Search

Introduction: While African countries have expanded access to HIV pre-exposure prophylaxis (PrEP) since 2015, regional targets for PrEP uptake remain unmet. Understanding which populations are prioritized for PrEP at the policy level is an important step in determining the scope of PrEP distribution across Africa and identifying gaps in programme implementation. We reviewed national guidance to characterize populations prioritized for PrEP in Africa., Methods: Between January and June 2023, we searched for current National HIV Treatment and Prevention Guidelines, National HIV Strategic Plans, and the United States President's Emergency Plan for AIDS Relief (PEPFAR) Country Operational Plans (COPs) for all African countries implementing PrEP programmes supported by PEPFAR in 2022. From each document, we summarize the populations prioritized for PrEP within a country and describe PrEP eligibility., Results: In 2022, 19 African countries implemented PrEP programmes supported by PEPFAR. Eighteen of these countries contributed National Guidelines (2016-2022), 18 contributed National Strategic Plans (2017-2023) and 19 contributed COPs (2022) to this review. Twenty-nine population groups were prioritized for PrEP in these documents. All countries prioritized HIV-serodifferent couples, female sex workers (FSWs), adolescent girls and young women (AGYW), pregnant and breastfeeding women (PBFW) and people who inject drugs (PWID), and most prioritized men who have sex with men (MSM; n = 18), transgender people (n = 18) and people in prisons (n = 17). The remaining 21 populations were prioritized in fewer than two-thirds of countries., Discussion: FSWs, MSM, PWID, transgender people and people in prisons were typically prioritized for PrEP with no eligibility restrictions. In contrast, most countries had at least one document indicating that HIV-serodifferent couples, AGYW and PBFW were only eligible for PrEP if classified as high risk. Few documents specified how risk was determined, and no document included validated HIV risk assessment tools to guide implementation. We observed similarities in priority populations across countries with different HIV epidemics and inconsistencies in who was prioritized for PrEP within a country's own set of policy documents., Conclusions: Understanding how PrEP prioritization policies impact HIV incidence in different epidemiologic settings is critical for strengthening PrEP implementation across the continent., (© 2025 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Women in Africa disproportionately acquire human immunodeficiency virus type 1 (HIV-1). Understanding which women are most likely to acquire HIV-1 can guide focused prevention with preexposure prophylaxis (PrEP). Our objective was to identify women at the highest risk of HIV-1 and estimate PrEP efficiency at different sensitivity levels., Methods: Nationally representative data were collected from 2015 through 2019 from 15 population-based household surveys. This analysis included women aged 15-49 who tested HIV-1 seronegative or had recent HIV-1. Least absolute shrinkage and selection operator regression models were fit with 28 variables to predict recent HIV-1. Models were trained on the full population and internally cross-validated. Performance was evaluated using area under the receiver operating characteristic curve (AUC), sensitivity, and number needed to treat (NNT) with PrEP to avert 1 infection., Results: Among 209 012 participants, 248 had recent HIV-1 infection, representing 118 million women and 402 000 (95% confidence interval [CI], 309 000-495 000) annual infections. Two variables were retained: living in a subnational area with high HIV-1 viremia and having a sexual partner living outside the home. The full-population AUC was 0.80 (95% CI, .76-.84); cross-validated AUC was 0.79 (95% CI, .75-.84). At 33% sensitivity, 130 000 cases could be averted if 7.9 million women were perfectly adherent to PrEP; NNT would be 61. At 67% sensitivity, 260 000 cases could be averted if 25.1 million women were perfectly adherent; NNT would be 96., Conclusions: This risk assessment tool was generalizable, predictive, and parsimonious with trade-offs between reach and efficiency., Competing Interests: Potential conflicts of interest. L.-G. B. received honoraria from ViiV Healthcare, Janssen, Sanofi, Novartis, Cepheid, and MSD (Pty) Ltd. J. J.’s travel was supported by Future of Health and Economic Resiliency in Africa (FHERA); she served on the Viiv Healthcare Advisory Board. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Purpose: Generalized (g-) computation is a useful tool for causal inference in epidemiology. However, in settings when the outcome is a survival time subject to right censoring, the standard pooled logistic regression approach to g-computation requires arbitrary discretization of time, parametric modeling of the baseline hazard function, and the need to expand one's dataset. We illustrate a semiparametric Breslow estimator for g-computation with time-fixed treatments and survival outcomes that is not subject to these limitations., Methods: We compare performance of the Breslow g-computation estimator to the pooled logistic g-computation estimator in simulations and illustrate both approaches to estimate the effect of a 3-drug vs 2-drug antiretroviral therapy regimen among people with HIV., Results: In simulations, both approaches performed well at the end of follow-up. The pooled logistic approach was biased at times between the endpoints of the discrete time intervals used, while the Breslow approach was not. In the example, both approaches estimated a 1-year risk difference of about 6 % in favor of the 3-drug regimen, but the shape of the survival curves differed., Conclusions: The Breslow g-computation estimator of counterfactual risk functions does not rely on strong parametric assumptions about the time-to-event distribution or onerous dataset expansions., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jessie K. Edwards reports financial support was provided by National Institutes of Health. Jessie K. Edwards reports a relationship with The University of North Carolina at Chapel Hill that includes: employment. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: While noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to placebo. We estimate the efficacy of TAF/FTC PrEP versus placebo for the prevention of HIV infection., Methods: We used data from the DISCOVER and iPrEx trials to compare TAF/FTC to placebo. DISCOVER was a noninferiority trial conducted from 2016 to 2017. iPrEx was a placebo-controlled trial conducted from 2007 to 2009. Inverse probability weights were used to standardize the iPrEx participants to the distribution of demographics and risk factors in the DISCOVER trial. To check the comparison, we evaluated whether risk of HIV infection in the shared tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) arms was similar., Results: Notable differences in demographics and risk factors occurred between trials. After standardization, the difference in risk of HIV infection between the TDF/FTC arms was near zero. The risk of HIV with TAF/FTC was 5.8 percentage points lower (95% confidence interval [CI], -2.0% to -9.6%) or 12.5-fold lower (95% CI, .02 to .31) than placebo standardized to the DISCOVER population., Conclusions: There was a reduction in HIV infection with TAF/FTC versus placebo across 96 weeks of follow-up., Clinical Trials Registration: NCT02842086 and NCT00458393., Competing Interests: Potential conflicts of interest. D. V. G. has accepted funds from Gilead Sciences. M. D., M. L. M., and Y. S. are employees of Gilead Sciences and hold stock interest in the company. A. A. A. has received consulting fees from Merck and Gilead; and research funding to her institution from Merck and Gilead. J. J. E. is an ad hoc consultant to Gilead Sciences and ViiV Healthcare. University of North Carolina at Chapel Hill receives clinical research funding from ViiV Healthcare and Gilead Science for studies on which J. J. E. is an investigator. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: This study aims to describe the cohort of Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) research program participants and evaluate whether the ATN's recently completed 5-year cycle recruited study participants who parallel the populations most impacted by HIV in the United States., Methods: Harmonized measures across ATN studies collected at baseline were aggregated for participants aged 13-24 years. Pooled means and proportions stratified by HIV status (at risk for or living with HIV) were calculated using unweighted averages of study-specific aggregate data. Medians were estimated using a weighted median of medians method. Public use 2019 Centers for Disease Control and Prevention surveillance data for state-level new HIV diagnoses and HIV prevalence among US youth aged 13-24 years were obtained for use as reference populations for ATN at-risk youth and youth living with HIV (YLWH), respectively., Results: Data from 3,185 youth at-risk for HIV and 542 YLWH were pooled from 21 ATN study phases conducted across the United States. Among ATN studies tailored to at-risk youth, a higher proportion of participants were White and a lower proportion were Black/African American and Hispanic/Latinx compared to youth newly diagnosed with HIV in the United States in 2019. Participants in ATN studies tailored to YLWH were demographically similar to YLWH in the United States., Discussion: The development of data harmonization guidelines for ATN research activities facilitated this cross-network pooled analysis. These findings suggest the ATN's YLWH are representative, but that future studies of at-risk youth should prioritize recruitment strategies to enroll more participants from African American and Hispanic/Latinx populations., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: When accounting for misclassification, investigators make assumptions about whether misclassification is "differential" or "nondifferential." Most guidance on differential misclassification considers settings where outcome misclassification varies across levels of exposure, or vice versa. Here, we examine when covariate-differential misclassification must be considered when estimating overall outcome prevalence., Methods: We generated datasets with outcome misclassification under five data generating mechanisms. In each, we estimated prevalence using estimators that (a) ignored misclassification, (b) assumed misclassification was nondifferential, and (c) allowed misclassification to vary across levels of a covariate. We compared bias and precision in estimated prevalence in the study sample and an external target population using different sources of validation data to account for misclassification. We illustrated use of each approach to estimate HIV prevalence using self-reported HIV status among people in East Africa cross-border areas., Results: The estimator that allowed misclassification to vary across levels of the covariate produced results with little bias for both populations in all scenarios but had higher variability when the validation study contained sparse strata. Estimators that assumed nondifferential misclassification produced results with little bias when the covariate distribution in the validation data matched the covariate distribution in the target population; otherwise estimates assuming nondifferential misclassification were biased., Conclusions: If validation data are a simple random sample from the target population, assuming nondifferential outcome misclassification will yield prevalence estimates with little bias regardless of whether misclassification varies across covariates. Otherwise, obtaining valid prevalence estimates requires incorporating covariates into the estimators used to account for misclassification., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Harmonised population-based surveys with recent HIV-1 infection testing algorithms permit pooled cross-sectional estimation of HIV incidence across multiple countries. We aimed to estimate adult HIV-1 incidence rates and number of new infections by sex, age, and subregion in sub-Saharan Africa., Methods: We analysed data from 13 Population-Based HIV Impact Assessment (PHIA) surveys and two additional population-based surveys done between 2015 and 2019 in 15 sub-Saharan African countries. HIV-seropositive samples from adults aged 15-59 years were tested for recent HIV-1 infection by use of an algorithm consisting of the HIV-1 limiting antigen avidity enzyme immunoassay, HIV-1 viral load, and qualitative detection of antiretroviral agents. Data were pooled across countries; sampling weights were incorporated to represent all adults in the 15 national populations. Analyses accounted for the complex sample designs. HIV incidence rates, incidence rate differences, and number of new annual infections were estimated., Findings: Among 445 979 adults sampled, 382 had recent HIV-1 infection. The estimated HIV-1 incidence rate was 3·3 per 1000 person-years (95% CI 2·6-4·0) among women and 2·0 per 1000 person-years (1·2-2·7) among men (incidence rate difference 1·3 per 1000 person-years, 95% CI 0·3-2·3). Among adults aged 15-24 years, the incidence rate was higher for women (3·5 per 1000 person-years) than men (1·2 per 1000 person-years; difference 2·3, 95% CI 0·8-3·8), but infection rates were similar between sexes in all other age groups. The HIV-1 incidence rate was 7·4 per 1000 person-years (95% CI 5·0-9·7) in southern sub-Saharan Africa, 2·3 per 1000 person-years (1·7-2·9) in the eastern subregion, and 0·9 per 1000 person-years (0·6-1·2) in the western and central subregion. 689 000 (95% CI 546 000-833 000) new HIV cases were estimated annually among the 265 million susceptible adults (61·6% in women)., Interpretation: HIV-1 incidence and number of new infections differed by age, sex, and subregion. Approaches for risk stratification are needed to guide comprehensive HIV-1 prevention., Funding: National Institutes of Health., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: U.S. women who have been incarcerated report high rates of sexual risk behavior and sexually transmitted infections (STIs). Materials and Methods: We estimated the effect of incarceration on the time to first incident STI in a multicenter cohort of U.S. women with or at risk for HIV. We used marginal structural models to compare time to first self-reported gonorrhea, chlamydia, or trichomonas infection for nonincarcerated women and incarcerated women. Covariates included demographic factors, HIV status, sex exchange, drug/alcohol use, and prior incarceration. Results: Three thousand hundred twenty-four women contributed a median of 4 at-risk years and experienced 213 first incident STI events. The crude incidence of STIs was 3.7 per 100 person-years for incarcerated women and 1.9 per 100 person-years for nonincarcerated women. The weighted hazard ratio for incident STIs was 4.05 (95% confidence interval: 1.61-10.19). Conclusion: Women with or at risk for HIV in the United States who have recently experienced incarceration may be at increased STI risk.

Background: To estimate the incidence, prevalence, frequency, and duration of incarceration and to identify risk factors for incarceration among women at risk for human immunodeficiency virus (HIV) in the United States. Methods: During semiannual study visits in a multicenter cohort study, 970 HIV sero-negative participants at risk for HIV were asked about their own incarceration (10/2007-09/2017) and incarceration of sexual partners (10/2013-09/2017). We used descriptive statistics and multivariable log-binomial regression to identify baseline predictors of incident incarceration. Results: Median follow-up time across the 970 participants was 5.5 years (IQR 3.5-9.5). Nearly half ( n  = 453, 46.7%) of participants were incarcerated during or before the study, and the incarceration rate was 5.5 per 100 person-years. In multivariable models, incident incarceration was associated with prior incarceration (RR 5.20, 95% CI: 3.23-8.41) and noninjection drug use (RR 1.57, 95% CI: 1.10-2.25). Conclusions: Incarceration is common for women at risk for HIV. Prevention interventions that address the complex interplay of drug use, sex exchange, and housing instability for women who have experienced incarceration have the potential to reach an important group of U.S. women at risk of HIV infection.

Objective: Vietnam, Indonesia, and Ukraine have major burdens of IDU and HIV. We estimated the prevalence of depressive symptoms at baseline among people living with HIV who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups., Design: HPTN 074 was a randomized study. The study intervention included psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4+ cell count., Methods: Moderate-to-severe depression was defined as a Patient Health Questionnaire-9 score of 10 or above. ART and MAT were self-reported. Eligibility criteria were: 18-60 years of age, active IDU, and viral load of at least 1000 copies/ml. Adjusted probability differences (aPD) were estimated using inverse-probability weighting., Results: A total of 502 participants enrolled from April 2015 to June 2016. Median age was 35 years; 85% identified as men. Prevalence of baseline moderate-to-severe depression was 14% in Vietnam, 14% in Indonesia, and 56% in Ukraine. No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up. The study intervention improved the proportions of people who inject drugs achieving 12-month viral suppression in both the depressed [intervention 44%; standard of care 24%; estimated aPD = 25% (95% confidence interval: 4.0%, 45%)] and nondepressed subgroups [intervention 38%; standard of care 24%; aPD = 13% (95% confidence interval: 2.0%, 25%)]., Conclusion: High levels of depressive symptoms were common among people living with HIV who inject drugs in Ukraine but were less common in Vietnam and Indonesia. The study intervention was effective among participants with or without baseline depression symptoms., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Persistent HIV infection of long-lived resting CD4 T cells, despite antiretroviral therapy (ART), remains a barrier to HIV cure. Women have a more robust type 1 interferon response during HIV infection relative to men, contributing to lower initial plasma viremia. As lower viremia during acute infection is associated with reduced frequency of latent HIV infection, we hypothesized that women on ART would have a lower frequency of latent HIV compared to men., Methods: ART-suppressed, HIV seropositive women (n = 22) were matched 1:1 to 22 of 39 ART-suppressed men. We also compared the 22 women to all 39 men, adjusting for age and race as covariates. We measured the frequency of latent HIV using the quantitative viral outgrowth assay, the intact proviral DNA assay, and total HIV gag DNA. We also performed activation/exhaustion immunophenotyping on peripheral blood mononuclear cells and quantified interferon-stimulated gene (ISG) expression in CD4 T cells., Results: We did not observe evident sex differences in the frequency of persistent HIV in resting CD4 T cells. Immunophenotyping and CD4 T-cell ISG expression analysis revealed marginal differences across the sexes., Conclusions: Differences in HIV reservoir frequency and immune activation appear to be small across sexes during long-term suppressive therapy., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

The article introduces proximal causal inference, where proximal denotes that the pair of measured variables is a consequence of the unmeasured confounder, to the epidemiology community and demonstrate its application using a simulation study. Topics include illustrative application, simulation results from a comparison of standard g-computation with proximal g-computation for estimation of the average causal effect, and simulation setup.

Objective s. To examine whether women's incarceration increases numbers of total and new sexual partners. Methods. US women with or at risk for HIV in a multicenter cohort study answered incarceration and sexual partner questions semiannually between 2007 and 2017. We used marginal structural models to compare total and new partners at visits not following incarceration with all visits following incarceration and visits immediately following incarceration. Covariates included demographics, HIV status, sex exchange, drug or alcohol use, and housing instability. Results. Of the 3180 participants, 155 were incarcerated. Women reported 2 partners, 3 or more partners, and new partners at 5.2%, 5.2%, and 9.3% of visits, respectively. Relative to visits not occurring after incarceration, odds ratios were 2.41 (95% confidence interval [CI] = 1.20, 4.85) for 2 partners, 2.03 (95% CI = 0.97, 4.26) for 3 or more partners, and 3.24 (95% CI = 1.69, 6.22) for new partners at visits immediately after incarceration. Odds ratios were similar for all visits following incarceration. Conclusions. Women had more total partners and new partners immediately and at all visits following incarceration after confounders and loss to follow-up had been taken into account. [ABSTRACT FROM AUTHOR]