Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial.

BACKGROUND: Despite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease-HIV-to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as "TASKPEN," that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness. METHODS: The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor's Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM. DISCUSSION: Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).

Money, chores and emotional support: Kenyan and Zambian fathers' perceptions of male partner involvement in maternal and infant health within the context of HIV.

In sub-Saharan Africa, involving male partners in the prevention of mother-to-child transmission of HIV improves maternal and infant outcomes. Male involvement is typically conceptualised as male partners attending antenatal care, which is difficult for many men. Little is known about how men view their involvement in family health within the context of HIV, particularly outside of clinic attendance. Through interviews with 35 male partners of pregnant or postpartum women living with HIV in Kenya and Zambia, this study elicited perceptions of male involvement in maternal and infant health in families affected by HIV. Men supported the importance of clinic attendance but reported conflicts with the need to work and fulfil their role as the family's financial provider. Providing money for necessities was deemed more critical for their family's health than clinic attendance. Men's involvement was conveyed through various other supportive actions, including helping with household chores and providing emotional support (showing love and reducing women's stress). Future strategies to promote male partner involvement in the prevention of mother-to-child transmission of HIV and maternal and child health should build upon the actions men view as most meaningful to promote their family's health within their real-world life circumstances and cultural context, particularly their role as financial providers.

Effect of systematic tuberculosis detection on mortality in young children with severe pneumonia in countries with high incidence of tuberculosis: a stepped-wedge cluster-randomised trial.

BACKGROUND: Tuberculosis diagnosis might be delayed or missed in children with severe pneumonia because this diagnosis is usually only considered in cases of prolonged symptoms or antibiotic failure. Systematic tuberculosis detection at hospital admission could increase case detection and reduce mortality. METHODS: We did a stepped-wedge cluster-randomised trial in 16 hospitals from six countries (Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Uganda, and Zambia) with high incidence of tuberculosis. Children younger than 5 years with WHO-defined severe pneumonia received either the standard of care (control group) or standard of care plus Xpert MTB/RIF Ultra (Xpert Ultra; Cepheid, Sunnyvale, CA, USA) on nasopharyngeal aspirate and stool samples (intervention group). Clusters (hospitals) were progressively switched from control to intervention at 5-week intervals, using a computer-generated random sequence, stratified on incidence rate of tuberculosis at country level, and masked to teams until 5 weeks before switch. We assessed the effect of the intervention on primary (12-week all-cause mortality) and secondary (including tuberculosis diagnosis) outcomes, using generalised linear mixed models. The primary analysis was by intention to treat. We described outcomes in children with severe acute malnutrition in a post hoc analysis. This study is registered with ClinicalTrials.gov (NCT03831906) and the Pan African Clinical Trial Registry (PACTR202101615120643). FINDINGS: From March 21, 2019, to March 30, 2021, we enrolled 1401 children in the control group and 1169 children in the intervention group. In the intervention group, 1140 (97·5%) children had nasopharyngeal aspirates and 942 (80·6%) had their stool collected; 24 (2·1%) had positive Xpert Ultra. At 12 weeks, 110 (7·9%) children in the control group and 91 (7·8%) children in the intervention group had died (adjusted odds ratio [OR] 0·986, 95% CI 0·597-1·630, p=0·957), and 74 (5·3%) children in the control group and 88 (7·5%) children in the intervention group had tuberculosis diagnosed (adjusted OR 1·238, 95% CI 0·696-2·202, p=0·467). In children with severe acute malnutrition, 57 (23·8%) of 240 children in the control group and 53 (17·8%) of 297 children in the intervention group died, and 36 (15·0%) of 240 children in the control group and 56 (18·9%) of 297 children in the intervention group were diagnosed with tuberculosis. The main adverse events associated with nasopharyngeal aspirates were samples with blood in 312 (27·3%) of 1147 children with nasopharyngeal aspirates attempted, dyspnoea or SpO2 less than 95% in 134 (11·4%) of children, and transient respiratory distress or SpO2 less than 90% in 59 (5·2%) children. There was no serious adverse event related to nasopharyngeal aspirates reported during the trial. INTERPRETATION: Systematic molecular tuberculosis detection at hospital admission did not reduce mortality in children with severe pneumonia. High treatment and microbiological confirmation rates support more systematic use of Xpert Ultra in this group, notably in children with severe acute malnutrition. FUNDING: Unitaid and L'Initiative. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Men's perceptions of sexual and reproductive health education within the context of pregnancy and HIV in Zambia: a descriptive qualitative analysis.

BACKGROUND: Although health care providers are beginning to focus on men's roles as fathers and husbands, there is limited understanding of how men view their ability to promote sexual and reproductive health in families affected by HIV and their experiences with receiving education through antenatal care. This paper aims to explore men's perceptions of the education they need regarding sexual and reproductive health within the family in the context of HIV. METHODS: We interviewed a convenience sample of 18 male partners of pregnant women living with HIV in Lusaka, Zambia. Atlas.ti was used to facilitate data management and content analysis. RESULTS: Men reported being the primary decision-makers regarding sexual and reproductive issues in the family; however, they admitted far-reaching unmet needs in terms of information on sexual and reproductive health in the context of HIV. Most men felt that antenatal care was not a conducive setting to fully educate men on sexual and reproductive health because it is a woman's space where their health concerns were generally neglected. There was a strong desire for more education that was specific to men's sexual and reproductive health, especially because all the couples were affected by HIV. Men especially requested education on sexual preparedness, safe sex, the use of condoms in sero-concordant and sero-discordant relationships and general health information. Although men stated they were the main decision-makers regarding sexual and reproductive issues such as pregnancy, most men were not confident in their ability to promote sexual and reproductive health in the family because of limited knowledge in this area. CONCLUSION: There is need to change the environment and messaging of antenatal care, as well as offer relevant education opportunities outside health facility settings to empower men with essential information for meaningful involvement in sexual and reproductive health in the context of HIV.

HIV Research Training Partnership of the University of Zambia and Vanderbilt University: Features and Early Outcomes.

Background: Despite the burden of HIV being highest in sub-Saharan Africa (SSA), research expertise and capacity to address scientific questions regarding complications of HIV and ART, especially chronic non-communicable conditions, is limited in the region. The comorbidities prevalent in persons with HIV are mediated through diverse mechanisms, many of which can be context or region-specific and are yet to be elucidated. The phenotype, risk factors, and effective interventions for these conditions may differ between populations and settings, and therefore there is an urgent need for research to help understand these processes and how to best address them in SSA. Here, we report the research capacity building activities in SSA conducted by the University of Zambia (UNZA)-Vanderbilt Training Partnership for HIV-Nutrition-Metabolic Research (UVP), drawing lessons and challenges for a wide global health audience. Methods: We reviewed program data and conducted interviews with program leaders and participants to understand and document the progress and outcomes of the partnership. We report the program's early achievements, highlighting drivers and challenges. Results: Between 2015 and 2019, UVP made substantial progress on its goals of training new UNZA PhD scientists to investigate complex nutritional and metabolic factors related to long-term HIV complications and comorbidities. The program has supported 11 UNZA PhD students with dual UNZA-Vanderbilt mentorship; three have graduated, and other candidates are progressing in their PhD studies. The project also supported institutional capacity through UNZA faculty participation in Vanderbilt grant writing workshops, with strong success in obtaining grants among those who participated. UVP also supported development of greater structure to UNZA's PhD program and a mentorship curriculum, both now adopted by UNZA. The major drivers for success included UVP's alignment of goals between UNZA and Vanderbilt, and local institutional ownership. The longstanding history of collaborations between the two institutions contributed substantially to alignment and mutual support of UVP's goals. Several challenges were noted, including limits on direct research funding for students and a relatively small pool of funded investigators at UNZA. Conclusions: Despite some challenges, UVP has achieved positive outcomes over its first four years. Longstanding partnerships and local institutional ownership were the main drivers. We expect the challenges to mitigated as the project continues and produces more UNZA researchers and teams and more funded projects, collectively building the local research community. With continued resources and clear focus, we expect that UNZA's investigators and partners will attract research funding and generate high-impact research outputs across a broad range of studies in HIV as well as newer threats from non-communicable conditions experienced by long-term survivors of HIV and by the general population.

Assessing capacity and readiness to manage NCDs in primary care setting: Gaps and opportunities based on adapted WHO PEN tool in Zambia.

INTRODUCTION: Sub-Saharan Africa is experiencing an epidemiological transition as the burden of NCDs overtake communicable diseases. However, it is unknown what capacity and gaps exist at primary care level to address the growing burden of NCDs. This study aimed to assess the Zambian health system's capacity to address in NCDs, using an adapted WHO Essential Non Communicable Disease Interventions (WHO PEN) tool. METHODOLOGY: This was a cross-sectional facility survey in the three districts conducted from September 2017 to October 2017. We defined facility readiness along five domains: basic equipment, essential services, diagnostic capacity, counseling services, and essential medicines. For each domain, we calculated an index as the mean score of items expressed as percentage. These indices were compared to an agreed cutoff at 70%, meaning that a facility index or district index below 70% off was considered as 'not ready' to manage NCDs at that level. All analysis were performed using Stata 15 MP. RESULTS: There appeared to be wide heterogeneity between facilities in respect of readiness to manage NCDs. Only 6 (including the three 1st level hospitals) out of the 46 facilities were deemed ready to manage NCDs. Only the first level hospitals scored a mean index higher than the 70% cut off; With regard to medications needed to manage NCDs, urban and rural health facilities were comparably equipped. However, there was evidence that calcium channel blockers (p = 0.013) and insulin (p = 0.022) were more likely to be available in urban and semi-urban health facilities compared to rural facilities. CONCLUSION: Our study revealed gaps in primary health care capacity to manage NCDs in Zambia, with almost all health facilities failing to reach the minimum threshold. These results could be generalized to other similar districts in Zambia and the sub-region, where health systems remain focused on infectious rather than non-communicable Disease. These results should attract policy attention and potentially form the basis to review current approach to NCD care at the primary care level in Zambia and Sub-Saharan Africa.

Risk factors for impaired fasting glucose or diabetes among HIV infected patients on ART in the Copperbelt Province of Zambia.

BACKGROUND: Africa has a high prevalence of both Human Immunodeficiency Virus and Non Communicable Diseases (NCDs) but in Zambia there are few data on co-morbid NCDs like Diabetes Mellitus (DM) among HIV-infected individuals. We aimed to identify risk factors for impaired fasting glucose or diabetes among HIV-infected Zambians on long-term Combined Antiretroviral Treatment (cART). METHODS: This was a cross sectional study of adult HIV patients in five health facilities of Copperbelt Province in Zambia. HIV/AIDS patients aged 18 years and above, enrolled in care at those health facilities and had been on cART for more than 2 years were included. All patients known to have Diabetes mellitus were excluded from the study. Participants underwent assessment of random blood sugar levels at enrolment and returned the following morning for fasting glucose measured by glucometers. The primary outcome was proportion with impaired fasting glucose or DM. Multivariable logistic regression was used to examine if demographics, time on ART, type of ART regimen, body mass index and baseline CD4 count were predictors of impaired fasting glucose. RESULTS: Overall (n = 270) there were 186 females (69%) and 84 males (31%). The prevalence of impaired fasting blood sugar or diabetes after 8 h of fasting was 15% (95%CI: 11.1, 20.0). Ten percent (26/270) had impaired fasting glucose and 5 % (14/270) had diabetes. Impaired fasting glucose was higher in males than females [AOR = 3.26, (95% CI: 1.15-9.25; p-value = 0.03)]; as well as among patients on second line treatment than those on first line [AOR = 3.87 (95% CI 1.16-12.9); p-value = 0.03]. In contrast those with less likelihood of impaired fasting glucose included patients with a normal BMI (18.5-24.9) than overweight or obese patients [AOR = 0.09 (95% CI 0.03-0.31; p-value < 0.001)]; and participants who had less than 4 diabetes symptoms than those with more than 4 diabetes symptoms [AOR = 0.04 (95% CI 0.02-0.12); p-value < 0.001]. CONCLUSION: We have found high levels of impaired fasting glucose or diabetes among ART patients compared to what is reported in the general population suggesting missed care and support opportunities associated with metabolic imbalance management. There is thus a need to re-package HIV programming to include integration of diabetes screening as part of the overall care and support strategy.