scholarly journals 880. Interim Analysis of Real-World Community-Based HIV Rapid Start Antiretroviral with BFTAF Versus Conventional HIV Antiretroviral Therapy Start – The RoCHaCHa Study, A Pilot Study

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S531-S532
Author(s):  
Ashley R Zuppelli ◽  
Jacob Scutaru ◽  
Alexandra Danforth ◽  
Robert Biernbaum ◽  
Roberto Corales ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Interim Analysis ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Retention In Care ◽  
Community Based ◽  
Art Initiation ◽  
Study Participants ◽  
Historical Controls ◽  
Research Grant

Abstract Background Trillium Health (TH) is a Federally Qualified Health Center look-alike and Ryan White C grantee in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start Antiretroviral therapy (RSA) has been shown to decrease time to viral suppression while increasing linkage to and retention in care. However, data on a fixed-dose combination of BFTAF with these benefits are limited. We aim to show RSA with BFTAF time to viral suppression, adherence to medication, and retention in care is statistically significant in comparison to older treatment models. Additionally, we aim to demonstrate the feasibility and acceptability of RSA with BFTAF. Methods This is an interim analysis of participants who enrolled in the study and been in care at TH for at least 3 months as of May 2021. All participants complete a baseline assessment and start BFTAF. Follow up visits are conducted through 48 weeks. Primary and secondary endpoints are included in the attached table 2 Barriers to care and patient reported outcomes were evaluated through a standardized questionnaire at the final study visit. Study results were compared with non-RSA historical control data from patients who received standard of care universal ART initiation at TH. Results Thirty-four participants have been enrolled in the study for at least 12 weeks, 33 (97%) of whom have reached and maintained viral suppression. Twenty-one participants have completed all 48 weeks, with 20 (95%) reaching and maintaining viral suppression. In comparison to historical controls, the RSA study participants had a statistically significant shorter time to viral suppression, both from diagnosis and from ART initiation. The RSA patients had statistically significant higher retention at 12, 24, and 48 weeks in comparison to historical controls. Adherence was higher in the RSA patients, though not statistically significant. Enrollment Graphic for the Rochacha Study Baseline Demographics of Study Participants and Controls Clinical Outcomes of Study Participants compared to Controls Conclusion Our data show that RSA with BFTAF can be effective in a community based health center setting in participants facing barriers to care. The patients who were treated by RSA with BFTAF had a high viral suppression rate. To date, no BFTAF regimen had to be changed due to resistance or virologic failure in this study. These data support implementation of RSA with BFTAF as standard of care. Disclosures Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences (Research Grant or Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences (Research Grant or Support) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee, Scientific Research Study Investigator) Shealynn Hilliard, MS, Gilead Sciences (Research Grant or Support) William M. Valenti, MD, FIDSA, Gilead Sciences (Research Grant or Support)

scholarly journals Rapid Antiretroviral Therapy (ART) Initiation at a Community-Based Clinic in Jackson, MS

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Courtney E. Sims Gomillia ◽  
Kandis V. Backus ◽  
James B. Brock ◽  
Sandra C. Melvin ◽  
Jason J. Parham ◽  
...  
Keyword(s):  
Viral Load ◽  
Antiretroviral Therapy ◽  
Median Time ◽  
Viral Suppression ◽  
Hiv Care ◽  
Virologic Suppression ◽  
Community Based ◽  
Art Initiation ◽  
Healthcare Center ◽  
The Impact

Abstract Background Rapid antiretroviral therapy (ART), ideally initiated within twenty-four hours of diagnosis, may be crucial in efforts to increase virologic suppression and reduce HIV transmission. Recent studies, including demonstration projects in large metropolitan areas such as Atlanta, Georgia; New Orleans, Louisiana; San Francisco, California; and Washington D.C., have demonstrated that rapid ART initiation is a novel tool for expediting viral suppression in clinical settings. Here we present an evaluation of the impact of a rapid ART initiation program in a community-based clinic in Jackson, MS. Methods We conducted a retrospective chart review of patients who were diagnosed with HIV at Open Arms Healthcare Center or were linked to the clinic for HIV care by the Mississippi State Department of Health Disease Intervention Specialists from January 1, 2016 to December 31, 2018. Initial viral load, CD4+ T cell count, issuance of an electronic prescription (e-script), subsequent viral loads until suppressed and patient demographics were collected for each individual seen in clinic during the review period. Viral suppression was defined as a viral load less than 200 copies/mL. Rapid ART initiation was defined as receiving an e-script for antiretrovirals within seven days of diagnosis. Results Between January 1, 2016 and December 31, 2018, 70 individuals were diagnosed with HIV and presented to Open Arms Healthcare Center, of which 63 (90%) completed an initial HIV counseling visit. Twenty-seven percent of patients were provided with an e-script for ART within 7 days of diagnosis. The median time to linkage to care for this sample was 12 days and 5.5 days for rapid ART starters (p < 0.001). Median time from diagnosis to viral suppression was 55 days for rapid ART starters (p = 0.03), a 22 day decrease from standard time to viral suppression. Conclusion Our results provide a similar level of evidence that rapid ART initiation is effective in decreasing time to viral suppression. Evidence from this evaluation supports the use of rapid ART initiation after an initial HIV diagnosis, including same-day treatment.

scholarly journals VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

2019 ◽  
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Josephine Muhairwe ◽  
Bienvenu Lengo Nsakala ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Southern Africa ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Community Based ◽  
Art Initiation ◽  
Home Based ◽  
Cluster Randomized ◽  
Village Health ◽  
Art Delivery

Abstract Background: There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access continuous care. This cluster-randomized clinical trial aims to evaluate the efficacy of a multicomponent differentiated ART delivery model (VIBRA model) after home-based same-day ART initiation in remote villages in Lesotho, Southern Africa. Methods: VIBRA (Village-Based Refill of ART) trial is a cluster-randomized, parallel-group, superiority clinical trial conducted in two districts of Lesotho, Southern Africa. Clusters (i.e. villages) are randomly assigned to either the VIBRA model or standard of care, stratified by district, village size, and village access to the nearest health facility. Eligible individuals (HIV-positive, aged 10 years or older, not taking ART) found during community-based HIV testing campaigns are offered same-day home-based ART initiation. Intervention clusters offer a differentiated ART delivery package with two features: Firstly, drug-refill and follow-up through trained and supervised village health workers. Secondly, the option of receiving individually tailored adherence reminders and viral load result notifications via SMS. Standard of care applies for the control clusters, i.e. ART visits at the clinic and no SMS. The primary endpoint is viral suppression 12 months after enrolment. Secondary endpoints include linkage to and engagement in care. Furthermore, safety and cost-effectiveness analyses plus qualitative research are planned. Minimum target sample size is 262 participants. Statistical analyses will follow CONSORT guidelines. VIBRA trial is linked to another trial, the HOSENG (HOme-based SElf-testiNG) trial, in the GET ON (GETing tOwards Ninety) research project. Discussion: VIBRA trial is among the first to evaluate ART delivery through VHW immediately after ART-initiation and it assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres similar to the VHW program in Lesotho, this model – if shown to be effective – has potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could further be modified to optimize impact. Trial Registration: This trial has been registered at clinicaltrials.gov (NCT03630549) on August 15, 2018. Keywords: HIV, cluster randomized controlled trial, village health worker, community health worker, home-based, differentiated care and delivery, antiretroviral therapy, Lesotho, Southern Africa, multi component intervention.

scholarly journals A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mohammed Limbada ◽  
◽  
Chiti Bwalya ◽  
David Macleod ◽  
Sian Floyd ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Community Based Interventions ◽  
Community Based ◽  
Resource Limited Settings ◽  
Hiv Patients ◽  
Resource Limited ◽  
Cluster Randomized ◽  
Art Delivery

Abstract Background Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. Methods A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as “stable” on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. Discussion This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. Trial registration ClinicalTrials.gov NCT03025165. Registered on 19 January 2017

scholarly journals VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

2019 ◽  
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Josephine Muhairwe ◽  
Bienvenu Lengo Nsakala ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Qualitative Research ◽  
Southern Africa ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Community Based ◽  
Art Initiation ◽  
Home Based ◽  
Cluster Randomized ◽  
Art Delivery

Abstract BACKGROUND There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access continuous care. This cluster-randomized clinical trial aims to evaluate the efficacy of a multicomponent differentiated ART delivery model (VIBRA model) after home-based same-day ART initiation in remote villages in Lesotho, Southern Africa. METHODS VIBRA (Village-Based Refill of ART) trial is a cluster-randomized, parallel-group, superiority clinical trial conducted in two districts of Lesotho, Southern Africa. Clusters (i.e. villages) are randomly as-signed to either the VIBRA model or standard of care, stratified by district, village size, and village access to the nearest health facility. Eligible individuals (HIV-positive, aged 10 years or older, not taking ART) found during community-based HIV testing campaigns are offered same-day home-based ART initiation. Intervention clusters offer a differentiated ART delivery package with two fea-tures: Firstly, drug-refill and follow-up through trained and supervised village health workers (VHW). Secondly, the option of receiving individually tailored adherence reminders and viral load result notifications via SMS. Standard of care applies for the control clusters, i.e. ART visits at the clinic and no SMS. The primary endpoint is viral suppression 12 months after enrolment. Second-ary endpoints include linkage to and engagement in care. Furthermore, safety and cost-effectiveness analyses plus qualitative research are planned. Minimum target sample size is 262 participants. Statistical analyses will follow CONSORT guidelines. VIBRA trial is linked to another trial, the HOSENG (HOme-based SElf-testiNG) trial, in the GET ON (GETing tOwards Ninety) re-search project. DISCUSSION VIBRA trial is among the first to evaluate ART delivery through VHW immediately after ART-initiation and it assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres similar to the VHW program in Lesotho, this model – if shown to be effective – has potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could further be modified to optimize impact. TRIAL REGISTRATION This trial has been registered at clinicaltrials.gov (NCT03630549) on August 15, 2018.

scholarly journals Effects of community-based antiretroviral therapy initiation models on HIV treatment outcomes: A systematic review and meta-analysis

PLoS Medicine ◽  
2021 ◽  
Vol 18 (5) ◽  
pp. e1003646
Author(s):  
Ingrid Eshun-Wilson ◽  
Ajibola A. Awotiwon ◽  
Ashley Germann ◽  
Sophia A. Amankwaa ◽  
Nathan Ford ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Facility ◽  
Viral Suppression ◽  
Meta Analysis ◽  
Community Setting ◽  
Standard Of Care ◽  
Hiv Treatment ◽  
Community Based ◽  
Community Art ◽  
Art Initiation

Background Antiretroviral therapy (ART) initiation in the community and outside of a traditional health facility has the potential to improve linkage to ART, decongest health facilities, and minimize structural barriers to attending HIV services among people living with HIV (PLWH). We conducted a systematic review and meta-analysis to determine the effect of offering ART initiation in the community on HIV treatment outcomes. Methods and findings We searched databases between 1 January 2013 and 22 February 2021 to identify randomized controlled trials (RCTs) and observational studies that compared offering ART initiation in a community setting to offering ART initiation in a traditional health facility or alternative community setting. We assessed risk of bias, reporting of implementation outcomes, and real-world relevance and used Mantel–Haenszel methods to generate pooled risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals. We evaluated heterogeneity qualitatively and quantitatively and used GRADE to evaluate overall evidence certainty. Searches yielded 4,035 records, resulting in 8 included studies—4 RCTs and 4 observational studies—conducted in Lesotho, South Africa, Nigeria, Uganda, Malawi, Tanzania, and Haiti—a total of 11,196 PLWH. Five studies were conducted in general HIV populations, 2 in key populations, and 1 in adolescents. Community ART initiation strategies included community-based HIV testing coupled with ART initiation at home or at community venues; 5 studies maintained ART refills in the community, and 4 provided refills at the health facility. All studies were pragmatic, but in most cases provided additional resources. Few studies reported on implementation outcomes. All studies showed higher ART uptake in community initiation arms compared to facility initiation and refill arms (standard of care) (RR 1.73, 95% CI 1.22 to 2.45; RD 30%, 95% CI 10% to 50%; 5 studies). Retention (RR 1.43, 95% CI 1.32 to 1.54; RD 19%, 95% CI 11% to 28%; 4 studies) and viral suppression (RR 1.31, 95% CI 1.15 to 1.49; RD 15%, 95% CI 10% to 21%; 3 studies) at 12 months were also higher in the community-based ART initiation arms. Improved uptake, retention, and viral suppression with community ART initiation were seen across population subgroups—including men, adolescents, and key populations. One study reported no difference in retention and viral suppression at 2 years. There were limited data on adherence and mortality. Social harms and adverse events appeared to be minimal and similar between community care and standard of care. One study compared ART refill strategies following community ART initiation (community versus facility refills), and found no difference in viral suppression (RD −7%, 95% CI −19% to 6%) or retention at 12 months (RD −12%, 95% CI −23% to 0.3%). This systematic review was limited by there being overall few studies for inclusion, poor-quality observational data, and short-term outcomes. Conclusions Based on data from a limited set of studies, community ART initiation appears to result in higher ART uptake, retention, and viral suppression at 1 year compared to facility-based ART initiation. Implementation on a wider scale necessitates broader exploration of costs, logistics, and acceptability by providers and PLWH to ensure that these effects are reproducible when delivered at scale, in different contexts, and over time.

scholarly journals Retesting for verification of HIV diagnosis before antiretroviral therapy initiation in Harare, Zimbabwe: Is there a gap between policy and practice?

2019 ◽  
Vol 113 (10) ◽  
pp. 610-616
Author(s):  
Beatrice Dupwa ◽  
Ajay M V Kumar ◽  
Jaya Prasad Tripathy ◽  
Owen Mugurungi ◽  
Kudakwashe C Takarinda ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Secondary Data ◽  
Future Research ◽  
Hiv Positive ◽  
National Guidelines ◽  
Hiv Diagnosis ◽  
Policy And Practice ◽  
The Public ◽  
Art Initiation ◽  
Study Participants

Abstract Background WHO recommends retesting of HIV-positive patients before starting antiretroviral therapy (ART). There is no evidence on implementation of retesting guidelines from programmatic settings. We aimed to assess implementation of HIV retesting among clients diagnosed HIV-positive in the public health facilities of Harare, Zimbabwe, in June 2017. Methods This cohort study involved analysis of secondary data collected routinely by the programme. Results Of 1729 study participants, 639 (37%) were retested. Misdiagnosis of HIV was found in six (1%) of the patients retested—all were infants retested with DNA-PCR. There was no HIV misdiagnosis among adults. Among those retested, 95% were retested on the same day and two-thirds were tested by a different provider as per national guidelines. Among those retested and found positive, 95% were started on ART, while none of those with negative retest results were started on ART. Of those not retested, about half (51%) were started on ART. The median (IQR) time to ART initiation from diagnosis was 0 (0–1) d. Conclusion The implementation of HIV-retesting policy in Harare was poor. While most HIV retest positives were started on ART, only half non-retested received ART. Future research is needed to understand the reasons for non-retesting and non-initiation of ART among those not retested.

scholarly journals 1322. A Mobile Technology-Based Intervention Improves HIV Care Continuum for Young People Living with HIV

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S478-S478
Author(s):  
Ping Du ◽  
John Zurlo ◽  
Tarek Eshak ◽  
Tonya Crook ◽  
Cynthia Whitener
Keyword(s):  
Mobile Technology ◽  
Viral Suppression ◽  
Retention In Care ◽  
Hiv Care ◽  
People Living With Hiv ◽  
Hiv Care Continuum ◽  
Care Continuum ◽  
Hiv Viral Suppression ◽  
Study Participants ◽  
Living With Hiv

Abstract Background Young people living with HIV (YPLWH) have lower rates of retention in care and HIV viral suppression. Multiple barriers exist to engage YPLWH in care. As nearly all YPLWH use their mobile phones to access health information and to communicate with other people, we implemented a mobile technology-based intervention with the goal to improve HIV care continuum in YPLWH. Methods YPLWH were eligible for this study if they were: (1) aged 18–34 years; (2) newly diagnosed with HIV; (3) having a history of being out of care; or (4) not virally suppressed. We recruited YPLWH during January 2017-May 2018 and followed them every 6 months. We developed a HIPAA-compliant mobile application, “OPT-In For Life,” and let participants use this app to manage their HIV care. The app integrated multiple features that enabled users to communicate with the HIV treatment team via a secure messaging function, to access laboratory results and HIV prevention resources, and to set up appointment or medication reminders. We obtained participants’ demographics, app-usage data, and medical records to evaluate if this mobile technology-based intervention would improve HIV care continuum among YPLWH. We used a quasi-experiment study design to compare the rates of retention in care and HIV viral suppression every 6 months between study participants and YPLWH who were eligible but not enrolled in the study. Results 92 YPLWH participated in this study (70% male, 56% Hispanics or Blacks, 54% retained in care, and 66% virally suppressed at baseline). On average study participants used the app 1–2 times/week to discuss various health issues and supportive services with HIV providers, to access HIV-related health information, and to manage their HIV care. At the 6-month evaluation, compared with 88 eligible YPLWH who were not enrolled in this intervention, study participants had increased rates of retention in care (baseline-to-6-month between participants and nonparticipants: 54%–84% vs. 26%–25%) and HIV viral suppression (66%–80% vs. 56%–60%). Conclusion Our study demonstrates using a HIPAA-compliant mobile app as an effective intervention to engage YPLWH in care. This intervention can be adapted by other HIV programs to improve HIV care continuum for YPLWH or broader HIV populations. Disclosures All authors: No reported disclosures.

Does Rapid Initiation of Antiretroviral Therapy At HIV Diagnosis Impact On Virological Response in a Real-Life Setting? A Single Centre Experience in Northern Italy

2021 ◽  
Author(s):  
Natalia Gregori ◽  
Stefano Renzetti ◽  
Ilaria Izzo ◽  
Giulio Faletti ◽  
Benedetta Fumarola ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Median Time ◽  
Virological Response ◽  
Viral Suppression ◽  
Real Life ◽  
Hiv Care ◽  
Baseline Viral Load ◽  
Hiv Diagnosis ◽  
Art Initiation ◽  
Late Group

Abstract Background Rapid initiation of antiretroviral therapy (ART) has been largely proven efficacious and safe mostly through clinical trials. Further investigations are needed to better define feasibility and acceptability of rapid ART approach in real-life settings. Methods We conducted a retrospective, observational study on newly HIV-diagnosed patients referred to Infectious and Tropical Diseases department of ASST Spedali Civili Hospital of Brescia from September 1st, 2015, to July 31st, 2019. All patients’ baseline characteristics were anonymously extracted from medical records. According to the timing of ART initiation, we distinguished 3 groups of patients (rapid, intermediate and late group) and represented the trend of virological response during a 400 day-period. The hazard ratios of each predictor on viral suppression (HIV RNA < 50 copies/ml) were estimated through Cox proportional hazard model. Results Median time from HIV diagnosis to first medical referral was 15 days and median time from first HIV care access to therapy start was 24 days. Three groups of patients were differentiated depending on ART initiation: within 7 days (rapid group, 37.6%), between 8 and 30 days (intermediate group, 20.6%) and after 30 days (late group, 41.8%). Longer time to ART start and higher baseline viral load were associated with a reduced probability of viral suppression. After one year, all groups showed high viral suppression rate (99%). Conclusions In high-income setting as Italy, rapid ART approach seems to be useful to accelerate time to viral suppression. The latter tends to be great over time regardless the timing of ART initiation.

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