Dataset Information

The Impact of Same-Day Antiretroviral Therapy Initiation Under the World Health Organization Treat-All Policy.

ABSTRACT: Rapid initiation of antiretroviral therapy (ART) is recommended for people living with human immunodeficiency virus (HIV), with the option to start treatment on the day of diagnosis (same-day ART). However, the effect of same-day ART remains unknown in realistic public sector settings. We established a cohort of ≥16-year-old patients who initiated first-line ART under a treat-all policy in Nhlangano (Eswatini) during 2014-2016, either on the day of HIV care enrollment (same-day ART) or 1-14 days thereafter (early ART). Directed acyclic graphs, flexible parametric survival analysis, and targeted maximum likelihood estimation (TMLE) were used to estimate the effect of same-day-ART initiation on a composite unfavorable treatment outcome (loss to follow-up, death, viral failure, treatment switch). Of 1,328 patients, 839 (63.2%) initiated same-day ART. The adjusted hazard ratio of the unfavorable outcome was higher, 1.48 (95% confidence interval: 1.16, 1.89), for same-day ART compared with early ART. TMLE suggested that after 1 year, 28.9% of patients would experience the unfavorable outcome under same-day ART compared with 21.2% under early ART (difference: 7.7%; 1.3%-14.1%). This estimate was driven by loss to follow-up and varied over time, with a higher hazard during the first year after HIV care enrollment and a similar hazard thereafter. We found an increased risk with same-day ART. A limitation was that possible silent transfers that were not captured.

SUBMITTER: Kerschberger B

PROVIDER: S-EPMC8327202 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:INTRODUCTION:The World Health Organization recommends the Treat-All policy of immediate antiretroviral therapy (ART) initiation, but questions persist about its feasibility in resource-poor settings. We assessed the feasibility of Treat-All compared with standard of care (SOC) under routine conditions. METHODS:This prospective cohort study from southern Eswatini followed adults from HIV care enrolment to ART initiation. Between October 2014 and March 2016, Treat-All was offered in one health zone and SOC according to the CD4 350 and 500 cells/mm3 treatment eligibility thresholds in the neighbouring health zone, each of which comprised one secondary and eight primary care facilities. We used Kaplan-Meier estimates, multivariate flexible parametric survival models and standardized survival curves to compare ART initiation between the two interventions. RESULTS:Of the 1726 (57.3%) patients enrolled under Treat-All and 1287 (42.7%) under SOC, cumulative three-month ART initiation was higher under Treat-All (91%) than SOC (74%; p < 0.001) with a median time to ART of 1 (IQR 0 to 14) and 10 (IQR 2 to 117) days respectively. Under Treat-All, ART initiation was higher in pregnant women (vs. non-pregnant women: adjusted hazard ratio (aHR) 1.96, 95% confidence interval (CI) 1.70 to 2.26), those with secondary education (vs. no formal education: aHR 1.48, 95% CI 1.12 to 1.95), and patients with an HIV-positive diagnosis before care enrolment (aHR 1.22, 95% CI 1.10 to 1.36). ART initiation was lower in patients attending secondary care facilities (aHR 0.64, 95% CI 0.58 to 0.72) and for CD4 351 to 500 when compared with CD4 201 to 350 cells/mm3 (aHR 0.84, 95% CI 0.72 to 1.00). ART initiation varied over time for TB cases, with lower hazard during the first two weeks after HIV care enrolment and higher hazards thereafter. Of patients with advanced HIV disease (n = 1085; 36.0%), crude 3-month ART initiation was similar in both interventions (91% to 92%) although Treat-All initiated patients more quickly during the first month after HIV care enrolment. CONCLUSIONS:ART initiation was high under Treat-All and without evidence of de-prioritization of patients with advanced HIV disease. Additional studies are needed to understand the long-term impact of Treat-All on patient outcomes.

Project description:Same-day initiation (SDI) of antiretroviral therapy (ART) has been recommended to improve ART programme outcomes in South Africa since August 2017. This study assessed implementation of SDI over time in two South African districts, describing the characteristics of same-day initiators and evaluating the impact of SDI on retention in ART care. Routine data were analysed for HIV-infected adults who were newly initiating ART in Johannesburg or Mopani Districts between October 2017 and June 2018. Characteristics of same-day ART initiators were compared to later initiators, and losses to follow-up (LTFU) to six months were assessed using Kaplan Meier survival analysis and multivariate logistic regression. The dataset comprised 32 290 records (29 964 from Johannesburg and 2 326 from Mopani). The overall rate of SDI was 40.4% (n = 13 038), increasing from 30.3% in October 2017 to 54.2% in June 2018. Same-day ART initiators were younger, more likely to be female and presented with less advanced clinical disease than those initiating treatment at later times following diagnosis (p<0.001 for all). SDI was associated with disengagement from care: LTFU was 30.1% in the SDI group compared to 22.4%, 19.8% and 21.9% among clients initiating ART 1-7 days, 8-21 days and ≥22 days after HIV diagnosis, respectively (p<0.001). LTFU was significantly more likely among clients in Johannesburg versus Mopani (adjusted odds ratio (aOR) = 1.43, p<0.001) and among same-day versus later initiators (aOR = 1.45, p<0.001), while increasing age reduced LTFU (aOR = 0.97, p<0.001). In conclusion, SDI has increased over time as per national guidelines, but there is serious concern regarding the reduced rate of retention among same-day initiators. Nevertheless, SDI may result in a net programmatic benefit provided that interventions are implemented to support client readiness for treatment and ongoing engagement in ART care, particularly among younger adults in large ART programmes such as Johannesburg.

Project description:IntroductionSame-day antiretroviral therapy (SDART) initiation has been implemented at the Thai Red Cross Anonymous Clinic (TRCAC) in Bangkok, Thailand, since 2017. HIV-positive, antiretroviral therapy (ART)-naïve clients who are willing and clinically eligible start ART on the day of HIV diagnosis. In response to the first wave of the coronavirus disease 2019 (COVID-19) outbreak in March 2020, telehealth follow-up was established to comply with COVID-19 preventive measures and allow service continuation. Here, we evaluate its implementation.MethodsPre-COVID-19 (until February 2020) clients who initiated SDART received a 2-week ART supply and returned to the clinic for evaluation before being referred to long-term ART maintenance facilities. If no adverse events (AEs) occurred, another 8-week ART supply was provided while referral was arranged. During the first wave of COVID-19 (March-May 2020), clients received a 4-week ART supply and the option of conducting follow-up consultation and physical examination via video call. Clients with severe AEs were required to return to TRCAC; those without received another 6-week ART supply by courier to bridge transition to long-term facilities. This adaptation continued post-first wave (May-August 2020). Routine service data were analysed using data from March to August 2019 for the pre-COVID-19 period. Interviews and thematic analysis were conducted to understand experiences of clients and providers, and gain feedback for service improvement.ResultsOf 922, 183 and 321 eligible clients from the three periods, SDART reach [89.9%, 96.2% and 92.2% (p = 0.018)] and ART initiation rates [88.1%, 90.9% and 94.9% (p<0.001)] were high. ART uptake, time to ART initiation and rates of follow-up completion improved over time. After the integration, 35.3% received the telehealth follow-up. The rates of successful referral to a long-term facility (91.8% vs. 95.3%, p = 0.535) and retention in care at months 3 (97.5% vs. 98.0%, p = 0.963) and 6 (94.1% vs. 98.4%, p = 0.148) were comparable for those receiving in-person and telehealth follow-up. Six clients and nine providers were interviewed; six themes on service experience and feedback were identified.ConclusionsTelehealth follow-up with ART delivery for SDART clients is a feasible option to differentiate ART initiation services at TRCAC, which led to its incorporation into routine service.

Project description:INTRODUCTION:Many prevention of mother-to-child HIV transmission programmes across Africa initiate HIV-infected (HIV positive) pregnant women on lifelong antiretroviral therapy (ART) on the first day of antenatal care ("same-day" initiation). However, there are concerns that same-day initiation may limit patient preparation before starting ART and contribute to subsequent non-adherence, disengagement from care and raised viral load. We examined if same-day initiation was associated with viral suppression and engagement in care during pregnancy. METHODS:Consecutive ART-eligible pregnant women making their first antenatal care (ANC) visit at a primary care facility in Cape Town, South Africa were enrolled into a prospective cohort between March 2013 and June 2014. Before July 2013, ART eligibility was based on CD4 cell count ≤350 cells/μL ("Option A"), with a 1 to 2 week delay from the first ANC visit to ART initiation for patient preparation; thereafter all women were eligible regardless of CD4 cell count ("Option B+") and offered ART on the same day as first ANC visit. Women were followed with viral load testing conducted separately from routine ART services, and engagement in ART services was measured using routinely collected clinic, pharmacy and laboratory records through 12 months postpartum. RESULTS:Among 628 HIV-positive women (median age, 28 years; median gestation at ART start, 21 weeks; 55% newly diagnosed with HIV), 73% initiated ART same-day; this proportion was higher under Option B+ versus Option A (85% vs. 20%). Levels of viral suppression (viral load <50 copies/mL) at delivery (74% vs. 82%) and 12 months postpartum (74% vs. 71%) were similar under same-day versus delayed initiation respectively. Findings were consistent when viral suppression was defined at <1000 copies/mL, after adjustment for demographic/clinical measures and across subgroups of age, CD4 and timing of HIV diagnosis. Time to first viral rebound following initial suppression did not differ by timing of ART initiation nor did engagement in care through 12 months postpartum (same-day = 73%, delayed = 73%, p = 0.910). CONCLUSIONS:These data suggest that same-day ART initiation during pregnancy is not associated with lower levels of engagement in care or viral suppression through 12 months post-delivery in this setting, providing reassurance to ART programmes implementing Option B+.

Project description:BackgroundIn August 2016, Ethiopia endorsed a universal "test and treat" strategy for people living with human immunodeficiency virus (PLHIV) based on World Health Organization recommendation. However, there is limited evidence on the routine application of the same-day "test and treat" recommendation in low-income settings. This study assessed the effect of same-day treatment initiation on individual-level retention at 6- and 12-months follow-up.MethodsA multicenter facility-based retrospective cohort study was conducted to compare retention-in-care between PLHIV who started antiretroviral therapy (ART) on the same-day and those started ART > 7 days following HIV diagnoses. Participants were at least 15 years-old and were newly diagnosed and started on ART between October 2016 and July 2018 in 11 health facilities in the Amhara region of Ethiopia. Multivariable logistic regression controlling for potential confounders and Kaplan-Meier survival analysis were used to assess differences in outcomes between the groups.ResultsIn total, 433 PLHIV started ART on the same-day of diagnosis and 555 PLHIV who started ART > 7 days after HIV diagnosis were included in the study. At 6-months, 82.0% (355) in the same-day group vs 89.4% (496) in the > 7 days group were retained-in-care (absolute risk difference (RD) = 7.4%; 95% confidence interval (CI): 2.9-11.8%). At 12-months, 75.8% (328) in the same-day group vs 82.0% (455) in the > 7 days group were retained-in-care (absolute RD = 6.2%; 95% CI: 1.1, 11.4%). The major drop in retention was in the first 30 days following ART initiation among same-day group. After adjusting for baseline and non-baseline covariates, the same-day group was less likely to be retained-in-care at 6- and 12-months (adjusted risk ratio (RR) = 0.89; 95% CI: 0.87, 0.90 and adjusted RR = 0.86; 95% CI: 0.83, 0.89, respectively).ConclusionsReduced retention-in-care can threaten the benefit of the same-day "test and treat" policy. The policy needs to be implemented cautiously with greater emphasis on assessment and preparation of PLHIV for ART to ensure treatment readiness before starting them on same-day ART and close monitoring of patients during early follow-up periods.

Project description:BackgroundAttrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.Methods and findingsWe conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.ConclusionsSame-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease.Trial registrationThis study is registered with ClinicalTrials.gov number NCT01900080.

Project description:ObjectivesTo assess delays to antiretroviral therapy (ART) initiation before and after the Universal Test and Treat (UTT) and the same-day initiation (SDI) of ART policy periods in Johannesburg, South Africa.DesignProspective cohort study.SettingPatients were recruited from six primary health clinics in Johannesburg.ParticipantsOverall, 1029 newly diagnosed HIV positive adults (≥18 years) were consecutively enrolled by referral from the testing counsellor between April and December 2015 (pre-UTT n=146), July and August 2017 (UTT, n=141) and October 2017 and August 2018 (SDI, n=742).Main outcome measuresCox proportional hazards regression was used to assess predictors of 30 days ART initiation. Additionally, predictors of immediate ART initiation were evaluated using Poisson regression.ResultsOverall, 30 days ART proportions were 71.9% overall, 36.9% pre-UTT (44.3% of those eligible), 65.9% under UTT and 79.9% under the SDI policy. The median days to ART initiation declined from 21 pre-UTT (IQR: 15-30) to 8 (IQR: 6-16) under UTT and 5 days (IQR: 0-8) under the SDI policy. However, only 150 (20.2%) of the SDI cohort-initiated ART immediately after HIV diagnosis. Living in a two-adult home (adjusted HR (aHR) 1.2 vs living alone, 95% CI 1.0 to 1.5) increased the likelihood of 30-day ART. Missing baseline cluster of differentiation four (CD4) data decreased the likelihood of 30 days ART by 40% (aHR 0.6 vs CD4 <350 cells/µL, 95% CI 0.5 to 0.7). More women took up immediate ART (adjusted relative risk (aRR) 1.3, 95% CI 1.0 to 1.9). Participants ≥40 years (aRR 0.6 vs 18-24 years, 95% CI 0.4 to 0.9) were less likely to start ART immediately after HIV diagnosis. However, immediate ART rates increased with longer policy implementation time (aRR 0.2 for <3 months vs >10 months, 95% CI 0.1 to 0.4).ConclusionsThe study results highlight a positive move towards earlier ART initiation during the UTT and SDI periods and emphasise a need to increase same-day ART implementation further.

Project description:BackgroundSame-day antiretroviral therapy (SDART) initiation, in which people living with HIV (PLHIV) who are antiretroviral therapy (ART)-naïve, willing, and clinically eligible start ART on the same day of HIV diagnosis, has been implemented in several healthcare facilities in Thailand since 2017. This evidence-based practice has demonstrated increased ART uptake, virologic suppression, and retention in care. However, linkage to care gaps exist in community-based organizations (CBOs) in Bangkok whereby as much as 20% of key populations (KP), mainly men who have sex with men and transgender women, living with HIV were lost to follow-up pre-ART initiation. To increase access to and uptake of ART among these populations, this study proposes that trained KP lay providers should lead community-based ART (CB-SDART) initiation service. This protocol describes the combined use of the Proctor's implementation outcome framework and the Consolidated Framework for Implementation Research to guide and evaluate the CB-SDART implementation.MethodsThis study follows the hybrid design type 3: it is an implementation trial that secondarily assesses service and client outcomes by comparative interrupted time series analysis. Five strategies have been formulated to meet three implementation outcomes (i.e., feasibility, fidelity, and sustainability): (1) developing stakeholder relationships by engaging the CBO leaderships, (2) training and educating KP lay providers, (3) adapting and tailoring SDART to CBO-specific context, (4) using evaluative and iterative strategies to assess adherence to standard operating procedures, and (5) developing stakeholder relationships by engaging external stakeholders. Teleconsultation with physicians and ART home delivery will be integrated as another ART initiation option for clients and allow service provision during the COVID-19 pandemic. A mixed-method assessment will be conducted on key stakeholders and PLHIV diagnosed at two implementing CBOs, Rainbow Sky Association of Thailand and Service Workers in Group Foundation, in Bangkok, Thailand.DiscussionThis implementation research may be the first to provide robust data at the implementation, service, and client levels to inform how to successfully task-shift SDART initiation service to trained KP lay providers and facilitate the expansion of CB-SDART in the future.Trial registrationThis trial was registered with the Thai Clinical Trial Registry as TCTR20210709004 on July 9, 2021.

Dataset Information

The Impact of Same-Day Antiretroviral Therapy Initiation Under the World Health Organization Treat-All Policy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets