Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial

Amanyire, Gideon; Semitala, Fred C.; Namusobya, Jennifer; Katuramu, Richard; Kampiire, Leatitia; Wallenta, Jeanna; Charlebois, Edwin D.; Camlin, Carol S.; Kahn, James G.; Chang, Wei; Glidden, David V.; Kamya, Moses R.; Havlir, Diane V.; Geng, Elvin

doi:10.1016/s2352-3018(16)30090-x

Cited by 113 publications

(133 citation statements)

References 32 publications

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“…Elul 2017 offered ART on the first clinic visit; McNairy 2017 aimed to offer ART within seven days of diagnosis and Amanyire 2016 within 14 days of diagnosis. We have summarized the main characteristics of the included studies in Table 7.…”

Section: Resultsmentioning

confidence: 99%

“…One study also described expediting tuberculosis (TB) screening before they offered ART (Rosen 2016). In Amanyire 2016, Rosen 2016, and Stevens 2017, healthcare workers received training on the new procedures and instruments implemented (for example, POC instruments) before rapid ART was delivered.…”

Section: Resultsmentioning

confidence: 99%

“…Five studies reported virological suppression at 12 months, with only Elul 2017 and Stevens 2017 not reporting on this outcome. One study, Amanyire 2016, reported mortality and viral suppression for a randomly selected subset of study participants; these were then inverse‐probability weighted to represent the total study population and determine effect estimates.…”

Section: Resultsmentioning

confidence: 99%

“…Elul 2017 aimed to offer ART within the first clinic visit in the intervention arm, which was expedited. Amanyire 2016 aimed to offer ART within 14 days of enrolment to those in the rapid ART group. Also, during the review process, we identified significant variation in study design.…”

Section: Methodsmentioning

confidence: 99%

“…There is high heterogeneity between studies. Although this is partly explained by the different designs (for example, Koenig 2017 and Rosen 2016 offered ART on same day of diagnosis/enrolment, whilst Amanyire 2016 aimed to offer it within 14 days of diagnoses), heterogeneity remains high when similar studies are grouped together. m Downgraded by two for imprecision.…”

Section: Summary Of Findingsmentioning

confidence: 99%

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Rapid initiation of antiretroviral therapy for people living with HIV

Urdiales

Johnson

Smith

et al. 2019

Cochrane Database of Systematic Reviews

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Background Despite antiretroviral therapy (ART) being widely available, HIV continues to cause substantial illness and premature death in low‐and‐middle‐income countries. High rates of loss to follow‐up after HIV diagnosis can delay people starting ART. Starting ART within seven days of HIV diagnosis (rapid ART initiation) could reduce loss to follow‐up, improve virological suppression rates, and reduce mortality. Objectives To assess the effects of interventions for rapid initiation of ART (defined as offering ART within seven days of HIV diagnosis) on treatment outcomes and mortality in people living with HIV. We also aimed to describe the characteristics of rapid ART interventions used in the included studies. Search methods We searched CENTRAL, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, and four other databases up to 14 August 2018. There was no restriction on date, language, or publication status. We also searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, and websites for unpublished literature, including conference abstracts. Selection criteria We included randomized controlled trials (RCTs) that compared rapid ART versus standard care in people living with HIV. Children, adults, and adolescents from any setting were eligible for inclusion. Data collection and analysis Two review authors independently assessed the eligibility of the studies identified in the search, assessed the risk of bias and extracted data. The primary outcomes were mortality and virological suppression at 12 months. We have presented all outcomes using risk ratios (RR), with 95% confidence intervals (CIs). Where appropriate, we pooled the results in meta‐analysis. We assessed the certainty of the evidence using the GRADE approach. Main results We included seven studies with 18,011 participants in the review. All studies were carried out in low‐ and middle‐income countries in adults aged 18 years old or older. Only one study included pregnant women. In all the studies, the rapid ART intervention was offered as part of a package that included several cointerventions targeting individuals, health workers and health system processes delivered alongside rapid ART that aimed to facilitate uptake and adherence to ART. Comparing rapid ART with standard initiation probably results in greater viral suppression at 12 months (RR 1.18, 95% CI 1.10 to 1.27; 2719 participants, 4 studies; moderate‐certainty evidence) and better ART uptake at 12 months (RR 1.09, 95% CI 1.06 to 1.12; 3713 participants, 4 studies; moderate‐certainty evidence), and may improve retention in care at 12 months (RR 1.22, 95% CI 1.11 to 1.35; 5001 participants, 6 studies; low‐certainty evidence). Rapid ART initiation was associated with a lower mortality estimate, however the CIs included n...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Summary Of Findingsmentioning

confidence: 99%

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Rapid initiation of antiretroviral therapy for people living with HIV

Urdiales

Johnson

Smith

et al. 2019

Cochrane Database of Systematic Reviews

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Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Saag

Benson

Gandhi

et al. 2018

JAMA

518

287

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IMPORTANCE Antiretroviral therapy (ART) is the cornerstone of prevention and management of HIV infection. OBJECTIVE To evaluate new data and treatments and incorporate this information into updated recommendations for initiating therapy, monitoring individuals starting therapy, changing regimens, and preventing HIV infection for individuals at risk. EVIDENCE REVIEW New evidence collected since the International Antiviral Society–USA 2016 recommendations via monthly PubMed and EMBASE literature searches up to April 2018; data presented at peer-reviewed scientific conferences. A volunteer panel of experts in HIV research and patient care considered these data and updated previous recommendations. FINDINGS ART is recommended for virtually all HIV-infected individuals, as soon as possible after HIV diagnosis. Immediate initiation (eg, rapid start), if clinically appropriate, requires adequate staffing, specialized services, and careful selection of medical therapy. An integrase strand transfer inhibitor (InSTI) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is generally recommended for initial therapy, with unique patient circumstances (eg, concomitant diseases and conditions, potential for pregnancy, cost) guiding the treatment choice. CD4 cell count, HIV RNA level, genotype, and other laboratory tests for general health and co-infections are recommended at specified points before and during ART. If a regimen switch is indicated, treatment history, tolerability, adherence, and drug resistance history should first be assessed; 2 or 3 active drugs are recommended for a new regimen. HIV testing is recommended at least once for anyone who has ever been sexually active and more often for individuals at ongoing risk for infection. Preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine and appropriate monitoring is recommended for individuals at risk for HIV. CONCLUSIONS AND RELEVANCE Advances in HIV prevention and treatment with antiretroviral drugs continue to improve clinical management and outcomes for individuals at risk for and living with HIV.

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