Publications by authors named "Wendy Davis"

213 Publications

Family planning use and correlates among female sex workers in a community empowerment HIV prevention intervention in Iringa, Tanzania: a case for tailored programming.

BMC Public Health 2021 Jul 12;21(1):1377. Epub 2021 Jul 12.

Johns Hopkins School of Public Health; Department of Health, Behavior and Society, 624 N Broadway HH 757, Baltimore, MD, 21205, USA.

Background: Female sex workers in sub-Saharan Africa face high unmet need for family planning and higher risk for unintended pregnancy. Community empowerment HIV prevention approaches have the potential to increase family planning uptake and present an opportunity to integrate HIV, reproductive health, and contraception. This article describes family planning use and pregnancy among female sex workers in Iringa, Tanzania and evaluates whether engagement in a community empowerment HIV prevention program is associated with contraceptive use.

Methods: This study consists of secondary analysis from a two-community randomized controlled trial following a longitudinal cohort over 18 months. We implemented a year-long community empowerment intervention consisting of 1) a community-led drop-in-center; 2) venue-based peer education, condom distribution, and HIV testing; 3) peer service navigation; 4) sensitivity trainings for providers and police; and 5) text messages to promote engagement. Additionally, monthly seminars were held at the drop-in-center, one of which focused on family planning. Modified Poisson regression models were used to estimate the association between program exposure and family planning use in the intervention arm. (Trials Registration NCT02281578, Nov 2, 2014.) RESULTS: Among the 339 participants with follow-up data on family planning, 60% reported current family planning use; 6% reported dual use of modern contraception and condoms; over 90% had living children; and 85% sought antenatal care at their most recent pregnancy. Among the 185 participants in the intervention arm, the adjusted relative risk (aRR) of family planning use among female sex workers who reported ever attending the Shikamana drop-in-center and among female sex workers who reported attending a family planning-related workshop was respectively 26% (aRR 1.26 [95% Confidence Interval (CI): 1.02-1.56]) and 36% (aRR 1.36 [95%CI: 1.13-1.64) higher than among those who had not attended.

Conclusion: There is a clear need for family planning among this population. General program exposure and exposure to a family planning workshop were associated with higher family planning use, which suggests that community empowerment models have potential to increase family planning uptake for this vulnerable group.
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http://dx.doi.org/10.1186/s12889-021-11426-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8274018PMC
July 2021

Cognitive Impairment in People with Diabetes-Related Foot Ulceration.

J Clin Med 2021 Jun 25;10(13). Epub 2021 Jun 25.

Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Murdoch 6150, Australia.

Aims: To determine whether there is an excess of cognitive impairment in patients with type 2 diabetes and foot ulceration.

Methods: 55 patients with type 2 diabetes and foot ulcers attending Multidisciplinary Diabetes Foot Ulcer clinics (MDFU cohort) were compared with 56 patients with type 2 diabetes attending Complex Diabetes clinics (CDC cohort) using commonly used screening tests for cognitive impairment (Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA)), as well as foot self-care, mood and health literacy. MMSE was also compared between the MDFU cohort and a historical community-based cohort of patients with type 2 diabetes (FDS2 cohort).

Results: Median MMSE scores were the same in all three groups (28/30). Median MOCA scores did not differ between the MDFU and CDC cohorts (25/30). There were no significant differences in the percentages of patients with MMSE ≤ 24 or MOCA ≤ 25 between MDFU and CDC cohorts (3.6% versus 10.7%, = 0.27 and 56.4% versus 51.8%, = 0.71, respectively), findings that did not change after adjustment for age, sex, education, diabetes duration, and random blood glucose.

Conclusions: Using conventionally applied instruments, patients with type 2 diabetes and foot ulceration have similar cognition compared with patients without, from either hospital-based clinic or community settings.
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http://dx.doi.org/10.3390/jcm10132808DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268193PMC
June 2021

Wound healing with "spray-on" autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: an open-label randomised controlled trial.

Int Wound J 2021 Jun 22. Epub 2021 Jun 22.

Multidisciplinary Diabetes Foot Ulcer Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.

There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes-related foot wounds. In this randomised, open-label trial, participants were randomised to receive an application of non-cultured autologous skin cells ("spray-on" skin; ReCell) or standard care interventions for large (>6 cm ), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty-nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8-17.6) cm . A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray-on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35-3.65), P = .845). Lower body mass index (P = .002) and non-plantar wounds (P = .009) were the only patient- or wound-related factors associated with complete healing at 6 months. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).
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http://dx.doi.org/10.1111/iwj.13646DOI Listing
June 2021

Mobility for sex work and recent experiences of gender-based violence among female sex workers in Iringa, Tanzania: A longitudinal analysis.

PLoS One 2021 3;16(6):e0252728. Epub 2021 Jun 3.

Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States of America.

Female sex workers are highly mobile, which may influence their risk of experiencing physical and sexual violence. However, there remains a paucity of research, particularly longitudinal, from Sub-Saharan Africa exploring mobility and gender-based violence among female sex workers. To address this gap, this study examined the longitudinal relationship between work-related mobility and recent experience of physical or sexual gender-based violence from a client or partner among female sex workers in Iringa, Tanzania. A secondary data analysis was conducted using baseline and 18-month follow-up data from Project Shikamana, a community empowerment-based combination HIV prevention intervention. Responses from 387 female sex workers aged 18 years and older participating in both baseline and follow-up were analyzed. Unadjusted and adjusted Poisson regression models with robust variance estimations, accounting for clustering of female sex workers' responses over time, were fit. Final models adjusted for socio-demographic characteristics and aspects of participants' living situations and work environments. Recent physical or sexual violence from a client or partner was common (baseline: 40%; follow-up: 29%). Twenty-six percent of female sex workers at baseline, and 11% at follow-up, had recently traveled outside of Iringa for sex work. In the final adjusted longitudinal model, female sex workers recently mobile for sex work had a 25% increased risk of any recent experience of physical or sexual gender-based violence when compared with their non-mobile counterparts (adjusted incidence rate ratio: 1.25; 95% CI: 1.03-1.53; p<0.05). Interventions must identify ways-such as mobile support services, linkages and referrals to health and other social services while traveling, or the use of mobile or digital technology-to address mobile female sex workers' unique needs while traveling. Future quantitative and qualitative research is needed to understand the context of female sex workers' mobility and how and why mobility influences risk environments and experiences of gender-based violence.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252728PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174717PMC
June 2021

Immunizing Against Hate: Overcoming Asian American and Pacific Islander Racism.

Pediatrics 2021 May 3. Epub 2021 May 3.

University of Maryland Schools of Medicine and Public Health, College Park, Maryland.

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http://dx.doi.org/10.1542/peds.2021-051836DOI Listing
May 2021

Intra-abdominal hypertension and hypoxic respiratory failure together predict adverse outcome - A sub-analysis of a prospective cohort.

J Crit Care 2021 Aug 17;64:165-172. Epub 2021 Apr 17.

Division of Trauma and Acute Care Surgery, Department of Surgery, Fundación Valle del Lili - Universidad del Valle, Cali, Colombia.

Purpose: To assess whether the combination of intra-abdominal hypertension (IAH, intra-abdominal pressure ≥ 12 mmHg) and hypoxic respiratory failure (HRF, PaO2/FiO2 ratio < 300 mmHg) in patients receiving invasive ventilation is an independent risk factor for 90- and 28-day mortality as well as ICU- and ventilation-free days.

Methods: Mechanically ventilated patients who had blood gas analyses performed and intra-abdominal pressure measured, were included from a prospective cohort. Subgroups were defined by the absence (Group 1) or the presence of either IAH (Group 2) or HRF (Group 3) or both (Group 4). Mixed-effects regression analysis was performed.

Results: Ninety-day mortality increased from 16% (Group 1, n = 50) to 30% (Group 2, n = 20) and 27% (Group 3, n = 100) to 49% (Group 4, n = 142), log-rank test p < 0.001. The combination of IAH and HRF was associated with increased 90- and 28-day mortality as well as with fewer ICU- and ventilation-free days. The association with 90-day mortality was no longer present after adjustment for independent variables. However, the association with 28-day mortality, ICU- and ventilation-free days persisted after adjusting for independent variables.

Conclusions: In our sub-analysis, the combination of IAH and HRF was not independently associated with 90-day mortality but independently increased the odds of 28-day mortality, and reduced the number of ICU- and ventilation-free days.
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http://dx.doi.org/10.1016/j.jcrc.2021.04.009DOI Listing
August 2021

Multi-level considerations for optimal implementation of long-acting injectable antiretroviral therapy to treat people living with HIV: perspectives of health care providers participating in phase 3 trials.

BMC Health Serv Res 2021 Mar 20;21(1):255. Epub 2021 Mar 20.

George Washington University, Washington, DC, USA.

Background: Long-acting injectable antiretroviral therapy (LA ART) has been shown to be non-inferior to daily oral ART, with high patient satisfaction and preference to oral standard of care in research to date, and has recently been approved for use in the United States and Europe. This study examined the perspectives of health care providers participating in LA ART clinical trials on potential barriers and solutions to LA ART roll-out into real world settings.

Methods: This analysis draws on two data sources: (1) open-ended questions embedded in a structured online survey of 329 health care providers participating in the ATLAS-2 M trial across 13 countries; and (2) in-depth interviews with 14 providers participating in FLAIR/ ATLAS/ATLAS-2 M trials in the United States and Spain. Both assessments explored provider views and clinic dynamics related to the introduction of LA ART and were analyzed using thematic content analysis. The Consolidated Framework for Implementation Research (CFIR) was drawn on as the conceptual framework underpinning development of a model depicting study findings.

Results: Barriers and proposed solutions to LA ART implementation were identified at the individual, clinic and health system levels. Provider perceptions of patient level barriers included challenges with adhering to frequent injection appointments and injection tolerability. Proposed solutions included patient education, having designated staff for clinic visit retention, and clinic flexibility with appointment scheduling. The main provider concern was identifying appropriate candidates for LA ART; proposed solutions focused on patient provider communication and decision making. Clinic level barriers included the need for additional skilled individuals to administer injections, shifts in workflow as demand increases and the logistics of cold-chain storage. Proposed solutions included staff hiring and training, strategic planning around workflow and logistics, and the possibility of offering injections in other settings, including the home. Health system level barriers included cost and approvals from national regulatory bodies. Potential solutions included governments subsidizing treatment, ensuring cost is competitive with oral ART, and offering co-pay assistance.

Conclusions: Results suggest the importance of multi-level support systems to optimize patient-provider communication and treatment decision-making; clinic staffing, workflow, logistics protocols and infrastructure; and cost-related factors within a given health system.
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http://dx.doi.org/10.1186/s12913-021-06214-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980753PMC
March 2021

Acceptability and perceptions of HIV oral self-testing across settings: A comparative qualitative study among Dominican and Tanzanian female sex workers.

Glob Public Health 2021 Mar 19:1-15. Epub 2021 Mar 19.

Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.

Rapid oral HIV self-tests (HIVST) have potential to increase the proportion of people who know their HIV status, especially among stigmatised populations. This study was embedded in two cohorts of female sex workers (FSW) in the Dominican Republic (DR) and Tanzania. Qualitative interviews with 40 FSW were conducted to explore perceived acceptability of HIVST. Interviews were analysed using inductive and deductive thematic coding. Emergent themes were organised by socio-ecological framework levels. FSW in both settings responded positively to the ease of use of HIVST but questioned test accuracy due to the use of saliva rather than blood. FSW in the DR had a more cautious response, while women in Tanzania had favourable perceptions expressing eagerness to use it. At the individual level, themes shaping participants' interest included autonomy, HIV risk perception, and emotional well-being for those with reactive test results, and self-efficacy. At the interpersonal level, privacy, confidentiality, sex work and HIV stigma and social support were salient. Structural level themes focused on health systems including linkages to HIV treatment, provider roles, and access (cost, travel, distribution). Understanding FSW's perceptions and acceptability of HIVST is essential to its integration into health systems and programmes using a community-driven approach.
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http://dx.doi.org/10.1080/17441692.2021.1901129DOI Listing
March 2021

Development of the Experiences of Sex Work Stigma Scale Using Item Response Theory: Implications for Research on the Social Determinants of HIV.

AIDS Behav 2021 Mar 17. Epub 2021 Mar 17.

Medstar Health Research Institute, Washington DC, USA.

While HIV stigma has received significant attention, limited work has been conducted on the measurement of intersecting stigmas. We developed the Experiences of Sex Work Stigma (ESWS) scale in the Dominican Republic (DR) and Tanzania. We conducted in-depth interviews with 20 female sex workers (FSW) per country to identify scale domains followed by cognitive debriefing interviews to assess content validity. Items were administered in a survey to FSW in DR (n = 211) and Tanzania (n = 205). Factor analysis established four sex work stigma domains including: shame (internalized), dignity (resisted), silence (anticipated) and treatment (enacted). Reliability across domains ranged from 0.81 to 0.93. Using item response theory (IRT) we created context-specific domain scores accounting for differential item functioning between countries. ESWS domains were associated with internalized HIV stigma, depression, anxiety, sexual partner violence and social cohesion across contexts. The ESWS is the first reliable and valid scale to assess multiple domains of sex work stigma and can be used to examine the effects of this form of intersectional stigma on HIV-related outcomes across settings.
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http://dx.doi.org/10.1007/s10461-021-03211-1DOI Listing
March 2021

Reevaluating Patient Eligibility for Inotuzumab Ozogamicin Based on CD22 Expression: Is Dim Expression Sufficient?

Curr Oncol 2020 12 31;28(1):252-259. Epub 2020 Dec 31.

Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z4, Canada.

Salvage options for patients with relapsed B-cell acute lymphoblastic leukemia (B-ALL) include inotuzumab ozogamicin (InO), a recombinant, humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin. However, the benefit of InO in patients with dim CD22 expression remains unclear. We present a case of a patient with B-ALL who responded to InO despite only dim surface expression of CD22 by flow cytometry, achieving a survival benefit concordant with that reported in the literature and maintaining a good quality of life as a transfusion-independent outpatient. Our observation has broad relevance to clinicians who manage patients with B-ALL who are candidates for InO.
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http://dx.doi.org/10.3390/curroncol28010027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900888PMC
December 2020

A Peer-Based Strategy to Overcome HPV Vaccination Inequities in Rural Communities: A Physical Distancing-Compliant Approach.

Crit Rev Eukaryot Gene Expr 2021 ;31(1):61-69

KM Consulting, New Jersey, USA.

The human papilloma virus (HPV) vaccine is the world's first proven and effective vaccine to prevent cancers in males and females when administered pre-exposure. Like most of the US, barely half of Vermont teens are up-to-date with the vaccination, with comparable deficits in New Hampshire and Maine. The rates for HPV vaccine initiation and completion are as low as 33% in rural New England. Consequently, there is a compelling responsibility to communicate its importance to unvaccinated teenagers before their risk for infection increases. Messaging in rural areas promoting HPV vaccination is compromised by community-based characteristics that include access to appropriate medical care, poor media coverage, parental and peer influence, and skepticism of science and medicine. Current strategies are predominantly passive access to literature and Internet-based information. Evidence indicates that performance-based messaging can clarify the importance of HPV vaccination to teenagers and their parents in rural areas. Increased HPV vaccination will significantly contribute to the prevention of a broadening spectrum of cancers. Reducing rurality-based inequities is a public health priority. Development of a performance-based peer-communication intervention can capture a window of opportunity to provide increasingly effective and sustained HPV protection. An effective approach can be partnering rural schools and regional health teams with a program that is nimble and scalable to respond to public health policies and practices compliant with COVID-19 pandemic-related modifications on physical distancing and interacting in the foreseeable future.
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http://dx.doi.org/10.1615/CritRevEukaryotGeneExpr.2021036945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8128079PMC
March 2021

Incidence and predictors of idiopathic pulmonary fibrosis complicating Type 2 diabetes: the Fremantle Diabetes Study Phase I.

Intern Med J 2021 Feb;51(2):276-279

Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.

During 106 865 person-years of follow up, 17 (1.3%) Fremantle Diabetes Study Phase I participants with Type 2 diabetes and 57 (1.1%) matched individuals without diabetes developed idiopathic pulmonary fibrosis (IPF), an incidence rate ratio (95% confidence interval) of 1.40 (0.76-2.44) (P = 0.22). In the diabetes cohort, age at diabetes diagnosis and total serum cholesterol (inversely) predicted incident IPF in competing risk multivariable models. The incidence of IPF was low in community-based cohorts, regardless of Type 2 diabetes status.
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http://dx.doi.org/10.1111/imj.15191DOI Listing
February 2021

Knowledge of ocular complications of diabetes in community-based people with type 2 diabetes: The Fremantle Diabetes Study II.

Prim Care Diabetes 2021 Jun 5;15(3):554-560. Epub 2021 Feb 5.

Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia. Electronic address:

Aims: To assess knowledge of diabetes-related eye disease in Australians with type 2 diabetes and its associations with diabetic retinopathy (DR), other ocular complications and vision-related quality of life.

Methods: A random sample from the Fremantle Diabetes Study Phase II cohort (n = 360) was invited to participate. Knowledge was assessed using 10 multiple-choice questions covering how diabetes affects the eyes, frequency of ophthalmic screening, risk factors, prevention, available treatments, and prognosis. DR was assessed from fundus photographs. Multiple linear regression was used to identify independent associates of the knowledge score (KS).

Results: We included 264 participants (mean ± SD age 72.1 ± 9.2 years, 56.8% male, median [IQR] diabetes duration 15.4 [11.1-22.3] years). The mean ± SD KS out of 10 was 5.3 ± 1.8. Most (67%) participants knew diabetes can affect the eye and lead to blindness. Only 13.6% knew that DR screening intervals depend on risk factors. Those with moderate non-proliferative DR (NPDR) or worse had a better knowledge score (B = 1.37,P = 0.008) after adjusting for age (B = -0.03, P = 0.004) and education beyond primary school (B = 1.75, P < 0.001).

Conclusions: Overall knowledge of diabetes-related ocular complications was suboptimal. Education targeting eye disease may benefit people with type 2 diabetes who are older, less well educated and/or who have no DR/mild NPDR.
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http://dx.doi.org/10.1016/j.pcd.2021.01.008DOI Listing
June 2021

Mindfulness, Mental Health and HIV Outcomes Among Female Sex Workers in the Dominican Republic and Tanzania.

AIDS Behav 2021 Jan 28. Epub 2021 Jan 28.

Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

We examined the relationship between mindfulness, mental health and HIV outcomes among female sex workers (FSW) from the Dominican Republic (DR) (n = 201) and Tanzania (n = 208) using cross-sectional survey and biologic data. We employed stratified multivariate linear and logistic regression. Depression was associated with lower odds of ART adherence in the DR (AOR 0.25, 95% CI: 0.08-0.78) and of viral suppression in Tanzania (AOR 0.49, 95% CI: 0.24-0.97). In both countries, mindfulness was associated with lower odds of moderate to severe depression (AOR 0.82, 95% CI: 0.76-0.88 for the DR; AOR 0.85, 95% CI: 0.77-0.95 for Tanzania). In the DR, mindfulness was associated with lower odds of anxiety (AOR 0.83, 95% CI: 0.77-0.89), lower HIV stigma (β = - 0.28 per unit change, 95% CI: - 0.37 to - 0.19) and greater odds of viral suppression (AOR 1.09, 95% CI: 1.02-1.15). Findings demonstrate the potential of tailored mindfulness interventions to improve mental health and HIV outcomes among FSW.
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http://dx.doi.org/10.1007/s10461-021-03168-1DOI Listing
January 2021

Assessment of biomarkers associated with rapid renal decline in the detection of retinopathy and its progression in type 2 diabetes: The Fremantle Diabetes Study Phase II.

J Diabetes Complications 2021 Apr 9;35(4):107853. Epub 2021 Jan 9.

Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia. Electronic address:

Aims: To determine whether biomarkers for diabetic kidney disease (DKD) can be used to determine the prevalence, progression and/or incidence of diabetic retinopathy (DR) complicating type 2 diabetes.

Methods: Proteomic biomarkers were measured in baseline fasting plasma from 958 Fremantle Diabetes Study Phase II participants whose baseline and, in those returning for follow-up (n = 764), Year 4 fundus photographs were graded for DR presence/severity. The performance of PromarkerD (three biomarkers and readily available clinical variables which identify prevalent DKD and predict incident DKD and estimated glomerular filtration rate decline ≥30% over four years) for detecting DR prevalence, progression and incidence was assessed using the area under the receiver operating curve (AUC). Logistic regression determined whether individual proteins were associated with DR outcomes after adjusting for the most parsimonious model.

Results: Plasma apolipoprotein A-IV (APOA4) was independently associated with moderate non-proliferative DR at baseline (OR (95% CI): 1.64 (1.01, 2.67), P = 0.047). Model discrimination was poor for all PromarkerD predicted probabilities against all DR outcomes (AUC ≤0.681).

Conclusions: PromarkerD and its constituent biomarkers were not consistently associated with DR prevalence or temporal change. APOA4 was associated with prevalent DR, but not DR incidence or progression. Distinct pathophysiological mechanisms may underlie DKD and DR.
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http://dx.doi.org/10.1016/j.jdiacomp.2021.107853DOI Listing
April 2021

Temporal Trends in Incident Hospitalization for Diabetes-Related Foot Ulcer in Type 2 Diabetes: The Fremantle Diabetes Study.

Diabetes Care 2021 Mar 13;44(3):722-730. Epub 2021 Jan 13.

Medical School, University of Western Australia, Perth, Western Australia, Australia

Objective: To determine whether, reflecting trends in other chronic complications, incident hospitalization for diabetes-related foot ulcer (DFU) has declined over recent decades in type 2 diabetes.

Research Design And Methods: Participants with type 2 diabetes from the community-based Fremantle Diabetes Study phases I (FDS1; 1,296 participants, mean age 64.0 years, 48.6% males, recruited 1993-1996) and II (FDS2; 1,509 participants, mean age 65.4 years, 51.8% males, recruited 2008-2011) were followed from entry to first hospitalization for/with DFU, death, or 5 years (whichever came first). Incident rate ratios (IRRs) and incident rate differences (IRDs) were calculated for FDS2 versus FDS1 overall and in 10-year age-groups. Cox proportional hazards modeling determined independent predictors of first DFU hospitalization in the combined cohort.

Results: Incident DFU hospitalization (95% CI) was 1.9 (0.9-3.3)/1,000 person-years in FDS1 during 5,879 person-years of follow-up and 4.5 (3.0-6.4)/1,000 person-years in FDS2 during 6,915 person-years of follow-up. The crude IRR (95% CI) was 2.40 (1.17-5.28) ( = 0.013) and IRD 2.6 (0.7-4.5)/1,000 person-years ( = 0.010). The highest IR for any age-group was 23.6/1,000 person-years in FDS2 participants aged 31-40 years. Age at diabetes diagnosis (inverse), HbA, insulin use, height, ln(urinary albumin/creatinine), absence of any foot pulse, previous peripheral revascularization, and peripheral sensory neuropathy (PSN) were independent predictors of incident hospitalization for/with DFU.

Conclusions: Incident DFU hospitalizations complicating type 2 diabetes increased between FDS phases, especially in younger participants, and were more likely in those with PSN, peripheral arterial disease, and suboptimal glycemic control at baseline.
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http://dx.doi.org/10.2337/dc20-1743DOI Listing
March 2021

Relative incidence and predictors of pulmonary arterial hypertension complicating type 2 diabetes: The Fremantle Diabetes Study Phase I.

J Diabetes Complications 2021 Feb 27;35(2):107773. Epub 2020 Oct 27.

Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia. Electronic address:

Aims: To determine the relative incidence and predictors of pulmonary arterial hypertension (PAH) in type 2 diabetes.

Methods: Hospitalizations for/with and death from/with PAH, and all-cause mortality, were ascertained from validated databases for participants from the longitudinal, community-based Fremantle Diabetes Study Phase I (FDS1; n = 1287) and age-, sex- and zip code-matched people without diabetes (n = 5153) between entry (1993-1996) and end-2017. Incidence rates (IRs) and IR ratios (IRRs) were calculated. Cox proportional hazards and competing risk models generated cause-specific (cs) and subdistribution (sd) hazard ratios (HRs) for incident PAH.

Results: In the pooled cohort (mean age 64.0 years, 49% males), 49 (3.8%) of the type 2 diabetes participants and 133 (2.6%) of those without diabetes developed PAH during 106,556 person-years of follow-up (IRs (95% CI) 262 (194-346) and 151 (127-179) /100,000 person-years, respectively; IRR 1.73 (1.22-2.42), P = 0.001). Type 2 diabetes was associated with an unadjusted csHR of 1.97 (1.42-2.74) and sdHR of 1.44 (1.04-2.00) (P ≤ 0.03); after adjustment for age, sex, and co-morbidities, these were 1.43 (0.83-2.47) and 1.36 (0.97-1.91), respectively (P ≥ 0.07).

Conclusions: Type 2 diabetes is associated with an increased risk of PAH but this is no longer significant after adjustment for other explanatory variables and the competing risk of death.
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http://dx.doi.org/10.1016/j.jdiacomp.2020.107773DOI Listing
February 2021

Antiretroviral drug use and HIV drug resistance in female sex workers in Tanzania and the Dominican Republic.

PLoS One 2020 29;15(10):e0240890. Epub 2020 Oct 29.

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.

Objective: Female sex workers (FSW) have increased risk of HIV infection. Antiretroviral treatment (ART) can improve HIV outcomes and prevent HIV transmission. We analyzed antiretroviral (ARV) drug use and HIV drug resistance among HIV-positive FSW in the Dominican Republic and Tanzania.

Methods: Plasma samples collected at study entry with viral loads >1,000 copies/mL were tested for ARV drugs and HIV drug resistance. ARV drug testing was performed using a qualitative assay that detects 22 ARV drugs in five classes. HIV genotyping was performed using the ViroSeq HIV-1 Genotyping System. Phylogenetic analyses were performed to determine HIV subtype and assess transmission clusters.

Results: Among 410 FSW, 144 (35.1%) had viral loads >1,000 copies/mL (DR: n = 50; Tanzania: n = 94). ARV drugs were detected in 36 (25.0%) of 144 samples. HIV genotyping results were obtained for 138 (95.8%) cases. No transmission clusters were observed in either country. HIV drug resistance was detected in 54 (39.1%) of 138 samples (31/35 [88.6%] with drugs detected; 23/103 [22.3%] without drugs detected); 29/138 (21.0%) had multi-class resistance (MCR). None with MCR had integrase strand transfer inhibitor resistance. In eight cases, one or more ARV drug was detected without corresponding resistance mutations; those women were at risk of acquiring additional drug resistance. Using multivariate logistic regression, resistance was associated with ARV drug detection (p<0.001), self-reported ART (full adherence [p = 0.034]; partial adherence [p<0.001]), and duration of HIV infection (p = 0.013).

Conclusions: In this cohort, many women were on ART, but were not virally suppressed. High levels of HIV drug resistance, including MCR, were observed. Resistance was associated with detection of ARV drugs, self-report of ART with full or partial adherence, and duration of HIV infection. These findings highlight the need for better HIV care among FSW to improve their health, reduce HIV drug resistance, and decrease risk of transmission to others.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240890PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595323PMC
December 2020

Changes in the Epidemiology of Hepatobiliary Disease Complicating Type 2 Diabetes over 25 Years: The Fremantle Diabetes Study.

J Clin Med 2020 Oct 24;9(11). Epub 2020 Oct 24.

University of Western Australia Medical School, Fremantle Hospital, Fremantle 6959, WA, Australia.

Objective: To determine whether the incidence/outcome of hepatobiliary disease (HBD) has increased over recent decades in community-based Australians with and without type 2 diabetes (T2D).

Methods: Longitudinal data from the Fremantle Diabetes Study Phase I (FDS1; recruitment 1993-1996; = 1291 with T2D) and Phase II (FDS2; 2008-2011; = 1509) were analyzed. Participants with T2D from both Phases were age-, sex-, and postcode-matched 1:4 to people without diabetes. Incident HBD and associated mortality were ascertained from hospitalization, cancer registration, and/or death certification codes. Incidence rates (IRs) and IR ratios (IRRs) for those with versus without diabetes in FDS1 and FDS2 were calculated.

Results: HBD IRs for people without diabetes did not change between Phases. The IRR (95% CI) for people with T2D in FDS2 versus FDS1 was 1.30 (1.01-1.68) with the highest IRRs in participants aged <65 years. Non-alcoholic fatty liver disease/steatohepatitis (NAFLD/NASH) events were 54% greater in FDS2 than FDS1 in the presence of greater abdominal adiposity. NAFLD/NASH was coded in one in 11 HBD events in FDS2 and in 10% of HBD deaths (<4% of total mortality).

Conclusions: HBD is more frequent in people with versus without T2D and this discrepancy is increasing. Hospitalizations/deaths due to NAFLD/NASH remain uncommon.
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http://dx.doi.org/10.3390/jcm9113409DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690874PMC
October 2020

Carotid Disease and Retinal Optical Coherence Tomography Angiography Parameters in Type 2 Diabetes: The Fremantle Diabetes Study Phase II.

Diabetes Care 2020 12 14;43(12):3034-3041. Epub 2020 Oct 14.

Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, Australia.

Objective: To use optical coherence tomography angiography (OCTA) to determine whether retinal microvascular parameters are associated with carotid arterial disease in people with type 2 diabetes.

Research Design And Methods: Participants (community-based) underwent detailed assessments including carotid ultrasonography and OCTA. Ultrasound images were assessed for mean intima-media thickness (IMT) and the presence of stenosis. OCTA image analysis provided measures of vessel density, foveal avascular zone (FAZ) area, blood flow areas, and retinal thickness. For each OCTA variable, the most parsimonious model was generated using generalized estimating equations, then ipsilateral and contralateral carotid disease-related variables were added to determine their significance.

Results: A total of 474 eyes from 261 participants (mean ± SD age 72.0 ± 9.3 years, 57.1% males, median diabetes duration 15.4 years [interquartile range 11.1-22.4]) were analyzed. When carotid variables were added to the most parsimonious models, the ipsilateral natural logarithm of common carotid artery IMT (coefficient -2.56 [95% CI -4.76, -0.35], = 0.023) and presence of any ipsilateral stenosis (-0.82 [-1.48, -0.17], = 0.014) were statistically significantly associated with a lower parafoveal density in the deep capillary plexus. A mean bifurcation IMT ≥1 mm was associated with a decreased vessel density in the 300-μm ring surrounding the FAZ (coefficient -0.79 [-1.50, -0.08], = 0.030)). Contralateral carotid disease-related variables were also significantly associated with retinal microvascular parameters.

Conclusions: This is the first study to show that carotid disease is an independent associate of retinal microvascular disease assessed by OCTA in type 2 diabetes. Appropriately intensive management of carotid disease may improve the retinal microcirculation.
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http://dx.doi.org/10.2337/dc20-0370DOI Listing
December 2020

Differences in retinopathy prevalence and progression between Anglo-Celt and Aboriginal Australians: The Fremantle Diabetes Study Phase II.

Intern Med J 2020 Oct 11. Epub 2020 Oct 11.

Medical School The University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.

Background: Indigenous populations have higher rates of diabetes and diabetic complications, yet there is a paucity of contemporary data on diabetic retinopathy (DR) prevalence and incidence in urban dwelling Aboriginal Australians.

Aims: To compare the prevalence of DR and incidence of new or worsening DR between Aboriginal Australians and Anglo Celts with type 2 diabetes.

Methods: Participants from the community-based Fremantle Diabetes Study Phase II (817 Anglo-Celts, 94 Aboriginal people) recruited between 2008 and 2011 underwent fundus photography at baseline and biennial reviews. The prevalence of any DR and moderate non-proliferative DR (NPDR), and the incidence of new or worsening DR, were ascertained using baseline and four-year follow-up data.

Results: Compared to Anglo-Celts, the Aboriginal participants had a higher prevalence of any DR (33.0% vs 52.1%) and moderate NPDR or worse (5.1% vs 24.4%), and new or worsening DR during follow-up (6.7% vs 23.5%). The unadjusted odds ratios (95% CI) of any DR and moderate NPDR at baseline were 2.21 (1.43, 3.39) and 5.98 (3.40, 10.50), respectively, and of new or worsening DR 4.32 (1.33, 13.98). In adjusted models, Aboriginal ethnicity was only associated with the prevalence of moderate NPDR or worse (5.58 (2.44, 12.76)).

Conclusions: Aboriginal participants had a higher prevalence of DR and new or worsening DR, reflecting conventional risk factors including suboptimal glycaemic control. Their significantly higher odds of moderate NPDR or worse in adjusted models suggest ethnic-specific determinants of DR severity. These findings highlight the need for equitable, culturally appropriate diabetes/ophthalmic care. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/imj.15090DOI Listing
October 2020

PromarkerD Predicts Renal Function Decline in Type 2 Diabetes in the Canagliflozin Cardiovascular Assessment Study (CANVAS).

J Clin Med 2020 Oct 6;9(10). Epub 2020 Oct 6.

Proteomics International, Nedlands, WA 6009, Australia.

The ability of current tests to predict chronic kidney disease (CKD) complicating diabetes is limited. This study investigated the prognostic utility of a novel blood test, PromarkerD, for predicting future renal function decline in individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS). PromarkerD scores were measured at baseline in 3568 CANVAS participants ( = 1195 placebo arm, = 2373 canagliflozin arm) and used to predict incident CKD (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m during follow-up in those above this threshold at baseline) and eGFR decline ≥30% during the 4 years from randomization. Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3) measured by mass spectrometry were combined with clinical data (age, serum high-density lipoprotein (HDL)-cholesterol, eGFR) using a previously defined algorithm to provide PromarkerD scores categorized as low-, moderate- or high-risk. The participants (mean age 63 years, 33% females) had a median PromarkerD score of 2.9%, with 70.5% categorized as low-risk, 13.6% as moderate-risk and 15.9% as high-risk for developing incident CKD. After adjusting for treatment, baseline PromarkerD moderate-risk and high-risk scores were increasingly prognostic for incident CKD (odds ratio 5.29 and 13.52 versus low-risk, respectively; both < 0.001). Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.
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http://dx.doi.org/10.3390/jcm9103212DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7600174PMC
October 2020

A quality improvement collaborative to increase human papillomavirus vaccination rates in local health department clinics.

Prev Med 2020 10 12;139:106235. Epub 2020 Aug 12.

Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochetester, NY, United States of America.

Human papillomavirus (HPV) vaccination rates are well below the Healthy People 2020 goal of 80%. Vaccinating in settings other than primary care, such as local health departments (LHDs), may help achieve higher HPV immunization rates. We tested the effect of a quality improvement (QI) collaborative to reduce missed opportunities (MOs) for HPV vaccine in LHDs. Between 2016 and 2019, we conducted four consecutive cohorts of a virtual QI collaborative at 24 LHDs across multiple states. Participants were trained on topics including how to provide an effective recommendation for HPV vaccine, strategies to reduce MOs, and motivational interviewing. Throughout the 6-month project implementation, LHDs tested strategies to reduce MOs through Plan-Do-Study-Act cycles, performed chart reviews to identify and characterize MOs, and received feedback reports to assess progress on MOs. HPV vaccination rates were assessed pre- and post-intervention. LHDs reduced MOs for HPV vaccine in all four cohorts with aggregated data showing a 25.3 percentage point reduction in MOs. Modified Poisson regression analysis found a 44% reduction in the relative risk of missing the opportunity for an HPV vaccine at a visit (RR = 0.56, 0.46-0.68, p < .001). This project shows that strategies effective in reducing MO for HPV vaccine in primary care settings are also effective in LHD settings. Training LHD staff on these strategies may help the U.S. approach national goals for HPV vaccine coverage.
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http://dx.doi.org/10.1016/j.ypmed.2020.106235DOI Listing
October 2020

Complementary and alternative medicine beliefs in type 2 diabetes: The Fremantle Diabetes Study Phase II.

Diabetes Res Clin Pract 2020 Aug 14;166:108311. Epub 2020 Jul 14.

University of Western Australia, Medical School, Crawley, Western Australia, Australia. Electronic address:

Complementary medicine (CM) treatment beliefs of people with type 2 diabetes were assessed using a validated three-domain questionnaire. Belief in holistic health, but not natural treatments or participation in treatment, was independently associated with CM use (P = 0.003). Strong holistic health beliefs could identify present/future CM use, with potential management implications.
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http://dx.doi.org/10.1016/j.diabres.2020.108311DOI Listing
August 2020

Influence of Renin-Angiotensin System Inhibitors on Lower-Respiratory Tract Infections in Type 2 Diabetes: The Fremantle Diabetes Study Phase II.

Diabetes Care 2020 09 2;43(9):2113-2120. Epub 2020 Jul 2.

Medical School, University of Western Australia, and Fremantle Hospital, Fremantle, Western Australia, Australia

Objective: To determine whether ACE inhibitors (ACEi) and angiotensin receptor blockers (ARB) protect against lower-respiratory tract infections complicating type 2 diabetes.

Research Design And Methods: Of 1,732 participants with diabetes recruited to the longitudinal observational Fremantle Diabetes Study Phase II (FDS2) between 2008 and 2011, 1,482 had confirmed type 2 diabetes (mean age 65.8 years and median diabetes duration 9.0 years; 51.6% were male). All were followed for hospitalizations for or with, or deaths from, pneumonia/influenza, ascertained from validated administrative data linkage from study entry to end of 2016. Cox regression and competing risk regression were used to identify independent predictors of this outcome.

Results: Two-thirds of participants ( = 982) were taking an ACEi and/or ARB at study entry (498 [33.6%] ACEi, 408 [27.5%] ARB, 76 [5.1%] both). During 9,511 person-years of follow-up (mean ± SD 6.4 ± 2.0 years), 174 participants had incident pneumonia/influenza (156 hospitalizations and 18 deaths without hospitalization). In Cox regression analysis, baseline ACEi/ARB use was independently associated with a reduced risk of incident pneumonia/influenza (cause-specific hazard ratio [HR] 0.64 [95% CI 0.45, 0.89], = 0.008). Allowing for the competing risk of death did not change this finding (subdistribution HR 0.67 [0.48, 0.95], = 0.024), and similar reductions were seen for ACEi, ARB alone, and ACEi/ARB combination therapy. There was no significant change in use of ACEi/ARB during follow-up [interaction with ln(time), = 0.70]. Other significant predictors of incident pneumonia/influenza were previously reported, clinically plausible variables.

Conclusions: ACEi/ARB reduce the risk of pneumonia/influenza in people with type 2 diabetes.
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http://dx.doi.org/10.2337/dc20-0895DOI Listing
September 2020

Identifying Strategies to Reduce Missed Opportunities for HPV Vaccination in Primary Care: A Qualitative Study of Positive Deviants.

Clin Pediatr (Phila) 2020 10 29;59(12):1058-1068. Epub 2020 Jun 29.

Department of Pediatrics, UCLA Mattel Children's Hospital, University of California, Los Angeles, CA, USA.

The objectives of this study were to assess the contextual factors, practice strategies, and sustainability of interventions implemented during a national quality improvement (QI) project to raise human papillomavirus (HPV) vaccination rates. We conducted semistructured interviews with positive deviant practices that successfully reduced missed opportunities by ≥20% for HPV vaccination in the prior year. We assessed leadership support, motivators, interventions used, and sustainability. Key themes related to QI teams included strong leadership support, multidisciplinary teams, having a practice champion, and a collaborative environment. Themes related to the interventions included using a presumptive bundled recommendation for all appropriate vaccines at age 11, previsit planning, and reminders for preventive visits, which were sustainable for most practices 1-year postintervention. Both internal practice-level factors (multidisciplinary teams, collaboration, and previsit planning) and organizational factors (institutional support and health system-level reminders for preventive visits) were key to a successful QI intervention to improve HPV vaccination.
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http://dx.doi.org/10.1177/0009922820930357DOI Listing
October 2020

"A dream come true": Perspectives on long-acting injectable antiretroviral therapy among female sex workers living with HIV from the Dominican Republic and Tanzania.

PLoS One 2020 12;15(6):e0234666. Epub 2020 Jun 12.

Department of Health Behavior, University of North Carolina, Chapel Hill, North Carolina, United States of America.

Background: Long-acting injectable antiretroviral therapy (LA ART) was found to be non-inferior to daily oral ART in Phase 3 clinical trials. LA ART may offer an important alternative for people living with HIV with challenges adhering to daily oral ART or preferences for non-pill-based regimens.

Methods: Using a mixed methods approach integrating survey, in-depth interview and biological data from female sex workers (FSW) living with HIV in Tanzania (N = 208) and the Dominican Republic (DR) (N = 201), we assessed factors associated with the potential likelihood of LA ART use if it were available. We conducted multivariate logistic regression and thematic content analysis.

Results: Likelihood of LA ART use was high with 84.92% of FSW from the DR and 92.27% of FSW from Tanzania reporting they would be "likely" or "very likely" to use LA ART if available (p = 0.02). In Tanzania better HIV-related patient-provider communication (AOR 4.58; 95% CI 1.90-11.05) and quality of HIV clinical care (AOR 3.68; 95% CI 1.05-12.86) were positively associated with the high likelihood of LA ART use. In the DR, easier clinic access was associated with a higher likelihood of LA ART use (AOR 3.04; 95% CI 1.41-6.56), as was greater monthly income from sex work (AOR 2.37; 95% CI 1.27-4.41). In both settings, years on ART was significantly associated with a strong likelihood of LA ART use (TZ: AOR 1.16 per year; 95% CI 1.00-1.34/DR: AOR 1.07 per year; 95% CI 1.00-1.14). Qualitative findings underscored enthusiasm for LA ART and reinforced its potential to address sex work-specific barriers to daily oral ART adherence including work-related schedules and substance use.

Conclusions: We found a high likelihood of LA ART use if available among FSW in two diverse settings and documented barriers to future uptake. Community-driven approaches which include tailored health education and improved patient-provider communication and quality of care, as well as strategies to facilitate appointment adherence are needed to optimize LA ART use among FSW.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0234666PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7292359PMC
August 2020

"I feel empowered": women's perspectives on and experiences with long-acting injectable antiretroviral therapy in the USA and Spain.

Cult Health Sex 2020 May 21:1-13. Epub 2020 May 21.

Department of Sociology, American University, Washington, DC, USA.

Long-acting injectable antiretroviral therapy has been shown to be non-inferior to daily oral antiretroviral therapy in clinical trials and may soon become part of clinical care. While most trial participants to date have been men, approximately one quarter of ongoing Phase 3 trial participants are women offering an important opportunity to understand how long-acting antiretroviral therapy is perceived and experienced by women. We conducted in-depth interviews with 80 people living with HIV participating in Phase 2 and 3 clinical trials of long-acting antiretroviral therapy in the USA and Spain. Fifteen percent (12/80) of trial participants interviewed were women. Interviews were audio-recorded, transcribed and coded using content analysis, focused on gender-specific themes. Women shared many of the positive perceptions expressed by men but also had unique perspectives, including finding that long-acting antiretroviral therapy addressed the challenge of remembering pills amidst busy day-to-day realities including multiple roles and responsibilities, is less time consuming and creates less stress compared to oral antiretroviral therapy, and is emotionally freeing and empowering. The gendered nature of women's lives shaped why and how they were satisfied with long-acting antiretroviral therapy. Findings can inform interventions and support systems to facilitate uptake of and adherence to long-acting antiretroviral therapy in women.
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http://dx.doi.org/10.1080/13691058.2020.1752397DOI Listing
May 2020

Efficacy and Freedom: Patient Experiences with the Transition from Daily Oral to Long-Acting Injectable Antiretroviral Therapy to Treat HIV in the Context of Phase 3 Trials.

AIDS Behav 2020 Dec;24(12):3473-3481

American University, Washington, D.C., USA.

Long-acting injectable antiretroviral therapy (LA ART) may be an alternative for people living with HIV (PLHIV) with adherence challenges or who prefer not to take pills. Using in-depth interviews, this study sought to understand the experiences of PLHIV (n = 53) participating in Phase 3 LA ART trials in the United States and Spain. The most salient consideration when contemplating LA ART was its clinical efficacy; many participants reported wanting to ensure that it worked as well as daily oral ART, including with less frequent dosing (every 8 versus 4 weeks). While injection side effects were often reported, most participants felt that regimen benefits outweighed such drawbacks. Participants described the main benefit of LA ART as the "freedom" it afforded both logistically and psychosocially, including through reduced HIV stigma. Findings highlight the importance of patient-provider communication related to weighing potential benefits and side effects and the continued need to address HIV stigma.
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http://dx.doi.org/10.1007/s10461-020-02918-xDOI Listing
December 2020