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1.
PLoS One ; 17(4): e0265166, 2022.
Article in English | MEDLINE | ID: covidwho-1785191

ABSTRACT

JUSTIFICATION: The WHO 95-95-95 targets for 2030 do not imply that people living with HIV (PLHIV) achieve a good quality of life. The current 30-day dispensing interval for antiretroviral (ART) burdens the healthcare system. Lengthening dispensing intervals could alleviate this burden as well as enhance patient well-being. OBJECTIVES: To capture perceptions on 90-day dispensing interval (90D) for ART from the perspective of PLHIV, people on pre-exposure prophylaxis (PrEP), doctors, and pharmacists. METHODS: Multi-centre observational survey led in France from 16 to 20 October 2020, among doctors agreeing to participate via regional coordinated care organisations for HIV, all PLHIV or people on PrEP consulting these outpatient-clinic doctors, and pharmacists doing ART dispensing. RESULTS: The survey was completed by 220 doctors who saw 1087 people (999 PLHIV; 88 on PrEP) and 176 pharmacists from 55 centres. Among the PLHIV, 855 (85.6%, 95% CI: 83.2%-87.7%) and among the patients on PrEP, 70 (79.5%, 95% CI: 69.6%-87.4%) stated they would be interested in 90D. All in all, patients who were more likely to endorse 90D are those who opt exclusively for hospital dispensing (OR 3.22 [1.57-6.58]) and who rotate between hospital and community pharmacy dispensing (OR 3.29 [1.15-9.32]). Patients who were less likely to endorse 90-D were those who consult in a city located outside the 3 French high HIV prevalence regions (OR 0.66 [0.44-0.99]), receive 2 vs 1 pill QD regimens (OR 0.53 [0.31-0.91]), and anticipate at least one vs no limitation to 90D (OR 0.27 [0.17-0.42]). 90D was perceived as possible by 152 pharmacists (86.4%), including 8 (5%) without restriction, and 219 doctors (99.6%), including 42 (19.2%) regardless of PLHIV's immunovirologic status or social conditions (health insurance coverage, access to housing or accommodation, access to rights, resources). Comparison of the benefits and limitations of a 90-day ART dispensing interval as perceived by PLHIV and people on PrEP, doctors and pharmacists shows that doctors anticipate a higher number of benefits than people on ART and/or pharmacists, chiefly that 90D would be more convenient and create less risk of drug shortages and that patients would gain autonomy and a better quality of life. Pharmacists were found to clearly perceive the economic benefits (90D would be less expensive) but anticipate more drawbacks than doctors and the people on ART themselves: more administrative burdens, more non-dispensing if doses get lost, harder to track adherence and more drug-drug interaction issues, and more work as they shall have to warn the patient of potential risks of shortages due to the cost of the stock. CONCLUSION: A clear majority of PLHIV, people on PrEP, doctors, and pharmacists endorsed 90D of ART. Most patients thought that 90D would be a good option, whereas most pharmacists and doctors thought that eligibility for 90D dispensing should depend on immunovirologic factors and social condition criteria. Moreover, pharmacists thought it would be necessary to commit regulatory resources and a better follow-up on adherence and drug-drug interactions.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , HIV Infections/epidemiology , Humans , Pharmacists , Quality of Life
2.
PLoS One ; 17(4): e0266280, 2022.
Article in English | MEDLINE | ID: covidwho-1775460

ABSTRACT

BACKGROUND: Mitigation measures for the first wave of the COVID-19 pandemic and burden on health systems created challenges for pre-exposure prophylaxis (PrEP) service delivery. We examined PrEP uptake in PEPFAR programs before and after the start of the COVID-19 pandemic. METHODS: We studied two PEPFAR program monitoring indicators, using routine Monitoring, Evaluation, Reporting (MER) indicators capturing uptake of PrEP (PrEP_NEW) and overall use of PrEP (PrEP_CURR). We also analyzed descriptive program narratives to understand successes and challenges field teams encountered after the start of the COVID-19 pandemic. To assess changes in coverage of PrEP across 21 countries, we calculated the "PrEP to need ratio" (PnR) using a published methodology. We defined the pre-COVID time period as April 1, 2019 -March 31, 2020 and the COVID time period as April 1, 2020 -March 31, 2021. FINDINGS: The total number of persons who initiated PrEP increased by 157% from 233,250 in the pre-COVID-19 period compared with 599,935 in the COVID-19 period. All countries, except five, noted significant increases in PrEP uptake. PrEP uptake among adolescent girls and young women (AGYW) increased by 159% from 80,452 AGYW in the pre-COVID-19 period to 208,607 AGYW in the COVID-19 period. There were 77,430 key populations (KP) initiated on PrEP in the pre-COVID-19 period and 209,114 KP initiated in the COVID-19 period (a 170% increase). The PnR increased 214% in the COVID-19 period across all PEPFAR-supported countries. Adaptations, such as multi-month dispensing (MMD) of PrEP; virtual demand creation activities; decentralized, community-based and virtual service delivery, were implemented to maintain PrEP services. CONCLUSIONS: PEPFAR programs continued to maintain and initiate new clients on PrEP despite the challenges posed by the COVID-19 pandemic. Adaptations such as MMD of PrEP and use of technology were vital in expanding service delivery and increasing PrEP coverage. FUNDING: This project has been supported by the U.S. President's Emergency Plan for AIDS Relief.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Pre-Exposure Prophylaxis , Adolescent , Anti-HIV Agents/therapeutic use , COVID-19/epidemiology , COVID-19/prevention & control , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/prevention & control , Humans , Pandemics/prevention & control
4.
PLoS One ; 17(3): e0265434, 2022.
Article in English | MEDLINE | ID: covidwho-1742024

ABSTRACT

BACKGROUND: Despite the established efficacy of PrEP to prevent HIV and the advantages of a user-controlled method, PrEP uptake and persistence by women in both trials and demonstration projects has been suboptimal. We utilized real-world data from an HIV service provider to describe persistence on oral PrEP among female sex workers (FSW) in eThekwini, South Africa. METHODS: We examined time from PrEP initiation to discontinuation among all FSW initiating PrEP at TB HIV Care in eThekwini between 2016-2020. We used a discrete time-to-event data setup and stacked cumulative incidence function plots, displaying the competing risks of 1) not returning for PrEP, 2) client discontinuation, and 3) provider discontinuation. We calculated hazard ratios using complementary log-log regression and sub-hazard ratios using competing risks regression. RESULTS: The number of initiations increased each year from 155 (9.3%, n = 155/1659) in 2016 to 1224 (27.5%, n = 1224/4446) in 2020. Persistence 1-month after initiation was 53% (95% CI: 51%-55%). Younger women were more likely to discontinue PrEP by not returning compared with those 25 years and older. Risk of discontinuation through non-return declined for those initiating in later years. Despite the COVID-19 pandemic, a greater number of initiations and sustained persistence were observed in 2020. CONCLUSIONS: Low levels of PrEP persistence were observed, consistent with data among underserved women elsewhere. Encouragingly, the proportion of women persisting increased over time, even as the number of women newly initiating PrEP and staff workload increased. Further research is needed to understand which implementation strategies the program may have enacted to facilitate these improvements and what further changes may be necessary.


Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/prevention & control , Medication Adherence/statistics & numerical data , Pre-Exposure Prophylaxis/statistics & numerical data , Sex Workers/statistics & numerical data , Administration, Oral , Adult , Anti-HIV Agents/administration & dosage , Female , Humans , Medication Adherence/psychology , Sex Workers/psychology , South Africa/epidemiology , Young Adult
5.
Br J Clin Pharmacol ; 88(3): 942-964, 2022 03.
Article in English | MEDLINE | ID: covidwho-1701553

ABSTRACT

AIMS: In 2018, 1.07 million pregnant women received antiretroviral drugs, raising whether this affects pregnancy outcomes. We assessed the adverse pregnancy outcomes associated with prenatal antiretroviral drug exposure, notified to the French ANRS pharmacovigilance system. METHODS: An exhaustive case report series has been performed using the ANRS pharmacovigilance database. All ANRS-sponsored HIV clinical research studies using antiretroviral drugs either in pregnant women or women of childbearing age were eligible from 2004 to 2019. We analysed the following pregnancy outcomes: abortion, ectopic pregnancy, stillbirth, prematurity (<37 weeks of gestational age), low birth weight (<2500 g) and congenital abnormalities. A logistic regression was performed to assess the odds ratio (OR) for each outcome separately (if occurrence >50) compared to the outcome observed when exposed to non-nucleoside-reverse-transcriptase-inhibitor (NNRTI)-based regimen as the reference. RESULTS: Among the 34 studies selected, 918 deliveries occurred, of whom 88% had pregnancy outcomes documented. Pregnant women were mainly exposed to PI (n = 387, 48.6%), NNRTI (n = 331, 41.5%) and INI-based combinations (n = 40, 5.0%, 18 on dolutegravir). Compared to NNRTI-based combinations, there was no significant association observed with exposure to other antiretroviral combination for spontaneous abortion, prematurity or low birth weight, except an increased risk of low birth weight in new-born exposed to exclusive nucleoside-reverse-transcriptase-inhibitor (NRTI) combinations (n = 4; OR 7.50 [1.49-37.83]). CONCLUSIONS: Our study, mainly based on protease inhibitor (PI) and NNRTI-based regimens, is overall reassuring on the risk of adverse pregnancy outcomes, except for NRTI which should be interpreted cautiously (small number, indication bias). In this study, the number of integrase inhibitor (INI)-based combinations was too low to draw any conclusions.


Subject(s)
Anti-HIV Agents , HIV Infections , HIV Integrase Inhibitors , Anti-HIV Agents/adverse effects , DNA-Directed RNA Polymerases/therapeutic use , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Pharmacovigilance , Pregnancy , Pregnancy Outcome/epidemiology , Reverse Transcriptase Inhibitors/adverse effects
7.
J Acquir Immune Defic Syndr ; 88(3): 299-304, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1574388

ABSTRACT

BACKGROUND: We assessed the impact of the coronavirus disease 2019 (COVID-19) pandemic on HIV suppression rates in people living with HIV (PLWH) attending a large Italian HIV clinic. SETTING: The HIV outpatient clinic of the Infectious Diseases Department of Luigi Sacco Hospital, Milan, Italy, which serves more than 5000 PLWH per year. METHODS: A before and after quasi-experimental study design was used to make a retrospective assessment of the monthly trend of HIV-RNA determinations of ≥50 among the PLWH attending our clinic, with "before" being the period from January 1, 2016 to February 20, 2020, and "after" being the period from February 21, 2020 to December 31, 2020 (the COVID-19 period). Interrupted time series analysis was used to evaluate any changes in the trend. RESULTS: During the study period, 70,349 HIV-RNA viral load determinations were made, and the percentage of HIV-RNA viral load determinations of <50 copies/mL increased from 88.4% in 2016 to 93.2% in 2020 (P < 0.0001). There was a significant monthly trend toward a decrease in the number of HIV-RNA determinations of ≥50 copies/mL before the pandemic (ß -0.084; standard error 0.015; P < 0.001), and this did not significantly change after it started (ß -0.039, standard error 0.161; P = 0.811). CONCLUSIONS: A high prevalence of viral suppression was maintained among the PLWH referring to our clinic, despite the structural barriers raised by the COVID-19 pandemic. The use of simplified methods of delivering care (such as teleconsultations and multiple antiretroviral treatment prescriptions) may have contributed to preserving this continuum.


Subject(s)
Anti-HIV Agents/therapeutic use , COVID-19/complications , COVID-19/epidemiology , HIV Infections/complications , HIV Infections/epidemiology , Ambulatory Care Facilities , Anti-HIV Agents/administration & dosage , Delivery of Health Care/methods , HIV Infections/drug therapy , HIV-1 , Humans , Italy/epidemiology , RNA, Viral/blood , SARS-CoV-2 , Viral Load/drug effects
8.
Int J Environ Res Public Health ; 18(23)2021 12 03.
Article in English | MEDLINE | ID: covidwho-1554891

ABSTRACT

The social measures taken to control the COVID-19 pandemic can potentially disrupt the management of HIV. The objective of this study was to examine the impact of the Australian COVID-19 lockdown restrictions on access to antiretroviral therapy (ART) for people living with HIV in Melbourne. Using data from the Melbourne Sexual Health Centre (MSHC), we assessed the changes in rates of ART postal delivery, controlled viral load, and ART dispensing from 2018 to 2020. The percentage of ART delivered by postage from the MSHC pharmacy was calculated weekly. The percentage of people living with HIV with a controlled viral load (≤200 copies/mL) was calculated monthly. We calculated a yearly Medication Possession Ratio (MPR). The average percentage of HIV ART dispensed through postage for the years 2018, 2019, and 2020 was 3.7% (371/10,023), 3.6% (380/10,685), and 14% (1478/10,765), respectively (Ptrend < 0.0001). Of the 3115 people living with HIV, the average MPR for 2018, 2019, and 2020 was 1.05, 1.06, and 1.14, respectively (Ptrend = 0.28). The average percentage of people with an HIV viral load of <200 copies/mL for the years 2018, 2019, and 2020 was 97.6% (2271/2327), 98.0% (2390/2438), and 99.2% (2048/2064), respectively (Ptrend < 0.0001). This study found that the proportion of controlled viral load and access to ART of people living with HIV in Melbourne was largely unaffected by the COVID-19 lockdown restrictions. This suggests that some of the services provided by the MSHC during the pandemic, such as HIV ART postal delivery, may assist long-term HIV management.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Anti-HIV Agents/therapeutic use , Australia/epidemiology , Communicable Disease Control , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Pandemics , SARS-CoV-2 , Viral Load
9.
Int J STD AIDS ; 33(1): 99-102, 2022 01.
Article in English | MEDLINE | ID: covidwho-1542034

ABSTRACT

AIMS: The national PrEP programme launched in Ireland in November 2019 with tenofovir/emtricitabine free to those meeting eligibility criteria. We assessed the impact of the first year of the PrEP programme on new HIV diagnoses in the largest sexual health and HIV service in Ireland. METHODS: A free PrEP service was established in November 2019. We reviewed the number of new diagnoses of HIV between November 2018-2019, before the introduction of the national PrEP programme and compared this with the number of new HIV diagnosis between November 2019-2020. RESULTS: There were 95 new HIV diagnoses (63.3% MSM) between November 2018 and 2019 and 73 new HIV diagnoses (65.7% MSM) between November 2019 and 2020. There was a statistically significant decline in new HIV diagnoses between the 2 years (P = 0.0003). 546 patients were prescribed PrEP as of December 2020.106 patients (19.4%) changed their PrEP dosing regimen due to lockdown. 178 individuals (32.6%) had a rectal infection diagnosed. CONCLUSION: There has been a reduction in new HIV diagnoses in our cohort (although this has occurred during a global pandemic). It is too early to say if PrEP reduces late presentations of HIV based on our findings. A significant number of rectal infections were identified in the PrEP clinic suggesting ongoing risk despite pandemic restrictions. Further research into sexual practices during COVID-19 is needed to assess if this had an impact on the lower rates of HIV acquisition.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Anti-HIV Agents/therapeutic use , Communicable Disease Control , HIV , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/prevention & control , Homosexuality, Male , Humans , Male , Pandemics , SARS-CoV-2
11.
Trials ; 22(1): 831, 2021 Nov 23.
Article in English | MEDLINE | ID: covidwho-1529943

ABSTRACT

BACKGROUND: Remdesivir is a novel broad-spectrum antiviral therapeutic with activity against several viruses that cause emerging infectious diseases. The purpose of this study is to explore how commonly utilized antiretroviral therapy (tenofovir disoproxil fumarate/lamivudine [TDF/3TC] and atazanavir/ritonavir [ATV/r]) influence plasma and intracellular concentrations of remdesivir. METHODS: This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B). Healthy volunteers satisfying study entry criteria will be enrolled in the study and randomized to either Study A; N=16 (Sequence 1 or Sequence 2) or Study B; N=8. Participants will receive standard adult doses of antiretroviral therapy for 7 days and a single 200mg remdesivir infusion administered over 60 min. Pharmacokinetic blood sampling will be performed relative to the start of remdesivir infusion; predose (before the start of remdesivir infusion) and 30 min after the start of remdesivir infusion. Additional blood samples will be taken at 2, 4, 6, 12, and 24 h after the end of remdesivir infusion. DISCUSSION: This study will characterize the pharmacokinetics of remdesivir from a typical African population in whom clinical use is anticipated. Furthermore, this study will deliver pharmacokinetic datasets for remdesivir drug concentrations and demographic characteristics which could support pharmacometric approaches for simulation of remdesivir treatment regimens in patients concurrently using tenofovir/lamivudine and/or atazanavir/ritonavir. TRIAL REGISTRATION: ClinicalTrials.gov NCT04385719 . Registered 13 May 2020.


Subject(s)
Anti-HIV Agents , Lamivudine , Adenosine Monophosphate/analogs & derivatives , Adult , Alanine/analogs & derivatives , Atazanavir Sulfate , Healthy Volunteers , Humans , Oligopeptides , Pyridines , Ritonavir , Tenofovir , Uganda
12.
J Acquir Immune Defic Syndr ; 88(5): 477-486, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1522410

ABSTRACT

BACKGROUND: Out-of-facility multi-month dispensing (MMD) is a differentiated service delivery model which provides antiretroviral treatment (ART) at intervals of up to 6 monthly in the community. Limited randomized evidence investigating out-of-facility MMD is available. We evaluated participant outcomes and compared out-of-facility MMD models using data from cluster-randomized trials in Southern Africa. SETTING: Eight districts in Zimbabwe and Lesotho. METHODS: Individual-level participant data from 2 cluster-randomized trials that included stable adults receiving ART at 60 facilities were pooled. Both trials had 3 arms: ART collected 3-monthly at healthcare facilities (3MF, control); ART provided three-monthly in community ART groups (CAGs) (3MC); and ART provided 6-monthly in either CAGs or on an individual provider-patient basis (6MC). Participant retention, viral suppression and incidence of unscheduled facility visits were compared. RESULTS: Ten thousand one hundred thirty-six participants were included, 3817 (37.7%), 2893 (28.5%) and 3426 (33.8%) in arms 3MF, 3MC and 6MC, respectively. After 12 months, retention was non-inferior for 3MC (95.7%) vs. 3MF (95.0%) {adjusted risk difference (aRD) = 0.3 [95% confidence interval (CI): -0.8 to 1.4]}; and 6MC (95.1%) vs. 3MF [aRD = -0.2 (95% CI: -1.4 to 1.0)]. Retention was greater amongst intervention arm participants in CAGs versus 6MC participants not in CAGs, aRD = 1.5% (95% CI: 0.2% to 2.9%). Viral suppression was excellent (≥98%) and unscheduled facility visits were not increased in the intervention arms. CONCLUSIONS: Three and 6-monthly out-of-facility MMD was non-inferior versus facility-based care for stable ART patients. Out-of-facility 6-monthly MMD should incorporate small group peer support whenever possible. CLINICALTRIAL REGISTRATION: ClinicalTrials.gov NCT03238846 and NCT03438370.


Subject(s)
Antiretroviral Therapy, Highly Active , HIV Infections/drug therapy , Adolescent , Adult , Africa, Southern , Anti-HIV Agents/therapeutic use , COVID-19 , Female , Humans , Male , Middle Aged , Randomized Controlled Trials as Topic , Retention in Care , Time Factors , Young Adult
13.
J Acquir Immune Defic Syndr ; 88(5): 448-456, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1511112

ABSTRACT

INTRODUCTION: Recent studies project thousands of additional AIDS-related deaths because of COVID-19-related disruptions in HIV care. However, the extent to which disruptions in care have materialized since the start of the pandemic is not well understood. METHODS: We use electronic health records to investigate how the pandemic has affected clinic visits, patients' antiretroviral therapy (ART) supply, and viral suppression for a cohort of 14,632 HIV clients from a large HIV clinic in Kampala, Uganda. We complement this with an analysis of electronically measured longitudinal ART adherence data from a subcohort of 324 clients. RESULTS: Clinic visits decreased by more than 50% after a national lockdown started. The risk of patients running out of ART on a given day increased from 5% before the lockdown to 25% 3 months later (Relative Risk Ratio of 5.11, 95% confidence interval: 4.99 to 5.24) and remained higher than prelockdown 6 months later at 13% (Relative Risk Ratio of 2.60; 95% confidence interval: 2.52 to 2.70). There was no statistically significant change in electronically measured adherence or viral suppression. CONCLUSION: We document substantial gaps in HIV care after the start of the COVID-19 pandemic in Uganda. This suggests that measures to improve access should be explored as the pandemic persists. However, ART adherence was unaffected for the subcohort for whom we measured electronic adherence. This suggests that some clients may have stockpiles of ART tablets from previous prescriptions that allowed them to keep taking their medication even when they could not visit the clinic for ART refills.


Subject(s)
Anti-HIV Agents/therapeutic use , COVID-19/epidemiology , HIV Infections/drug therapy , HIV Infections/virology , Medication Adherence/statistics & numerical data , Viral Load/drug effects , Adult , Cohort Studies , Communicable Disease Control , Female , HIV Infections/epidemiology , Humans , Male , Pandemics , Uganda/epidemiology
15.
Am J Epidemiol ; 190(11): 2339-2349, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1493666

ABSTRACT

We assessed the teratogenicity of tenofovir, a human immunodeficiency virus (HIV) drug similar to remdesivir that is currently being evaluated for the treatment of coronavirus disease 2019 (COVID-19). Using US Medicaid Analytic eXtract (MAX) claims data (2000-2014), we identified a population-based pregnancy cohort of women with HIV who filled at least 1 prescription for antiretroviral therapies (ART) during the first trimester. Women on tenofovir disoproxil fumarate (TDF) were compared with women receiving ART without TDF. Major malformations were identified by International Classification of Diseases, Ninth Revision, codes using validated algorithms. Relative risks and 95% confidence intervals were estimated using propensity score stratification to control for potential confounders. We incorporated the results into prior knowledge by conducting a systematic literature review and a meta-analysis. Major congenital malformations were diagnosed in 37 out of 866 (4.27%) infants exposed to TDF and 38 out of 1,020 (3.73%) infants exposed to ART other than TDF; the adjusted relative risk was 1.21 (95% confidence interval: 0.77, 1.90). Estimates for specific malformations were imprecise. The pooled relative risk from the meta-analysis with 6 prior studies was 0.88 (95% confidence interval: 0.75, 1.03). Based on evidence accumulated in patients with HIV, first-trimester TDF use does not increase the risk of major congenital malformations overall in the newborn compared with other ART.


Subject(s)
Antiviral Agents/adverse effects , Pregnancy Complications, Infectious/drug therapy , Tenofovir/adverse effects , Adult , Anti-HIV Agents/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/epidemiology , Cohort Studies , Female , HIV Infections/drug therapy , Humans , Pandemics , Pregnancy , Pregnancy Outcome , Pregnant Women , Reverse Transcriptase Inhibitors/adverse effects , Reverse Transcriptase Inhibitors/therapeutic use , SARS-CoV-2 , Tenofovir/therapeutic use
16.
J Int AIDS Soc ; 24 Suppl 6: e25820, 2021 10.
Article in English | MEDLINE | ID: covidwho-1487494

ABSTRACT

INTRODUCTION: The rapid increase in the number of people living with HIV (PLHIV) on antiretroviral therapy (ART) in Akwa Ibom and Cross River states in Nigeria led to overcrowding at clinics. Patients were devolved to receive ART refills through five differentiated service delivery (DSD) models: fast-track (FT), adolescent refill clubs (ARCs), community pharmacy ART refill programs (CPARPs), community ART refill clubs (CARCs) and community ART refill groups (CARGs) designed to meet the needs of different groups of PLHIV. In the context of COVID-19-related travel restrictions, out-of-facility models offered critical mechanisms for continuity of treatment. We compared retention and viral suppression among those devolved to DSD with those who continued standard care at facilities. METHODS: A retrospective cohort study was conducted among patients devolved to DSD from January 2018 to December 2020. Bivariate analyses were conducted to assess differences in retention and viral suppression by socio-demographic characteristics. Kaplan-Meier assessed retention at 3, 6, 9 and 12 months. Differences in proportions were compared using the chi-square test; a p-value of <0.05 was considered significant. RESULTS: A total of 40,800 PLHIV from 84 facilities received ART through the five models: CARC (53%), FT (19.1%), ARC (12.1%), CPARP (10.4%) and CARG (5.4%). Retention rates at 6 months exceeded 96% for all models compared to 94% among those continuing standard care. Among those using DSD, retention rate at 12 months was higher among adults than children (97.8% vs. 96.7%, p = 0.04). No significant sex differences in retention rates were found among those enrolled in DSD. Viral suppression rates among PLHIV served through DSD were significantly higher among adults than children (95.4% vs. 89.2%; p <0.01). Among adults, 95.4% enrolled in DSD were virally suppressed compared to 91.8% of those in standard care (p <0.01). For children, 89.2% enrolled in DSD were virally suppressed compared to 83.2% in standard care (p <0.01). CONCLUSIONS: PLHIV receiving ART through DSD models had retention but higher viral suppression rates compared to those receiving standard care. Expanding DSD during COVID-19 has helped ensure uninterrupted access to ART in Nigeria. Further scale-up is warranted to decongest facilities and improve clinical outcomes.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Adolescent , Adult , Anti-HIV Agents/therapeutic use , Child , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Male , Nigeria , Pandemics , Retrospective Studies , SARS-CoV-2
17.
J Int AIDS Soc ; 24 Suppl 6: e25819, 2021 10.
Article in English | MEDLINE | ID: covidwho-1487493

ABSTRACT

INTRODUCTION: Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility-based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster-randomized trials investigating community-based DSD in Zimbabwe and Lesotho. METHODS: Individual-level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard-of-care three-monthly ART provision at healthcare facilities (SoC, control); ART provided three-monthly in community ART groups (CAGs) (3MC) and ART provided six-monthly in either CAGs or at community-distribution points (6MC). Clinical visits were three-monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual-level regression analyses were conducted by intention-to-treat specifying for clustering and adjusted for country. RESULTS AND DISCUSSION: A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%-8.5%). Retention in 6MC was non-inferior versus SoC, aRD = 1.7% (95% CI: -2.5%-5.9%) (prespecified non-inferiority aRD margin -3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92-1.03) for 3MC versus SoC, and 0.98 (CI: 0.95-1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16-1.80) for 3MC versus SoC; and 0.82 (CI: 0.25-2.79) for 6MC versus SoC. CONCLUSIONS: Community-based DSD incorporating three- and six-monthly ART refills and single annual clinical visits were at least non-inferior to standard facility-based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Adult , Africa, Southern , Anti-HIV Agents/therapeutic use , Community Health Services , HIV Infections/drug therapy , Humans , Randomized Controlled Trials as Topic , SARS-CoV-2 , Time Factors , Viral Load
18.
J Int AIDS Soc ; 24 Suppl 6: e25816, 2021 10.
Article in English | MEDLINE | ID: covidwho-1487492

ABSTRACT

INTRODUCTION: Same-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. METHODS: Pre-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. RESULTS: Of 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. CONCLUSIONS: Telehealth 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.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Telemedicine , Anti-HIV Agents/therapeutic use , HIV Infections/diagnosis , HIV Infections/drug therapy , Humans , SARS-CoV-2 , Thailand
19.
J Int AIDS Soc ; 24 Suppl 6: e25813, 2021 10.
Article in English | MEDLINE | ID: covidwho-1487490

ABSTRACT

INTRODUCTION: Sisters with a Voice (Sisters), a programme providing community-led differentiated HIV prevention and treatment services, including condoms, HIV testing, pre-exposure prophylaxis (PrEP) and antiretroviral therapy linkage for sex workers, reached over 26,000 female sex workers (FSW) across Zimbabwe in 2020. Zimbabwe's initial Covid "lockdown" in March 2020 and associated movement restrictions interrupted clinical service provision for 6 weeks, particularly in mobile clinics, triggering the adaptation of services for the Covid-19 context and a scale up of differentiated service delivery (DSD) models. PrEP service delivery decentralized with shifts from clinical settings towards community/home-based, peer-led PrEP services to expand and maintain access. We hypothesize that peer-led community-based provision of PrEP services influenced both demand and supply-side determinants of PrEP uptake. We observed the effect of these adaptations on PrEP uptake among FSW accessing services in Sisters in 2020. METHODS: New FSW PrEP initiations throughout 2020 were tracked by analysing routine Sisters programme data and comparing it with national PrEP initiation data for 2020. We mapped PrEP uptake among all negative FSW attending services in Sisters alongside Covid-19 adaptations and shifts in the operating environment throughout 2020: prior to lockdown (January-March 2020), during severe restrictions (April-June 2020), subsequent easing (July-September 2020) and during drug stockouts that followed (October-December 2020). RESULTS AND DISCUSSION: PrEP uptake in 2020 occurred at rates <25% (315 initiations or fewer) per month prior to the emergence of Covid-19. In response to Covid-19 restrictions, DSD models were scaled up in April 2020, including peer demand creation, community-based delivery, multi-month dispensing and the use of virtual platforms for appointment scheduling and post-PrEP initiation support. Beginning May 2020, PrEP uptake increased monthly, peaking at an initiation rate of 51% (n = 1360) in September 2020. Unexpected rise in demand coincided with national commodity shortages between October and December 2020, resulting in restriction of new initiations with sites prioritizing refills. CONCLUSIONS: Despite the impact of Covid-19 on the Sisters Programme and FSW mobility, DSD adaptations led to a large increase in PrEP initiations compared to pre-Covid levels demonstrating that a peer-led, community-based PrEP service delivery model is effective and can be adopted for long-term use.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Pre-Exposure Prophylaxis , Sex Workers , Anti-HIV Agents/therapeutic use , Communicable Disease Control , Female , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans , SARS-CoV-2
20.
J Int AIDS Soc ; 24 Suppl 6: e25808, 2021 10.
Article in English | MEDLINE | ID: covidwho-1487487

ABSTRACT

INTRODUCTION: Differentiated service delivery (DSD) models aim to improve the access of human immunodeficiency virus treatment on clients and reduce requirements for facility visits by extending dispensing intervals. With the advent of the COVID-19 pandemic, minimising client contact with healthcare facilities and other clients, while maintaining treatment continuity and avoiding loss to care, has become more urgent, resulting in efforts to increase DSD uptake. We assessed the extent to which DSD coverage and antiretroviral treatment (ART) dispensing intervals have changed during the COVID-19 pandemic in Zambia. METHODS: We used client data from Zambia's electronic medical record system (SmartCare) for 737 health facilities, representing about three-fourths of all ART clients nationally. We compared the numbers and proportional distributions of clients enrolled in DSD models in the 6 months before and 6 months after the first case of COVID-19 was diagnosed in Zambia in March 2020. Segmented linear regression was used to determine whether the outbreak of COVID-19 in Zambia further accelerated the increase in DSD scale-up. RESULTS AND DISCUSSION: Between September 2019 and August 2020, 181,317 clients aged 15 or older (81,520 and 99,797 from 1 September 2019 to 1 March 2020 and from 1 March to 31 August 2020, respectively) enrolled in DSD models in Zambia. Overall participation in all DSD models increased over the study period, but uptake varied by model. The rate of acceleration increased in the second period for home ART delivery (152%), ≤ 2-month fast-track (143%) and 3-month MMD (139%). There was a significant reduction in the enrolment rates for 4- to 6-month fast-track (-28%) and "other" models (-19%). CONCLUSIONS: Participation in DSD models for stable ART clients in Zambia increased after the advent of COVID-19, but dispensing intervals diminished. Eliminating obstacles to longer dispensing intervals, including those related to supply chain management, should be prioritized to achieve the expected benefits of DSD models and minimize COVID-19 risk.


Subject(s)
Anti-HIV Agents , COVID-19 , HIV Infections , Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Interrupted Time Series Analysis , Pandemics , SARS-CoV-2 , Zambia/epidemiology
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