Protocol of a cost-effectiveness analysis of a combined intervention for depression and parenting compared with enhanced standard of care for perinatally depressed, HIV-positive women and their infants in rural South Africa

Introduction
Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.
Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa.

Methods and analysis
This cost-effectiveness analysis (CEA) protocol complies with the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. A societal perspective will be chosen.
The proposed methods will determine the cost and efficiency of implementing the intervention as per the randomised control trial protocol, as well as the cost of replicating the intervention in a non-research setting. The costs will be calculated using an appropriately adjusted version of the Standardised Early Childhood Development Costing Tool.
Primary health outcomes will be used in combination with costs to determine the cost per improvement in maternal perinatal depression at 12 months postnatal and the cost per improvement in child cognitive development at 24 months of age. To facilitate priority setting, the incremental cost-effectiveness ratios for improvements in child cognitive development will be ranked against six other child cognitive-development interventions according to Verguet et al’s methodology (2022).
A combination of activity-based and ingredient-based costing approaches will be used to identify, measure and value activities and inputs for all alternatives. Outcomes data will be sourced from the RCT team.

Ethics and dissemination
The University of Oxford is the sponsor of the CEA. Ethics approval has been obtained from the Human Sciences Research Council (HSRC, #REC 5/23/08/17), South Africa and the Oxford Tropical Research Ethics Committee (OxTREC #31–17), UK.
Consent for publication is not applicable since no participant data are used in this protocol.
We plan to disseminate the CEA results to key policymakers and researchers in the form of a policy brief, meetings and academic papers.

Trial registration details
ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).

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Agosto 2024

Global burden of HIV among long-distance truck drivers: a systematic review and meta-analysis

Objectives
The purpose of this study was to systematically summarise the empirical evidence on the prevalence of HIV among long-distance truck drivers (LDTDs) from all parts of the world.

Design
A systematic review and meta-analysis were conducted.

Data sources
We searched PubMed, ProQuest Central, PubMed Central, Cumulated Index to Nursing and Allied Health Literature and Global Index Medicus to identify relevant information published from 1989 to 16 May 2023.

Eligibility criteria
Peer-reviewed publications of English language reporting on the prevalence of HIV among LDTDs were included. Non-empirical studies like literature reviews were excluded.

Data extraction and synthesis
Using a standardised data abstraction form, we extracted information on study characteristics and HIV prevalence levels. Crude prevalence estimates per 100 participants were computed and later transformed using logit transformation to have them follow a normal distribution. A meta-analysis of prevalences using the random effects model was performed. The I2 statistic was used to quantify the degree of heterogeneity across studies. A subgroup analysis using meta-regression was performed to investigate factors that could explain variability across studies. The Joanna Briggs Institute tools and Newcastle-Ottawa Scale were used to assess the quality of the included studies. To assess the certainty of evidence, the Grading of Recommendations Assessment, Development, and Evaluation approach was used.

Results
Of the 1787 articles identified, 42 were included. Most of the included studies were conducted in sub-Saharan Africa (45.23%, n=19) and Asia and the Pacific (35.71%, n=15). The pooled prevalence of HIV was 3.86%, 95% CI (2.22% to 6.64%). The burden of HIV was highest in sub-Saharan Africa at 14.34%, 95% CI (9.94% to 20.26%), followed by Asia and the Pacific at 2.12%, 95 CI (0.94% to 4.7%) and lastly Western, Central Europe and North America at 0.17%, 95% CI (0.03% to 0.82%). The overall heterogeneity score was (I2=98.2%, p

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Agosto 2024

Rates of adverse events of antiretroviral therapy in women living with HIV/AIDS: a systematic review and meta-analysis

Objective
There is limited information regarding the incidence of treatment-related adverse events (AE) following antiretroviral therapy (ART) in women. So, this review aimed to describe the incidence of AE of ART in women living with HIV/AIDS.

Design
Systematic review and meta-analysis.

Data sources
Medline, Embase, Cochrane Library, Epistemonikos, Lilacs and Who Index, from inception to 9 April 2023.

Eligibility criteria
We included randomised controlled trials with at least 12 weeks of follow-up and evaluated AE of ART in women at any age living with HIV/AIDS, without restrictions on status, year or language of publication. We excluded post hoc or secondary analyses and open-label extensions without comparator, and trials involving pregnant or breastfeeding women or with a focus on coinfection with tuberculosis, hepatitis B or C. The primary outcomes were the incidence rate of participants with any clinical and/or laboratory AE related or not to ART and treatment discontinuation.

Data extraction and synthesis
Two independent reviewers extracted data and assessed the risk of bias using Cochrane’s risk of bias tool 2. We used Bayesian random-effects meta-analysis to summarise event rates. Results were presented as event rates per 1000 person-years (95% credibility intervals, 95% CrI). The pooled incidence rate per 1000 person-years adjusted for duration and loss to follow-up was estimated. We assessed the certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation.

Results
A total of 24 339 studies were identified for screening, of which 10 studies (2871 women) met the eligibility criteria, with 11 different antiretrovirals (ARVs) regimens. Seven studies included exclusively women, while in the remaining three, the proportion of women ranged from 11% to 46%. Nine studies received industry funding. The pooled analysis showed a mean incidence rate of ART-related clinical and laboratory AE of 341.60 events per 1000 person-years (95% CrI 133.60–862.70), treatment discontinuation of 20.78 events per 1000 person-years (95% CrI 5.58–57.31) and ART-related discontinuation of 4.31 per 1000 person-years (95% CrI 0.13–54.72). Summary estimates were subject to significant uncertainty due to the limited number of studies and sparse data. The certainty of the evidence was graded as very low for all outcomes assessed.

Conclusion
Existing randomised trials do not provide sufficient evidence on the incidence rates of safety outcomes from antiretroviral treatment in women living with HIV/AIDS. Large comparative studies in well-characterised populations are needed to provide a more comprehensive landscape of the safety profile of these ARV therapies in women with HIV/AIDS.

PROSPERO registration number
CRD42021251051.

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Agosto 2024

Loss to follow-up and its predictors among children living with HIV on antiretroviral therapy, southern Oromia, Ethiopia: a 5-year retrospective cohort study

Background
Loss to follow-up (LTFU) among paediatric patients living with HIV presents a significant challenge to the global scale-up of life-saving antiretroviral therapy (ART).

Objectives
This study aims to estimate LTFU incidence and its determinants among children with HIV on ART in Shashemene town public health institutions, Oromia, Ethiopia.

Design
A retrospective cohort study from 1 January 2015 to 30 December 2020.

Setting
This study was conducted in Shashemene town, Oromia, Ethiopia.

Participants
Medical records of 269 children receiving ART at health facilities in Shashemene town were included.

Methods
Data from patients’ medical records were collected using a standardised checklist. EpiData V.3.1 was employed for data entry, while Statistical Package for the Social Sciences (SPSS) V.25 facilitated analysis. The Kaplan-Meier survival curve was used for estimation of survival time. To measure association, adjusted HRs (AHRs) with 95% CIs were calculated. Both bivariable and multivariable Cox proportional hazards regression models were employed to identify predictors of LTFU.

Results
Of the 269 children living with HIV included in the final analysis, 43 (16%) were lost to follow-up. The overall incidence rate of LTFU was 3.3 (95% CI 2.4 to 4.4) per 100 child-years of observation. Age less than 5 years (AHR 0.03, 95% CI 0.00 to 0.36), non-orphan status of the child (AHR 0.13, 95% CI 0.05 to 0.34), < 30 min distance to health facility (AHR 0.24, 95% CI 0.08 to 0.73), disclosed HIV status (AHR 0. 32, 95% CI 0.13 to 0.80), history of opportunistic infection (AHR 3.54, 95% CI 1.15 to 10.87) and low CD4 count (AHR 5.17, 95% CI 2.08 to 12.85) were significant predictors of LTFU. Conclusion The incidence rate of LTFU was lower compared with other studies in Ethiopia. This result indicated that age less than 5 years, non-orphans, low CD4, disclosed HIV status and distance from health facility were predictors of LTFU.

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Agosto 2024