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People who inject drugs (PWID) in Zambia are an understudied population at high risk for HIV acquisition and transmission. We report here on the progress within the PWID communities of Livingstone, Lusaka, and Ndola, Zambia towards the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 targets. A biobehavioral survey used respondent-driven sampling to survey 235 PWID in Livingstone, 349 in Lusaka, and 259 in Ndola in 2021-22. Questions on HIV and injection drug use were administered, and blood was collected for HIV, syphilis, Hepatitis B, and Hepatitis C testing. Weighted prevalence and 95% confidence intervals (CIs) were calculated using Gile's sequential sampling estimator. In Livingstone, Lusaka, and Ndola, HIV prevalence among PWID was 11.9% (95% CI: 7.3, 16.5), 7.3% (95% CI: 4.5, 10.2), and 21.9% (95% CI: 14.5, 29.3), respectively. Among HIV-positive PWID in Livingstone, 70.7% (95% CI: 55.4, 85.0) were aware of their HIV status (95% is 1st UNAIDS target), 100% of those were on antiretroviral therapy (ART) (95% is 2nd UNAIDS target), and 100% of those achieved viral load suppression (VLS) (95% is 3rd UNAIDS target). In Lusaka, 66.0% (95% CI: 49.3, 82.2) were aware, 75.7% (95% CI: 51.1, 99.9) were on ART, and 66.3% (95% CI: 42.1, 90.9) achieved VLS. In Ndola, 60.2% (95% CI: 44.1, 76.0), 100%, and 90.2% (95% CI: 82.2, 98.3) were aware, on ART, and achieved VLS, respectively. Awareness of HIV status was low among PWID living in Livingstone, Lusaka, and Ndola, Zambia. Treatment and VLS progress were lacking in Lusaka and Ndola as well with Lusaka showing the least progress toward all three UNAIDS targets. Our site-level findings highlight critical gaps in PWID-specific HIV awareness, treatment, and VLS status in three major urban areas in Zambia that limit progress toward HIV epidemic control in this hard-to-reach population.

With the highest HIV incidence and prevalence globally, the government of Eswatini started a substantial scale-up of HIV treatment and prevention services in 2011. Two sequential large population-based surveys were conducted before and after service expansion to assess the impact of the national response. Cross-sectional, household-based, nationally representative samples of adults, ages 18 to 49 years, were sampled in 2011 and 2016. We measured HIV prevalence, incidence (recent infection based on limiting antigen ≤1.5 optical density units and HIV RNA ≥1000 copies/mL), viral load suppression (HIV RNA <1000 copies/mL among all seropositive adults) and unsuppressed viremia (HIV RNA ≥1000 copies/mL among all, regardless of HIV status) and assessed for temporal changes by conducting a trend analysis of the log ratio of proportions, using a Z statistic distribution. HIV prevalence remained stable from 2011 to 2016 [32% versus 30%, p = 0.10]. HIV incidence significantly declined 48% [2.48% versus 1.30%, p = 0.01]. Incidence remained higher among women than men [2011: 3.16% versus 1.83%; 2016: 1.76% versus 0.86%], with a smaller but significant relative reduction among women [44%; p = 0.04] than men [53%; p = 0.09]. The proportion of seropositive adults with viral load suppression significantly increased from 35% to 71% [p < .001]. The proportion of the total adult population with unsuppressed viremia decreased from 21% to 9% [p < .001]. National HIV incidence in Eswatini decreased by nearly half and viral load suppression doubled over a five-year period. Unsuppressed viremia in the total population decreased 58%. These population-based findings demonstrate the national impact of expanded HIV services in a hyperendemic country.

Introduction HIV pre‐exposure prophylaxis (PrEP) is an effective biomedical intervention for preventing HIV; however, PrEP adoption initially lagged across sub‐Saharan Africa (SSA) and may have been affected by barriers to engagement in PrEP care. Stable, heterosexual HIV‐serodifferent couples are a priority population of PrEP expansion efforts. We assessed factors associated with PrEP awareness and willingness among HIV‐serodifferent couples in SSA to guide PrEP interventions for this population. Methods We conducted a cross‐sectional analysis using pooled data from nationally representative, two‐stage cluster sampling, HIV‐focused household surveys completed during 2019–2022 in seven African countries. We analysed data from 1738 persons without HIV aged ≥15 years in stable, heterosexual HIV‐serodifferent couples and included clinical information from their partners with HIV. Higher HIV risk was defined by unawareness of a partner's HIV‐positive status or having a partner with an unsuppressed viral load (≥200 copies/ml). Lower HIV risk was defined by awareness of a partner's HIV‐positive status and having a partner with a suppressed viral load (<200 copies/ml). We conducted multivariable logistic regression using survey weights and jackknife variance estimation to assess factors associated with PrEP awareness and willingness. Results Overall, 18.1% were aware of PrEP, 69.1% were willing to use PrEP and 5.1% had ever used PrEP. Forty‐four percent had higher HIV risk. Higher odds of PrEP awareness were associated with being female (adjusted odds ratio [aOR]: 1.73; 95% confidence interval [CI]: 1.15–2.59), secondary education or higher (aOR: 6.42; 95% CI: 2.97–13.91) and lower HIV risk (aOR: 1.58; 95% CI: 1.00–2.48). Higher odds of PrEP willingness were associated with employment in the past year (aOR: 1.55; 95% CI: 1.01–2.37), previous PrEP awareness (aOR: 2.44; 95% CI: 1.36–4.36) and lower HIV risk (aOR: 1.70; 95% CI: 1.07–2.70). Conclusions Persons in stable, heterosexual HIV‐serodifferent couples with lower HIV risk were more aware of and willing to use PrEP than those with higher risk. Our findings highlight the importance of encouraging HIV status disclosure, educating about HIV‐serodifference and PrEP, and providing PrEP linkage during HIV testing and prevention counselling to increase PrEP awareness, willingness and use among HIV‐serodifferent couples in SSA.

Objectives The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. Trial Design This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. Participants Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. Intervention and comparator The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 – 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 – 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. Main outcomes The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. Randomization Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. Blinding (masking) The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. Numbers to be randomized (sample size) We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. Trial Status Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. Trial registration ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Introduction Women who engage in commercial sex (WCS) have a higher prevalence of HIV in sub-Saharan Africa than other women of reproductive age. We aimed to describe the burden of HIV, testing, treatment, and viral load suppression (VLS) coverage among WCS and the correlates of not being engaged in each step of the HIV cascade across six countries between 2015 and 2017. Methods Using pooled data from six Population-based HIV Impact Assessment (PHIA) surveys from Eswatini, Lesotho, Malawi, Tanzania, Zambia, and Zimbabwe, socio-demographic, behavioral, and health-related indicators were assessed by commercial sex engagement and steps in the HIV cascade, using prevalence ratios with 95% confidence intervals and statistical significance of p  < 0.05. All analyses were weighted, and variance was estimated using Taylor series. Results Among women aged 18 and older, 3.3% reported selling sex ever or in the last 12 months. HIV prevalence among WCS was 18.3%. HIV status awareness was 65.9% and among those aware of their status, only 57.0% were on treatment. Only half (51.9%) were virally suppressed. Women unmarried and with no reported history of pregnancy who engaged in commercial sex were less likely to be engaged in the HIV care cascade. Discussion Overall, women engaged in commercial sex have higher rates of non-engagement at each step in the HIV care cascade and have a higher prevalence of HIV than women in the general population in the countries surveyed. More efforts to engage young, unmarried women engaged in commercial sex who have never had a pregnancy in HIV testing and treatment are needed.

Accurate population size estimates (PSE) of key populations-those disproportionately affected by HIV-are critical to forecast need and inform HIV prevention and treatment programs, though they can be difficult to ascertain due to low visibility of these groups. In Zambia, reliable estimates on the number of people who inject drugs are limited, inhibiting public health response. We sought to estimate the population size of people who inject drugs in 3 large cities in Zambia, assess how PSEs vary across different estimation methods, and explore the strengths and limitations of each approach. We applied 2-source capture-recapture (2S-CRC), 3-source capture-recapture (3S-CRC), and successive sampling population size estimation (SS-PSE) methods in Lusaka, Livingstone, and Ndola, Zambia. 3S-CRC methods included location-based 2S-CRC in combination with a respondent-driven sampling (RDS) survey. Data were collected from November 2021 to February 2022 and analyzed using a Bayesian nonparametric latent class model. SS-PSEs were produced using the RDS recruitment and network sizes. Kruskal tests and general linear models were used to examine sociodemographic and behavioral factors associated with being captured in 2S-CRC among RDS participants. Final city population estimates, incorporating 3S-CRC and SS-PSE with imputed visibility estimates, were generated using a Bayesian consensus estimator. Bayesian consensus PSEs ranged between 0.5% and 1.8% of the adult male population and were below 1% of the total adult population in each city. Consensus estimates were highest in Lusaka (3700, 95% credible interval [CRI] 1500-7500), followed by Ndola (2200, 95% CRI 1600-2900) and Livingstone (1200, 95% CRI 900-1,900). There was variability in estimates by method, with SS-PSE with imputed visibility generally providing the lowest estimates across cities, excluding Lusaka. Across methods, PSEs and uncertainty bounds (95% confidence interval [CI] or CRI depending on method) ranged from 1510 (95% CRI 1030-2070) to 4350 (95% CI 1410-18,890) in Lusaka, 360 (95% CI 290-530) to 2620 (95% CRI 1510-4680) in Livingstone, and 760 (95% CI 390-3060) to 4030 (95% CRI 960-5480) in Ndola. In all cities, fewer recaptures occurred in capture 3 (RDS) than with location sampling via 2S-CRC. Though results varied across cities, RDS participants captured through 2S-CRC differed from those captured solely through RDS in sociodemographic and behavioral risk factors, including housing, education, injection or needle sharing frequency, time since last injection, receipt of drug treatment, and experience with a peer educator in at least one city. This study used rigorous methods to produce PSEs in Zambia, and is the first to produce these for major geographies in the country. Through RDS, 3S-CRC reached people who inject drugs with distinct characteristics that were less accessible via location-based sampling (2S-CRC), yielding a PSE that may better reflect the population and informing the Bayesian consensus estimate. Findings from this study can guide program planning and future surveillance activities.

An amendment to this paper has been published and can be accessed via the original article.

An amendment to this paper has been published and can be accessed via the original article.

South Africa has the highest national burden of HIV globally. Understanding drivers of HIV acquisition in recently completed, prospective studies in which HIV was an endpoint may help inform the strategy and investments in national HIV prevention efforts and guide the design of future HIV prevention trials. We assessed HIV incidence and correlates of incidence among women enrolled in ECHO (Evidence for Contraceptive Options and HIV Outcomes), a large, open-label randomized clinical trial that compared three highly effective. reversible methods of contraception and rates of HIV acquisition. During December 2015 to October 2018, ECHO followed sexually active, HIV-seronegative women, aged 16-35 years, seeking contraceptive services and willing to be randomized to one of three contraceptive methods (intramuscular depot medroxyprogesterone acetate, copper intrauterine device, or levonorgestrel implant) for 12-18 months at nine sites in South Africa. HIV incidence based on prospectively observed HIV seroconversion events. Cox proportional hazards regression models were used to define baseline cofactors related to incident HIV infection. 5768 women were enrolled and contributed 7647 woman-years of follow-up. The median age was 23 years and 62.5% were ≤24 years. A total of 345 incident HIV infections occurred, an incidence of 4.51 per 100 woman-years (95%CI 4.05-5.01). Incidence was >3 per 100 woman-years at all sites. Age ≤24 years, baseline infection with sexually transmitted infections, BMI≤30, and having new or multiple partners in the three months prior to enrollment were associated with incident HIV. HIV incidence was high among South African women seeking contraceptive services. Integration of diagnostic management of sexually transmitted infections alongside delivery of HIV prevention options in health facilities providing contraception services are needed to mitigate ongoing risks of HIV acquisition for this vulnerable population. ClinicalTrials.gov, number NCT02550067 was the main Clinical Trial from which this secondary, non-randomized / observational analysis was derived with data limited to just South African sites.

The human immunodeficiency virus (HIV) epidemic has had an extraordinary global impact. Even as it has devastated societies, it has also inspired community empowerment, motivated impressive scientific discoveries, and provoked an unprecedented mobilization of vast resources for a single health condition. Not yet fully realized, however, is the epidemic's potential for expanding the core mission of academic institutions to include the pursuit of a wider range of research. Most universities focus on three core missions: transmitting knowledge to undergraduate students, developing the next generation of scholars through graduate education, and producing new discoveries through research. In both education and research, . . .