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1.  Neonatal Mortality in HIV-Exposed Infants Born to Women Receiving Combination Antiretroviral Therapy in Rural Uganda 
Journal of Tropical Pediatrics  2013;59(6):441-446.
As human immunodeficiency virus (HIV)-infected women gain access to combination antiretroviral therapy throughout sub-Saharan Africa, a growing number of infants are being born HIV-exposed but uninfected. Data about neonatal mortality and the impact of premature delivery, in this population are limited. We describe the 28-day mortality outcomes in a cohort of HIV-exposed infants who had ultrasound-confirmed gestational age in rural Uganda. There were 13 deaths among 351 infants, including 9 deaths in the perinatal period. Premature delivery was a strong predictor of mortality. The prevention of HIV transmission to infants is now possible in rural low-resource settings but the frequency of neonatal death among HIV-exposed infants remains extremely high, calling for new comprehensive interventions to reduce mortality in this growing population.
doi:10.1093/tropej/fmt044
PMCID: PMC3842848  PMID: 23764539
HIV; neonatal; mortality; prematurity; Africa
2.  Hair and Plasma Data Show that Lopinavir, Ritonavir and Efavirenz All Transfer from Mother to Infant in Utero, but only Efavirenz Transfers via Breastfeeding 
Background
As efforts intensify to eliminate perinatal HIV transmission, understanding kinetics of maternal-to-child transfer of antiretrovirals during pregnancy and breastfeeding is critical. Antiretroviral levels in plasma, cord blood and breastmilk reflect exposure over short intervals. Hair concentrations reflect cumulative exposure and can uniquely quantify in-utero transfer of maternal medications to infants. We measured plasma and hair antiretroviral levels in HIV-infected Ugandan mothers and their infants at delivery and during breastfeeding to assess transfer.
Methods
HIV-infected pregnant women were randomized to lopinavir/ritonavir- or efavirenz-based therapy in a larger trial (PROMOTE). At 0, 8 and 12 weeks postpartum, plasma antiretroviral levels were measured in 117 mother-infant pairs; hair levels were assayed at 12 weeks. Ratios and correlations of infant:maternal concentrations were calculated.
Results
By 12 weeks, 90.4% of mothers reported exclusive breastfeeding. Hair and plasma levels over time suggest moderate (47%) to extensive (87%) in-utero transfer of lopinavir and ritonavir, respectively, but negligible transfer of either via breastfeeding. Moderate transfer of efavirenz occurs during pregnancy and breastfeeding (40% cumulative; 15% during breastfeeding). Despite differences in exposure, no infant seroconversions or correlations between infant hair/plasma antiretroviral levels and adverse effects were observed.
Conclusions
Using a unique approach combining hair and plasma data, we found that different antiretrovirals had distinct kinetics of mother-to-infant transfer. Efavirenz transfers during both pregnancy and breastfeeding, whereas lopinavir and ritonavir transfer only in-utero. Further study of the degree and timing of maternal-to-child transfer by antiretroviral will help optimize strategies that protect infants and minimize toxicities during periods of risk.
doi:10.1097/QAI.0b013e31829c48ad
PMCID: PMC3800282  PMID: 24135775
3.  The Cost-Effectiveness of Repeat HIV Testing During Pregnancy in a Resource-Limited Setting 
OBJECTIVE
To estimate the cost-effectiveness of HIV screening strategies for the prevention of perinatal transmission in Uganda, a resource-limited country with high HIV prevalence and incidence.
STUDY DESIGN
We designed a decision-analytic model from a health care system perspective to assess the vertical transmission rates and cost-effectiveness of four different HIV screening strategies in pregnancy: 1) Rapid HIV antibody (Ab) test at initial visit (current standard of care); 2) Strategy 1 + HIV RNA at initial visit (adds detection of acute HIV); 3) Strategy 1 + repeat HIV Ab at delivery (adds detection of incident HIV); 4) Strategy 3 + HIV RNA at delivery (adds detection of acute HIV at delivery). Model estimates were derived from the literature and local sources, and life years saved were discounted at a rate of 3% per year. Based on World Health Organization guidelines, we defined our cost-effectiveness threshold as ≤3 times the gross domestic product per capita, which for Uganda was US$3300 in 2008.
RESULTS
Using base case estimates of 10% HIV prevalence among women entering prenatal care and 3% incidence during pregnancy, strategy 3 was incrementally the cost-effective option that led to the greatest total life years.
CONCLUSION
Repeat rapid HIV Ab testing at the time of labor is a cost-effective strategy even in a resource-limited setting such as Uganda.
doi:10.1097/QAI.0b013e3182895565
PMCID: PMC3653987  PMID: 23392461
HIV; pregnancy; perinatal transmission; decision analysis; cost-effectiveness analysis
4.  Early Experiences Implementing Pre-exposure Prophylaxis (PrEP) for HIV Prevention in San Francisco 
PLoS Medicine  2014;11(3):e1001613.
Albert Liu and colleagues report early experiences with uptake and delivery of pre-exposure prophylaxis(PrEP)for HIV prevention in three different settings in San Francisco. PrEP can be an important component of a comprehensive HIV prevention program and can complement efforts to increase HIV testing, linkage to care, and early initiation of antiretroviral therapy.
Please see later in the article for the Editors' Summary
doi:10.1371/journal.pmed.1001613
PMCID: PMC3942317  PMID: 24595035
6.  Trends in Contraceptive Use Among Women With Human Immunodeficiency Virus 
Obstetrics and gynecology  2012;120(4):783-790.
Objective
To estimate trends in contraceptive use, especially long-acting reversible contraceptives (LARC) and condoms, among human immunodeficiency virus (HIV)-seropositive and HIV-seronegative women.
Methods
HIV-seropositive and HIV-seronegative women in a multicenter longitudinal cohort were interviewed semiannually between 1998 and 2010 about sexual behaviors and contraceptive use. Trends in contraceptive use by women aged 18–45 years who were at risk for unintended pregnancy but not trying to conceive were analyzed using generalized estimating equations.
Results
Condoms were the dominant form of contraception for HIV-seropositive women and showed little change across time. Fewer than 15% of these women used no contraception. Between 1998 and 2010, LARC use rose among HIV-seronegative women from 4.8% (6/126) to 13.5% (19/141, p=0.02), but not significantly among seropositive women (0.9% (4/438) to 2.8% (6/213, p = 0.09). Use of highly effective contraceptives, including pills, patches, rings, injectable progestin, implants and intrauterine devices, ranged from 15.2% (53/348) in 1998 to 17.4% (37/213) in 2010 (p = 0.55). HIV-seronegative but not seropositive LARC users were less likely than nonusers to use condoms consistently (HR=0.51, 95% C.I. 0.32–0.81, p = 0.004 for seronegative women; HR = 1.09, 95% C.I. 0.96, 1.23 for seropositive women).
Conclusion
Although most HIV-seropositive women use contraception, they rely primarily on condoms and have not experienced the increase in LARC use seen among seronegative women. Strategies to improve simultaneous use of condoms and LARC are needed to minimize risk of unintended pregnancy as well as HIV transmission and acquisition of sexually transmitted infections.
doi:10.1097/AOG.0b013e318269c8bb
PMCID: PMC3449062  PMID: 22996095
7.  Antiretrovirals and safer conception for HIV-serodiscordant couples 
Current opinion in HIV and AIDS  2012;7(6):569-578.
Purpose of review
Many men and women living with HIV and their uninfected partners attempt to conceive children. HIV-prevention science can be applied to reduce sexual transmission risk while respecting couples’ reproductive goals. Here we discuss antiretrovirals as prevention in the context of safer conception for HIV-serodiscordant couples.
Recent findings
Antiretroviral therapy (ART) for the infected partner and pre-exposure prophylaxis (PrEP) for the uninfected partner reduce the risk of heterosexual HIV transmission. Several demonstration projects suggest the feasibility and acceptability of antiretroviral (ARV)s as periconception HIV-prevention for HIV-serodiscordant couples. The application of ARVs to periconception risk reduction may be limited by adherence.
Summary
For male-infected (M+F−) couples who cannot access sperm processing and female-infected (F+M−) couples unwilling to carry out insemination without intercourse, ART for the infected partner, PrEP for the uninfected partner, combined with treatment for sexually transmitted infections, sex limited to peak fertility, and medical male circumcision (for F+M couples) provide excellent, well tolerated options for reducing the risk of periconception HIV sexual transmission.
doi:10.1097/COH.0b013e328358bac9
PMCID: PMC3695736  PMID: 23032734
antiretrovirals as prevention; conception; fertility; HIV prevention; HIV-serodiscordance; perinatal HIV transmission; sexual HIV transmission
9.  Interferon Gamma Release Assay Compared With Tuberculin Skin Test for Latent Tuberculosis Detection in Pregnancy 
Obstetrics and gynecology  2011;118(6):1363-1370.
Objective
To estimate agreement and correlation between the tuberculin skin test and an interferon gamma release assay for detecting latent tuberculosis (TB) infection in pregnant women.
Methods
We conducted a cross-sectional study of pregnant women initiating prenatal care at a university-affiliated public hospital between January 5, 2009 and March 15, 2010. Eligible women received a questionnaire about tuberculosis history and risk factors, as well as the tuberculin skin test and phlebotomy for the interferon gamma release assay. Agreement and correlation between tests were estimated, and different cut-offs for interferon gamma release assay positivity were used to assess effect on agreement. Furthermore, predictors of test positivity and test discordance were evaluated using multivariable analysis.
Results
Of the 220 enrolled women, 199 (90.5%) returned for tuberculin skin test evaluation. Over 70% were Hispanic and 65% were born in a country with high tuberculosis prevalence. Agreement between tuberculin skin test and interferon gamma release assay was 77.39 (k=0.26). This agreement was not significantly changed using different cut-offs for the assay. Birth bacille Calmette-Guérin vaccination was associated with tuberculin skin test positivity (OR 4.33, 95%CI 1.4–13.48, p=0.01), but not interferon gamma release assay positivity. There were no statistically significant predictors of tuberculin skin test and interferon gamma release assay result discordance, however birth in high prevalence country was marginally associated with tuberculin skin test positive and interferon gamma release assay negative results (OR 2.94, 95% CI 0.86–9.97, p=0.08).
Conclusion
Comparing tuberculin skin test and interferon gamma release assay results in pregnancy, concordance and agreement were poor. Given that much is still unknown about the performance of interferon gamma release assays in pregnancy, further research is necessary before tuberculin skin test is abandoned for screening of latent TB infection in pregnancy.
doi:10.1097/AOG.0b013e31823834a9
PMCID: PMC3232049  PMID: 22105266
10.  Relative time to pregnancy among HIV-infected and uninfected women in the Women’s Interagency HIV Study, 2002–2009 
AIDS (London, England)  2011;25(5):707-711.
Objectives
To determine the incidence rate of, and the relative time to pregnancy by HIV status in US women between 2002 and 2009.
Design
The Women’s Interagency HIV Study (WIHS) is an ongoing, multicenter prospective cohort study of the natural and treated history of HIV infection and related outcomes among women with and without HIV.
Methods
Eligible participants were ≤45 years of age; sexually active with male partner(s) or reported a pregnancy outcome within the past year; and never reported hysterectomy, tubal ligation, or oopherectomy. Poisson regression was conducted to compare pregnancy incidence rates over time by HIV status. Relative time to pregnancy was ascertained via Kaplan-Meier plots and generalized gamma survival analysis.
Results
Adjusting for age, number of male sex partners, contraception, parity, exchanging sex, and alcohol use, HIV infection was associated with a 40% reduction in the incidence rate of pregnancy (incidence rate ratio=0.60, 95% confidence interval: [C.I.] 0.46–0.78). The time for HIV-infected women to become pregnant was 73% longer relative to HIV-uninfected women (relative time=1.73, 95% C.I.: 1.35–2.36). In addition to HIV infection, decreased parity and older age were independent predictors of lower pregnancy incidence.
Conclusions
Despite the beneficial effects of modern antiretroviral therapy on survival and prevention of maternal-to-child transmission, our findings suggest that pregnancy incidence remains lower among HIV-infected women. Whether this lower incidence is due to behavioral differences or reduced biologic fertility remains an area worthy of further study.
doi:10.1097/QAD.0b013e3283445811
PMCID: PMC3496791  PMID: 21297418
women; HIV; pregnancy; time to pregnancy; parity
11.  Perinatal Depressive Symptoms in HIV-Infected Versus HIV-Uninfected Women: A Prospective Study from Preconception to Postpartum 
Journal of Women's Health  2011;20(9):1287-1295.
Abstract
Objective
Depression is common among HIV-infected women, predicts treatment nonadherence, and consequently may impact vertical transmission of HIV. We report findings from a study evaluating preconception, pregnancy, and postpartum depressive symptoms in HIV-infected vs. at-risk, HIV-uninfected women.
Methods
We examined the prevalence and predictors of elevated perinatal (i.e., pregnancy and/or postpartum) depressive symptoms using a Center for Epidemiological Studies-Depression (CES-D) scale score of ≥16 in 139 HIV-infected and 105 HIV-uninfected women (62% African American) from the Women's Interagency HIV Study (WIHS).
Results
The prevalence of elevated perinatal depressive symptoms did not differ by HIV serostatus (HIV-infected 44%, HIV-uninfected 50%, p=0.44). Among HIV-infected women, the strongest predictor of elevated symptoms was preconception depression (odds ratio [OR] 5.71, 95% confidence interval [CI] 2.67-12.19, p<0.001); crack, cocaine, and/or heroin use during preconception was marginally significant (OR 3.10, 95% CI 0.96-10.01, p=0.06). In the overall sample, additional significant predictors of perinatal depression included having multiple sex partners preconception (OR 2.20, 95% CI 1.12-4.32, p=0.02), use of preconception mental health services (OR 2.51, 95% CI 1.03-6.13, p=0.04), and not graduating from high school (OR 1.92, 95% CI 1.06-3.46, p=0.03).
Conclusions
Elevated perinatal depressive symptoms are common among HIV-infected and at-risk HIV-uninfected women. Depressive symptoms before pregnancy were the strongest predictor of perinatal symptoms. Findings underscore the importance of early and ongoing assessment and treatment to ensure low vertical transmission rates and improving postpregnancy outcomes for mothers and children.
doi:10.1089/jwh.2010.2485
PMCID: PMC3168970  PMID: 21732738
12.  Evaluating Safer Conception Options for HIV-Serodiscordant Couples (HIV-Infected Female/HIV-Uninfected Male): A Closer Look at Vaginal Insemination 
HIV serodiscordant couples represent at least half of all HIV-affected couples worldwide. Many of these couples have childbearing desires. Safer methods of conception may allow for pregnancy while minimizing the risk of sexual transmission of HIV. In serodiscordant partnerships with an HIV-infected female and HIV-uninfected male, vaginal insemination of a partner's semen during the fertile period coupled with 100% condom use may be the safest method of conception.
doi:10.1155/2012/587651
PMCID: PMC3423871  PMID: 22927714
13.  Maternal Nutritional Status Predicts Adverse Birth Outcomes among HIV-Infected Rural Ugandan Women Receiving Combination Antiretroviral Therapy 
PLoS ONE  2012;7(8):e41934.
Objective
Maternal nutritional status is an important predictor of birth outcomes, yet little is known about the nutritional status of HIV-infected pregnant women treated with combination antiretroviral therapy (cART). We therefore examined the relationship between maternal BMI at study enrollment, gestational weight gain (GWG), and hemoglobin concentration (Hb) among 166 women initiating cART in rural Uganda.
Design
Prospective cohort.
Methods
HIV-infected, ART-naïve pregnant women were enrolled between 12 and 28 weeks gestation and treated with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor-based combination regimen. Nutritional status was assessed monthly. Neonatal anthropometry was examined at birth. Outcomes were evaluated using multivariate analysis.
Results
Mean GWG was 0.17 kg/week, 14.6% of women experienced weight loss during pregnancy, and 44.9% were anemic. Adverse fetal outcomes included low birth weight (LBW) (19.6%), preterm delivery (17.7%), fetal death (3.9%), stunting (21.1%), small-for-gestational age (15.1%), and head-sparing growth restriction (26%). No infants were HIV-infected. Gaining <0.1 kg/week was associated with LBW, preterm delivery, and a composite adverse obstetric/fetal outcome. Maternal weight at 7 months gestation predicted LBW. For each g/dL higher mean Hb, the odds of small-for-gestational age decreased by 52%.
Conclusions
In our cohort of HIV-infected women initiating cART during pregnancy, grossly inadequate GWG was common. Infants whose mothers gained <0.1 kg/week were at increased risk for LBW, preterm delivery, and composite adverse birth outcomes. cART by itself may not be sufficient for decreasing the burden of adverse birth outcomes among HIV-infected women.
Trial Registration
Clinicaltrials.gov NCT00993031
doi:10.1371/journal.pone.0041934
PMCID: PMC3413694  PMID: 22879899
14.  Current Knowledge and Future Research on Infant Feeding in the Context of HIV: Basic, Clinical, Behavioral, and Programmatic Perspectives12 
Advances in Nutrition  2011;2(3):225-243.
In 2008, between 129,000 and 194,000 of the 430,000 pediatric HIV infections worldwide were attributable to breastfeeding. Yet in many settings, the health, economic, and social consequences of not breastfeeding would have dire consequences for many more children. In the first part of this review we provide an overview of current knowledge about infant feeding in the context of HIV. Namely, we describe the benefits and risks of breastmilk, the evolution of recommended infant feeding modalities in high-income and low-income countries in the last two decades, and contextualize the recently revised guidelines for infant feeding in the context of HIV current knowledge. In the second section, we suggest areas for future research on the postnatal prevention of mother-to-child transmission of HIV (PMTCT) in developing and industrialized countries. We suggest two shifts in perspective. The first is to evaluate PMTCT interventions more holistically, to include the psychosocial and economic consequences as well as the biomedical ones. The second shift in perspective should be one that contextualizes postnatal PMTCT efforts in the cascade of maternal health services. We conclude by discussing basic, clinical, behavioral, and programmatic research questions pertaining to a number of PMTCT efforts, including extended postnatal ARV prophylaxis, exclusive breastfeeding promotion, counseling, breast milk pasteurization, breast milk banking, novel techniques for making breast milk safer, and optimal breastfeeding practices. We believe the research efforts outlined here will maximize the number of healthy, thriving, HIV-free children around the world.
doi:10.3945/an.110.000224
PMCID: PMC3090166  PMID: 22332055
15.  The Human Fetal Immune Response to Hepatitis C Virus Exposure in Utero 
The Journal of Infectious Diseases  2011;203(2):196-206.
Background. Although the rate of mother-to-child transmission of hepatitis C virus (HCV) is low, the effect of HCV exposure in utero on the fetal immune system is unknown.
Methods. Umbilical cord blood was obtained from 7 neonates born to HCV-seropositive, HCV RNA-positive women and 8 neonates born to HCV-seronegative women. Cord blood mononuclear cells were analyzed by immunophenotyping and by intracellular cytokine staining after HCV-specific and polyclonal stimulation. Plasma was analyzed for anti-HCV immunoglobulin M (IgM), cytokine/granzyme concentrations, and indoleamine 2,3-dioxygenase (IDO) activity.
Results. HCV-exposed neonates had significantly lower levels of regulatory T cells expressing HLA-DR, lower CD4+ and CD8+ T cell activation, and lower plasma levels of pro-inflammatory markers than did controls. However, CD4+ and CD8+ T cells from HCV-exposed neonates had higher IFN-γ production in response to polyclonal stimulation than did T cells from controls. IDO activity was similar between groups. No HCV-specific T cell responses or anti-HCV IgM were detected in any neonates.
Conclusions. HCV-exposed neonates showed a relative suppression of immune activation and pro-inflammatory markers, which was counterbalanced by an increased production capacity for IFN-γ. These results suggest that HCV encounters the fetal immune system in utero, and alters the balance between suppressive and pro-inflammatory responses.
doi:10.1093/infdis/jiq044
PMCID: PMC3071071  PMID: 21288819
16.  Emergency Contraception for Newly Arrested Women: Evidence for an Unrecognized Public Health Opportunity 
Incarceration affords an opportunity to provide health care to populations with limited access to care. Women in this population are at high risk for experiencing unintended pregnancies. It is not known what proportion of these women engage in unprotected intercourse in the days prior to incarceration and therefore may benefit from being offered emergency contraception upon their arrest to decrease their risk of unintended pregnancies. We sought to describe the proportion and characteristics of newly arrested women who are eligible for and interested in taking emergency contraception by conducting a cross-sectional study in an urban county jail booking facility. A 63-item survey was administered to women ages 18–44 within 24 h of being arrested in San Francisco. Eighty-four (29%) women were eligible for emergency contraception. Of these, 48% indicated a willingness to take emergency contraception if offered. Half of the women eligible for emergency contraception expressed ambivalent attitudes about pregnancy. Women who had taken emergency contraception in the past were more likely to say they would accept it (45%) than women who had never used it (25%, p = .05). The strongest predictor of willingness to take emergency contraception was not having a misperception about its safety, efficacy, or mechanism of action (RR = 1.9, 95% CI 1.2–3.0). Seventy-one percent of all women indicated that they would accept an advance supply of emergency contraception upon release from jail. Emergency contraception counseling and provision should be offered to newly arrested women as a key reproductive and public health intervention for a traditionally marginalized, high-risk population.
doi:10.1007/s11524-009-9418-8
PMCID: PMC2845828  PMID: 20012702
Incarcerated women; Emergency contraception; Reproductive health
17.  Placental malaria among HIV-infected and uninfected women receiving anti-folates in a high transmission area of Uganda 
Malaria Journal  2009;8:254.
Background
HIV infection increases the risk of placental malaria, which is associated with poor maternal and infant outcomes. Recommendations in Uganda are for HIV-infected pregnant women to receive daily trimethoprim-sulphamethoxazole (TS) and HIV-uninfected women to receive intermittent sulphadoxine-pyrimethamine (SP). TS decreases the risk of malaria in HIV-infected adults and children but has not been evaluated among pregnant women.
Methods
This was a cross sectional study comparing the prevalence of placental malaria between HIV-infected women prescribed TS and HIV-uninfected women prescribed intermittent preventive therapy with sulphadoxine-pyrimethamine (IPT-SP) in a high malaria transmission area in Uganda. Placental blood was evaluated for malaria using smear and PCR.
Results
Placentas were obtained from 150 HIV-infected women on TS and 336 HIV-uninfected women on IPT-SP. The proportion of HIV-infected and HIV-uninfected women with placental malaria was 19% vs. 26% for those positive by PCR and 6% vs. 9% for those positive by smear, respectively. Among all infants, smear+ placental malaria was most predictive of low birth weight (LBW). Primigravidae were at higher risk than multigravidae of having placental malaria among HIV-uninfected, but not HIV-infected, women. Adjusting for gravidity, age, and season at the time of delivery, HIV-infected women on TS were not at increased risk for placental malaria compared to HIV-uninfected women on IPT-SP, regardless of the definition used.
Conclusion
Prevalence of placental malaria was similar in HIV-infected women on TS and HIV-uninfected women on IPT-SP. Nonetheless, while nearly all of the women in this study were prescribed anti-folates, the overall risk of placental malaria and LBW was unacceptably high. The population attributable risk of placental malaria on LBW was substantial, suggesting that future interventions that further diminish the risk of placental malaria may have a considerable impact on the burden of LBW in this population.
doi:10.1186/1475-2875-8-254
PMCID: PMC2781026  PMID: 19912657
18.  Patient Perspectives with Abbreviated versus Standard Pre-Test HIV Counseling in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial 
PLoS ONE  2009;4(4):e5166.
Background
In the US, an unacceptably high percentage of pregnant women do not undergo prenatal HIV testing. Previous studies have found increased uptake of prenatal HIV testing with abbreviated pre-test counseling, however little is known about patient decision making, testing satisfaction and knowledge in this setting.
Methodology/Findings
A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco. A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit. Patient decision making experience was compared between abbreviated versus standard HIV counseling strategies among a sample of low-income, urban, ethnically diverse prenatal patients. The primary outcome was the decisional conflict score (DCS) using O'Connor low-literacy scale and secondary outcomes included satisfaction with test decision, basic HIV knowledge and HIV testing uptake. We conducted an intention-to-treat analysis of 278 women – 134 (48.2%) in the abbreviated arm (AA) and 144 (51.8%) in the standard arm (SA). There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: −0.65, 8.41) did not exceed the non-inferiority margin. HIV testing uptake was very high (97. 8%) and did not differ significantly between the 2 groups (99.3% in AA vs. 96.5% in SA, p = .12). Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36). However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p<0.01).
Conclusions/Significance
This study suggests that streamlining the pre-test counseling process, while associated with slightly lower knowledge, does not compromise patient decision making or satisfaction regarding HIV testing.
Trial Registration
ClinicalTrials.gov NCT00503308
doi:10.1371/journal.pone.0005166
PMCID: PMC2666158  PMID: 19367335
19.  Impact of Round-the-Clock, Rapid Oral Fluid HIV Testing of Women in Labor in Rural India 
PLoS Medicine  2008;5(5):e92.
Background
Testing pregnant women for HIV at the time of labor and delivery is the last opportunity for prevention of mother-to-child HIV transmission (PMTCT) measures, particularly in settings where women do not receive adequate antenatal care. However, HIV testing and counseling of pregnant women in labor is a challenge, especially in resource-constrained settings. In India, many rural women present for delivery without any prior antenatal care. Those who do get antenatal care are not always tested for HIV, because of deficiencies in the provision of HIV testing and counseling services. In this context, we investigated the impact of introducing round-the-clock, rapid, point-of-care HIV testing and counseling in a busy labor ward at a tertiary care hospital in rural India.
Methods and Findings
After they provided written informed consent, women admitted to the labor ward of a rural teaching hospital in India were offered two rapid tests on oral fluid and finger-stick specimens (OraQuick Rapid HIV-1/HIV-2 tests, OraSure Technologies). Simultaneously, venous blood was drawn for conventional HIV ELISA testing. Western blot tests were performed for confirmatory testing if women were positive by both rapid tests and dual ELISA, or where test results were discordant. Round-the-clock (24 h, 7 d/wk) abbreviated prepartum and extended postpartum counseling sessions were offered as part of the testing strategy. HIV-positive women were administered PMTCT interventions. Of 1,252 eligible women (age range 18 y to 38 y) approached for consent over a 9 mo period in 2006, 1,222 (98%) accepted HIV testing in the labor ward. Of these, 1,003 (82%) women presented with either no reports or incomplete reports of prior HIV testing results at the time of admission to the labor ward. Of 1,222 women, 15 were diagnosed as HIV-positive (on the basis of two rapid tests, dual ELISA and Western blot), yielding a seroprevalence of 1.23% (95% confidence interval [CI] 0.61%–1.8%). Of the 15 HIV test–positive women, four (27%) had presented with reported HIV status, and 11 (73%) new cases of HIV infection were detected due to rapid testing in the labor room. Thus, 11 HIV-positive women received PMTCT interventions on account of round-the-clock rapid HIV testing and counseling in the labor room. While both OraQuick tests (oral and finger-stick) were 100% specific, one false-negative result was documented (with both oral fluid and finger-stick specimens). Of the 15 HIV-infected women who delivered, 13 infants were HIV seronegative at birth and at 1 and 4 mo after delivery; two HIV-positive infants died within a month of delivery.
Conclusions
In a busy rural labor ward setting in India, we demonstrated that it is feasible to introduce a program of round-the-clock rapid HIV testing, including prepartum and extended postpartum counseling sessions. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion (82%) of rural women who were unaware of their HIV status when admitted to the labor room. In addition, 11 (73%) of a total of 15 HIV-positive women received PMTCT interventions because of round-the-clock rapid testing in the labor ward. These findings are relevant for PMTCT programs in developing countries.
Nitika Pant Pai and colleagues report the results of offering a round-the-clock rapid HIV testing program in a rural labor ward setting in India.
Editors' Summary
Background.
Since the first reported case of AIDS (acquired immunodeficiency syndrome) in 1981, the number of people infected with the human immunodeficiency virus (HIV), which causes AIDS, has risen steadily. Now, more than 33 million people are infected, almost half of them women. HIV is most often spread through unprotected sex with an infected partner, but mother-to-child transmission (MTCT) of HIV is also an important transmission route. HIV-positive women often pass the virus to their babies during pregnancy, labor and delivery, and breastfeeding, if nothing is done to prevent viral transmission. In developed countries, interventions such as voluntary testing and counseling, safe delivery practices (for example, offering cesarean delivery to HIV-positive women), and antiretroviral treatment of the mother during pregnancy and labor and of her newborn baby have minimized the risk of MTCT. In developing countries, the prevention of MTCT (PMTCT) is much less effective, in part because pregnant women often do not know their HIV status. Consequently, in 2007, nearly half a million children became infected with HIV mainly through MTCT.
Why Was This Study Done?
In many developing countries, women do not receive adequate antenatal care. In India, for example, nearly half the women living in rural areas do not receive any antenatal care until they are in labor. This gives health care providers very little time in which to counsel women about HIV infection, test them for the virus, and start interventions to prevent MTCT. Furthermore, testing pregnant women in labor for HIV and counseling them is a challenge, particularly where resources are limited. In this study, therefore, the researchers investigate the feasibility and impact of introducing round-the-clock, rapid HIV testing and counseling in a busy labor ward in a rural teaching hospital in Sevagram, India.
What Did the Researchers Do and Find?
Women admitted to the labor ward between January and September 2006 were offered two rapid HIV tests—one that used a saliva sample and the other that used blood taken from a finger prick. Blood was also taken from a vein for conventional HIV testing. All the women were given a 15-minute counseling session about how HIV is transmitted, the importance of HIV testing, and information on PMTCT before their child was born (prepartum counseling), and a longer postpartum counseling session. HIV-positive women were given a cesarean delivery where possible and antiretroviral drug treatment to reduce MTCT. 1,222 women admitted to the labor ward during the study period (1,003 of whom did not know their HIV status) accepted HIV testing. Of 15 study participants who were HIV positive, 11 learnt of their HIV status in the labor room. Two babies born to these HIV-positive women were HIV positive and died within a month of delivery; the other 13 babies were HIV negative at birth and at 1 and 4 months after delivery. Finally, the rapid HIV tests missed only one HIV-positive woman (no false-positive results were given), and the time from enrolling a woman into the study through referring her for PMTCT intervention where necessary averaged 40–60 minutes.
What Do These Findings Mean?
These findings show the feasibility and positive impact of the introduction of round-the-clock pre- and postpartum HIV counseling and rapid HIV testing into a busy rural Indian labor ward. Few of the women entering this ward knew their HIV status previously but the introduction of these facilities in this setting successfully informed these women of their HIV status. In addition, the round-the-clock counseling and testing led to 11 women and their babies receiving PMTCT interventions who would otherwise have been missed. These findings need to be confirmed in other settings and the cost-effectiveness and sustainability of this approach for the improvement of PMTCT in developing countries needs to be investigated. Nevertheless, these findings suggest that round-the-clock rapid HIV testing might be an effective and acceptable way to reduce MTCT of HIV in many developing countries.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050092.
Read a related PLoS Medicine Perspective article
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS and on HIV infection in women
HIV InSite has comprehensive information on all aspects of HIV/AIDS
Women, Children, and HIV provides extensive information on the prevention of mother-to-child transmission of HIV in developing countries
Information is available from Avert, an international AIDS charity, on HIV and AIDS in India, on women, HIV, and AIDS, and on HIV and AIDS prevention, including the prevention of mother-to-child transmission
AIDSinfo, a service of the US Department of Health and Human Services provides health information for HIV-positive pregnant women (in English and Spanish)
doi:10.1371/journal.pmed.0050092
PMCID: PMC2365974  PMID: 18462011

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