Disrupting the status quo to achieve early inclusion of pregnant women in studies of new agents for prevention and treatment of HIV infection
In: Journal of the International AIDS Society, Band 25, Heft S2
ISSN: 1758-2652
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In: Journal of the International AIDS Society, Band 25, Heft S2
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 18, Heft 7S6
ISSN: 1758-2652
IntroductionThe new "90‐90‐90" UNAIDS agenda proposes that 90% of all people living with HIV will know their HIV status, 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy and 90% of all people receiving antiretroviral therapy will have viral suppression by 2020. By focusing on children, the global community is in the unique position of realizing an end to the paediatric HIV epidemic.DiscussionDespite vast scientific advances in the prevention and treatment of paediatric HIV infection over the last two decades, in 2014 there were an estimated 220,000 new paediatric infections attributed to mother‐to‐child HIV transmission (MTCT) and 150,000 HIV‐related paediatric deaths. Furthermore, adolescents remain at particularly high risk for acquisition of new HIV infections, and HIV/AIDS remains the second leading cause of death in this age group. Among the estimated 2.6 million children less than 15 years of age living with HIV infection, only 32% were receiving life‐saving antiretroviral treatment. After decades of languishing, good progress is now being made to prevent MTCT. Unfortunately, efforts to scale up HIV treatment services have been less robust for children and adolescents compared with adult populations. These discrepancies reflect substantial gaps in essential services and numerous missed opportunities to prevent HIV transmission and provide effective life‐saving antiretroviral treatment to children, adolescents and families. The road to an AIDS‐free generation will require bridging the gaps in HIV services and addressing the particular needs of children across the developmental spectrum from infancy through adolescence. To reach the ambitious new targets, innovations and service improvements will need to be rapidly escalated at each step along the prevention‐treatment cascade.ConclusionsCharting a successful course to reach the 90‐90‐90 targets will require sustained political and financial commitment as well as the rapid implementation of a broad set of systematic improvements in service delivery. The prospect of a world where HIV no longer threatens the lives of infants, children and adolescents may finally be within reach.
In: Journal of the International AIDS Society, Band 25, Heft 9
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 19, Heft 1
ISSN: 1758-2652
IntroductionThe tremendous success of antiretroviral therapy has resulted in a diminishing population of perinatally HIV‐infected children on the one hand and a mounting number of HIV‐exposed uninfected (HEU) children on the other. As the oldest of these HEU children are reaching adolescence, questions have emerged surrounding the implications of HEU status disclosure to these adolescents. This article outlines the arguments for and against disclosure of a child's HEU status.DiscussionDisclosure of a child's HEU status, by definition, requires disclosure of maternal HIV status. It is necessary to weigh the benefits and harms which could occur with disclosure in each of the following domains: psychosocial impact, long‐term physical health of the HEU individual and the public health impact. Does disclosure improve or worsen the psychological health of the HEU individual and extended family unit? Do present data on the long‐term safety of in utero HIV/ARV exposure reveal potential health risks which merit disclosure to the HEU adolescent? What research and public health programmes or systems need to be in place to afford monitoring of HEU individuals and which, if any, of these require disclosure?ConclusionsAt present, it is not clear that there is sufficient evidence on whether long‐term adverse effects are associated with in utero HIV/ARV exposures, making it difficult to mandate universal disclosure. However, as more countries adopt electronic medical record systems, the HEU status of an individual should be an important piece of the health record which follows the infant not only through childhood and adolescence but also adulthood. Clinicians and researchers should continue to approach the dialogue around mother–child disclosure with sensitivity and a cogent consideration of the evolving risks and benefits as new information becomes available while also working to maintain documentation of an individual's perinatal HIV/ARV exposures as a vital part of his/her medical records. As more long‐term adult safety data on in utero HIV/ARV exposures become available these decisions may become clearer, but at this time, they remain complex and multi‐faceted.
In: Journal of the International AIDS Society, Band 13, Heft S2
ISSN: 1758-2652
BackgroundPrevention of mother to child transmission (PMTCT) programmes have traditionally been narrow in scope, targeting biomedical interventions during the perinatal period, rather than considering HIV as a family disease. This limited focus restricts programmes' effectiveness, and the opportunity to broaden prevention measures has largely been overlooked.Although prevention of vertical transmission is crucial, consideration of the family environment can enhance PMTCT. Family‐centred approaches to HIV prevention and care present an important direction for preventing paediatric infections while improving overall family health. This paper reviews available literature on PMTCT programmatic models that have taken a broader or family‐centred approach. We describe findings and barriers to the delivery of family‐centred PMTCT and identify a number of promising new directions that may achieve more holistic services for children and families.MethodsLiterature on the effectiveness of family‐centred PMTCT interventions available via PubMed, EMBASE and PsycINFO were searched from 1990 to the present. Four hundred and three abstracts were generated. These were narrowed to those describing or evaluating PMTCT models that target broader aspects of the family system before, during and/or after delivery of an infant at risk of acquiring HIV infection (N = 14).ResultsThe most common aspects of family‐centred care incorporated by PMTCT studies and programme models included counselling, testing, and provision of antiretroviral treatment for infected pregnant women and their partners. Antiretroviral therapy was also commonly extended to other infected family members. Efforts to involve fathers in family‐based PMTCT counselling, infant feeding counselling, and general decision making were less common, though promising. Also promising, but rare, were PMTCT programmes that use interventions to enrich family capacity and functioning; these include risk assessments for intimate partner violence, attention to mental health issues, and the integration of early childhood development services.ConclusionsDespite barriers, numerous opportunities exist to expand PMTCT services to address the health needs of the entire family. Our review of models utilizing these approaches indicates that family‐centred prevention measures can be effectively integrated within programmes. However, additional research is needed in order to more thoroughly evaluate their impact on PMTCT, as well as on broader family health outcomes.
In: Journal of the International AIDS Society, Band 20, Heft S6
ISSN: 1758-2652
AbstractIntroduction: Rapid diagnostic tests (RDTs) are the primary diagnostic tools for HIV used in resource‐constrained settings. Without a proper confirmation algorithm, there is concern that false‐positive (FP) RDTs could result in misdiagnosis of HIV infection and inappropriate antiretroviral treatment (ART) initiation, but programmatic data on FP are few.Methods: We examined the accuracy of RDT diagnosis among HIV‐infected pregnant women attending public sector antenatal services in Cape Town, South Africa. We describe the proportion of women found to have started on ART erroneously due to FP RDT results based on pre‐ART viral load (VL) testing and enzyme‐linked immunosorbent assay (ELISA).Results: We analysed 952 consecutively enrolled pregnant women diagnosed as HIV infected based on two RDTs per local guideline and found 4.5% (43/952) of pre‐ART VL results to be <50 copies/ml. After excluding 6 women who had detectable virus on subsequent VL measurements, ELISA was performed on the 37 remaining women. Of these, 3/952 (0.3%) HIV RDT diagnoses were found to be FP. We estimate that using ELISA to confirm all positive RDTs would cost $1110 (uncertainty interval $381–$5382) to identify one patient erroneously initiated on ART, while it costs $3912 for a lifetime of antiretrovirals with VL monitoring for one person.Conclusions: Compared to the cost of confirming the RDT‐based diagnoses, the cost of HIV misdiagnosis is high. While testing programmes based on RDT should strive for constant quality improvement, where resources permit, laboratory confirmation algorithms can play an important role in strengthening the quality of HIV diagnosis in the era of universal ART.
In: Journal of the International AIDS Society, Band 26, Heft S4
ISSN: 1758-2652
AbstractIntroductionSeveral HIV‐related syndemics have been described among adults. We investigated syndemic vulnerability to hazardous drinking (HD), intimate partner violence (IPV) and household food insecurity (HFIS) in breastfed children born without HIV in urban South Africa. We compared those who were perinatally HIV exposed (CHEU) to those who were not (CHU), under conditions of universal maternal antiretroviral therapy (ART) and breastfeeding.MethodsA prospective cohort of pregnant women living with HIV (WLHIV), and without HIV, were enrolled and followed with their infants for 12 months postpartum (2013–2017). All WLHIV initiated antenatal efavirenz‐based ART. Measurements of growth (∼3 monthly), infectious cause hospitalisation, ambulatory childhood illness (2‐week recall) and neurodevelopment (BSID‐III, measured at ∼12 months' age) were compared across bio‐social strata using generalised linear regression models, with interaction terms; maternal data included interview‐based measures for HD (AUDIT‐C), IPV (WHO VAW) and HFIS.ResultsAmong 872 breastfeeding mother‐infant pairs (n = 461 CHEU, n = 411 CHU), WLHIV (vs. HIV negative) reported more unemployment (279/461, 60% vs. 217/411, 53%; p = 0.02), incomplete secondary education (347/461, 75% vs. 227/411, 55%; p < 0.0001), HD (25%, 117/459 vs. 7%, 30/411; p < 0.0001) and IPV (22%, 101/457 vs. 8%, 32/411; p < 0.0001) at enrolment; and HFIS at 12 months (45%, 172/386 vs. 30%, 105/352; p > 0.0001). There were positive interactions between maternal HIV and other characteristics. Compared to food secure CHU, the mean difference (95% CI) in weight‐for‐age Z‐score (WAZ) was 0.06 (−0.14; 0.25) for food insecure CHU; −0.26 (−0.42; −0.10) for food secure CHEU; and −0.43 (−0.61; −0.25), for food insecure CHEU. Results were similar for underweight (WAZ < −2), infectious‐cause hospitalisation, cognitive and motor delay. HIV‐IPV interactions were evident for ambulatory diarrhoea and motor delay. There were HIV‐HD interactions for odds of underweight, stunting, cognitive and motor delay. Compared to HD‐unexposed CHU, the odds ratios (95% CI) of underweight were 2.31 (1.11; 4.82) for HD‐exposed CHU; 3.57 (0.84; 15.13) for HD‐unexposed CHEU and 6.01 (2.22; 16.22) for HD‐exposed CHEU.ConclusionsThese data suggest that maternal HIV‐related syndemics may partly drive excess CHEU health risks, highlighting an urgent need for holistic maternal and family care and support alongside ART to optimise the health of CHEU.
In: Journal of the International AIDS Society, Band 21, Heft S4
ISSN: 1758-2652
AbstractIntroductionLinkage to care and mobility postpartum present challenges to long‐term retention after initiating antiretroviral therapy (ART) in pregnancy, but there are few insights from sub‐Saharan Africa. We aimed to describe postpartum linkage to care, mobility, retention and viral suppression after ART initiation in pregnancy.MethodsUsing routine electronic data we assessed HIV‐specific health contacts and clinic movements among women initiating ART in an integrated antenatal care (ANC) and ART clinic in Cape Town, South Africa. The local care model includes mandatory transfer to general ART clinics postpartum. We investigated linkage to care after leaving the integrated clinic and mobility to new clinics until 30 months on ART. We used Poisson regression to explore predictors of linkage, retention (accessing care at least once at both 12 [6 to <18] and 24 [18 to <30] months on ART), and viral suppression (HIV viral load [VL] ≤50 and ≤1000 copies/mL after 12 months on ART).ResultsAmong 617 women, 23% never linked to care; 71% and 65% were retained at 12 and 24 months on ART respectively, with 59% retained in care at both times. Those who linked (n = 485) accessed HIV care at 98 different clinics and 21% attended ≥2 clinics. Women >25 years, married/cohabiting or presenting early for ANC were more likely to link. Younger and unemployed women were more likely to attend ≥2 clinics (adjusted risk ratio [aRR] 1.10 95% confidence interval [CI] 1.02 to 1.18 and aRR 1.06 95% CI 0.99 to 1.12 respectively). Age >25 years (aRR 1.17 95% CI 1.02 to 1.33) and planned pregnancy (aRR 1.20 95% CI 1.09 to 1.33) were associated with being retained. Among 338 retained women with VL available, attending ≥2 clinics reduced the likelihood of viral suppression when defined as ≤50 copies/mL (aRR 0.81 95% CI 0.69 to 0.95). Distance moved was not associated with VL.ConclusionsThese data show that a substantial proportion of women do not link to postpartum ART care in this setting and, among those that do, long‐term retention remains a challenge. Women move to a variety of clinics and young women appear particularly vulnerable to attrition. Interventions promoting linkage and continued retention for women initiating ART during pregnancy warrant urgent consideration.
In: Journal of the International AIDS Society, Band 21, Heft 6
ISSN: 1758-2652
AbstractIntroductionMany prevention of mother‐to‐child HIV transmission programmes across Africa initiate HIV‐infected (HIV positive) pregnant women on lifelong antiretroviral therapy (ART) on the first day of antenatal care ("same‐day" initiation). However, there are concerns that same‐day initiation may limit patient preparation before starting ART and contribute to subsequent non‐adherence, disengagement from care and raised viral load. We examined if same‐day initiation was associated with viral suppression and engagement in care during pregnancy.MethodsConsecutive ART‐eligible pregnant women making their first antenatal care (ANC) visit at a primary care facility in Cape Town, South Africa were enrolled into a prospective cohort between March 2013 and June 2014. Before July 2013, ART eligibility was based on CD4 cell count ≤350 cells/μL ("Option A"), with a 1 to 2 week delay from the first ANC visit to ART initiation for patient preparation; thereafter all women were eligible regardless of CD4 cell count ("Option B+") and offered ART on the same day as first ANC visit. Women were followed with viral load testing conducted separately from routine ART services, and engagement in ART services was measured using routinely collected clinic, pharmacy and laboratory records through 12 months postpartum.ResultsAmong 628 HIV‐positive women (median age, 28 years; median gestation at ART start, 21 weeks; 55% newly diagnosed with HIV), 73% initiated ART same‐day; this proportion was higher under Option B+ versus Option A (85% vs. 20%). Levels of viral suppression (viral load <50 copies/mL) at delivery (74% vs. 82%) and 12 months postpartum (74% vs. 71%) were similar under same‐day versus delayed initiation respectively. Findings were consistent when viral suppression was defined at <1000 copies/mL, after adjustment for demographic/clinical measures and across subgroups of age, CD4 and timing of HIV diagnosis. Time to first viral rebound following initial suppression did not differ by timing of ART initiation nor did engagement in care through 12 months postpartum (same‐day = 73%, delayed = 73%, p = 0.910).ConclusionsThese data suggest that same‐day ART initiation during pregnancy is not associated with lower levels of engagement in care or viral suppression through 12 months post‐delivery in this setting, providing reassurance to ART programmes implementing Option B+.
In: Journal of the International AIDS Society, Band 20, Heft S7
ISSN: 1758-2652
AbstractIntroductionHIV viral load (VL) monitoring is a central tool to evaluate ART effectiveness and transmission risk. There is a global movement to expand VL monitoring following recent recommendations from the World Health Organization (WHO), but there has been little research into VL monitoring in pregnant women. We investigated one important question in this area: when and how frequently VL should be monitored in women initiating ART during pregnancy to predict VL at the time of delivery in a simulated South African population.MethodsWe developed a mathematical model simulating VL from conception through delivery using VL data from the Maternal and Child Health – Antiretroviral Therapy (MCH‐ART) cohort. VL was modelled based on three major compartments: pre‐ART VL, viral decay immediately after ART initiation and viral maintenance (including viral suppression and viraemic episodes). Using this simulation, we examined the performance of various VL monitoring schema in predicting elevated VL at delivery.Results and discussionIf WHO guidelines for non‐pregnant adults were used, the majority of HIV‐infected pregnant women (69%) would not receive a VL test during pregnancy. Most models that based VL monitoring in pregnancy on the time elapsed since ART initiation (regardless of gestation) performed poorly (sensitivity <50%); models that based VL measures in pregnancy on the woman's gestation (regardless of time on ART) appeared to perform better overall (sensitivity >60%). Across all permutations, inclusion of pre‐ART VL values had a negligible impact on predictive performance (improving test sensitivity and specificity <6%). Performance of VL monitoring in predicting VL at delivery generally improved at later gestations, with the best performing option a single VL measure at 36 weeks' gestation.ConclusionsDevelopment and evaluation of a novel simulation model suggests that strategies to measure VL relative to gestational age may be more useful than strategies relative to duration on ART, in women initiating ART during pregnancy, supporting better integration of maternal and HIV health services. Testing turnaround times require careful consideration, and point‐of‐care VL testing may be the best approach for measuring VL at delivery. Broadening the scope of this simulation model in the light of current scale up of VL monitoring in high burden countries is important.
In: Journal of the International AIDS Society, Band 17, Heft 1
ISSN: 1758-2652
IntroductionRecent international guidelines call for expanded access to triple‐drug antiretroviral therapy (ART) in HIV‐positive women during pregnancy and postpartum. However, high levels of non‐adherence and/or disengagement from care may attenuate the benefits of ART for HIV transmission and maternal health. We examined the frequency and predictors of disengagement from care among women initiating ART during pregnancy in Cape Town, South Africa.MethodsWe used routine medical records to follow‐up pregnant women initiating ART within prevention of mother‐to‐child transmission of HIV services in Cape Town, South Africa. Outcomes assessed through six months postpartum were (1) disengagement (no attendance within 56 days of a scheduled visit) and (2) missed visits (returning to care 14–56 days late for a scheduled visit).ResultsA total of 358 women (median age, 28 years; median gestational age, 26 weeks) initiated ART during pregnancy. By six months postpartum, 24% of women (n=86) had missed at least one visit and an additional 32% (n=115) had disengaged from care; together, 49% of women had either missed a visit or had disengaged by six months postpartum. Disengagement was more than twice as frequent postpartum compared to in the antenatal period (6.2 vs. 2.4 per 100 woman‐months, respectively; p<0.0001). In a proportional hazards model, later gestational age at initiation (HR: 1.04; 95% CI: 1.00–1.07; p=0.030) and being newly diagnosed with HIV (HR: 1.57; 95% CI: 1.07–2.33; p=0.022) were significant predictors of disengagement after adjusting for patient age, starting CD4 cell count and site of ART initiation.ConclusionsThese results demonstrate that missed visits and disengagement from care occur frequently, particularly post‐delivery, among HIV‐positive women initiating ART during pregnancy. Women who are newly diagnosed with HIV may be particularly vulnerable and there is an urgent need for interventions both to promote retention overall, as well as targeting women newly diagnosed with HIV during pregnancy.
In: Journal of the International AIDS Society, Band 24, Heft 1
ISSN: 1758-2652
AbstractIntroductionWomen living with HIV are required to transition into the prevention of mother‐to‐child transmission of HIV (PMTCT) services when they become pregnant and back to ART services after delivery. Transition can be a vulnerable time when many women are lost from HIV care yet there is little guidance on the optimal transition approaches to ensure continuity of care. We reviewed the available evidence on existing approaches to transitioning women into and out of PMTCT, outcomes following transition and factors influencing successful transition.MethodsWe searched PubMed and SCOPUS, as well as abstracts from international HIV‐focused meetings, from January 2006 to July 2020. Studies were included that examined three points of transition: pregnant women already on ART into PMTCT (transition 1), pregnant women living with HIV not yet on ART into treatment services (transition 2) and postpartum women from PMTCT into general ART services after delivery (transition 3). Results were grouped and reported as descriptions of transition approach, comparison of outcomes following transition and factors influencing successful transition.Results & discussionOut of 1809 abstracts located, 36 studies (39 papers) were included in this review. Three studies included transition 1, 26 transition 2 and 17 transition 3. Approaches to transition were described in 26 studies and could be grouped into the provision of information at the point of transition (n = 8), strengthened communication or linkage of data between services (n = 4), use of transition navigators (n = 12), and combination approaches (n = 4). Few studies were designed to directly assess transition and only nine compared outcomes between transition approaches, with substantial heterogeneity in study design, setting and outcomes. Four themes were identified in 25 studies reporting on factors influencing successful transition: fear, knowledge and preparedness, clinic characteristics and the transition requirements and process.ConclusionsThis review highlights that, despite the need for women to transition into and out of PMTCT services for continued ART in many settings, there is very limited evidence on optimal transition approaches. Ongoing operational research is required to identify sustainable and acceptable transition approaches and service delivery models that support continuity of HIV care during and after pregnancy.
In: Journal of the International AIDS Society, Band 20, Heft S7
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 20, Heft 1
ISSN: 1758-2652
AbstractIntroduction: Decentralization of HIV care for children has been recommended to improve paediatric outcomes by making antiretroviral treatment (ART) more accessible. We documented outcomes of children transferred after initiating ART at a large tertiary hospital in the Eastern Cape of South Africa.Methods: Electronic medical records for all children 0–15 years initiating ART at Dora Nginza Hospital (DNH) in Port Elizabeth, South Africa January 2004 to September 2015 were examined. Records for children transferred to primary and community clinics were searched at 16 health facilities to identify children with successful (at least one recorded visit) and unsuccessful transfer (no visits). We identified all children lost to follow‐up (LTF) after ART initiation: those LTF at DNH (no visit >6 months), children with unsuccessful transfer, and children LTF after successful transfer (no visit >6 months). Community tracing was conducted to locate caregivers of children LTF and electronic laboratory data were searched to measure reengagement in care, including silent transfers.Results: 1,582 children initiated ART at median age of 4 years [interquartile range (IQR): 1–8] and median CD4+ of 278 cells/mm3 [IQR: 119–526]. A total of 901 (57.0%) children were transferred, 644 (71.5%) to study facilities; 433 (67.2%) children had successful transfer and 211 (32.8%) had unsuccessful transfer. In total, 399 children were LTF: 105 (26.3%) from DNH, 211 (52.9%) through unsuccessful transfer and 83 (20.8%) following successful transfer. Community tracing was conducted for 120 (30.1%) of 399 children LTF and 66 (55.0%) caregivers were located and interviewed. Four children had died. Among 62 children still alive, 8 (12.9%) were reported to not be in care or taking ART and 18 (29.0%) were also not taking ART. Overall, 65 (16.3%) of 399 children LTF had a laboratory result within 18 months of their last visit indicating silent transfer and 112 (28.1%) had lab results from 2015 to 2016 indicating current care.Conclusion: We found that only two‐thirds of children on ART transferred to primary and community health clinics had successful transfer. These findings suggest that transfer is a particularly vulnerable step in the paediatric HIV care cascade.
In: Journal of the International AIDS Society, Band 24, Heft 8
ISSN: 1758-2652
AbstractIntroductionYoung pregnant and postpartum women living with HIV (WLHIV) are at high risk of poor outcomes in prevention of mother‐to‐child transmission services. The aim of this systematic review was to collate evidence on strategies to improve retention in antenatal and/or postpartum care in this population. We also conducted a secondary review of strategies to increase attendance at antenatal care (ANC) and/or facility delivery among pregnant adolescents, regardless of HIV status, to identify approaches that could be adapted for adolescents and young WLHIV.MethodsSelected databases were searched on 1 December 2020, for studies published between January 2006 and November 2020, with screening and data abstraction by two independent reviewers. We identified papers that reported age‐disaggregated results for adolescents and young WLHIV aged <25 years at the full‐text review stage. For the secondary search, we included studies among female adolescents aged 10 to 19 years.Results and discussionOf 37 papers examining approaches to increase retention among pregnant and postpartum WLHIV, only two reported age‐disaggregated results: one showed that integrated care during the postpartum period increased retention in HIV care among women aged 18 to 24 years; and another showed that a lay counsellor‐led combination intervention did not reduce attrition among women aged 16 to 24 years; one further study noted that age did not modify the effectiveness of a combination intervention. Mobile health technologies, enhanced support, active follow‐up and tracing and integrated services were commonly examined as standalone interventions or as part of combination approaches, with mixed evidence for each strategy. Of 10 papers identified in the secondary search, adolescent‐focused services and continuity of care with the same provider appeared to be effective in improving attendance at ANC and/or facility delivery, while home visits and group ANC had mixed results.ConclusionsThis review highlights the lack of evidence regarding effective strategies to improve retention in antenatal and/or postpartum care among adolescents and young WLHIV specifically, as well as a distinct lack of age‐disaggregated results in studies examining retention interventions for pregnant WLHIV of all ages. Identifying and prioritizing approaches to improve retention of adolescents and young WLHIV are critical for improving maternal and child health.