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Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding.
Brummel, SS, Taha, TE, Angelidou, KN, Saidi, F, Atuhaire, P, Dula, D, Moodley, D, Matubu, A, Chareka, G, Nevrekar, N, et al
Journal of acquired immune deficiency syndromes (1999). 2021;(4):450-454
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IMPAACT PROMISE 1077BF/FF was a sequentially randomized study of pregnant and postpartum women living with HIV to investigate the efficacy and safety of antiretroviral therapy (ART). This Maternal Health Component investigated efficacy for the risk of developing AIDS or death; and safety among women randomized to continue ART (CTART N = 289) or discontinue ART (N = 268) after cessation of breastfeeding or after confirmation of infant infection. No AIDS-defining illnesses were reported during follow-up in either arm. Adverse events of grade 3 or higher were more frequent in the CTART arm [hazard ratio = 1.78, 95% confidence interval: (1.05 to 3.02), P-value = 0.03]. The difference in adverse events in the 2 groups was mostly driven by moderate weight loss for women on the CTART arm.
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Brief Report: Vaginal Viral Shedding With Undetectable Plasma HIV Viral Load in Pregnant Women Receiving 2 Different Antiretroviral Regimens: A Randomized Clinical Trial.
Frenkel, LM, Morrison, RL, Fuller, TL, Gouvêa, MI, Benamor Teixeira, ML, Coombs, RW, Shapiro, DE, Mirochnick, M, Hennessey, R, Whitson, K, et al
Journal of acquired immune deficiency syndromes (1999). 2021;(4):361-365
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BACKGROUND Pregnant women using antiretrovirals (ARVs) may have persistent vaginal viral shedding, which could be associated with sexual and perinatal HIV transmission. However, there are scant data on vaginal viral load (VVL) in pregnant women with undetectable plasma viral load (PVL). METHODS This study was a post hoc analysis of an open-label randomized trial to evaluate the virologic response of 2 ART regimens. The participants were ART-naive women living with HIV initiating ART regimens between 20 and 36 weeks of pregnancy recruited at 19 clinical sites in 6 countries. Participants were randomized to receive 400 mg of raltegravir 2 times a day or 600 mg of efavirenz 4 times a day in addition to 150 mg of lamivudine and 300 mg of zidovudine 2 times a day. VVL and PVL tests were performed at every study visit. The primary outcome measures were HIV-1 PVL and VVL at maternal study week 4 and rates of perinatal HIV transmission. RESULTS A total of 408 were enrolled, of whom 323 had VVL samples 4 weeks after enrollment and were included in this analysis. Among women with undetectable/nonquantifiable PVL during ART, the overall rate of quantifiable VVL at week 4 was 2.54% (7/275). Of the 275 with nonquantifiable PVL, 99.1% (115/116) and 96.2% (153/159) had nonquantifiable VVL in the efavirenz and raltegravir arms, respectively. None of the 7 women with quantifiable VVL at the week 4 study visit transmitted HIV to their infants. CONCLUSIONS Detectable VVL in pregnant women with undetectable/nonquantifiable PVL while receiving ART was rare and not associated with perinatal HIV transmission.
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Effects of selenium supplementation on pregnancy outcomes and disease progression in HIV-infected pregnant women in Lagos: A randomized controlled trial.
Okunade, KS, Olowoselu, OF, John-Olabode, S, Hassan, BO, Akinsola, OJ, Nwogu, CM, Ugwu, AO, Moses, OE, Rabiu, KA, Ajepe, A, et al
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2021;(3):533-541
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OBJECTIVE To examine the effects of selenium supplementation on pregnancy outcomes and disease progression among HIV-infected pregnant women in Lagos. METHODS A randomized, placebo-controlled trial conducted among HIV-positive pregnant women between September 2018 and August 2019. At enrollment, 90 women were randomly assigned into each treatment arm to receive either a daily tablet of 200 μg elemental selenium or a placebo. Relevant participants' sociodemographic and clinical data were collected at enrollment and delivery. RESULTS Women in the selenium arm had a significantly lower risk of preterm delivery (relative risk [RR] 0.32, 95% confidence interval [CI] 0.11-0.96) and a non-significant reduction in the risk of delivering term neonates with a low delivery weight (RR 0.24, 95% CI 0.05-1.19). Supplemental selenium does not increase the risk of perinatal death and adverse drug events. CONCLUSION The study reported a beneficial effect of prenatal selenium supplements on the risk of preterm delivery with no further reduction in risk among HIV-infected women who used the supplements for more than 14 weeks. TRIAL REGISTRATION Pan African Clinical Trial Registry (PACTR201809756724274).
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Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa.
Haskins, L, Chiliza, J, Barker, P, Connolly, C, Phakathi, S, Feeley, A, Horwood, C
BMC public health. 2020;(1):318
Abstract
BACKGROUND Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement (QI) intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa. METHODS A three-month intervention comprised of six QI mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1. RESULTS Improvements in some growth monitoring indicators were achieved in intervention clinics compared to control clinics, including measuring the length of the baby (77% vs 63%; p = 0.001) and health workers asking mothers about the child's feeding (74% vs 67%; p = 0.003), but the proportion of mothers who received feeding advice remained unchanged (38% vs 35%; p = 0.48). Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001). Discussions with the mother about some maternal health services improved: significantly more mothers in the intervention group were asked about HIV (26.5% vs 19.5%; p = 0.009) and family planning (33.5% vs 19.5%; p < 0.001), but this did not result in additional services being provided to mothers at the clinic visit. CONCLUSION This robust evaluation shows significant improvements in coverage of some services, but the QI intervention was unable to achieve the substantial changes required to provide a comprehensive package of services to all mothers and children. We suggest the QI process be adapted to complex under-resourced health systems, building on the strengths of this approach, to provide workable health systems strengthening solutions for scalable implementation. TRIAL REGISTRATION ClinicalTrials.gov NCT04278612. Date of Registration: February 19, 2020. Retrospectively registered.
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Provider- and patient-level costs associated with providing antiretroviral therapy during the postpartum phase to women living with HIV in South Africa: A cost comparison of three postpartum models of care.
Cunnama, L, Abrams, EJ, Myer, L, Phillips, TK, Dugdale, CM, Ciaranello, AL, Zerbe, A, Iyun, V, MacQuilkan, K, Daries, V, et al
Tropical medicine & international health : TM & IH. 2020;(12):1553-1567
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OBJECTIVE To compare the unit and total costs of three models of ART care for mother-infant pairs during the postpartum phase from provider and patient's perspectives: (i) local standard of care with women in general ART services and infants at well-baby clinics; (ii) women and infants continue to receive care through an integrated maternal and child care approach during the postpartum breastfeeding period; and (iii) referral of women directly to community adherence clubs with their infants receiving care at well-baby clinics. METHODS Capital and recurrent cost data (relating to buildings, furniture, equipment, personnel, overheads, maintenance, medication, diagnostic tests and immunisations) were collected from a provider's perspective at six sites in Cape Town, South Africa. Patient time, collected via time-and-motion observation and questionnaires, was used to estimate patient perspective costs and is comprised of lost productivity time, time spent travelling and the direct cost of travelling. RESULTS The cost of postpartum ART visits under models I, II and III was US $13, US $10 and US $7 per visit for a mother-infant pair, respectively, in 2018 US$. The annual costs for the mother-infant pair utilising the average visit frequencies (a mean of 4.5, 6.9 and 6.7 visits postpartum for models I, II and III, respectively) including costs for infant immunisations, visits, medication and diagnostic tests for both mothers and infants were: I - US $222, II - US $335 and III - US $249. Sensitivity analysis to assess the impact of visit frequency on visit cost showed that Model I annual costs would be most costly if visit frequency was equalised. CONCLUSION This comparative analysis of three models of care provides novel data on unit costs and insight into the costs to provide ART and care to mother-infant pairs during the delicate postpartum phase. These costs may be used to help make decisions around integrated services models and differentiated service delivery for postpartum WLH and their children.
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Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.
Abioye, AI, McDonald, EA, Park, S, Ripp, K, Bennett, B, Wu, HW, Pond-Tor, S, Sagliba, MJ, Amoylen, AJ, Baltazar, PI, et al
Pediatric research. 2019;(3):396-402
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BACKGROUND We evaluated the association between etiology of maternal anemia and iron status throughout infancy. METHODS Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated. RESULTS Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status. CONCLUSIONS Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.
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Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial.
Myer, L, Phillips, TK, Zerbe, A, Brittain, K, Lesosky, M, Hsiao, NY, Remien, RH, Mellins, CA, McIntyre, JA, Abrams, EJ
PLoS medicine. 2018;(3):e1002547
Abstract
BACKGROUND As the number of HIV-infected women initiating lifelong antiretroviral therapy (ART) during pregnancy increases globally, concerns have emerged regarding low levels of retention in HIV services and suboptimal adherence to ART during the postpartum period. We examined the impact of integrating postpartum ART for HIV+ mothers alongside infant follow-up within maternal and child health (MCH) services in Cape Town, South Africa. METHODS AND FINDINGS We conducted a randomised trial among HIV+ postpartum women aged ≥18 years who initiated ART during pregnancy in the local antenatal care clinic and were breastfeeding when screened before 6 weeks postpartum. We compared an integrated postnatal service among mothers and their infants (the MCH-ART intervention) to the local standard of care (control)-immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to separate routine infant follow-up. Evaluation data were collected through medical records and trial measurement visits scheduled and located separately from healthcare services involved in either arm. The primary trial outcome was a composite endpoint of women's retention in ART care and viral suppression (VS) (viral load < 50 copies/ml) at 12 months postpartum; secondary outcomes included duration of any and exclusive breastfeeding, mother-to-child HIV transmission, and infant mortality. Between 5 June 2013 and 10 December 2014, a total of 471 mother-infant pairs were enrolled and randomised (mean age, 28.6 years; 18% nulliparous; 57% newly diagnosed with HIV in pregnancy; median duration of ART use at randomisation, 18 weeks). Among 411 women (87%) with primary endpoint data available, 77% of women (n = 155) randomised to the MCH-ART intervention achieved the primary composite outcome of retention in ART services with VS at 12 months postpartum, compared to 56% of women (n = 117) randomised to the control arm (absolute risk difference, 0.21; 95% CI: 0.12-0.30; p < 0.001). The findings for improved retention in care and VS among women in the MCH-ART intervention arm were consistent across subgroups of participants according to demographic and clinical characteristics. The median durations of any breastfeeding and exclusive breastfeeding were longer in women randomised to the intervention versus control arm (6.9 versus 3.0 months, p = 0.006, and 3.0 versus 1.4 months, p < 0.001, respectively). For the infants, overall HIV-free survival through 12 months of age was 97%: mother-to-child HIV transmission was 1.2% overall (n = 4 and n = 1 transmissions in the intervention and control arms, respectively), and infant mortality was 1.9% (n = 6 and n = 3 deaths in the intervention and control arms, respectively), and these outcomes were similar by trial arm. Interpretation of these findings should be qualified by the location of this study in a single urban area as well as the self-reported nature of breastfeeding outcomes. CONCLUSIONS In this study, we found that integrating ART services into the MCH platform during the postnatal period was a simple and effective intervention, and this should be considered for improving maternal and child outcomes in the context of HIV. TRIAL REGISTRATION ClinicalTrials.gov NCT01933477.
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A Cluster Randomised Trial to Determine the Efficacy of the "Feeding Buddies" Programme in Improving Exclusive Breastfeeding Rates Among HIV-Infected Women in Rural KwaZulu-Natal, South Africa.
Reimers, P, Israel-Ballard, K, Craig, M, Spies, L, Thior, I, Tanser, F, Coutsoudis, A
AIDS and behavior. 2018;(1):212-223
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This cluster randomised trial in KwaZulu-Natal South Africa, evaluated the implementation of a Feeding Buddies (FB) programme to improve exclusive breastfeeding (EBF) amongst human immunodeficiency virus infected mothers. Eight clinics were randomly allocated to intervention and control arms respectively. Pregnant women attending the prevention of mother-to-child transmission program and intending to EBF were enrolled: control (n = 326), intervention (n = 299). Intervention mothers selected FBs to support them and they were trained together (four sessions). Interviews of mothers occurred prenatally and at post-natal visits (day 3, weeks 6, 14 and 22). Breastfeeding results were analysed (Stata) as interval-censored time-to-event data, with up to four time intervals per mother. EBF rates at the final interview were similar for control and intervention groups: 44.68% (105/235) and 42.75% (109/255) respectively (p = 0.67). In Cox regression analysis better EBF rates were observed in mothers who received the appropriate training (p = 0.036), had a community care giver visit (p = 0.044), while controlling for other factors. Implementation realities reduced the potential effectiveness of the FBs.
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Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women.
Brites, C, Nóbrega, I, Luz, E, Travassos, AG, Lorenzo, C, Netto, EM
HIV clinical trials. 2018;(3):94-100
Abstract
Background Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods We did a single-center, pilot, open-label, randomized trial in Brazil (N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1). The primary endpoint was virological suppression at delivery (HIV-1 RNA <50 copies per mL), in all patients who received at least one dose of study drugs (modified intention-to-treat analysis). Missing information was treated as failure. We assessed safety in all patients. Results We enrolled and randomly assigned treatment to 33 patients (17 in raltegravir group) between June 2015 and June 2017. The study was interrupted by the IRB because a significant difference between arms was detected in an interim analysis. All patients completed follow up at delivery. At delivery, virological suppression was achieved by 13/17 (76.5%) of patients in raltegravir group, versus 4/16 (25.0%) in lopinavir/ritonavir group (RR 3.1, 95% CI: 1.3-7.4). Patients in raltegravir group had significantly higher proportion of virological suppression at 2, 4, and 6 weeks than lopinavir/ritonavir group. Adverse events were most of mild intensity, but patients in lopinavir/ritonavir group had significantly more gastrointestinal adverse events. There was neither discontinuation nor deaths in this trial. Conclusion Raltegravir might be a first-line option for treatment of HIV-infected late-presenting pregnant women.
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Child Health Outcomes After Presumptive Infection Treatment in Pregnant Women: A Randomized Trial.
Hallamaa, L, Cheung, YB, Maleta, K, Luntamo, M, Ashorn, U, Gladstone, M, Kulmala, T, Mangani, C, Ashorn, P
Pediatrics. 2018;(3)
Abstract
BACKGROUND AND OBJECTIVES We showed earlier that presumptive infection treatment in pregnancy reduced the prevalence of neonatal stunting in a rural low-income setting. In this article, we assess how these gains were sustained and reflected in childhood growth, development, and mortality. METHODS We enrolled 1320 pregnant Malawian women in a randomized trial and treated them for malaria and other infections with either 2 doses of sulfadoxine-pyrimethamine (SP) (control), monthly SP, or monthly sulfadoxine-pyrimethamine and 2 doses of azithromycin (AZI-SP). Child height or length and mortality were recorded at 1, 6, 12, 24, 36, 48, and 60 months and development at 60 months by using Griffith's Mental Development Scales. RESULTS Throughout follow-up, the mean child length was 0.4 to 0.7 cm higher (P < .05 at 1-12 months), the prevalence of stunting was 6 to 11 percentage points lower (P < .05 at 12-36 months), and the 5-year cumulative incidence of stunting was 13 percentage points lower (hazard ratio: 0.70, 95% confidence interval [CI]: 0.60 to 0.83, P < .001) in the AZI-SP group than in the control group. The mean developmental score was 3.8 points higher in the AZI-SP group than in the control group (95% CI: 1.1 to 6.4, P = .005). Total mortality during pregnancy and childhood was 15.3%, 15.1%, and 13.1% (P = .60) in the control, monthly SP, and AZI-SP groups, respectively. Postneonatal mortality (secondary outcome) was 5.5%, 3.3%, and 1.9%, respectively (risk ratio of AZI-SP versus control: 0.34, 95% CI: 0.15 to 0.76, P = .008). CONCLUSIONS Provision of AZI-SP rather than 2 doses of SP during pregnancy reduced the incidence of stunting in childhood. AZI-SP during pregnancy also had a positive effect on child development and may have reduced postneonatal mortality.