Assessing inclusion of trans people in HIV national strategic plans: a review of 60 high HIV prevalence countries

IntroductionTrans people are disproportionately impacted by HIV yet have not been adequately prioritized in national HIV responses or policy documents. This review aims to understand the extent of meaningful inclusion of trans people in national strategic plans (NSPs) for HIV/AIDS as an essential step in ensuring that HIV policy aligns with epidemiologic data, and trans‐specific programming is funded, implemented and sustained.MethodsHIV NSPs from 60 countries, across five global regions, were assessed for the level of inclusion of trans populations between January and March 2021. The most recently available NSP for each country, published after 2011, was obtained through publicly accessible online sources or through researcher networks. Data were manually extracted from NSPs using a framework of indicators focusing on trans inclusion in these five major sections of NSPs: (1) narratives; (2) epidemiological data; (3) monitoring and evaluation (M&E) indicators and targets; (4) activities; and (5) budgets.Results and discussionWithin all reviewed NSPs, 65.0% (39/60) mentioned trans people in at least one of the five key sections but only 8.3% (5/60) included trans people in all five key sections. Trans people were more commonly mentioned in the background/narratives of NSPs (61.7%, 37/60) but less commonly included NSP activities (38.3%, 23/60), in M&E indicators and targets (23.7%, 14/60), in epidemiological data (20.0% 12/60), and in NSP budgets (13.3%, 8/60). Countries in the Asia and Pacific region most frequently included trans people in all five key sections (38%, 5/13), while no countries in Eastern and Southern Africa included trans people in all NSP sections.ConclusionsThis analysis finds substantial gaps in the inclusion of trans populations in NSPs globally. Results highlight the pressing need for states, technical partners, and international funders to engage with trans communities to improve trans‐inclusion in all key sections of NSPs. Trans inclusion in NSPs is an essential step towards reaching the populations most at risk of HIV and ultimately achieving country‐level epidemic control.     

HIV prevention: better choice for better coverage

IntroductionAntiretroviral‐based pre‐exposure prophylaxis (PrEP) is today an established, effective and safe method of HIV prevention used in multiple countries worldwide by a broad range of populations at risk of HIV infection. Biomedical innovations are critical in supporting the primary prevention of HIV; however, their potential can only be maximized if end‐user challenges are recognized, described and used to develop next‐generation models.DiscussionFirst‐generation PrEP, a daily oral pill, is highly efficacious, discreet and affords users the ability to commence and conclude treatment rapidly. However, consistent daily adherence and persistence is challenging, especially among younger populations, due in part to side effects, the risk of stock‐outs and a lack of pill storage options. Second‐generation PrEP, longer acting agents that require less frequent dosing, could overcome such challenges. Agents that have shown efficacy in clinical trials include a monthly vaginal ring and PrEP injectables to be administered every 8 weeks, while products in development include 6 monthly injectables, oral therapy that uses monthly rather than daily pills, implants and the potential for long‐acting passive immunization.ConclusionsSecond‐generation PrEP agents will have the potential to offer improved adherence and less frequent reminders once they have undergone further development and the delivery systems that will best support them have been established. In order to pursue global UNAIDS targets of reducing new HIV infections to fewer than 500,000 annually by 2025, and to ensure that all people have access to prevention options that meet their specific prevention needs, both early and next‐generation PrEP options are needed.     

HIV prevention metrics: lessons to be learned from contraception

IntroductionAs the range of effective HIV prevention options, including multiple biomedical tools, increases, there are many challenges to measuring HIV prevention efforts. In part, there is the challenge of varying prevention needs, between individuals as well as within individuals over time. The field of contraception faces many similar challenges, such as the range of prevention methods and changing contraceptive needs, and has developed many metrics for assessing contraceptive use at the program level, using frameworks that move beyond the HIV prevention cascade. We explore these similarities and differences between these two prevention fields and then discuss how each of these contraceptive metrics could be adapted to assessing HIV prevention.DiscussionWe examined measures of initiation, coverage and persistence. Among measures of initiation, HIV Prevention–Post Testing would be a useful corollary to Contraceptive Use–Post Partum for a subset of the population. As a measure of coverage, both Net Prevention Coverage and HIV Protection Index (modelled off the Contraception Protection Index) may be useful. Finally, as a measure of persistence, Person‐Years of HIV Protection could be adapted from Couple‐Years Protection. As in contraception, most programs will not reach 100% on HIV prevention metrics but these metrics are highly useful for making comparisons.ConclusionsWhile we may not be able to perfectly capture the true population of who would benefit from HIV prevention, by building off the work of the contraceptive field to use and refine these metrics, we can assess and compare HIV prevention over time and across programs. Furthermore, these metrics can help us reach global targets, such as the 2025 UNAIDS Goals, and reduce HIV incidence.     

Use of quality‐of‐life instruments for people living with HIV: a global systematic review and meta‐analysis

IntroductionDue to the effectiveness of combined antiretroviral therapy and its growing availability worldwide, most people living with HIV (PLHIV) have a near‐normal life expectancy. However, PLHIV continue to face various health and social challenges that severely impact their health‐related quality‐of‐life (HRQoL). The UNAIDS Global AIDS Strategy discusses the need to optimize quality‐of‐life, but no guidance was given regarding which instruments were appropriate measures of HRQoL. This study aimed to review and assess the use of HRQoL instruments for PLHIV.MethodsWe conducted a global systematic review and meta‐analysis, searching five databases for studies published between January 2010 and February 2021 that assessed HRQoL among PLHIV aged 16 years and over. Multivariable regression analyses were performed to identify factors associated with the choice of HRQoL instruments. We examined the domains covered by each instrument. Random‐effects meta‐analysis was conducted to explore the average completion rates of HRQoL instruments.Results and discussionFrom 714 publications, we identified 65 different HRQoL instruments. The most commonly used instruments were the World Health Organization Quality‐of‐Life‐ HIV Bref (WHOQOL‐HIV BREF)—19%, Medical Outcome Survey‐HIV (MOS‐HIV)—17%, Short Form‐36 (SF‐36)—12%, European Quality‐of‐Life Instrument‐5 Dimension (EQ‐5D)—10%, World Health Organization Quality‐of‐Life Bref (WHOQOL BREF)—8%, Short Form‐12 (SF‐12)—7% and HIV/AIDS Targeted Quality‐of‐Life (HAT‐QOL)—6%. There were greater odds of using HIV‐specific instruments for middle‐ and low‐income countries (than high‐income countries), studies in the Americas and Europe (than Africa) and target population of PLHIV only (than both PLHIV and people without HIV). Domains unique to the HIV‐specific instruments were worries about death, stigma and HIV disclosure. There were no significant differences in completion rates between different HRQoL instruments. The overall pooled completion rate was 95.9% (95% CI: 94.7−97.0, I ² = 99.2%, p < 0.01); some heterogeneity was explained by country‐income level and study type.ConclusionsA wide range of instruments have been used to assess HRQoL in PLHIV, and the choice of instrument might be based on their different characteristics and reason for application. Although completion rates were high, future studies should explore the feasibility of implementing these instruments and the appropriateness of domains covered by each instrument.     

Global scoping review of HIV prevention research with transgender people: Transcending from trans‐subsumed to trans‐centred research

IntroductionGlobally, transgender populations are disproportionally impacted by HIV and effective HIV prevention interventions targeting these populations are critically needed. Such interventions require research focused on the specific needs and experiences of transgender people. This methodological review aims to determine the extent to which HIV prevention research has included transgender participants by subsuming them into non‐transgender populations, or by centring them either in comparison with other groups or as the sole focus of research.MethodsWe searched five electronic databases (e.g. SCOPUS) for empirical studies that focused on HIV prevention and included transgender participants, published through 31 December 2020. For each study, we extracted information on: (a) types of inclusion of transgender participants; (b) total sample size and number/percentage of transgender participants; (c) country(ies) where study was conducted; (d) HIV research topics; (e) methods (i.e. quantitative, qualitative or mixed‐methods research) and (f) gender identity of transgender participants.Results and discussionOf 667 HIV prevention studies included in the review, 38.5% subsumed transgender participants into cisgender populations (most frequently combining transgender women with cisgender men who have sex with men), 20.4% compared transgender and cisgender participants and 41.1% focused exclusively on transgender populations. Our global scoping review also revealed that these three types of transgender inclusion in HIV prevention research vary greatly over time, place and thematic areas. Transgender women are the focus of the majority of reviewed studies, whereas transgender men and gender expansive people are rarely included as participants.ConclusionsInclusion of transgender persons as participants in HIV prevention research has significantly increased, particularly in the last decade. Further research centred on transgender participants and their experiences are needed to develop effective HIV prevention interventions for transgender populations. We advocate for HIV prevention research to move from subsuming transgender people, to trans‐centred research that asks questions that focus on their specific needs and experiences. We provide recommendations to move from trans‐subsumed to trans‐centred HIV prevention research.     

Ending the evidence gap for pregnancy,HIV and co‐infections: ethics guidance from the PHASES project

IntroductionWhile pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co‐infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy‐specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next‐generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co‐infections research.DiscussionThe 26‐member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics‐centred guidance for advancing timely, responsible HIV/co‐infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug‐related risks, timely access to biomedical advances and equitable respect for pregnant people''s health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post‐approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co‐infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups.ConclusionsThere are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for – and the promise of – advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.     

Declining HIV incidence in sub‐Saharan Africa: a systematic review and meta‐analysis of empiric data

IntroductionUNAIDS models suggest HIV incidence is declining in sub‐Saharan Africa. The objective of this study was to assess whether modelled trends are supported by empirical evidence.MethodsWe conducted a systematic review and meta‐analysis of adult HIV incidence data from sub‐Saharan Africa by searching Embase, Scopus, PubMed and OVID databases and technical reports published between 1 January 2010 and 23 July 2019. We included prospective and cross‐sectional studies that directly measured incidence from blood samples. Incidence data were abstracted according to population risk group, geographic location, sex, intervention arm and calendar period. Weighted regression models were used to assess incidence trends across general population studies by sex. We also identified studies reporting greater than or equal to three incidence measurements since 2010 and assessed trends within them.ResultsTotal 291 studies, including 22 sub‐Saharan African countries, met inclusion criteria. Most studies were conducted in South Africa (n = 102), Uganda (n = 46) and Kenya (n = 41); there were 26 countries with no published incidence data, most in western and central Africa. Data were most commonly derived from prospective observational studies (n = 163; 56%) and from geographically defined populations with limited demographic or risk‐based enrolment criteria other than age (i.e., general population studies; n = 151; 52%). Across general population studies, average annual incidence declines since 2010 were 0.12/100 person‐years (95% CI: 0.06–0.18; p = 0.001) among men and 0.10/100 person‐years (95% CI: −0.02–0.22; p = 0.093) among women in eastern Africa, and 0.25/100 person‐years (95% CI: 0.17–034; p < 0.0001) among men and 0.42/100 person‐years (95% CI: 0.23–0.62; p = 0.0002) among women in southern Africa. In nine of 10 studies with multiple measurements, incidence declined over time, including in two studies of key populations. Across all population risk groups, the highest HIV incidence estimates were observed among men who have sex with men, with rates ranging from 1.0 to 15.4/100 person‐years. Within general population studies, incidence was typically higher in women than men with a median female‐to‐male incidence rate ratio of 1.47 (IQR: 1.11 to 1.83) with evidence of a growing sex disparity over time.ConclusionsEmpirical incidence data show the rate of new HIV infections is declining in eastern and southern Africa. However, recent incidence data are non‐existent or very limited for many countries and key populations.     

Preference for using a variety of future HIV pre‐exposure prophylaxis products among men who have sex with men in three US cities

BackgroundDaily oral pre‐exposure prophylaxis (PrEP) is available and recommended for men who have sex with men (MSM) at risk for HIV infection. Other HIV prevention products are being developed, including long‐acting injectable (LAI) and event‐based oral and topical formulations. Understanding preferences for potential products by MSM can help direct further development of prevention messaging.MethodsWe present baseline data from HIV‐negative participants enrolled in the US Mobile Messaging for Men (M‐cubed) Study. Participants were asked their likelihood of and rank order preference for using daily oral PrEP and various potential prevention products (one‐ to ‐three‐month injections, 2‐1‐1 sexual event oral dosing, anal or penile gel, or anal suppository), and their sociodemographic characteristics. Bivariate and multivariable logistics regression assessed demographic associations with likelihood of use and rank order preference.ResultsOverall, most MSM reported a likelihood of using LAI (74%), sexual event‐based pills (67%) and penile gel (64%). Men who reported recent unprotected (condomless and PrEPless) anal sex most preferred a penile gel formulation (74%), followed closely by LAI and event‐based pills (73% each). Current PrEP users (vs. non‐users) had greater odds of reporting likelihood to use LAI (AOR = 3.29, 95% CI = 2.12 to 5.11), whereas men reporting recent unprotected anal sex had a greater odds of likelihood to use a penile gel (AOR = 1.79, 95% CI = 1.27 to 2.52) and an anal suppository (AOR = 1.48, 95% CI = 1.08 to 2.02). Hispanic/Latino (vs. White) MSM (AOR = 2.29, 95% CI = 1.40 to 3.73) and, marginally, Black MSM (AOR = 1.54, 95% CI = 1.00 to 2.38) had greater odds of reporting likelihood to use penile gel. Similar patterns were found for rank ordering preference of products, including condoms.ConclusionsMost MSM were interested in using various potential future HIV prevention products, especially LAI. However, two typologies of potential users emerged: men who prefer sexual event‐based methods (condoms, event‐based pill, sexual gels and suppositories) and men who prefer non‐sexual event‐based methods (daily pill, LAI). Men who reported recent unprotected anal sex preferred a penile gel product most, followed closely by sexual event‐based pills and LAI. Racial/ethnic differences were noted as well. These findings on product preferences can help in formulation development and messaging.     

A qualitative exploration to understand barriers and facilitators to daily oral PrEP uptake and sustained adherence among HIV‐negative women planning for or with pregnancy in rural Southwestern Uganda

IntroductionAntiretroviral pre‐exposure prophylaxis (PrEP) may reduce periconception and pregnancy HIV incidence among women in settings, where gender power imbalances limit HIV testing, engagement in care and HIV viral suppression. We conducted qualitative interviews to understand factors influencing periconception and pregnancy PrEP uptake and use in a cohort of women (Trial registration: {"type":"clinical-trial","attrs":{"text":"NCT03832530","term_id":"NCT03832530"}}NCT03832530) offered safer conception counselling in rural Southwestern Uganda, where PrEP uptake was high.MethodsBetween March 2018 and January 2019, in‐depth interviews informed by conceptual frameworks for periconception risk reduction and PrEP adherence were conducted with 37 women including those with ≥80% and <80% adherence to PrEP doses measured by electronic pill cap, those who never initiated PrEP, and seven of their male partners. Content and dyadic analyses were conducted to identify emergent challenges and facilitators of PrEP use within individual and couple narratives.ResultsThe median age for women was 33 years (IQR 28, 35), 97% felt likely to acquire HIV and 89% initiated PrEP. Individual‐level barriers included unwillingness to take daily pills while healthy, side effects and alcohol use. Women overcame these barriers through personal desires to have control over their HIV serostatus, produce HIV‐negative children and prevent HIV transmission within partnerships. Couple‐level barriers included nondisclosure, mistrust and gender‐based violence; facilitators included shared goals and perceived HIV protection, which improved communication, sexual intimacy and emotional support within partnerships through a self‐controlled method. Community‐level barriers included multi‐level stigma related to HIV, ARVs/PrEP and serodifference; facilitators included active peer, family or healthcare provider support as women aspired to safely meet socio‐cultural expectations to conceive and preserve serodifferent relationships. Confidence in PrEP effectiveness was promoted by positive peer experiences with PrEP and ongoing HIV testing.ConclusionsMulti‐level forms of HIV‐, serodifference‐ and disclosure‐related stigma, side effects, pill burden, alcohol use, relationship dynamics, social, professional and partnership support towards adaptation and HIV risk reduction influence PrEP uptake and adherence among HIV‐negative women with plans for pregnancy in rural Southwestern Uganda. Confidence in PrEP, individually controlled HIV prevention and improved partnership communication and intimacy promoted PrEP adherence. Supporting individuals to overcome context‐specific barriers to PrEP use may be an important approach to improving uptake and prolonged use.     

Cross‐sectional trends in HIV prevalence among pregnant women in Botswana: an opportunity for PrEP?

IntroductionYoung women in sub‐Saharan Africa are at particularly high risk of HIV acquisition. Recent shifts towards “test and treat” strategies have potential to reduce transmission in this age group but have not been widely studied outside of clinical trials. Using data from nationwide surveillance among pregnant women in Botswana, where a “test and treat” program was implemented in 2016, we describe trends in HIV prevalence over time and highlight opportunities for targeted prevention.MethodsThe Tsepamo study abstracted data from obstetric records of all women delivering at eight government hospitals in Botswana between 2015 and 2019, accounting for 45% of all births in the country (n = 120,755). We used a stratified analysis to identify prevalence trends and evaluated decreases in HIV prevalence over time using the Cochrane–Armitage test for linear trend. A multivariable logistic regression analysis was also performed to identify factors associated with declines in HIV prevalence.ResultsOverall HIV prevalence was 24.1% among 120,755 women who delivered during the study period. Prevalence differed by site of delivery, ranging from 16.1% to 28.2%, and increased markedly with age. Lower educational attainment (adjusted odds ratio [aOR] = 3.28; 95% confidence interval [CI] 3.07–3.50) and being unmarried (aOR = 1.98; 95% CI 1.88–2.08) were associated with HIV infection. HIV prevalence was 10.0% with a first pregnancy, 21.0% with a second and 39.2% with a third or greater (aOR = 2.20; for any prior pregnancy; 95% CI 2.10–2.29). The same age‐adjusted trends were seen when data were limited to women aged 15–24, with a two‐ to three‐fold increase in HIV prevalence between a first and third pregnancy. Prevalence decreased linearly during the 5‐year study period from 25.8% to 22.7% (p <0.001). Among age‐specific strata, the greatest absolute decline occurred in those aged 35–39, with an 8.7% absolute decrease in HIV prevalence from 2015 to 2019. Minimal declines were seen in those 15–24, with a decrease of only 1.5% over the same period.ConclusionsWhile overall trends in Botswana show HIV prevalence declining among pregnant women, prevalence among the youngest age group has remained stagnant. Preventative interventions utilizing pre‐exposure prophylaxis should be prioritized during the high‐risk period surrounding a woman''s first pregnancy.     

Estimating HIV transmissions in a large U.S. clinic‐based sample: effects of time and syndemic conditions

IntroductionLittle is known about onward HIV transmissions from people living with HIV (PLWH) in care. Antiretroviral therapy (ART) has increased in potency, and treatment as prevention (TasP) is an important component of ending the epidemic. Syndemic theory has informed modelling of HIV risk but has yet to inform modelling of HIV transmissions.MethodsData were from 61,198 primary HIV care visits for 14,261 PLWH receiving care through the Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) at seven United States (U.S.) sites from 2007 to 2017. Patient‐reported outcomes and measures (PROs) of syndemic conditions – depressive symptoms, anxiety symptoms, drug use (opiates, amphetamines, crack/cocaine) and alcohol use – were collected approximately four to six months apart along with sexual behaviours (mean = 4.3 observations). Counts of syndemic conditions, HIV sexual risk group and time in care were modelled to predict estimated HIV transmissions resulting from sexual behaviour and viral suppression status (HIV RNA < 400/mL) using hierarchical linear modelling.ResultsPatients averaged 0.38 estimated HIV transmissions/100 patients/year for all visits with syndemic conditions measured (down from 0.83, first visit). The final multivariate model showed that per 100 patients, each care visit predicted 0.05 fewer estimated transmissions annually (95% confidence interval (CI): 0.03 to 0.06; p < 0.0005). Cisgender women, cisgender heterosexual men and cisgender men of undisclosed sexual orientation had, respectively, 0.47 (95% CI: 0.35 to 0.59; p < 0.0005), 0.34 (95% CI: 0.20 to 0.49; p < 0.0005) and 0.22 (95% CI: 0.09 to 0.35; p < 0.005) fewer estimated HIV transmissions/100 patients/year than cisgender men who have sex with men (MSM). Each within‐patient syndemic condition predicted 0.18 estimated transmissions/100 patients/year (95% CI: 0.12 to 0.24; p < 0.0005). Each between‐syndemic condition predicted 0.23 estimated HIV transmissions/100 patients/year (95% CI: 0.17 to 0.28; p < 0.0005).ConclusionsEstimated HIV transmissions among PLWH receiving care in well‐resourced U.S. clinical settings varied by HIV sexual risk group and decreased with time in care, highlighting the importance of TasP efforts. Syndemic conditions remained a significant predictor of estimated HIV transmissions notwithstanding the effects of HIV sexual risk group and time in care.     

Do not forget the children: a model‐based analysis on the potential impact of COVID‐19‐associated interruptions in paediatric HIV prevention and care

IntroductionThe COVID‐19 pandemic has affected women and children globally, disrupting antiretroviral therapy (ART) services and exacerbating pre‐existing barriers to care for both pregnant women and paediatric populations.MethodsWe used the Spectrum modelling package and the CEPAC‐Pediatric model to project the impact of COVID‐19‐associated care disruptions on three key populations in the 21 Global Plan priority countries in sub‐Saharan Africa: (1) pregnant and breastfeeding women living with HIV and their children, (2) all children (aged 0–14 years) living with HIV (CLWH), regardless of their engagement in care and (3) CLWH who were engaged in care and on ART prior to the start of the pandemic. We projected clinical outcomes over the 12‐month period of 1 March 2020 to 1 March 2021.ResultsCompared to a scenario with no care disruption, in a 3‐month lockdown with complete service disruption, followed by 3 additional months of partial (50%) service disruption, a projected 755,400 women would have received PMTCT care (a 21% decrease), 187,800 new paediatric HIV infections would have occurred (a 77% increase) and 516,800 children would have received ART (a 35% decrease). For children on ART as of March 2020, we projected 507,200 would have experienced ART failure (an 80% increase). Additionally, a projected 88,400 AIDS‐related deaths would have occurred (a 27% increase) between March 2020 and March 2021, with 51,700 of those deaths occurring among children engaged in care as of March 2020 (a 54% increase).ConclusionsWhile efforts will continue to curb morbidity and mortality stemming directly from COVID‐19 itself, it is critical that providers also consider the immediate and indirect harms of this pandemic, particularly among vulnerable populations. Well‐informed, timely action is critical to meet the health needs of pregnant women and children if the global community is to maintain momentum towards an AIDS‐free generation.     

Adequate funding of comprehensive community‐based programs for key populations needed now more than ever to reach and sustain HIV targets

IntroductionGlobally, over half of the estimated new HIV infections now occur among key populations, including men who have sex with men, sex workers, people who inject drugs, transgender individuals, and people in prisons and other closed settings, and their sexual partners. Reaching epidemic control will, for many countries, increasingly require intensified programming and targeted resource allocation to meet the needs of key populations and their sexual partners. However, insufficient funding, both in terms of overall amounts and the way the funding is spent, contributes to the systematic marginalization of key populations from needed HIV services.DiscussionThe Joint United Nations Programme on HIV/AIDS (UNAIDS) has recently highlighted the urgent need to take action to end inequalities, including those faced by key populations, which have only been exacerbated by the COVID‐19 pandemic. To address these inequalities and improve health outcomes, key population programs must expand the use of a trusted access platform, scale up differentiated service delivery models tailored to the needs of key populations, rollout structural interventions and ensure service integration. These critical program elements are often considered “extras,” not necessities, and consequently costing studies of key population programs systematically underestimate the total and unitary costs of services for key populations. Findings from a recent costing study from the LINKAGES project suggest that adequate funding for these four program elements can yield benefits in program performance. Despite this and other evidence, the lack of data on the true costs of these elements and the costs of failing to provide them prevents sufficient investment in these critical elements.ConclusionsAs nations strive to reach the 2030 UNAIDS goals, donors, governments and implementers should reconsider the true, but often hidden costs in future healthcare dollars and in lives if they fail to invest in the community‐based and community‐driven key population programs that address structural inequities. Supporting these efforts contributes to closing the remaining gaps in the 95‐95‐95 goals. The financial and opportunity cost of perpetuating inequities and missing those who must be reached in the last mile of HIV epidemic control must be considered.     

A cluster‐randomized controlled trial of a combination HIV risk reduction and microfinance intervention for female sex workers who use drugs in Kazakhstan

IntroductionFemale sex workers (FSW) who use drugs are a key population at risk of HIV in Kazakhstan, and face multiple structural barriers to HIV prevention. More research is needed on the role of structural interventions such as microfinance (MF) in reducing HIV risk. This paper describes the results of a cluster‐randomized controlled trial to test the efficacy of a combination HIVRR + MF intervention in reducing biologically confirmed STIs and HIV risk behaviours.MethodsThis study took place from May 2015 to October 2018 in two cities in Kazakhstan. We screened 763 participants for eligibility and enrolled 354 FSW who use drugs. Participants were randomized in cohorts to receive either a four‐session HIVRR intervention, or that same intervention plus 30 additional sessions of financial literacy training, vocational training and asset‐building through a matched‐savings programme. Repeated behavioural and biological assessments were conducted at baseline, 3‐, 6‐ and 12‐months post‐intervention. Biological and behavioural primary outcomes included HIV/STI incidence, sexual risk behaviours and drug use risk behaviours, evaluated over the 12‐month period.ResultsOver the 12‐month follow‐up period, few differences in study outcomes were noted between arms. There was only one newly‐detected HIV case, and study arms did not significantly differ on any STI incidence. At post‐intervention assessments compared to baseline, both HIVRR and HIVRR + MF participants significantly reduced sexual and drug use risk behaviours, and showed improvements in financial outcomes, condom use attitudes and self‐efficacy, social support, and access to medical care. In addition, HIVRR + MF participants showed a 72% greater reduction in the number of unprotected sex acts with paying partners at the six‐month assessment (IRR = IRR = 0.28, 95% CI = 0.08, 0.92), and a 10% greater reduction in the proportion of income from sex work at the three‐month assessment (b = −0.10, 95% CI = −0.17, −0.02) than HIVRR participants did. HIVRR + MF participants also showed significantly improved performance on financial self‐efficacy compared to HIVRR over the 12‐month follow‐up period.ConclusionsCompared to a combination HIVRR + MF intervention, a robust HIVRR intervention alone may be sufficient to reduce sexual and drug risk behaviours among FSW who use drugs. There may be structural limitations to the promise of microfinance for HIV risk reduction among this population.     

How community ART delivery may improve HIV treatment outcomes: Qualitative inquiry into mechanisms of effect in a randomized trial of community‐based ART initiation,monitoring and re‐supply (DO ART) in South Africa and Uganda

IntroductionUNAIDS fast track targets for ending the AIDS epidemic by 2030 call for viral suppression in 95% of people using antiretroviral therapy (ART) to treat HIV infection. Difficulties in linking to care following a positive HIV test have impeded progress towards meeting treatment targets. Community‐based HIV services may reduce linkage barriers and have been associated with high retention and favourable clinical outcomes. We use qualitative data from The Delivery Optimization of Antiretroviral Therapy (DO ART) Study, a three‐arm randomized trial of community ART initiation, monitoring and re‐supply conducted in western Uganda and KwaZulu‐Natal South Africa, to identify mechanisms through which community ART delivery may improve treatment outcomes, defined as viral suppression in people living with HIV (PLHIV).MethodsWe conducted open‐ended interviews with a purposeful sample of 150 DO ART participants across study arms and study sites, from October 2016 to November 2019. Interviews covered experiences of: (1) HIV testing; (2) initiating and refilling ART; and (3) participating in the DO ART Study. A combined inductive content analytic and thematic approach was used to characterize mechanisms through which community delivery of ART may have contributed to viral suppression in the DO ART trial.ResultsThe analysis yielded four potential mechanisms drawn from qualitative data representing the perspectives and priorities of DO ART participants. Empowering participants to schedule, re‐schedule and select the locations of community‐based visits via easy phone contact with clinical staff is characterized as flexibility. Integration refers to combining the components of clinic‐based visits into single interaction with a healthcare provider. Providers” willingness to talk at length with participants during visits, addressing non‐HIV as well as HIV‐related concerns, is termed “a slower pace”. Finally, increased efficiency denotes the time savings and increased income‐generating opportunities for participants brought about by delivering services in the community.ConclusionsUnderstanding the mechanisms through which HIV service delivery innovations produce an effect is key to transferability and potential scale‐up. The perspectives and priorities of PLHIV can indicate actionable changes for HIV care programs that may increase engagement in care and improve treatment outcomes.     

Optimizing infant HIV diagnosis with additional screening at immunization clinics in three sub‐Saharan African settings: a cost‐effectiveness analysis

IntroductionUptake of early infant HIV diagnosis (EID) varies widely across sub‐Saharan African settings. We evaluated the potential clinical impact and cost‐effectiveness of universal maternal HIV screening at infant immunization visits, with referral to EID and maternal antiretroviral therapy (ART) initiation.MethodsUsing the CEPAC‐Pediatric model, we compared two strategies for infants born in 2017 in Côte d’Ivoire (CI), South Africa (SA), and Zimbabwe: (1) existing EID programmes offering six‐week nucleic acid testing (NAT) for infants with known HIV exposure (EID), and (2) EID plus universal maternal HIV screening at six‐week infant immunization visits, leading to referral for infant NAT and maternal ART initiation (screen‐and‐test). Model inputs included published Ivoirian/South African/Zimbabwean data: maternal HIV prevalence (4.8/30.8/16.1%), current uptake of EID (40/95/65%) and six‐week immunization attendance (99/74/94%). Referral rates for infant NAT and maternal ART initiation after screen‐and‐test were 80%. Costs included NAT ($24/infant), maternal screening ($10/mother–infant pair), ART ($5 to 31/month) and HIV care ($15 to 190/month). Model outcomes included mother‐to‐child transmission of HIV (MTCT) among HIV‐exposed infants, and life expectancy (LE) and mean lifetime per‐person costs for children with HIV (CWH) and all children born in 2017. We calculated incremental cost‐effectiveness ratios (ICERs) using discounted (3%/year) lifetime costs and LE for all children. We considered two cost‐effectiveness thresholds in each country: (1) the per‐capita GDP ($1720/6380/2150) per year‐of‐life saved (YLS), and (2) the CEPAC‐generated ICER of offering 2 versus 1 lifetime ART regimens (e.g. offering second‐line ART; $520/500/580/YLS).ResultsWith EID, projected six‐week MTCT was 9.3% (CI), 4.2% (SA) and 5.2% (Zimbabwe). Screen‐and‐test decreased total MTCT by 0.2% to 0.5%, improved LE by 2.0 to 3.5 years for CWH and 0.03 to 0.07 years for all children, and increased discounted costs by $17 to 22/child (all children). The ICER of screen‐and‐test compared to EID was $1340/YLS (CI), $650/YLS (SA) and $670/YLS (Zimbabwe), below the per‐capita GDP but above the ICER of 2 versus 1 lifetime ART regimens in all countries.ConclusionsUniversal maternal HIV screening at immunization visits with referral to EID and maternal ART initiation may reduce MTCT, improve paediatric LE, and be of comparable value to current HIV‐related interventions in high maternal HIV prevalence settings like SA and Zimbabwe.     

Risk scores for predicting HIV incidence among adult heterosexual populations in sub‐Saharan Africa: a systematic review and meta‐analysis

IntroductionSeveral HIV risk scores have been developed to identify individuals for prioritized HIV prevention in sub‐Saharan Africa. We systematically reviewed HIV risk scores to: (1) identify factors that consistently predicted incident HIV infection, (2) review inclusion of community‐level HIV risk in predictive models and (3) examine predictive performance.MethodsWe searched nine databases from inception until 15 February 2021 for studies developing and/or validating HIV risk scores among the heterosexual adult population in sub‐Saharan Africa. Studies not prospectively observing seroconversion or recruiting only key populations were excluded. Record screening, data extraction and critical appraisal were conducted in duplicate. We used random‐effects meta‐analysis to summarize hazard ratios and the area under the receiver‐operating characteristic curve (AUC‐ROC).ResultsFrom 1563 initial search records, we identified 14 risk scores in 13 studies. Seven studies were among sexually active women using contraceptives enrolled in randomized‐controlled trials, three among adolescent girls and young women (AGYW) and three among cohorts enrolling both men and women. Consistently identified HIV prognostic factors among women were younger age (pooled adjusted hazard ratio: 1.62 [95% confidence interval: 1.17, 2.23], compared to above 25), single/not cohabiting with primary partners (2.33 [1.73, 3.13]) and having sexually transmitted infections (STIs) at baseline (HSV‐2: 1.67 [1.34, 2.09]; curable STIs: 1.45 [1.17; 1.79]). Among AGYW, only STIs were consistently associated with higher incidence, but studies were limited (n = 3). Community‐level HIV prevalence or unsuppressed viral load strongly predicted incidence but was only considered in 3 of 11 multi‐site studies. The AUC‐ROC ranged from 0.56 to 0.79 on the model development sets. Only the VOICE score was externally validated by multiple studies, with pooled AUC‐ROC 0.626 [0.588, 0.663] (I ²: 64.02%).ConclusionsYounger age, non‐cohabiting and recent STIs were consistently identified as predicting future HIV infection. Both community HIV burden and individual factors should be considered to quantify HIV risk. However, HIV risk scores had only low‐to‐moderate discriminatory ability and uncertain generalizability, limiting their programmatic utility. Further evidence on the relative value of specific risk factors, studies populations not restricted to “at‐risk” individuals and data outside South Africa will improve the evidence base for risk differentiation in HIV prevention programmes.PROSPERO NumberCRD42021236367     

HIV treatment outcomes among people who acquired HIV via injecting drug use in the Asia‐Pacific region: a longitudinal cohort study

INTRODUCTIONData on HIV treatment outcomes in people who inject drugs (PWID) in the Asia‐Pacific are sparse despite the high burden of drug use. We assessed immunological and virological responses, AIDS‐defining events and mortality among PWID receiving antiretroviral therapy (ART).METHODSWe investigated HIV treatment outcomes among people who acquired HIV via injecting drug use in the TREAT Asia HIV Observational Database (TAHOD) between January 2003 and March 2019. Trends in CD4 count and viral suppression (VS, HIV viral load <1000 copies/mL) were assessed. Factors associated with mean CD4 changes were analysed using repeated measures linear regression, and combined AIDS event and mortality were analysed using survival analysis.RESULTSOf 622 PWID from 12 countries in the Asia‐Pacific, 93% were male and the median age at ART initiation was 31 years (IQR, 28 to 34). The median pre‐ART CD4 count was 71 cells/µL. CD4 counts increased over time, with a mean difference of 401 (95% CI, 372 to 457) cells/µL at year‐10 (n = 78). Higher follow‐up HIV viral load and pre‐ART CD4 counts were associated with smaller increases in CD4 counts. Among 361 PWID with ≥1 viral load after six months on ART, proportions with VS were 82%, 88% and 93% at 2‐, 5‐ and 10‐years following ART initiation. There were 52 new AIDS‐defining events and 50 deaths during 3347 person‐years of follow‐up (PYS) (incidence 3.05/100 PYS, 95% CI, 2.51 to 3.70). Previous AIDS or TB diagnosis, lower current CD4 count and adherence <95% were associated with combined new AIDS‐defining event and death.CONCLUSIONSDespite improved outcomes over time, our findings highlight the need for rapid ART initiation and adherence support among PWID within Asian settings.