression was non-inferior in the Lesotho study [30], but not the Zimbabwean study, possibly because of low VL completion rates [31].…”

Section: Discussionsupporting

confidence: 89%

“…Our results add to the growing literature showing good retention and clinical outcomes associated with extended ART dispensing intervals [30,31,[46][47][48]. This is particularly important at a time when countries will be considering whether to continue or reverse six-monthly ART refills provided during the COVID-19 pandemic.…”

Section: Discussionsupporting

confidence: 53%

“…Cassidy T et al Journal of the International AIDS Society 2020, 23:e25649 http://onlinelibrary.wiley.com/doi/10.1002/jia2.25649/full | https://doi.org/10.1002/jia2.25649 reported 95% to 97% [8,35,43,44], and higher than 89.5% reported from a South African AC model evaluation comparing 24 randomly allocated intervention and control facilities undertaken in Gauteng, Kwa-Zulu Natal, Limpopo and North West provinces at the same time point [9]. Retention was also comparable to the six-monthly dispensing arms of the recently published non-inferiority trials from Zimbabwe (93.6%) and Lesotho (94.7%) [30,31]. VL completion was high in the first 12 months, and lower in the second year of the study (85.2% in SoC and 90.8% in intervention), but still equivalent or better than published data on similar AC cohorts (85.2% [43], 79.7% to 86.5% [7], 82% to 85% [14]).…”

Section: Discussionmentioning

confidence: 77%

“…It remains uncertain whether these emergency measures will be adopted into DSD country policy and/or implementation plans in a post-COVID era. Recent trials in Lesotho, Malawi, Zambia and Zimbabwe evaluated sixmonth ART refills in community and individual models [30][31][32].…”

mentioning

confidence: 99%

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Twenty‐four‐month outcomes from a cluster‐randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs

Cassidy

Grimsrud²,

Keene

et al. 2020

J. Intern. AIDS Soc.

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Introduction The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients’ retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non‐inferiority cluster randomized trial comparing standard of care (SoC) ACs and six‐month refill intervention ACs in a primary care facility in Khayelitsha, South Africa. Methods Existing community‐based and facility‐based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two‐month refills with a four‐month refill over year‐end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six‐month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention‐to‐treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC. Results Of 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of −1.0% (95% CI: −3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0). Conclusions Intervention AC patients receiving six‐month ART refills showed non‐inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 77%

mentioning

confidence: 99%

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Twenty‐four‐month outcomes from a cluster‐randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs

Cassidy

Grimsrud²,

Keene

et al. 2020

J. Intern. AIDS Soc.

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“…Evidence from two choice experiments in this synthesis showed a strong relative preference for three monthly as opposed to one monthly refills compared with other service attributes, and a further three experiments demonstrate no differences in preference for longer refill intervals when compared with 3-month prescribing. This mirrors findings from observational studies and trials which demonstrate improved retention with three or six monthly versus one monthly ART refill frequency [33,35] but minimal difference in HIV treatment outcomes for three versus six monthly refill comparisons [36,37]. Efforts should be made to optimize drug supply chains and pharmacy storage capacity to ensure that all settings are able to provide at minimum 3-month refills and where possible longer drug supplies should be considered [38].…”

Section: Discussionsupporting

confidence: 63%

Exploring Relative Preferences for HIV Service Features Using Discrete Choice Experiments: a Synthetic Review

et al. 2020

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Purpose of Review Aligning HIV treatment services with patient preferences can promote long-term engagement. A rising number of studies solicit such preferences using discrete choice experiments, but have not been systematically reviewed to seek generalizable insights. Using a systematic search, we identified eleven choice experiments evaluating preferences for HIV treatment services published between 2004 and 2020. Recent Findings Across settings, the strongest preference was for nice, patient-centered providers, for which participants were willing to trade considerable amounts of time, money, and travel distance. In low- and middle-income countries, participants also preferred collecting antiretroviral therapy (ART) less frequently than 1 monthly, but showed no strong preference for 3-compared with 6-month refill frequency. Facility waiting times and travel distances were also important but were frequently outranked by stronger preferences. Health facility–based services were preferred to community- or home-based services, but this preference varied by setting. In high-income countries, the availability of unscheduled appointments was highly valued. Stigma was rarely explored and costs were a ubiquitous driver of preferences. Summary While present improvement efforts have focused on designs to enhance access (reduced waiting time, travel distance, and ART refill frequency), few initiatives focus on the patient-provider interaction, which represents a promising critical area for inquiry and investment. If HIV programs hope to truly deliver patient-centered care, they will need to incorporate patient preferences into service delivery strategies. Discrete choice experiments can not only inform such strategies but also contribute to prioritization efforts for policy-making decisions.

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Acceleration of differentiated service delivery for HIV treatment in sub‐Saharan Africa during COVID‐19

Grimsrud¹,

Wilkinson

2021

J Int AIDS Soc

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Introduction In response to COVID‐19, national ministries of health adapted HIV service delivery guidelines to ensure uninterrupted access to antiretroviral therapy (ART) and limit the frequency of contact with health facilities. In this commentary, we summarize four ways in which differentiated service delivery (DSD) for HIV treatment has been accelerated during COVID‐19 in policy and implementation in sub‐Saharan Africa (SSA) – (i) expanding eligibility for DSD for HIV treatment, (ii) extending multi‐month dispensing (MMD) and reducing the frequency of clinical consultations, (iii) emphasizing community‐based models and (iv) integrating/aligning with TB preventative therapy (TPT), non‐communicable disease (NCD) treatments and family planning commodities. Discussion Across SSA in 2020, countries both adapted and emphasized policies supporting DSD for HIV treatment in response to COVID‐19. Access to DSD for HIV treatment was expanded by reducing the time required on ART before eligibility and being more inclusive of specific populations including children and adolescents, pregnant and breastfeeding women and those on second‐ and third‐line regimens. Access to extended ART refills, or MMD, was accelerated across many countries. A renewed focus was given to out‐of‐facility community‐based models of ART distribution. In some settings, there was acknowledgement of the need to integrate or align other chronic medications with ART. Conclusions Adaptations to DSD for HIV treatment in response to COVID‐19 have resulted in rapid policy change and in some cases, acceleration of implementation in SSA. As the COVID‐19 pandemic evolves, there is a critical need to assess the impact of these adaptations and, where beneficial, ensure that policies implemented in response to COVID‐19 become the new normal.

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Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe

Cited by 58 publications

References 23 publications

Twenty‐four‐month outcomes from a cluster‐randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs

Twenty‐four‐month outcomes from a cluster‐randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs

Exploring Relative Preferences for HIV Service Features Using Discrete Choice Experiments: a Synthetic Review

Acceleration of differentiated service delivery for HIV treatment in sub‐Saharan Africa during COVID‐19

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