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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.

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.

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.

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+.

IntroductionPlasma HIV viral load (VL) is the principle determinant of mother‐to‐child HIV transmission (MTCT), yet there are few data on VL in populations of pregnant women in sub‐Saharan Africa. We examined the distribution and determinants of VL in HIV‐positive women seeking antenatal care (ANC) in Cape Town, South Africa.MethodsConsecutive HIV‐positive pregnant women making their first antenatal clinic visit were recruited into a cross‐sectional study of viraemia in pregnancy, including a brief questionnaire and specimens for VL testing and CD4 cell enumeration.Results & discussionOverall 5551 pregnant women sought ANC during the study period, of whom 1839 (33%) were HIV positive and 1521 (85%) were included. Approximately two‐thirds of HIV‐positive women in the sample (n=947) were not on antiretrovirals at the time of the first ANC visit, and the remainder (38%, n=574) had initiated antiretroviral therapy (ART) prior to conception. For women not on ART, the median VL was 3.98 log10 copies/mL; in this group, the sensitivity of CD4 cell counts ≤350 cells/µL in detecting VL>10,000 copies/mL was 64% and this increased to 78% with a CD4 threshold of ≤500 cells/µL. Among women on ART, 78% had VL<50 copies/mL and 13% had VL >1000 copies/mL at the time of their ANC visit.ConclusionsVL >10,000 copies/mL was commonly observed in women not on ART with CD4 cell counts >350 cells/µL, suggesting that CD4 cell counts may not be adequately sensitive in identifying women at greatest risk of MTCT. A large proportion of women entering ANC initiated ART before conception, and in this group more than 10% had VL>1000 copies/mL despite ART use. VL monitoring during pregnancy may help to identify pregnancies that require additional clinical attention to minimize MTCT risk and improve maternal and child health outcomes.

AbstractBackground: The numbers of women initiating lifelong antiretroviral therapy (ART) during pregnancy and postpartum is increasing rapidly, presenting a burden on health systems and an urgent need for scalable models of care for this population. In a pilot project, we referred postpartum women who initiated ART during pregnancy to a community‐based model of differentiated ART services.Methods: Eligible women (on ART for at least 3 months with viral load (VL)<1000 copies/mL) were offered a choice of two ART models of care: (i) referral to an existing system of community‐based 'adherence clubs', operated by lay counsellors with medication collection every 2–4 months; or (ii) referral to local primary healthcare clinics (PHC) with services provided by clinicians and medication collection every 1–2 months (local standard of care for postpartum ART). For evaluation, women were followed through 6‐months postpartum with VL testing separate from either ART service.Results: Through September 2015, n = 129 women were enrolled (median age, 28 years; median time postpartum, 10 days). Overall, 65% (n = 84) chose adherence clubs and 35% (n = 45) chose PHCs; there were no demographic or clinical predictors of this choice. Location of service delivery was commonly cited as a reason for choice by women selecting either model of care; shorter waiting times, ability to receive ART from lay counsellors and less frequent appointments were motivations for choosing adherence clubs. Among women choosing adherence clubs, 15% never attended the service and another 11% attended the service but were not retained through six months postpartum. Overall, 86% of women (n = 111) remained in the evaluation through 6 months postpartum; in this group, there were no differences in VL<1000 copies/mL at six months postpartum between women choosing PHCs (88%) vs. adherence clubs (92%; p = 0.483), but women who were not retained in adherence clubs were more likely to have VL≥1000 copies/mL compared to those who remained (p = 0.002).Discussion: Adherence clubs may be a valuable model for postpartum women initiating ART in pregnancy, with good short‐term outcomes observed during this critical period. To support optimal implementation, further research is needed into patient preferences for models of care, with consideration of integration of maternal and child health services, while ART adherence and retention require ongoing consideration in this population.

BACKGROUND: Adolescents living with HIV (ALHIV) 15–19 years of age are a growing proportion of all people living with HIV globally and the population includes adolescents with vertically acquired HIV (AVH) and behaviorally acquired HIV (ABH). METHODS: We conducted a survey to measure sociodemographic characteristics, educational status, health history, and antiretroviral therapy (ART) adherence among a convenience sample of ALHIV at three government health facilities in 2019 in Nampula, Mozambique. ALHIV 15–19 years on ART, including females attending antenatal care, were eligible. Routine HIV care data were extracted from medical charts. Classification of ALHIV by mode of transmission was based on medical charts and survey data. ALHIV who initiated ART <15 years or reported no sex were considered AVH; all others ABH. Frequencies were compared by sex, and within sex, by mode of transmission (AVH vs. ABH) using Chi-square, Fishers exact tests and Wilcoxon rank-sum tests. RESULTS: Among 208 ALHIV, 143 (69%) were female and median age was 18 years [interquartile range (IQR) 16–19]. Just over half of ALHIV (53%) were in or had completed secondary or higher levels of education; the most common reason for not being in school reported by 36% of females was pregnancy or having a child. Of all ALHIV, 122 (59%) had VL data, 62% of whom were <1000 copies/mL. Almost half (46%) of ALHIV reported missing ARVs ≥ 1 day in the past month (62% of males vs. 39% of females; p = 0.003). Just over half (58%) of ALHIV in relationships had disclosed their HIV status: 13% of males vs. 69% of females (p<0.001). Among sexually active males, 61% reported using a condom at last sex compared to 26% of females (p<0.001). Among female ALHIV, 50 (35%) were AVH and 93 (65%) were ABH, 67% of whom were not in school compared to 16% of ABH, (p<0.001). DISCUSSION: Data from our study underscore the high level of deprivation among ALHIV enrolled in HIV care in Mozambique, as well as important disparities by sex and mode of ...