The burden of HIV among female sex workers, men who have sex with men and transgender women in Haiti: results from the 2016 Priorities for Local AIDS Control Efforts (PLACE) study

Introduction: Despite the higher risk of HIV among female sex workers (FSWs), men who have sex with men (MSM) and transgender women (TGW), these populations are under-represented in the literature on HIV in Haiti. Here, we present the first nationally representative estimates of HIV prevalence and the first care and treatment cascade for FSWs, MSM and TGW in Haiti. We also examine the social determinants of HIV prevalence in these groups and estimate FSW and MSM population size in Haiti. Methods: Data were collected between April 2016 and February 2017 throughout the 10 geographical departments of Haiti. The Priorities for Local AIDS Control Efforts (PLACE) method was used to: (1) recruit participants for a behavioural survey; (2) provide rapid testing, counselling and linkage to care for syphilis and HIV; and (3) measure viral load using dried blood spots for participants testing HIV positive. Results: Study participants included 990 FSWs, 520 MSM and 109 TGW. HIV prevalence was estimated at 7.7% (95% CI 6.2%, 9.6%) among FSWs, 2.2% (0.9%, 5.3%) among MSM and 27.6% (5.0%, 73.5%) among TGW. Of participants who tested positive for syphilis, 17% of FSWs, 19% of MSM and 74% of TGW were co-infected with HIV. Economic instability and intimate partner violence (IPV) were significantly associated with HIV among MSM; food insecurity, economic instability and history of rape were significantly associated with HIV among TGW. Fewer than one-third of participants living with HIV knew their status, and more than a quarter of those who knew their status were not on treatment. While approximately four in five FSW and MSM participants on treatment for HIV were virally suppressed, viral suppression was less common among TGW participants at only 46%. Conclusions: This study demonstrates a need for targeted interventions to prevent and treat HIV among key populations in Haiti. Potential high-impact interventions may include venue-based, peer navigator-led outreach and testing for HIV and syphilis and improving screening and case management for structural violence and IPV. TGW are in urgent need of such interventions due to our observations of alarmingly high HIV prevalence and low frequency of HIV viral suppression among TGW

Timing of HIV testing among pregnant and breastfeeding women and risk of mother-to-child HIV transmission in Malawi: a sampling-based cohort study

Introduction: Pregnant women living with HIV can achieve viral suppression and prevent HIV mother-to-child transmission (MTCT) with timely HIV testing and early ART initiation and maintenance. Although it is recommended that pregnant women undergo HIV testing early in antenatal care in Malawi, many women test positive during breastfeeding because they did not have their HIV status ascertained during pregnancy, or they tested negative during pregnancy but seroconverted postpartum. We sought to estimate the association between the timing of last positive HIV test (during pregnancy vs. breastfeeding) and outcomes of maternal viral suppression and MTCT in Malawi’s PMTCT programme. Methods: We conducted a two-stage cohort study among mother–infant pairs in 30 randomly selected high-volume health facilities across five nationally representative districts of Malawi between 1 July 2016 and 30 June 2017. Log-binomial regression was used to estimate prevalence ratios (PR) and risk ratios (RR) for associations between timing of last positive HIV test (i.e. breastfeeding vs. pregnancy) and maternal viral suppression and MTCT, controlling for confounding using inverse probability weighting. Results: Of 822 mother–infant pairs who had available information on the timing of the last positive HIV test, 102 mothers (12.4%) had their last positive test during breastfeeding. Women who lived one to two hours (PR = 2.15; 95% CI: 1.29 to 3.58) or >2 hours (PR = 2.36; 95% CI: 1.37 to 4.10) travel time to the nearest health facility were more likely to have had their last positive HIV test during breastfeeding compared to women living <1 hour travel time to the nearest health facility. The risk of unsuppressed VL did not differ between women who had their last positive HIV test during breastfeeding versus pregnancy (adjusted RR [aRR] = 0.87; 95% CI: 0.48 to 1.57). MTCT risk was higher among women who had their last positive HIV test during breastfeeding compared to women who had it during pregnancy (aRR = 6.57; 95% CI: 3.37 to 12.81). Conclusions: MTCT in Malawi occurred disproportionately among women with a last positive HIV test during breastfeeding. Testing delayed until the postpartum period may lead to higher MTCT. To optimize maternal and child health outcomes, PMTCT programmes should focus on early ART initiation and providing targeted testing, prevention, treatment and support to breastfeeding women

Differences in Access to HIV Services and Risky Sexual Behaviors Among Malawian Women at Social Venues Who Do and Do Not Engage in Sex Work

In the high HIV-burden country of Malawi, female sex workers (FSW) are one of the populations most profoundly affected by HIV. The Malawi Priorities for Local AIDS Control Efforts (PLACE) surveyed 1,004 self-identified FSW, 213 other FSW (OFSW), and 130 other high risk women (OHRW) at social venues. Analyses compared the three groups using survey-weighted log binomial regression models. Each group had a distinct pattern of usage and access to services: OFSW and FSW had greater access to condoms, while using a condom ever was greatest among FSW. Nearly all women knew where to get tested for HIV but very few used FSW drop-in centers. HIV prevalence was high in all three groups (35% FSW, 20% OFSW, 20% OHRW). Given these results, HIV services should be targeted to all women at social venues in Malawi, regardless of sex worker status to improve health outcomes and limit onward transmission of HIV

Achieving the first 90 for key populations in sub-Saharan Africa through venue-based outreach: Challenges and opportunities for HIV prevention based on PLACE study findings from Malawi and Angola

Introduction: Providing outreach HIV prevention services at venues (i.e. "hotspots") where people meet new sex partners can decrease barriers to HIV testing services (HTS) for key populations (KP) in sub-Saharan Africa (SSA). We offered venue-based HTS as part of bio-behavioural surveys conducted in urban Malawi and Angola to generate regional insights into KP programming gaps and identify opportunities to achieve the "first 90" for KP in SSA. Methods: From October 2016 to March 2017, we identified and verified 1054 venues in Luanda and Benguela, Angola and Zomba, Malawi and conducted bio-behavioural surveys at 166 using the PLACE method. PLACE interviews community informants to systematically identify public venues where KP can be reached and conducts bio-behavioural surveys at a stratified random sample of venues. We present survey results using summary statistics and multivariable modified Poisson regression modelling to examine associations between receipt of outreach worker-delivered HIV/AIDS education and HTS uptake. We applied sampling weights to estimate numbers of HIV-positive KP unaware of their status at venues. Results: We surveyed 959 female sex workers (FSW), 836 men who have sex with men (MSM), and 129 transgender women (TGW). An estimated 71% of HIV-positive KP surveyed were not previously aware of their HIV status, receiving a new HIV diagnosis through PLACE venue-based HTS. If venue-based HTS were implemented at all venues, 2022 HIV-positive KP (95% CI: 1649 to 2477) who do not know their status could be reached, including 1666 FSW (95% CI: 1397 to 1987), 274 MSM (95% CI: 160 to 374), and 82 TG (95% CI: 20 to 197). In multivariable analyses, FSW, MSM, and TGW who received outreach worker-delivered HIV/AIDS education were 3.15 (95% CI: 1.99 to 5.01), 3.12 (95% CI: 2.17 to 4.48), and 1.80 (95% CI: 0.67 to 4.87) times as likely, respectively, as those who did not to have undergone HTS within the last six months. Among verified venues, <=68% offered any on-site HIV prevention services. Conclusions: Availability of HTS and other HIV prevention services was limited at venues. HIV prevention can be delivered at venues, which can increase HTS uptake and HIV diagnosis among individuals not previously aware of their status. Delivering venue-based HTS may represent an effective strategy to reach the "first 90" for KP in SSA

Improving HIV outreach testing yield at cross-border venues in East Africa

Objective: The aim of this study was to evaluate HIV testing yield under several candidate strategies for outreach testing at venues (i.e. places where people socialize and meet new sex partners) in East Africa cross-border areas. Design: Population-based cross-sectional biobehavioural survey of people who had not been previously diagnosed with HIV found in venues. Methods: We identified participants who would have been tested for HIV under each of 10 hypothetical outreach testing strategies and calculated the proportion who would have newly tested positive for HIV under each strategy. On the basis of this proportion, we calculated the 'number needed to test' (NNT) to identify one new case of HIV under each strategy. All estimates were obtained by applying survey sampling weights to account for the complex sampling design. Results: If testing was performed at a random sample of venues, 35 people would need to be tested to identify one new case of HIV, but higher yield could be found by limiting testing to venues with specific characteristics. Strategies focusing on women had higher testing yield. Testing women employed by venues would result in highest yield of all strategies examined (NNT=15), while testing men under age 24 would result in the lowest yield (NNT=99). Conclusion: Quantitatively evaluating HIV testing strategies prior to implementation using survey data presents a new opportunity to refine and prioritize outreach testing strategies for the people and places most likely to result in high HIV testing yiel

A Two-stage Approach for Rapid Assessment of the Proportion Achieving Viral Suppression Using Routine Clinical Data

Background: Improving viral suppression among people with HIV reduces morbidity, mortality, and transmission. Accordingly, monitoring the proportion of patients with a suppressed viral load is important to optimizing HIV care and treatment programs. But viral load data are often incomplete in clinical records. We illustrate a two-stage approach to estimate the proportion of treated people with HIV who have a suppressed viral load in the Dominican Republic. Methods: Routinely collected data on viral load and patient characteristics were recorded in a national database, but 74% of patients on treatment at the time of the study did not have a recent viral load measurement. We recruited a subset of these patients for a rapid assessment that obtained additional viral load measurements. We combined results from the rapid assessment and main database using a two-stage weighting approach and compared results to estimates obtained using standard approaches to account for missing data. Results: Of patients with recent routinely collected viral load data, 60% had a suppressed viral load. Results were similar after applying standard approaches to account for missing data. Using the two-stage approach, we estimated that 77% (95% confidence interval [CI] = 74, 80) of those on treatment had a suppressed viral load. Conclusions: When assessing the proportion of people on treatment with a suppressed viral load using routinely collected data, applying standard approaches to handle missing data may be inadequate. In these settings, augmenting routinely collected data with data collected through sampling-based approaches could allow more accurate and efficient monitoring of HIV treatment program effectiveness

Gone but Not Lost: Implications for Estimating HIV Care Outcomes When Loss to Clinic Is Not Loss to Care

Background: In some time-to-event analyses, it is unclear whether loss to follow up should be treated as a censoring event or competing event. Such ambiguity is particularly common in HIV research that uses routinely collected clinical data to report the timing of key milestones along the HIV care continuum. In this setting, loss to follow up may be viewed as a censoring event, under the assumption that patients who are "lost" from a study clinic immediately enroll in care elsewhere, or a competing event, under the assumption that people "lost" are out of care all together. Methods: We illustrate an approach to address this ambiguity when estimating the 2-year risk of antiretroviral treatment initiation among 19,506 people living with HIV who enrolled in the IeDEA Central Africa cohort between 2006 and 2017, along with published estimates from tracing studies in Africa. We also assessed the finite sample properties of the proposed approach using simulation experiments. Results: The estimated 2-year risk of treatment initiation was 69% if patients were censored at loss to follow up or 59% if losses to follow up were treated as competing events. Using the proposed approach, we estimated that the 2-year risk of antiretroviral therapy initiation was 62% (95% confidence interval: 61, 62). The proposed approach had little bias and appropriate confidence interval coverage under scenarios examined in the simulation experiments. Conclusions: The proposed approach relaxes the assumptions inherent in treating loss to follow up as a censoring or competing event in clinical HIV cohort studies

Mitigating the effects of COVID-19 on HIV treatment and care in Lusaka, Zambia: A before-after cohort study using mixed effects regression

Introduction The Zambian Ministry of Health (MoH) issued COVID-19 mitigation guidance for HIV care immediately after the first COVID-19 case was confirmed in Zambia on 18 March 2020. The Centre for Infectious Disease Research in Zambia implemented MoH guidance by: 1) extending antiretroviral therapy (ART) refill duration to 6 multi-month dispensation (6MMD) and 2) task-shifting communication and mobilisation of those in HIV care to collect their next ART refill early. We assessed the impact of COVID-19 mitigation guidance on HIV care 3 months before and after guidance implementation. Methods We reviewed all ART pharmacy visit data in the national HIV medical record for PLHIV in care having ≥1 visit between 1 January - 30 June 2020 at 59 HIV care facilities in Lusaka Province, Zambia. We undertook a before-after evaluation using mixed-effects Poisson regression to examine predictors and marginal probability of early clinic return (pharmacy visit >7 days before next appointment), proportion of late visit (>7 days late for next appointment) and probability of receiving a 6MMD ART refill. Results A total of 101 371 individuals (64% female, median age 39) with 130 486 pharmacy visits were included in the analysis. We observed a significant increase in the adjusted prevalence ratio (4.63; 95% CI 4.45 to 4.82) of early return before compared with after guidance implementation. Receipt of 6MMD increased from a weekly mean of 47.9% (95% CI 46.6% to 49.2%) before to 73.4% (95% CI 72.0% to 74.9%) after guidance implementation. The proportion of late visits (8-89 days late) was significantly higher before (18.8%, 95% CI17.2%to20.2%) compared with after (15.1%, 95% CI13.8%to16.4%) guidance implementation. Conclusions Timely issuance and implementation of COVID-19 mitigation guidance involving task-shifted patient communication and mobilisation alongside 6MMD significantly increased early return to ART clinic, potentially reducing interruptions in HIV care during a global public health emergency

Prioritizing persons deprived of liberty in global guidelines for tuberculosis preventive treatment

Persons deprived of liberty (PDLs) are disproportionately impacted by tuberculosis, with high incidence rates and often limited access to diagnostics, treatment, and preventive measures. The World Health Organization (WHO) expanded its recommendations for tuberculosis preventive treatment (TPT) to many high-risk populations, but their guidance does not include PDL, and most low- and middle-income countries do not routinely provide edforthoseusedthroughoutthetext TPT in prisons. :Pleaseverifythatallentriesarecorrectlyabbreviated: Recent studies demonstrate high acceptability and completion rates of short-course TPT regimens in jails and prisons; costs of these regimens have been markedly reduced through international agreements, making this an opportune for further expanding their use. We argue that PDL should be a priority group for TPT in national guidelines and discuss implementation considerations and resource needs for TPT programs in carceral facilities. Scaling access to TPT for PDL is important for reducing disease and transmission in this population; it is also critical to advancing an equitable response to tuberculosis

Evaluation of a COVID-19 convalescent plasma program at a U.S. academic medical center

Amidst the therapeutic void at the onset of the COVID-19 pandemic, a critical mass of scientific and clinical interest coalesced around COVID-19 convalescent plasma (CCP). To date, the CCP literature has focused largely on safety and efficacy outcomes, but little on implementation outcomes or experience. Expert opinion suggests that if CCP has a role in COVID-19 treatment, it is early in the disease course, and it must deliver a sufficiently high titer of neutralizing antibodies (nAb). Missing in the literature are comprehensive evaluations of how local CCP programs were implemented as part of pandemic preparedness and response, including considerations of the core components and personnel required to meet demand with adequately qualified CCP in a timely and sustained manner. To address this gap, we conducted an evaluation of a local CCP program at a large U.S. academic medical center, the University of North Carolina Medical Center (UNCMC), and patterned our evaluation around the dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to systematically describe key implementation-relevant metrics. We aligned our evaluation with program goals of reaching the target population with severe or critical COVID-19, integrating into the structure of the hospital-wide pandemic response, adapting to shifting landscapes, and sustaining the program over time during a compassionate use expanded access program (EAP) era and a randomized controlled trial (RCT) era. During the EAP era, the UNCMC CCP program was associated with faster CCP infusion after admission compared with contemporaneous affiliate hospitals without a local program: median 29.6 hours (interquartile range, IQR: 21.2–48.1) for the UNCMC CCP program versus 47.6 hours (IQR 32.6–71.6) for affiliate hospitals; (P<0.0001). Sixty-eight of 87 CCP recipients in the EAP (78.2%) received CCP containing the FDA recommended minimum nAb titer of ≥1:160. CCP delivery to hospitalized patients operated with equal efficiency regardless of receiving treatment via a RCT or a compassionate-use mechanism. It was found that in a highly resourced academic medical center, rapid implementation of a local CCP collection, treatment, and clinical trial program could be achieved through redeployment of highly trained laboratory and clinical personnel. These data provide important pragmatic considerations critical for health systems considering the use of CCP as part of an integrated pandemic response