scholarly journals Retention in care and viral suppression after same-day ART initiation: One-year outcomes of the SLATE I and II individually randomized clinical trials in South Africa

2021 ◽  
Author(s):  
Mhairi Maskew ◽  
Alana T Brennan ◽  
Matthew P Fox ◽  
Lungisile Vezi ◽  
Willem DF Venter ◽  
...  
Keyword(s):  
Viral Suppression ◽  
Randomized Clinical Trials ◽  
Retention In Care ◽  
Pooled Analysis ◽  
Risk Difference ◽  
Self Report ◽  
Art Initiation ◽  
Patient Attrition ◽  
Early Retention ◽  
One Year

Introduction: Same-day initiation (SDI) of antiretroviral therapy (ART) for HIV consistently increases ART uptake, but concerns remain about higher attrition from care after initiation. We analysed twelve-month retention in the SLATE SDI trials. Methods: SLATE I and SLATE II were individually randomized trials at public outpatient clinics in Johannesburg that enrolled patients not yet on ART and administered the SLATE I or II algorithm, which included a symptom self-report, medical history, brief physical examination, and readiness questionnaire, to assess eligibility for SDI. ART uptake and early retention have been reported. Using routine clinic records, we conducted a pooled analysis of retention in care and HIV viral suppression 14 months after study enrolment. Results and discussion: We enrolled 1,193 study participants (standard arms, n=599, 50%; intervention arms, n=594, 50%) and analysed by originally assigned groups. By 14 months after study enrolment (equivalent to 12-month retention in care), 50% of intervention arm patients and 46% of standard arm patients remained in care at the initiating site (crude risk difference 4% (95% confidence interval -1% to 10%; crude relative risk 1.10 (0.97-1.23), with similar viral suppression between arms. Observed attrition from care at site by 14 months was high in both study arms, but we found no evidence that the offer of SDI led to greater overall attrition or lower rates of viral suppression one year after starting ART and may have led to small improvements. Same-day initiation may have shifted some attrition from before to after dispensing of the first dose of medication. Conclusions: An offer of same-day initiation of ART, following a carefully designed protocol to identify patients who are eligible and ready to start treatment, is not inherently associated with an overall increase in patient attrition from care.

scholarly journals Profile of patients undergoing third line anti-retroviral therapy

2020 ◽  
Vol 7 (9) ◽  
pp. 1394
Author(s):  
Dhileeban Maharajan P. ◽  
T. Jeetenkumar Singh ◽  
S. Bhagyabati Devi ◽  
H. Rebachandra Singh ◽  
Dipul Rudra Paul ◽  
...  
Keyword(s):  
Viral Load ◽  
Antiretroviral Therapy ◽  
Viral Suppression ◽  
Virologic Failure ◽  
Cd4 Count ◽  
Medical Sciences ◽  
Art Initiation ◽  
Number Of Patients ◽  
Third Line ◽  
One Year

Background: India has the third largest human HIV epidemic in the world. The advent of antiretroviral drug began a revolution in the management of HIV. Recent studies have shown that an increasing number of patients experiencing virologic failure on second line Antiretroviral therapy and require third line ART.Methods: This prospective cohort study was conducted in Regional Institute of Medical Sciences, Imphal for a period of two years, to study the clinical, immunological, and virological profile of patients undergoing third line Antiretroviral therapy and to study the early immuno-virological response to third line Antiretroviral therapy.Results: Mean CD4 count before third line ART initiation was 95.90±111.85 cells/μl with 60% of them had CD4 count <100 cells/μl. The mean CD4 count improved significantly (p<0.005) to 246.70±123.78 cells/μl after six months and 340.70±198.57 cells/μl after one year of the therapy. At the time of initiation of third line ART, none of the patients had viral load <150copies/ml while 60% of the population had viral load >100000 copies/ml. After one year of third line ART, 80 % of the patients showed viral suppression (VL<150copies/ml). At the end of one year, the improvement in CD4 count comparing to the Viral load was significant in those who showed viral suppression (VL<150 copies/ml).Conclusions: This study showed significant improvement in the CD4 count and viral suppression with third line medication without any major clinical adverse effect.

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 Poor retention and care-related sex disparities among youth living with HIV in rural Mozambique

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0250921
Author(s):  
Aima A. Ahonkhai ◽  
Muktar H. Aliyu ◽  
Carolyn M. Audet ◽  
Magdalena Bravo ◽  
Melynda Simmons ◽  
...  
Keyword(s):  
Retention In Care ◽  
Young Males ◽  
Targeted Interventions ◽  
Art Initiation ◽  
Before And After ◽  
Cox Proportional Hazard Models ◽  
One Year ◽  
The One ◽  
Youth Living With Hiv ◽  
Living With Hiv

Background There are few studies that characterize sex-related differences in HIV outcomes among adolescents and young adults (AYA) 15–24 years of age. Methods We conducted a retrospective cohort study among AYA who enrolled in a comprehensive HIV program in Mozambique between 2012–2016. We assessed patients by sex and pregnancy/lactation status, comparing time to combination antiretroviral therapy (ART) initiation using Cox proportional hazard models. We employed multivariable logistic regression to investigate pre- and post-ART retention. Patients were defined as ‘retained pre-ART’ if they attended at least 3 of 4 required visits or started ART in the 6 months after enrollment, and ‘retained post-ART’ if they had any ART pickup or clinical visit during the last 90 days of the one-year follow-up period. Results Of 47,702 patients in the cohort, 81% (n = 38,511) were female and 19% (n = 9,191) were male. Of the females, 57% (n = 21,770) were non-pregnant and non-lactating (NPNL) and 43% (n = 16,741) were pregnant or lactating (PL). PL (aHR 2.64, 95%CI:2.47–2.81) and NPNL females (aHR 1.36, 95%CI:1.30–1.42) were more likely to initiate ART than males. PL females had higher odds of pre-ART retention in care (aOR 3.56, 95%CI: 3.30–3.84), as did NPNL females (aOR 1.71, 95%CI: 1.62–1.81), compared to males. This was also true for retention post-ART initiation, with higher odds for both PL (aOR 1.78, 95%CI:1.63–1.94) and NPNL females (aOR 1.50, 95%CI:1.35–1.65) compared to males. Conclusions PL females were most likely to initiate ART and remain in care post-ART in this AYA cohort, likely reflecting expansion of Option B+. Despite pregnancy and policy driven factors, we observed important sex-related disparities in this cohort. NPNL females were more likely to initiate ART and be retained in care before and after ART initiation than males. These data suggest that young males need targeted interventions to improve these important care continuum outcomes.

scholarly journals Estimating the impact of disruptions due to COVID-19 on HIV transmission and control among men who have sex with men in China

2020 ◽  
Author(s):  
Ross. D. Booton ◽  
Gengfeng Fu ◽  
Louis MacGregor ◽  
Jianjun Li ◽  
Jason J. Ong ◽  
...  
Keyword(s):  
Condom Use ◽  
Viral Suppression ◽  
Hiv Transmission ◽  
Hiv Infections ◽  
Hiv Care ◽  
Art Initiation ◽  
Sex With Men ◽  
One Year ◽  
And Control ◽  
The Impact

AbstractIntroductionThe COVID-19 pandemic is impacting HIV care globally, with gaps in HIV treatment expected to increase HIV transmission and HIV-related mortality. We estimated how COVID-19-related disruptions could impact HIV transmission and mortality among men who have sex with men (MSM) in four cities in China.MethodsRegional data from China indicated that the number of MSM undergoing facility-based HIV testing reduced by 59% during the COVID-19 pandemic, alongside reductions in ART initiation (34%), numbers of sexual partners (62%) and consistency of condom use (25%). A deterministic mathematical model of HIV transmission and treatment among MSM in China was used to estimate the impact of these disruptions on the number of new HIV infections and HIV-related deaths. Disruption scenarios were assessed for their individual and combined impact over 1 and 5 years for a 3-, 4- or 6-month disruption period.ResultsOur China model predicted that new HIV infections and HIV-related deaths would be increased most by disruptions to viral suppression, with 25% reductions for a 3-month period increasing HIV infections by 5-14% over 1 year and deaths by 7-12%. Observed reductions in condom use increased HIV infections by 5-14% but had minimal impact (<1%) on deaths. Smaller impacts on infections and deaths (<3%) were seen for disruptions to facility testing and ART initiation, but reduced partner numbers resulted in 11-23% fewer infections and 0.4-1.0% fewer deaths. Longer disruption periods of 4 and 6 months amplified the impact of combined disruption scenarios. When all realistic disruptions were modelled simultaneously, an overall decrease in new HIV infections was always predicted over one year (3-17%), but not over 5 years (1% increase-4% decrease), while deaths mostly increased over one year (1-2%) and 5 years (1.2 increase – 0.3 decrease).ConclusionsThe overall impact of COVID-19 on new HIV infections and HIV-related deaths is dependent on the nature, scale and length of the various disruptions. Resources should be directed to ensuring levels of viral suppression and condom use are maintained to mitigate any adverse effects of COVID-19 related disruption on HIV transmission and control among MSM in China.

scholarly journals Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (10) ◽  
pp. e1003839
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Mathebe Kopo ◽  
Mpho Kao ◽  
...  
Keyword(s):  
Viral Load ◽  
Viral Suppression ◽  
Health Workers ◽  
Risk Difference ◽  
Small Sample ◽  
Engagement In Care ◽  
Adjusted Risk ◽  
Art Initiation ◽  
Home Based ◽  
Cluster Randomized

Background Community-based antiretroviral therapy (ART) dispensing by lay workers is an important differentiated service delivery model in sub-Sahara Africa. However, patients new in care are generally excluded from such models. Home-based same-day ART initiation is becoming widespread practice, but linkage to the clinic is challenging. The pragmatic VIBRA (Village-Based Refill of ART) trial compared ART refill by existing lay village health workers (VHWs) versus clinic-based refill after home-based same-day ART initiation. Methods and findings The VIBRA trial is a cluster-randomized open-label clinical superiority trial conducted in 249 rural villages in the catchment areas of 20 health facilities in 2 districts (Butha-Buthe and Mokhotlong) in Lesotho. In villages (clusters) randomized to the intervention arm, individuals found to be HIV-positive during a door-to-door HIV testing campaign were offered same-day ART initiation with the option of refill by VHWs. The trained VHWs dispensed drugs and scheduled clinic visits for viral load measurement at 6 and 12 months. In villages randomized to the control arm, participants were offered same-day ART initiation with clinic-based ART refill. The primary outcome was 12-month viral suppression. Secondary endpoints included linkage and 12-month engagement in care. Analyses were intention-to-treat. The trial was registered on ClinicalTrials.gov (NCT03630549). From 16 August 2018 until 28 May 2019, 118 individuals from 108 households in 57 clusters in the intervention arm, and 139 individuals from 130 households in 60 clusters in the control arm, were enrolled (150 [58%] female; median age 36 years [interquartile range 30–48]; 200 [78%] newly diagnosed). In the intervention arm, 48/118 (41%) opted for VHW refill. At 12 months, 46/118 (39%) participants in the intervention arm and 64/139 (46%) in the control arm achieved viral suppression (adjusted risk difference −0.07 [95% CI −0.20 to 0.06]; p = 0.256). Arms were similar in linkage (adjusted risk difference 0.03 [−0.10 to 0.16]; p = 0.630), but engagement in care was non-significantly lower in the intervention arm (adjusted risk difference −0.12 [−0.23 to 0.003]; p = 0.058). Seven and 0 deaths occurred in the intervention and control arm, respectively. Of the intervention participants who did not opt for drug refill from the VHW at enrollment, 41/70 (59%) mentioned trust or conflict issues as the primary reason. Study limitations include a rather small sample size, 9% missing viral load measurements in the primary endpoint window, the low uptake of the VHW refill option in the intervention arm, and substantial migration among the study population. Conclusions The offer of village-based ART refill after same-day initiation led to similar outcomes as clinic-based refill. The intervention did not amplify the effect of home-based same-day ART initiation alone. The findings raise concerns about acceptance and safety of ART delivered by lay health workers after initiation in the community. Trial registration Registered with Clinicaltrials.gov (NCT03630549).

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