Optimizing HIV retesting during pregnancy and postpartum in four countries: a cost‐effectiveness analysis

IntroductionHIV retesting during late pregnancy and breastfeeding can help detect new maternal infections and prevent mother‐to‐child HIV transmission (MTCT), but the optimal timing and cost‐effectiveness of maternal retesting remain uncertain.MethodsWe constructed deterministic models to assess the health and economic impact of maternal HIV retesting on a hypothetical population of pregnant women, following initial testing in pregnancy, on MTCT in four countries: South Africa and Kenya (high/intermediate HIV prevalence), and Colombia and Ukraine (low HIV prevalence). We evaluated six scenarios with varying retesting frequencies from late in antenatal care (ANC) through nine months postpartum. We compared strategies using incremental cost‐effectiveness ratios (ICERs) over a 20‐year time horizon using country‐specific thresholds.ResultsWe found maternal retesting once in late ANC with catch‐up testing through six weeks postpartum was cost‐effective in Kenya (ICER = $166 per DALY averted) and South Africa (ICER=$289 per DALY averted). This strategy prevented 19% (Kenya) and 12% (South Africa) of infant HIV infections. Adding one or two additional retests postpartum provided smaller benefits (1 to 2 percentage point increase in infections averted versus one retest). Adding three retests during the postpartum period averted additional infections (1 to 3 percentage point increase in infections averted versus one retest) but ICERs ($7639 and in Kenya and $11 985 in South Africa) greatly exceeded the cost‐effectiveness thresholds. In Colombia and Ukraine, all retesting strategies exceeded the cost‐effectiveness threshold and prevented few infant infections (up to 31 and 5 infections, respectively).ConclusionsIn high HIV burden settings with MTCT rates similar to those seen in Kenya and South Africa, HIV retesting once in late ANC, with subsequent intervention, is the most cost‐effective strategy for preventing infant HIV infections. In these settings, two HIV retests postpartum marginally reduced MTCT and were less costly than adding three retests. Retesting in low‐burden settings with MTCT rates similar to Colombia and Ukraine was not cost‐effective at any time point due to very low HIV prevalence and limited breastfeeding.     

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

IntroductionPregnant 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.MethodsWe 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.ResultsOf 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).ConclusionsMTCT 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.     

24‐Month HIV‐free survival among HIV‐exposed Infants in Lesotho: the PEAWIL cohort study

IntroductionFollowing the implementation of the provision of lifelong antiretroviral therapy to all HIV‐positive pregnant or breastfeeding women for prevention of mother‐to‐child transmission (PMTCT) of HIV by the Kingdom of Lesotho in 2013, we assessed the effectiveness of this approach by evaluating 24‐month HIV‐free survival among HIV‐exposed infants (HEIs).MethodsWe conducted a prospective observational cohort study that enrolled HIV‐positive and HIV‐negative pregnant women, with follow‐up of women and their infants for 24 months after delivery. Participant recruitment started in June 2014 and follow‐up ended in September 2018. Trained nurses collected study information through patient interviews and chart abstraction at enrolment and every three to six months thereafter. Maternal HIV testing, infant mortality, HIV transmission and HIV‐free survival rates were computed using Kaplan–Meier estimation. Cox regression hazard models were used to identify factors associated with infant HIV infection and death.ResultsBetween June 2014 and February 2016, we enrolled 653 HIV‐positive and 941 HIV‐negative pregnant women. Twenty‐seven HIV‐negative women acquired HIV during follow‐up. Ultimately, 634 liveborn HEI (382 (52%) male, 303 (48%) female, 3 missing) and 839 who remained HIV‐unexposed (HUIs) (409 (49.0%) male, 426 (51.0%) female, 4 missing) were followed; 550 HEIs and 701 HUIs completed the 24‐month follow‐up period. Of 607 (95.7%) HEIs who were tested for HIV at least once during follow‐up, 17 were found to be HIV‐positive. Two (9.5%) of 21 infants born to mothers who acquired HIV infection during follow‐up were HIV‐positive compared to 15 (2.4%) of 613 HEI born to women with known HIV infection. The risk of HIV transmission from HIV‐positive mothers to their infants by 24 months of age was 2.9% (95% CI: 1.8 to 4.7). The estimated 24‐month mortality rate among HEIs was 6.0% (95% CI: 4.4 to 8.2) compared to 3.8% (95% CI: 2.6 to 5.3) among HUIs (Log‐rank p = 0.065). HIV‐free survival at 24 months was 91.8% (95% CI: 89.2 to 93.7). Lower maternal age and birth weight were independently associated with increased HIV infection or death of infants.ConclusionsThe implementation of lifelong ART for PMTCT in the Lesotho public health system resulted in low HIV transmission, but survival of HEI remains lower than their HIV uninfected counterparts.     

Acceleration of differentiated service delivery for HIV treatment in sub‐Saharan Africa during COVID‐19

IntroductionIn response to COVID‐19, national ministries of health adapted HIV service delivery guidelines to ensure uninterrupted access to antiretroviral therapy (ART) and limit the frequency of contact with health facilities. In this commentary, we summarize four ways in which differentiated service delivery (DSD) for HIV treatment has been accelerated during COVID‐19 in policy and implementation in sub‐Saharan Africa (SSA) – (i) expanding eligibility for DSD for HIV treatment, (ii) extending multi‐month dispensing (MMD) and reducing the frequency of clinical consultations, (iii) emphasizing community‐based models and (iv) integrating/aligning with TB preventative therapy (TPT), non‐communicable disease (NCD) treatments and family planning commodities.DiscussionAcross SSA in 2020, countries both adapted and emphasized policies supporting DSD for HIV treatment in response to COVID‐19. Access to DSD for HIV treatment was expanded by reducing the time required on ART before eligibility and being more inclusive of specific populations including children and adolescents, pregnant and breastfeeding women and those on second‐ and third‐line regimens. Access to extended ART refills, or MMD, was accelerated across many countries. A renewed focus was given to out‐of‐facility community‐based models of ART distribution. In some settings, there was acknowledgement of the need to integrate or align other chronic medications with ART.ConclusionsAdaptations to DSD for HIV treatment in response to COVID‐19 have resulted in rapid policy change and in some cases, acceleration of implementation in SSA. As the COVID‐19 pandemic evolves, there is a critical need to assess the impact of these adaptations and, where beneficial, ensure that policies implemented in response to COVID‐19 become the new normal.     

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.     

A multi‐country cross‐sectional study to assess predictors of daily versus on‐demand oral pre‐exposure prophylaxis in youth from South Africa,Uganda and Zimbabwe

IntroductionSub‐Saharan Africa (SSA) carries the burden of the HIV epidemic, especially among adolescents and young people (AYP). Little is known about pre‐exposure prophylaxis (PrEP) uptake and preferences among AYP in SSA. We describe preferences for daily and on‐demand PrEP among AYP in South Africa, Uganda and Zimbabwe.MethodsA cross‐sectional survey was conducted in 2019 among 13‐ to 24‐year olds, capturing socio‐demographics, HIV risk behaviours and preferences for daily or on‐demand PrEP. Logistic regression models were used to estimate odds ratios, adjusting for site, sex and age.Results and discussionA total of 1330 participants from Cape Town (n = 239), Johannesburg (n = 200), Entebbe (n = 491) and Chitungwiza (n = 400) were enrolled; 673 (51%) were male, and the median age was 19 years (interquartile range 17–22 years). Of 1287 participants expressing a preference, 60% indicated a preference for on‐demand PrEP with differences by site (p < 0.001), sex (p < 0.001) and age group (p = 0.003). On‐demand PrEP was most preferred in Entebbe (75%), among males (65%) versus females (54%) and in older participants (62% in 18‐ to 24‐year‐olds vs. 47% in 13‐ to 15‐year‐olds). After adjusting for site, sex and age group, preference for on‐demand PrEP decreased as sex frequency over the past month increased (p‐trend = 0.004) and varied with the number of partners in the last 6 months, being least popular among those reporting four or more partners (p = 0.02). Participants knowing further in advance that they were likely to have sex were more likely to prefer on‐demand PrEP (p‐trend = 0.02). Participants having a larger age gap with their most recent partner and participants whose last partner was a transactional sex partner or client were both less likely to prefer on‐demand compared to daily PrEP (p = 0.05 and p = 0.09, respectively). Participants who knew their most recent partner was living with HIV or who did not know the HIV status of their most recent partner were less likely to prefer on‐demand PrEP (p = 0.05).ConclusionsOur data show that AYP in four SSA communities prefer on‐demand over daily PrEP options, with differences seen by site, age and sex. PrEP demand creation needs to be reviewed, optimized and tailored to socio‐demographic differences and designed in conjunction with AYP.     

Improved detection and management of advanced HIV disease through a community adult TB‐contact tracing intervention with same‐day provision of the WHO‐recommended package of care including ART initiation in a rural district of Mozambique

IntroductionAIDS‐mortality remains unacceptably high in sub‐Saharan Africa, largely driven by advanced HIV disease (AHD). We nested a study in an existing tuberculosis (TB) contact‐tracing intervention (Xpatial‐TB). The aim was to assess the burden of AHD among high‐risk people living with HIV (PLHIV) identified and to evaluate the provision of the WHO‐recommended package of care to this population.MethodsAll PLHIV ≥14 years old identified between June and December 2018 in Manhiça District by Xpatial‐TB were offered to participate in the study if ART naïve or had suboptimal ART adherence. Consenting individuals were screened for AHD. Patients with AHD (CD4 < 200 cells/μL or WHO stage 3 or 4) were offered a package of interventions in a single visit, including testing for cryptococcal antigen (CrAg) and TB‐lipoarabinomannan (TB‐LAM), prophylaxis and treatment for opportunistic infections, adherence support or accelerated ART initiation. We collected information on follow‐up visits carried out under routine programmatic conditions for six months.ResultsA total of 2881 adults were identified in the Xpatial TB‐contact intervention. Overall, 23% (673/2881) were HIV positive, including 351 TB index (64.2%) and 322 TB contacts (13.8%). Overall, 159/673 PLHIV (24%) were ART naïve or had suboptimal ART adherence, of whom 155 (97%, 124 TB index and 31 TB‐contacts) consented to the study and were screened for AHD. Seventy percent of TB index‐patients (87/124) and 16% of TB contacts (5/31) had CD4 < 200 cells/µL. Four (13%) of the TB contacts had TB, giving an overall AHD prevalence among TB contacts of 29% (9/31). Serum‐CrAg was positive in 4.6% (4/87) of TB‐index patients and in zero TB contacts. All ART naïve TB contacts without TB initiated ART within 48 hours of HIV diagnosis. Among TB cases, ART timing was tailored to the presence of TB and cryptococcosis. Six‐month mortality was 21% among TB‐index cases and zero in TB contacts.ConclusionsA TB contact‐tracing outreach intervention identified undiagnosed HIV and AHD in TB patients and their contacts, undiagnosed cryptococcosis among TB patients, and resulted in an adequate provision of the WHO‐recommended package of care in this rural Mozambican population. Same‐day and accelerated ART initiation was feasible and safe in this population including among those with AHD.     

Point‐of‐care testing can achieve same‐day diagnosis for infants and rapid ART initiation: results from government programmes across six African countries

IntroductionPoint‐of‐care (POC) early infant diagnosis (EID) testing has been shown to dramatically decrease turnaround times from sample collection to caregiver result receipt and time to ART initiation for HIV‐positive infants compared to centralized laboratory testing. As governments in sub‐Saharan Africa implement POC EID technologies, we report on the feasibility and effectiveness of POC EID testing and the impact of same‐day result delivery on rapid ART initiation within national programmes across six countries.MethodsThis pre‐/post‐evaluation compared centralized laboratory‐based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country‐dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time‐to‐event outcomes, visualized with Kaplan–Meier curves, and the Somers’ D test was used to compare continuous outcomes.ResultsData were collected for 2892 EID tests conducted on centralized laboratory‐based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV‐positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV‐positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV‐positive infants with a same‐day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85).ConclusionsSame‐day diagnosis and treatment initiation for infants is possible with POC EID within routine government‐led and ‐supported public sector healthcare facilities in resource‐limited settings. Given that POC EID allows for rapid ART initiation, aligning to the World Health Organization’s recommendation of ART initiation within seven days, its use in public sector programmes has the potential to reduce overall mortality for infants with HIV through early treatment initiation.     

Pathways for reduction of HIV‐related stigma: a model derived from longitudinal qualitative research in Kenya and Uganda

IntroductionThe rollout of antiretroviral therapy (ART) has been associated with reductions in HIV‐related stigma, but pathways through which this reduction occurs are poorly understood. In the newer context of universal test and treat (UTT) interventions, where rapid diffusion of ART uptake takes place, there is an opportunity to understand the processes through which HIV‐related stigma can decline, and how UTT strategies may precipitate more rapid and widespread changes in stigma. This qualitative study sought to evaluate how a UTT intervention influenced changes in beliefs, attitudes and behaviours related to HIV.MethodsLongitudinal qualitative in‐depth semi‐structured interview data were collected within a community‐cluster randomized UTT trial, the Sustainable East Africa Research in Community Health (SEARCH) study, annually over three rounds (2014 to 2016) from two cohorts of adults (n = 32 community leaders, and n = 112 community members) in eight rural communities in Uganda and Kenya. Data were inductively analysed to develop new theory for understanding the pathways of stigma decline.ResultsWe present an emergent theoretical model of pathways through which HIV‐related stigma may decline: internalized stigma may be reduced by two processes accelerated through the uptake and successful usage of ART: first, a reduced fear of dying and increased optimism for prolonged and healthy years of life; second, a restoration of perceived social value and fulfilment of subjective role expectations via restored physical strength and productivity. Anticipated stigma may be reduced in response to widespread engagement in HIV testing, leading to an increasing number of HIV status disclosures in a community, “normalizing” disclosure and reducing fears. Improvements in the perceived quality of HIV care lead to people living with HIV (PLHIV) seeking care in nearby facilities, seeing other known community members living with HIV, reducing isolation and facilitating opportunities for social support and “solidarity.” Finally, enacted stigma may be reduced in response to the community viewing the healthy bodies of PLHIV successfully engaged in treatment, which lessens the fears that trigger enacted stigma; it becomes no longer socially normative to stigmatize PLHIV. This process may be reinforced through public health messaging and anti‐discrimination laws.ConclusionsDeclines in HIV‐related stigma appear to underway and explained by social processes accelerated by UTT efforts. Widespread implementation of UTT shows promise for reducing multiple dimensions of stigma, which is critical for improving health outcomes among PLHIV.     

The efficacy and cost‐effectiveness of a family‐based economic empowerment intervention (Suubi + Adherence) on suppression of HIV viral loads among adolescents living with HIV: results from a Cluster Randomized Controlled Trial in southern Uganda

IntroductionEvidence from low‐resource settings indicates that economic insecurity is a major barrier to HIV treatment adherence. Economic empowerment (EE) interventions have the potential to improve adherence outcomes among adolescents living with HIV (ALWHIV) by mitigating the effects of poverty. This study aims to assess the efficacy and cost‐effectiveness of a savings‐led family‐based EE intervention, Suubi + Adherence, aimed at improving antiretroviral therapy (ART) adherence outcomes ALWHIV in Uganda.MethodsAdolescents (mean age 12 years at enrolment; 56% female) receiving ART for HIV at 39 health centres were randomized to Suubi + Adherence intervention (n = 358) or bolstered standard of care (BSOC; n = 344). A difference‐in‐differences analysis was employed to assess the change in the proportion of virally suppressed adolescents (HIV RNA viral load <40 copies/mL) over 24 months. The cost‐effectiveness analysis examined how much the intervention cost to virally suppress one additional adolescent relative to BSOC from the healthcare provider perspective.ResultsAt 24 months, the intervention was associated with an 8.85‐percentage point [95% confidence interval (CI) 0.80 to 16.90 percentage points] increase in the proportion of virally suppressed adolescents between the study arms (p = 0.032). Per‐participant costs were US$177 and US$263 for the BSOC and intervention groups respectively. The incremental cost of virally suppressing one additional adolescent was estimated at US$970 [95% CI, US$508 to 10,725] over two years.ConclusionsOur results support the integration of family‐based EE interventions into adherence‐support strategies as part of routine HIV care in low‐resource settings to address the underlying economic drivers of poor ART adherence among ALWHIV. Moreover, per‐participant costs to achieve viral suppression do not seem prohibitive compared to other community‐based adherence interventions targeted at ALWHIV in low‐resource settings. Further research on combination interventions at the nexus of economic security and HIV treatment and care is needed to inform the development of feasible and scalable HIV policies and programmes.     

Trends in demographic and clinical characteristics and initiation of antiretroviral therapy among adult patients enrolling in HIV care in the Central Africa International epidemiology Database to Evaluate AIDS (CA‐IeDEA) 2004 to 2018

IntroductionThe Central Africa International epidemiology Database to Evaluate AIDS (CA‐IeDEA) is an open observational cohort study investigating impact, progression and long‐term outcomes of HIV/AIDS among people living with HIV (PLWH) in Burundi, Cameroon, Democratic Republic of Congo (DRC), Republic of Congo (ROC) and Rwanda. We describe trends in demographic, clinical and immunological characteristics as well as antiretroviral therapy (ART) use of patients aged > 15 years entering into HIV care in the participating CA‐IeDEA site.MethodsInformation on sociodemographic characteristics, height, weight, body mass index (BMI), CD4 cell count, WHO staging and ART status at entry into care from 2004 through 2018 were extracted from clinic records of patients aged > 15 years enrolling in HIV care at participating clinics in Burundi, Cameroon, DRC, ROC and Rwanda. We assessed trends in patient characteristics at enrolment in HIV care including ART initiation within the first 30 days after enrolment in care and calculated proportions, means and medians (interquartile ranges) for the main variables of interest.ResultsAmong 69,176 patients in the CA‐IeDEA cohort, 39% were from Rwanda, 24% from ROC, 18% from Cameroon, 14% from Burundi and 5% from DRC. More women (66%) than men enrolled in care and subsequently initiated ART. Women were also younger than men (32 vs. 38 years, P < 0.001) at enrolment and at ART initiation. Trends over time show increases in median CD4 cell count at enrolment from 190 cells/µL in 2004 to 334 cells/µL in 2018 at enrolment. Among those with complete data on CD4 counts (60%), women had a higher median CD4 cell count at care entry than men (229 vs. 249 cells/µL, P < 0.001). Trends in the proportion of patients using ART within 30 days of enrolment at the participating site show an increase from 16% in 2004 to 75% in 2018.ConclusionsTrends from 2004 to 2018 in the characteristics of patients participating in the CA‐IeDEA cohort highlight improvements at entry into care and subsequent ART initiation including after the implementation of Treat All guidelines in the participating sites.     

A cluster‐randomized controlled trial to improve the quality of integrated HIV‐tuberculosis services in primary healthcareclinics in South Africa

Introduction: Tuberculosis (TB) remains the most common cause of death among people living with HIV. Integrating HIV and TB services reduces mortality but is sub‐optimally implemented. Quality improvement (QI) methods offer a low‐cost and easily implementable approach to strengthening healthcare delivery systems. This trial assessed a QI intervention on key process indicators for delivering integrated HIV‐TB care in rural South African primary healthcare (PHC) clinics.MethodsSixteen nurse supervisors, (each with a cluster of clinics) overseeing 40 PHC clinics, were randomized 1:1 to the intervention or the standard of care (SOC) groups. The QI intervention comprised three key components: clinical and QI skills training, on‐site mentorship of nurse supervisors and clinic staff, and data quality improvement activities to enhance accuracy and completeness of routine clinic data. The SOC comprised monthly supervision and data feedback meetings. From 01 December 2016 to 31 December 2018, data were collected monthly by a team of study‐appointed data capturers from all study clinics. This study''s outcomes were HIV testing services (HTS), TB screening, antiretroviral therapy (ART) initiation, isoniazid preventive therapy (IPT) initiation and viral load (VL) testing.ResultsThe QI group (eight clusters) comprised 244 clinic staff who attended to 13,347 patients during the trial compared to the SOC group (eight clusters) with 217 clinic staff who attended to 8141 patients. QI mentors completed 85% (510/600) of expected QI mentorship visits to QI clinics. HTS was 19% higher [94.5% vs. 79.6%; relative risk (RR)=1.19; 95% CI: 1.02–1.38; p=0.029] and IPT initiation was 66% higher (61.2 vs. 36.8; RR=1.66; 95% CI: 1.02–2.72; p=0·044), in the QI group compared to SOC group. The percentage of patients screened for TB (83.4% vs. 79.3%; RR=1.05; p=0.448), initiated on ART (91.7 vs. 95.5; RR=0.96; p=0.172) and VL testing (72.2% vs. 72.8%; RR=0.99; p=0.879) was similar in both groups.ConclusionsQI improved HIV testing and IPT initiation compared to SOC. TB screening, ART initiation and VL testing remained similar. Incorporating QI methods into routine supervision and support activities may strengthen integrated HIV‐TB service delivery and increase the success of future QI scale‐up activities.     

HIV self‐testing partially filled the HIV testing gap among men who have sex with men in China during the COVID‐19 pandemic: results from an online survey

IntroductionHIV self‐testing (HIVST) is a useful strategy to promote HIV testing among key populations. This study aimed to understand HIV testing behaviours among men who have sex with men (MSM) and specifically how HIVST was used during the coronavirus disease 2019 (COVID‐19) measures in China when access to facility‐based testing was limited.MethodsAn online cross‐sectional study was conducted to recruit men who have sex with men (MSM) in China from May to June of 2020, a period when COVID‐19 measures were easing. Data on socio‐demographic characteristics, sexual behaviours and HIV testing in the three months before and during COVID‐19 measures (23 January 2020) were collected. Chi‐square test and logistic regression were used for analyses.ResultsOverall, 685 MSM were recruited from 135 cities in 30 provinces of China, whose mean age was 28.8 (SD: 6.9) years old. The majority of participants self‐identified as gay (81.9%) and had disclosed their sexual orientation (66.7%). In the last three months, 69.6% ever had sex with men, nearly half of whom had multiple sexual partners (47.2%). Although the overall HIV testing rates before and during COVID‐19 measures were comparable, more MSM self‐tested for HIV during COVID‐19 measures (52.1%) compared to before COVID‐19 measures (41.6%, p = 0.038). Fewer MSM used facility‐based HIV testing during COVID‐19 measures (42.9%) compared to before COVID‐19 measures (54.1%, p = 0.038). Among 138 facility‐based testers before COVID‐19 measures, 59.4% stopped facility‐based testing during COVID‐19 measures. Among 136 self‐testers during COVID‐19 measures, 58.1% had no HIV self‐testing before COVID‐19 measures. Multivariable logistic regression showed that having sex with other men in the last three months (adjusted odds ratio, aOR = 2.04, 95% CI: 1.38 to 3.03), self‐identifying as gay (aOR = 2.03, 95% CI: 1.31 to 3.13), ever disclosing their sexual orientation (aOR = 1.72, 95% CI: 1.19 to 2.50) and tested for HIV in three months before COVID‐19 measures (aOR = 4.74, 95% CI: 3.35 to 6.70) were associated with HIV testing during COVID‐19 measures.ConclusionsFacility‐based HIV testing decreased and HIVST increased among MSM during COVID‐19 measures in China. MSM successfully accessed HIVST as substitute for facility‐based testing, with no overall decrease in HIV testing rates.     

Mitigation strategies to safely conduct HIV treatment research in the context of COVID‐19

IntroductionThe International AIDS Society convened a multidisciplinary committee of experts in December 2020 to provide guidance and key considerations for the safe and ethical management of clinical trials involving people living with HIV (PLWH) during the SARS‐CoV‐2 pandemic. This consultation did not discuss guidance for the design of prevention studies for people at risk of HIV acquisition, nor for the programmatic delivery of antiretroviral therapy (ART).DiscussionThere is strong ambition to continue with HIV research from both PLWH and the research community despite the ongoing SARS‐CoV‐2 pandemic. How to do this safely and justly remains a critical debate. The SARS‐CoV‐2 pandemic continues to be highly dynamic. It is expected that with the emergence of effective SARS‐CoV‐2 prevention and treatment strategies, the risk to PLWH in clinical trials will decline over time. However, with the emergence of more contagious and potentially pathogenic SARS‐CoV‐2 variants, the effectiveness of current prevention and treatment strategies may be compromised. Uncertainty exists about how equally SARS‐CoV‐2 prevention and treatment strategies will be available globally, particularly for marginalized populations, many of whom are at high risk of reduced access to ART and/or HIV disease progression. All of these factors must be taken into account when deciding on the feasibility and safety of developing and implementing HIV research.ConclusionsIt can be assumed for the foreseeable future that SARS‐CoV‐2 will persist and continue to pose challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment studies will evolve accordingly. The risks and benefits of performing an HIV clinical trial must be carefully evaluated in the local context on an ongoing basis. With this document, we hope to provide a broad guidance that should remain viable and relevant even as the nature of the pandemic continues to develop.     

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.     

Health‐related quality of life of female sex workers living with HIV in South Africa: a cross‐sectional study

IntroductionHealth‐related quality of life (HRQoL) is an important HIV outcome beyond viral suppression. However, there are limited data characterizing HRQoL of key populations, including female sex workers (FSW) living with HIV.MethodsWe used baseline data (22 June 2018–23 March 2020) of FSW who were diagnosed with HIV and enrolled into a randomized trial in Durban, South Africa. HRQoL information was collected by a generic preference‐accompanied tool with five domains (EQ‐5D), and summarized into a single score (range 0–1), which represents health utility. We employed multivariable beta regression models to identify determinants of HRQoL and to estimate subgroup‐specific HRQoL score. Using external estimates of life expectancy and population size, we estimated the number of quality adjusted life years reduced among FSW living with HIV in South Africa associated with violence and drug use.ResultsOf 1,363 individuals (mean age: 32.4 years; mean HRQoL score: 0.857) in our analysis, 62.6% used drugs, 61.3% experienced physical or sexual violence and 64.6% self‐reported taking antiretroviral treatment (ART). The following were associated with a reduction in the average marginal HRQoL score: older age (per decade: 0.018 [95% confidence interval (CI): 0.008, 0.027]), drug use (0.022 [0.007, 0.036]), experience of violence (0.024 [0.010, 0.038]) and moderate (vs. no) level of internalized stigma (0.023 [0.004, 0.041]). Current ART use was associated with a 0.015‐point (–0.001, 0.031) increase in the HRQoL score. The estimated mean (95% CI) HRQoL scores ranged from 0.838 (0.816, 0.860) for FSW who used drugs, experienced violence and were not on ART; to 0.899 (0.883, 0.916) for FSW who did not use drugs nor experience violence and were on ART. Our results can be translated into a reduction in 37,184 and 39,722 quality adjusted life years related to drug use and experience of violence, respectively, in South Africa.ConclusionsThese results demonstrate the association of ART with higher HRQoL among FSW and the need to further address structural risks, including drug use, violence and stigma. Population‐specific estimates of HRQoL score can be further used to calculate quality‐adjusted life years in economic evaluations of individual and structural interventions addressing the needs of FSW living with HIV.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT03500172","term_id":"NCT03500172"}}NCT03500172 (April 17, 2018).     

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