Safety, Tolerability, and Pharmacokinetics of Long-Acting Broadly Neutralizing HIV-1 Monoclonal Antibody VRC07523LS in Newborn Infants Exposed to HIV-1.

Background: Vertical HIV-1 transmission despite antiretroviral therapy may be mitigated by use of long-acting, broadly neutralizing, monoclonal antibodies (bNAb) such as VRC07523LS. The present study was designed to determine the safety and pharmacokinetics of VRC07523LS.

Methods: VRC07523LS, 80 mg/dose, was administered subcutaneously after birth to non-breastfed (Cohort 1; N=11, enrolled in USA) and breastfed (Cohort 2; N=11, enrolled in South Africa and Zimbabwe) infants exposed to HIV-1.

The Real-World Effectiveness of Inactivated COVID-19 Vaccines in Zimbabwe During the Omicron Variant Dominance: A Test-Negative Case-Control Study.

Background/objectives: The COVID-19 pandemic has significantly impacted global health, with varying vaccine effectiveness (VE) across different regions and vaccine platforms. In Africa, where vaccination rates are relatively low, inactivated vaccines like BBIP-CorV (Sinopharm) and Coronovac (Sinovac) have been widely used. This study evaluated the real-world effectiveness of licensed inactivated COVID-19 vaccines in Zimbabwe during a period dominated by Omicron variants.

'Making abortion safe': abortion and post-abortion care providers' experiences of stigma in Rwanda, Zimbabwe, Sierra Leone and Nigeria.

Background: Social stigma and the marginalisation of abortion care within medical settings can negatively affect abortion providers. While some research has evaluated stigma interventions in legally restrictive settings, little work has explored the experiences of healthcare professionals (HCPs) providing abortion and post-abortion care (PAC) outside the USA. This study, part of the Royal College of Obstetricians and Gynaecologists' 'Making Abortion Safe' programme, aimed to understand providers' experiences of abortion stigma in four African countries with restrictive legislation.

Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.

Background: The WHO HIV testing algorithm for high prevalence populations recommends the use of three different serologic assays, though this approach may lead to diagnostic misclassification. The study objective was to compare dried blood spot (DBS)-based HIV-1 nucleic acid detection methods to determine their suitability to confirm the diagnosis of HIV-1 in adults generally with suppressed or low-level plasma HIV-1 RNA.

Methods: Four methods were evaluated: Cepheid Xpert HIV-1 Qual Assay (Xpert), Hologic Aptima HIV-1 Quant Dx assay (Aptima), Roche Cobas Ampliprep/Cobas TaqMan HIV-1 test, v.

Prevalence and factors associated with uptake of pre-exposure prophylaxis amongst women vulnerable to HIV who received HIV antibodies in Antibody Mediated Prevention HVTN703/HPTN081 trial in Harare, Zimbabwe: a cross-sectional study.

Introduction: There is limited evidence on pre-exposure prophylaxis (PrEP) uptake post-trial participation for women vulnerable to HIV. This study investigates the prevalence and factors associated with PrEP uptake post-participation in an HIV prevention trial.

Methods: Former Antibody Mediated Prevention (AMP) study participants were invited to the three AMP clinical research sites in Zimbabwe after at least a year of exiting the study.

Predicting sexually transmitted infections among men who have sex with men in Zimbabwe using deep learning and ensemble machine learning models.

There is a substantial increase in sexually transmitted infections (STIs) among men who have sex with men (MSM) globally. Unprotected sexual practices, multiple sex partners, criminalization, stigmatisation, fear of discrimination, substance use, poor access to care, and lack of early STI screening tools are among the contributing factors. Therefore, this study applied multilayer perceptron (MLP), extremely randomized trees (ExtraTrees) and XGBoost machine learning models to predict STIs among MSM using bio-behavioural survey (BBS) data in Zimbabwe.

Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial.

Background: Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy.

Unintended pregnancy and contraception use among African women living with HIV: Baseline analysis of the multi-country US PEPFAR PROMOTE cohort.

Background: About 90% of unintended pregnancies are attributed to non-use of effective contraception-tubal ligation, or reversible effective contraception (REC) including injectables, oral pills, intra-uterine contraceptive device (IUCD), and implant. We assessed the prevalence of unintended pregnancy and factors associated with using RECs, and Long-Acting-Reversible-Contraceptives (LARCs)-implants and IUCDs, among women living with HIV (WLHIV) receiving antiretroviral therapy (ART).

Methods: We conducted cross-sectional analyses of the US-PEPFAR PROMOTE study WLHIV on ART at enrollment.

"Getting pregnant during COVID-19 was a big risk because getting help from the clinic was not easy": COVID-19 experiences of women and healthcare providers in Harare, Zimbabwe.

The COVID-19 pandemic and associated measures may have disrupted delivery of maternal and neonatal health services and reversed the progress made towards dual elimination of mother-to-child transmission of HIV and syphilis in Zimbabwe. This qualitative study explores the impact of the pandemic on the provision and uptake of prevention of mother-to-child transmission (PMTCT) services from the perspectives of women and maternal healthcare providers. Longitudinal in-depth interviews were conducted with 20 pregnant and breastfeeding women aged 20-39 years living with HIV and 20 healthcare workers in two maternity polyclinics in low-income suburbs of Harare, Zimbabwe.

Evaluation of a comprehensive health check offered to frontline health workers in Zimbabwe.

Health workers are essential for a functioning healthcare system, and their own health is often not addressed. During the COVID-19 pandemic health workers were at high risk of SARS-CoV-2 infection whilst coping with increased healthcare demand. Here we report the development, implementation, and uptake of an integrated health check combining SARS-CoV-2 testing with screening for other communicable and non-communicable diseases for health workers in Zimbabwe during the COVID-19 pandemic.

Method of Anesthesia and Perioperative Risk Factors, Maternal Anesthesia Complications, and Neonatal Mortality Following Cesarean Delivery in Africa: A Substudy of a 7-Day Prospective Observational Cohort Study.

Background: The African Surgical Outcomes Study (ASOS) found that maternal mortality following cesarean delivery in Africa is 50 times higher than in high-income countries, and associated with obstetric hemorrhage and anesthesia complications. Mothers who died were more likely to receive general anesthesia (GA). The associations between GA versus spinal anesthesia (SA) and preoperative risk factors, maternal anesthesia complications, and neonatal outcomes following cesarean delivery in Africa are unknown.

Hearing the voices of midwives through reflective writing journals: Qualitative research on an educational intervention for Respectful Maternity Care in Zimbabwe.

Women attending public and private sector health facilities in Africa have reported abuse and neglect during childbirth, which carries a risk of poor health outcomes. We explored from the midwives' perspective the influence of an educational intervention in changing the attitudes, behaviour and practices of a group of midwives in Zimbabwe, using transformative learning theory as the conceptual framework. The twelve-week educational intervention motivating for Respectful Maternity Care consisted of a two-day workshop and five follow-up sessions every two weeks.

Exploring COVID-19 vaccine uptake among healthcare workers in Zimbabwe: A mixed methods study.

With COVID-19 no longer categorized as a public health emergency of international concern, vaccination strategies and priority groups for vaccination have evolved. Africa Centres for Diseases Prevention and Control proposed the '100-100-70%' strategy which aims to vaccinate all healthcare workers, all vulnerable groups, and 70% of the general population. Understanding whether healthcare workers were reached during previous vaccination campaigns and what can be done to address concerns, anxieties, and other influences on vaccine uptake, will be important to optimally plan how to achieve these ambitious targets.

High monoclonal neutralization titers reduced breakthrough HIV-1 viral loads in the Antibody Mediated Prevention trials.

The Antibody Mediated Prevention (AMP) trials (NCT02716675 and NCT02568215) demonstrated that passive administration of the broadly neutralizing monoclonal antibody VRC01 could prevent some HIV-1 acquisition events. Here, we use mathematical modeling in a post hoc analysis to demonstrate that VRC01 influenced viral loads in AMP participants who acquired HIV. Instantaneous inhibitory potential (IIP), which integrates VRC01 serum concentration and VRC01 sensitivity of acquired viruses in terms of both IC50 and IC80, follows a dose-response relationship with first positive viral load (p = 0.

DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy.

Background: Pregnancy represents a period of high HIV acquisition risk. Safety data for the monthly dapivirine vaginal ring (DVR) during pregnancy are limited. Here, we report data from the first 2 cohorts of pregnant participants in MTN-042/DELIVER, a phase 3b, randomized, open-label safety trial of DVR and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).

Africa Guidelines for Hepatocellular Carcinoma Buildup Process.

Purpose: Hepatocellular carcinoma (HCC), the fourth most common cancer in Africa, has a dismal overall survival of only 3 months like in sub-Saharan Africa. This is affected by the low gross domestic product and human development index, absence of coherent guidelines, and other factors.

Methods: An open forum for HCC-experienced health care workers from Africa and the rest of the world was held in October 2021.

Micronutrients and nutritional status among children living with HIV with and without severe acute malnutrition: IMPAACT P1092.

Background: Micronutrient deficiencies from malabsorption, gut infections, and altered gut barrier function are common in children living with the human immunodeficiency virus (CLHIV) and may worsen with severe acute malnutrition (SAM). Exploratory data of baseline zinc and selenium levels and changes over 48 weeks in children living with HIV by nutritional status are presented.

Methods: Zinc, selenium, serum protein and albumin levels measured at study entry and over 48 weeks were compared between children aged 6 to < 36 months who were living with HIV and had SAM or mild malnutrition-normal nutrition.

Metabolomic profiling of preterm birth in pregnant women living with HIV.

Background: Preterm birth is a leading cause of death in children under the age of five. The risk of preterm birth is increased by maternal HIV infection as well as by certain antiretroviral regimens, leading to a disproportionate burden on low- and medium-income settings where HIV is most prevalent. Despite decades of research, the mechanisms underlying spontaneous preterm birth, particularly in resource limited areas with high HIV infection rates, are still poorly understood and accurate prediction and therapeutic intervention remain elusive.

Monocyte to lymphocyte ratio and hemoglobin level to predict tuberculosis after antiretroviral therapy initiation.

Objective: To determine the performance of the baseline monocyte to lymphocyte ratio (MLR), baseline anemia severity and combination of these biomarkers, to predict tuberculosis (TB) incidence in people with HIV (PWH) after antiretroviral therapy (ART) initiation.

Design: Multicenter, retrospective cohort study.

Methods: We utilized the data from study A5175 (Prospective Evaluation of Antiretroviral Therapy in Resource-limited Settings: PEARLS).

Barriers to childhood asthma care in sub-Saharan Africa: a multicountry qualitative study with children and their caregivers.

Objectives: This study identifies barriers and provides recommendations to improve asthma care in children across sub-Saharan Africa, where qualitative data is lacking despite high rates.

Design: One of the aims of our National Institute for Health Research global health research group 'Achieving Control of Asthma in Children in Africa' was to use qualitative thematic analysis of transcribed audio recordings from focus group discussions (FGDs) to describe barriers to achieving good asthma control.

Setting: Schools in Blantyre (Malawi), Lagos (Nigeria), Durban (South Africa), Kampala (Uganda) and Harare (Zimbabwe).

Exploring COVID-19 vaccine uptake among healthcare workers in Zimbabwe: A mixed methods study.

With COVID-19 no longer categorized as a public health emergency of international concern, vaccination strategies and priority groups for vaccination have evolved. Africa Centers for Diseases Prevention and Control proposed the '100-100-70%' strategy which aims to vaccinate all healthcare workers, all vulnerable groups, and 70% of the general population. Understanding whether healthcare workers were reached during previous vaccination campaigns and what can be done to address concerns, anxieties, and other influences on vaccine uptake, will be important to optimally plan how to achieve these ambitious targets.

Comparing in-person, blended and virtual training interventions; a real-world evaluation of HIV capacity building programs in 16 countries in sub-Saharan Africa.

We sought to evaluate the impact of transitioning a multi-country HIV training program from in-person to online by comparing digital training approaches implemented during the pandemic with in-person approaches employed before COVID-19. We evaluated mean changes in pre-and post-course knowledge scores and self-reported confidence scores for learners who participated in (1) in-person workshops (between October 2019 and March 2020), (2) entirely asynchronous, Virtual Workshops [VW] (between May 2021 and January 2022), and (3) a blended Online Course [OC] (between May 2021 and January 2022) across 16 SSA countries. Learning objectives and evaluation tools were the same for all three groups.

Neutralization profiles of HIV-1 viruses from the VRC01 Antibody Mediated Prevention (AMP) trials.

The VRC01 Antibody Mediated Prevention (AMP) efficacy trials conducted between 2016 and 2020 showed for the first time that passively administered broadly neutralizing antibodies (bnAbs) could prevent HIV-1 acquisition against bnAb-sensitive viruses. HIV-1 viruses isolated from AMP participants who acquired infection during the study in the sub-Saharan African (HVTN 703/HPTN 081) and the Americas/European (HVTN 704/HPTN 085) trials represent a panel of currently circulating strains of HIV-1 and offer a unique opportunity to investigate the sensitivity of the virus to broadly neutralizing antibodies (bnAbs) being considered for clinical development. Pseudoviruses were constructed using envelope sequences from 218 individuals.