Effectiveness of an intervention to improve ART adherence among men who have sex with men living with HIV: a randomized controlled trial in three public HIV clinics in Mexico.

We conducted a parallel-group randomized controlled trial in three HIV clinics in Mexico to evaluate a user-centred habit-formation intervention to improve ART adherence among MSM living with HIV. We randomized 74 participants to the intervention group and 77 to the control group. We measured adherence at one, four, and ten months through medication possession ratio and self-reported adherence. Additionally, we measured viral load, CD4 cell count, major depression disorder symptoms, and alcohol and substance use disorder at baseline, fourth and tenth months. We found no statistically significant effect on adherence between groups. However, the intervention demonstrated positive results in major depression disorder symptoms (21% vs. 6%, p = 0.008) and substance use disorder (11% vs. 1%, p = 0.018) in the fourth month. The latter is relevant because, in addition to its direct benefit, it might also improve the chances of maintaining adequate adherence in the long term. This trial was retrospectively registered at ClinicalTrials.gov (trial number NCT03410680) on 8 January 2018.Trial registration: ClinicalTrials.gov identifier: NCT03410680.

Androgen Receptor Status in Triple Negative Breast Cancer: Does It Correlate with Clinicopathological Characteristics?

Purpose: Triple negative breast cancer (TNBC) is a breast carcinoma subtype that neither expresses estrogen (ER) and progesterone receptors (PR) nor the human epidermal growth factor receptor 2 (HER2). Patients with TNBC have been shown to have poorer outcomes mainly owing to the limited treatment options available. However, some studies have shown TNBC tumors expressing androgen receptors (AR), raising hopes of its prognostic role. Patients and Methods: This retrospective study investigated the expression of AR in TNBC and its relationship with known patient demographics, tumor and survival characteristics. From the records of 205 TNBC patients, 36 had available archived tissue samples eligible for AR staining. For statistical purposes, tumors were classified as either "positive" or "negative" for AR expression. The nuclear expression of AR was scored by measuring the percentage of stained tumor cells and its staining intensity. Results: AR was expressed by 50% of the tissue samples in our TNBC cohort. The relationship between AR status with age at the time of TNBC diagnosis was statistically significant, with all AR positive TNBC patients being greater than 50 years old (vs 72.2% in AR negative TNBC). Also, the relationship between AR status and type of surgery received was statistically significant. There were no statistically significant associations between AR status with other tumor characteristics including "TNM status", tumor grade or treatments received. There was no statistically significant difference in median survival between AR negative and AR positive TNBC patients (3.5 vs 3.1 years; p = 0.581). The relationship between OS time and AR status (p = 0.581), type of surgery (p = 0.061) and treatments (p = 0.917) were not statistically significant. Conclusion: The androgen receptor may be an important prognostic marker in TNBC, with further research warranted. This research may benefit future studies investigating receptor-targeted therapies in TNBC.

SARS-CoV-2 Seroprevalence in a Cohort of International Travellers Returning to Rural Australia: Enablers and Barriers to Containment of COVID-19.

OBJECTIVE: To describe the effectiveness of the public health response to COVID-19 in our local region by documenting detection of SARS-CoV-2 infection by nucleic acid testing (NAT) positivity and seroprevalence. METHODS: In this prospective study (ACTRN12620000487910), symptomatic adult international travellers returning to regional Australia in March 2020 underwent SARS-CoV-2 NAT and SARS-CoV-2-specific serology. RESULTS: Ninety-nine eligible participants were included. Nine participants had laboratory confirmed SARS-CoV-2, all returning between 16-20 March 2020. Eight (89%) had a positive NAT and seven (78%) had a positive serology test. The majority returned from New Zealand. Participants most frequently presented with cough (100%), headache (66.7%) and sore throat (44.4%). No community cases were detected from 1 March to 30 June 2020. CONCLUSIONS: The study cohort of international travellers returning to regional Australia in March 2020 returned eight positive SARS-CoV-2 NAT results over a five-day window. Serology identified one additional case and was negative in two cases who were PCR positive. Longitudinal data confirmed an absence of local community transmission to 30 June 2020. IMPLICATIONS FOR PUBLIC HEALTH: A combination of local, national and environmental factors were necessary to prevent the establishment of community transmission in our local region.

Protocol for iSISTAQUIT: Implementation phase of the supporting indigenous smokers to assist quitting project.

INTRODUCTION: About 44% of Aboriginal and/or Torres Strait Islander women smoke during pregnancy compared to 12% of their general population counterparts. Evidence-based quit smoking advice received from health care professionals (HCPs) can increase smoking cessation rates. However, HCPs lack culturally appropriate smoking cessation training, which is a major barrier to provision of smoking cessation care for this population. METHODS AND ANALYSIS: iSISTAQUIT is a multicentre, single arm study aiming to implement and evaluate the evidence-based, culturally competent iSISTAQUIT smoking cessation training among health practitioners who provide support and assistance to pregnant, Aboriginal and Torres Strait Islander women in Australia. This project will implement the iSISTAQUIT intervention in Aboriginal Medical Services and Mainstream Health Services. The proposed sample size is 10 of each of these services (total N = 20), however if the demand is higher, we will aim to accommodate up to 30 services for the training. Participating sites and their HCPs will have the option to choose one of the two iSISTAQUIT packages available: a) Evaluation- research package b) Training package (with or without continued professional development points). Training will be provided via an online eLearning platform that includes videos, text, interactive elements and a treatment manual. A social media campaign will be conducted from December 2021 to September 2022 to raise brand and issue awareness about smoking cessation for Aboriginal and Torres Strait Islander women in pregnancy. This national campaign will consist of systematic advertising and promotion of iSISTAQUIT and video messages through various social media platforms. ANALYSIS: We will use the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance) to plan, evaluate and report the intervention impact of iSISTAQUIT. Effectiveness of social media campaign will be assessed via social media metrics, cross-sectional surveys, and interviews. DISCUSSION: This innovative research, using a multi-component intervention, aims to practically apply and integrate a highly translatable smoking cessation intervention in real-world primary care settings in Aboriginal Medical Services and Mainstream services. The research benefits Aboriginal women, babies and their family and community members through improved support for smoking cessation during pregnancy. The intervention is based on accepted Australian and international smoking cessation guidelines, developed and delivered in a culturally appropriate approach for Aboriginal communities.

Codeveloping a multibehavioural mobile phone app to enhance social and emotional well-being and reduce health risks among Aboriginal and Torres Strait Islander women during preconception and pregnancy: a three-phased mixed-methods study.

OBJECTIVE: Describe the development and pretest of a prototype multibehavioural change app MAMA-EMPOWER. DESIGN: Mixed-methods study reporting three phases: (1) contextual enquiry included stakeholder engagement and qualitative interviews with Aboriginal women, (2) value specification included user-workshop with an Aboriginal researcher, community members and experts, (3) codesign with Aboriginal researchers and community members, followed by a pretest of the app with Aboriginal women, and feedback from qualitative interviews and the user-Mobile Application Rating Scale (U-MARS) survey tool. SETTINGS: Aboriginal women and communities in urban and regional New South Wales, Australia. PARTICIPANTS: Phase 1: interviews, 8 Aboriginal women. Phase 2: workshop, 6 Aboriginal women. Phase 3: app trial, 16 Aboriginal women. U-MARS, 5 Aboriginal women. RESULTS: Phase 1 interviews revealed three themes: current app use, desired app characteristics and implementation. Phase 2 workshop provided guidance for the user experience. Phase 3 app trial assessed all content areas. The highest ratings were for information (mean score of 3.80 out of 5, SD=0.77) and aesthetics (mean score of 3.87 with SD of 0.74), while functionality, engagement and subjective quality had lower scores. Qualitative interviews revealed the acceptability of the app, however, functionality was problematic. CONCLUSIONS: Developing a mobile phone app, particularly in an Aboriginal community setting, requires extensive consultation, negotiation and design work. Using a strong theoretical foundation of behavioural change technique's coupled with the consultative approach has added rigour to this process. Using phone apps to implement behavioural interventions in Aboriginal community settings remains a new area for investigation. In the next iteration of the app, we aim to find better ways to personalise the content to women's needs, then ensure full functionality before conducting a larger trial. We predict the process of development will be of interest to other health researchers and practitioners.

Smoking Cessation Messages for Pregnant Aboriginal and Torres Strait Islander Women: A Rapid Review of Peer-Reviewed Literature and Assessment of Research Translation of Media Content.

This review summarized literature about knowledge, attitudes, and beliefs of Aboriginal and Torres Strait Islander women from Australia who smoke during pregnancy, then examined the extent that existing health promotion materials and media messages aligned with evidence on smoking cessation for pregnant Aboriginal and Torres Strait Islander women. Knowledge, attitudes, and beliefs of pregnant Aboriginal women who smoke tobacco were identified in the literature. Health promotion campaigns were retrieved from a grey literature search with keywords and social and professional networks. Key themes from peer-reviewed papers were compared against the content of health promotion campaigns using the Aboriginal Social and Emotional Wellbeing Model, the Behavior Change Wheel and thematic analysis. Eleven empirical studies and 17 campaigns were included. Empirical studies highlighted women sought holistic care that incorporated nicotine replacement therapy, engaged with their family and community and the potential for education about smoking cessation to empower a woman. Health promotion campaigns had a strong focus on 'engagement with family and community', 'knowledge of risks of smoking,' 'giving up vs cutting down' and 'culture in language and arts'. There were similarities and variances in the key themes in the research evidence and promotion materials. Topics highly aligned included risks from smoking and quitting related issues.

Efficiency, quality, and management practices in health facilities providing outpatient HIV services in Kenya, Nigeria, Rwanda, South Africa and Zambia.

Few studies have assessed the efficiency and quality of HIV services in low-resource settings or considered the factors that determine both performance dimensions. To provide insights on the performance of outpatient HIV prevention units, we used benchmarking methods to identify best-practices in terms of technical efficiency and process quality and uncover management practices with the potential to improve efficiency and quality. We used data collected in 338 facilities in Kenya, Nigeria, Rwanda, South Africa, and Zambia. Data envelopment analysis (DEA) was used to estimate technical efficiency. Process quality was estimated using data from medical vignettes. We mapped the relationship between efficiency and quality scores and studied the managerial determinants of best performance in terms of both efficiency and quality. We also explored the relationship between management factors and efficiency and quality independently. We found levels of both technical efficiency and process quality to be low, though there was substantial variation across countries. One third of facilities were mapped in the best-performing group with above-median efficiency and above-median quality. Several management practices were associated with best performance in terms of both efficiency and quality. When considering efficiency and quality independently, the patterns of associations between management practices and the two performance dimensions were not necessarily the same. One management characteristic was associated with best performance in terms of efficiency and quality and also positively associated with efficiency and quality independently: number of supervision visits to HIV units.

The relationship between management practices and the efficiency and quality of voluntary medical male circumcision services in four African countries.

INTRODUCTION: Given constrained funding for Human Immunodeficiency Virus (HIV) programs across Sub-Saharan Africa, delivering services efficiently is paramount. Voluntary medical male circumcision (VMMC) is a key intervention that can substantially reduce heterosexual transmission-the primary mode of transmission across the continent. There is limited research, however, on what factors may contribute to the efficient and high-quality execution of such programs. METHODS: We analyzed a multi-country, multi-stage random sample of 108 health facilities providing VMMC services in sub-Saharan Africa in 2012 and 2013. The survey collected information on inputs, outputs, process quality and management practices from facilities providing VMMC services. We analyzed the relationship between management practices, quality (measured through provider vignettes) and efficiency (estimated through data envelopment analysis) using Generalized Linear Models and Mixed-effects Models. Applying multivariate regression models, we assessed the relationship between management indices and efficiency and quality of VMMC services. RESULTS: Across countries, both efficiency and quality varied widely. After adjusting for type of facility, country and scale, performance-base funding was negatively correlated with efficiency -0.156 (p < 0.05). In our analysis, we did not find any significant relationships between quality and management practices. CONCLUSIONS: No significant relationship was found between process quality and management practices across 108 VMMC facilities. This study is the first to analyze the potential relationships between management and service quality and efficiency among a sample of VMMC health facilities in sub-Saharan Africa and can potentially inform policy-relevant hypotheses to later test through prospective experimental studies.

Influence of supply-side factors on voluntary medical male circumcision costs in Kenya, Rwanda, South Africa, and Zambia.

BACKGROUND: In this study, we described facility-level voluntary medical male circumcision (VMMC) unit cost, examined unit cost variation across facilities, and investigated key facility characteristics associated with unit cost variation. METHODS: We used data from 107 facilities in Kenya, Rwanda, South Africa, and Zambia covering 2011 or 2012. We used micro-costing to estimate economic costs from the service provider's perspective. Average annual costs per client were estimated in 2013 United States dollars (US$). Econometric analysis was used to explore the relationship between VMMC total and unit cost and facility characteristics. RESULTS: Average VMMC unit cost ranged from US$66 (SD US$79) in Kenya to US$160 (SD US$144) in South Africa. Total cost function estimates were consistent with economies of scale and scope. We found a negative association between the number of VMMC clients and VMMC unit cost with a 3% decrease in unit cost for every 10% increase in number of clients and we found a negative association between the provision of other HIV services and VMMC unit cost. Also, VMMC unit cost was lower in primary health care facilities than in hospitals, and lower in facilities implementing task shifting. CONCLUSIONS: Substantial efficiency gains could be made in VMMC service delivery in all countries. Options to increase efficiency of VMMC programs in the short term include focusing service provision in high yield sites when demand is high, focusing on task shifting, and taking advantage of efficiencies created by integrating HIV services. In the longer term, reductions in VMMC unit cost are likely by increasing the volume of clients at facilities by implementing effective demand generation activities.

Efficiency of HIV services in Nigeria: Determinants of unit cost variation of HIV counseling and testing and prevention of mother-to-child transmission interventions.

BACKGROUND: Like most countries with a substantial HIV burden, Nigeria continues to face challenges in reaching coverage targets of HIV services. A fundamental problem is stagnated funding in recent years. Improving efficiency is therefore paramount to effectively scale-up HIV services. In this study, we estimated the facility-level average costs (or unit costs) of HIV Counseling and Testing (HCT) and Prevention of Mother-to-Child Transmission (PMTCT) services and characterized determinants of unit cost variation. We investigated the role of service delivery modalities and the link between facility-level management practices and unit cost variability along both services' cascades. METHODS: We conducted a cross-sectional, observational, micro-costing study in Nigeria between December 2014 and May 2015 in 141 HCT, and 137 PMTCT facilities, respectively. We retrospectively collected relevant input quantities (personnel, supplies, utilities, capital, and training), input prices, and output data for the year 2013. Staff costs were adjusted using time-motion methods. We estimated the facility-level average cost per service along the HCT and PMTCT service cascades and analyzed their composition and variability. Through linear regressions analysis, we identified aspects of service delivery and management practices associated with unit costs variations. RESULTS: The weighted average cost per HIV-positive client diagnosed through HCT services was US$130. The weighted average cost per HIV-positive woman on prophylaxis in PMTCT services was US$858. These weighted values are estimates of nationally representative unit costs in Nigeria. For HCT, the facility-level unit costs per client tested and per HIV-positive client diagnosed were US$30 and US$1,364, respectively; and the median unit costs were US$17 and US$245 respectively. For PMTCT, the facility-level unit costs per woman tested, per HIV-positive woman diagnosed, and per HIV-positive woman on prophylaxis were US$46, US$2,932, and US$3,647, respectively, and the median unit costs were US$24, US$1,013 and US$1,448, respectively. Variability in costs across facilities was principally explained by the number of patients, integration of HIV services, task shifting, and the level of care. DISCUSSION: Our findings demonstrate variability in unit costs across facilities. We found evidence consistent with economies of scale and scope, and efficiency gains in facilities implementing task-shifting. Our results could inform program design by suggesting ways to improve resource allocation and efficiently scale-up the HIV response in Nigeria. Some of our findings might also be relevant for other settings.

Explaining the heterogeneity in average costs per HIV/AIDS patient in Nigeria: The role of supply-side and service delivery characteristics.

OBJECTIVE: We estimated the average annual cost per patient of ART per facility (unit cost) in Nigeria, described the variation in costs across facilities, and identified factors associated with this variation. METHODS: We used facility-level data of 80 facilities in Nigeria, collected between December 2014 and May 2015. We estimated unit costs at each facility as the ratio of total costs (the sum of costs of staff, recurrent inputs and services, capital, training, laboratory tests, and antiretroviral and TB treatment drugs) divided by the annual number of patients. We applied linear regressions to estimate factors associated with ART cost per patient. RESULTS: The unit ART cost in Nigeria was $157 USD nationally and the facility-level mean was $231 USD. The study found a wide variability in unit costs across facilities. Variations in costs were explained by number of patients, level of care, task shifting (shifting tasks from doctors to less specialized staff, mainly nurses, to provide ART) and provider´s competence. The study illuminated the potentially important role that management practices can play in improving the efficiency of ART services. CONCLUSIONS: Our study identifies characteristics of services associated with the most efficient implementation of ART services in Nigeria. These results will help design efficient program scale-up to deliver comprehensive HIV services in Nigeria by distinguishing features linked to lower unit costs.