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Hepatitis C virus (HCV) contributes to liver-related morbidity and mortality throughout Africa despite effective antivirals. HCV is endemic in the Democratic Republic of the Congo (DRC) but data on HCV/HIV co-infection in pregnancy is limited. We estimated the prevalence of and risk factors for HCV/HIV co-infection among pregnant women in the Kinshasa province of the DRC. This cross-sectional study was conducted as a sub-study of an ongoing randomized trial to assess continuous quality improvement interventions (CQI) for prevention of mother-to-child transmission (PMTCT) of HIV (CQI-PMTCT study, NCT03048669). HIV-infected women in the CQI-PMTCT cohort were tested for HCV, and risk factors were evaluated using logistic regression. The prevalence of HCV/HIV co-infection among Congolese women was 0.83% (95% CI 0.43-1.23). Women who tested positive for HCV were younger, more likely to live in urban areas, and more likely to test positive during pregnancy versus postpartum. HCV-positive women had significantly higher odds of infection with hepatitis B virus (HBV) (aOR 13.87 [3.29,58.6]). An inverse relationship was noted between HCV infection and the overall capacity of the health facility as measured by the service readiness index (SRI) (aOR:0.92 [0.86,0.98] per unit increase). Women who presented to rural, for-profit and PEPFAR-funded health facilities were more likely to test positive for HCV. In summary, this study identified that the prevalence of HCV/HIV co-infection was < 1% among Congolese women. We also identified HBV infection as a major risk factor for HCV/HIV co-infection. Individuals with triple infection should be linked to care and the facility-related differences in HCV prevalence should be addressed in future studies., (© 2022. The Author(s).)

The COVID-19 pandemic has raised important universal public health challenges. Conceiving ethical responses to these challenges is a public health imperative but must take context into account. This is particularly important in sub-Saharan Africa (SSA). In this paper, we examine how some of the ethical recommendations offered so far in high-income countries might appear from a SSA perspective. We also reflect on some of the key ethical challenges raised by the COVID-19 pandemic in low-income countries suffering from chronic shortages in health care resources, and chronic high morbidity and mortality from non-COVID-19 causes. A parallel is drawn between the distribution of severity of COVID-19 disease and the classic "Fortune at the bottom of the pyramid" model that is relevant in SSA. Focusing allocation of resources during COVID-19 on the 'thick' part of the pyramid in Low-to-Middle Income Countries (LMICs) could be ethically justified on utilitarian and social justice grounds, since it prioritizes a large number of persons who have been economically and socially marginalized. During the pandemic, importing allocation frameworks focused on the apex of the pyramid from the global north may therefore not always be appropriate. In a post-COVID-19 world, we need to think strategically about how health care systems can be financed and structured to ensure broad access to adequate health care for all who need it. The root problems underlying health inequity, exposed by COVID-19, must be addressed, not just to prepare for the next pandemic, but to care for people in resource poor settings in non-pandemic times., (© 2020 John Wiley & Sons Ltd.)

Background: Social support and relevant skills training can reduce the risk of postpartum depression (PPD) by reducing the impact of stressors. The 10-step program to encourage exclusive breastfeeding that forms the basis of the Baby-Friendly Hospital Initiative (BFHI) provides both, suggesting it may lessen depressive symptoms directly or by reducing difficulties associated with infant feeding. Our objective was to quantify the association of implementing Steps 1-9 or Steps 1-10 on postpartum depressive symptoms and test whether this association was mediated by breastfeeding difficulties., Methods and Findings: We used data from a breastfeeding promotion trial of all women who gave birth to a healthy singleton between May 24 and August 25, 2012 in 1 of the 6 facilities comparing different BFHI implementations (Steps 1-9, Steps 1-10) to the standard of care (SOC) randomized by facility in Kinshasa, Democratic Republic of Congo. Depressive symptoms, a non-registered trial outcome, was assessed at 14 weeks via the Edinburgh Postnatal Depression Scale (EPDS). Inverse probability weighting (IPW) was used to estimate the association of BFHI implementations on depressive symptoms and the controlled direct association through breastfeeding difficulties at 10 weeks postpartum. A total of 903 mother-infant pairs were included in the analysis. Most women enrolled had previously given birth (76%) and exclusively breastfed at 10 weeks (55%). The median age was 27 (interquartile range (IQR): 23, 32 years). The proportion of women reporting breastfeeding difficulties at week 10 was higher in both Steps 1-9 (75%) and Steps 1-10 (91%) relative to the SOC (67%). However, the number of reported difficulties was similar between Steps 1-9 (median: 2; IQR: 0, 3) and SOC (2; IQR: 0, 3), with slightly more in Steps 1-10 (2; IQR: 1, 3). The prevalence of symptoms consistent with probable depression (EPDS score >13) was 18% for SOC, 11% for Steps 1-9 (prevalence difference [PD] = -0.08; 95% confidence interval (CI): -0.14 to -0.01, p = 0.019), and 8% for Steps 1-10 (PD = -0.11, -0.16 to -0.05; p < 0.001). We found mediation by breastfeeding difficulties. In the presence of any difficulties, the PD was reduced for both Steps 1-9 (-0.15; 95% confidence level (CL): -0.25, -0.06; p < 0.01) and Steps 1-10 (-0.16; 95% CL: -0.25, -0.06; p < 0.01). If no breastfeeding difficulties occurred in the population, there was no difference in the prevalence of probable depression for Steps 1-9 (0.21; 95% CL: -0.24, 0.66; p = 0.365) and Steps 1-10 (-0.03; 95% CL: -0.19, 0.13; p = 0.735). However, a limitation of the study is that the results are based on 2 hospitals randomized to each group., Conclusions: In conclusion, in this cohort, the implementation of the BFHI steps was associated with a reduction in depressive symptoms in the groups implementing BFHI Steps 1-9 or 1-10 relative to the SOC, with the implementation of Steps 1-10 associated with the largest decrease. Specifically, the reduction in depressive symptoms was observed for women reporting breastfeeding difficulties. PPD has a negative impact on the mother, her partner, and the baby, with long-lasting consequences. This additional benefit of BFHI steps suggests that renewed effort to scale its implementation globally may be beneficial to mitigate the negative impacts of PPD on the mother, her partner, and the baby., Trial Registration: ClinicalTrials.gov NCT01428232., Competing Interests: The authors have declared that no competing interests exist.

The Covid-19 pandemic has sparked rapid and voluminous production of bioethics commentary in popular media and academic publications. Many of the discussions are new twists on an old theme: how to fairly allocate scarce medical resources, such as ventilators and intensive care unit beds. In this essay, we do not add another allocation scheme to the growing pile, partly out of appreciation that such schemes should be products of inclusive and transparent community engagement and partly out of recognition of their limited utility for physicians working in the field. Instead, we make the more modest claim that context matters when making such decisions and, more specifically, that recommendations from high-income countries about fair allocation during Covid-19 should not be cut and pasted into low-income settings. We offer a few examples of why seemingly universal, well-intentioned ethical recommendations could have adverse consequences if unreflectively applied in sub-Saharan Africa., (© 2020 The Hastings Center.)

Objective HIV-exposed uninfected infants are almost twice as likely to die compared to infants born to HIV-uninfected women. HIV-exposed uninfected children whose mothers are on ART and who are breastfed have the lowest risk of dying by 24 months of age. Interventions to improve breastfeeding among HIV-infected mothers are needed. We aimed to assess the association between support/counseling provided by healthcare workers following delivery and the rate of exclusive breastfeeding (EBF) at 6-week postpartum. Methods This is a secondary analysis of data collected as part of a trial to evaluate the effect of conditional cash transfers on retention in and uptake of PMTCT services. Between April 2013 and August 2014, newly diagnosed HIV-infected women, ≤ 32 weeks pregnant, registering for antenatal care (ANC), in 89 clinics in Kinshasa, Democratic Republic of Congo, were recruited and followed through 6 weeks postpartum. At 6-week, participants were asked if they had given anything other than breastmilk to their infant in the 24 h preceding the interview (No = EBF) and whether a nurse or a doctor talked to them about breastfeeding after they gave birth (YES = received breastfeeding support/counseling). Logistic regression was used to estimate the odds ratios (OR) and 95% confidence intervals (CI) measuring the strength of the association between EBF and receiving breastfeeding support/counseling by a healthcare provider following delivery. Results Of 433 women enrolled, 328 attended a 6-week postpartum visit including 320 (97%) with complete information on EBF. Of those 320, 202 (63%) reported giving nothing other than breastmilk to their infant in the previous 24 h; 252 (79%) reported that a healthcare provider came to talk to them about breastfeeding following delivery. Mothers who reported receiveing breastfeeding support/counseling from a healthcare provider were more likely to exclusively breastfeed compared to those who did not (69% vs. 38%, OR 3.74; 95% CI 2.14-6.54). Adjustment for baseline sociodemographic characteristics did not change the association substantially, (adjusted OR 3.72; 95% CI 2.06-6.71). Conclusion for Practice Receipt of breastfeeding support/counseling from a healthcare provider after delivery among HIV-infected mothers in care at 6-weeks postpartum in Kinshasa almost quadrupled the odds of EBF.

Introduction: Published data on viral suppression among pregnant and breastfeeding women in routine care settings are scarce. Here, we report provincial estimates of undetectable and suppressed viral load among pregnant or breastfeeding women in HIV care in Kinshasa, Democratic Republic of Congo (DRC) and associated risk factors., Methods: This cross-sectional study was conducted as part of a baseline assessment for the CQI-PMTCT study: an ongoing cluster randomized trial to evaluate the effect of continuous quality interventions (CQI) on long-term ART outcomes among pregnant and breastfeeding women (NCT03048669). From November 2016 to June 2018, in each of the 35 Kinshasa provincial health zones (HZ), study teams visited the three busiest maternal and child health clinics, enrolled all HIV-positive pregnant or breastfeeding women (≤1 year post-delivery) receiving ART, and performed viral load testing. Log binomial models with generalized estimating equations to account for clustering at the HZ level, were used to estimate prevalence ratios comparing participants with undetected (<40 copies/mL) or suppressed (<1000 copies/mL) viral load across levels of individual and site characteristics., Results: Of the 1752 eligible women, 1623 had viral load results available, including 38% who had been on ART for <6 months and 74% were on tenofovir-lamivudine-efavirenz. Viral load was undetectable in 53% of women and suppressed in 62%. Among women who were on ART for ≥12 months, only 60% and 67% respectively, had undetectable or suppressed viral load. Viral load was undetectable in 53%, 48% and 58% of women testing during pregnancy, at delivery, and in postpartum respectively. In multivariable log binomial models, duration of ART >12 months, older age, being married, disclosure of HIV status, receiving care in an urban health zone or one supported by PEPFAR were all positively associated with viral suppression., Conclusions: The observed high level of detectable viral load suggests that high ART coverage alone without substantial efforts to improve the quality of care for pregnant and breastfeeding women, will not be enough to achieve the goal of virtual elimination of vertical HIV transmission in high-burden and limited resources settings like DRC., (© 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Hepatitis B virus (HBV) co-infection in HIV-infected individuals increases the risk of hepatic complications and mortality. Further, the risk of perinatal HBV transmission increases among HBV/HIV co-infected pregnant women. Although HBV is endemic in the Democratic Republic of Congo, there is little data on HBV/HIV co-infection. We aimed to assess the burden and risk factors of HBV surface antigen (HBsAg) positivity among HIV-infected pregnant and post-partum women., Methods: This cross-sectional study was conducted as part of an ongoing trial to assess the effect of data-driven continuous quality improvement interventions (CQI) for optimal prevention of mother-to-child transmission (PMTCT) of HIV (CQI-PMTCT study, NCT03048669). In each of the 35 health zones of Kinshasa province, all HIV-infected pregnant or breastfeeding women (≤1 year post-delivery) presenting for care in one of the three busiest maternal and child health clinics of the health zone were tested for HBsAg using Alere Determine, Japan. We used logistic regression with general estimating equation accounting for within-clinic clustering to assess risk factors of HBsAg positivity., Results: Between November 2016 and June 2018, a total of 1377 women, all on antiretroviral therapy, were tested for HBsAg. Overall, 4.7% [95% binomial confidence interval (CI): 3.7%-5.7%] tested positive for HBsAg. HBsAg prevalence was 3.3% (95% CI: 2.1%-4.8%) for women tested during pregnancy, 4.5% (2.5%-7.4%) for those tested at delivery, and 8.5% (5.6%-12.2%) for those tested post-partum (Ptrend = 0.001). In multivariate models including socio-economic status (SES), type of care facility, duration of antiretroviral therapy, HIV viral load, and self-reported intimate partner violence (IPV), lowest tertile of SES, ≤ 6 months of ART, and IPV were all consistently and positively associated with higher prevalence of HBsAg across pregnancy, delivery, and postpartum period while been tested in a health centre or having a viral load ≥ 1000 copies/mL were consistently associated with lower prevalence. However, only the association with IPV (OR = 2.74, 95% CI: 1.10-6.84) and viral load between 40-1000 copies/ml (OR = 4.28, 95% CI: 1.22-15.01) achieved statistical significance among pregnant women., Conclusion: This study revealed an overall high prevalence of HBsAg among HIV-infected pregnant and post-partum women in Kinshasa with the latter showing the highest HBsAg prevalence. Among pregnant women, intimate partner violence was independently and statistically associated with HBsAg positivity, requiring further investigation., Competing Interests: The authors have declared that no competing interests exist.

Introduction Unintended pregnancy during the postpartum period is common. The aim of this study was to describe contraceptive use among postpartum women and assess whether family planning counseling offered by health care providers during well-baby clinic visits increased use of modern contraceptive methods at 6 months following delivery. Methods Data comes from a cohort of women enrolled in a breastfeeding promotion trial in Kinshasa, Democratic Republic of Congo who reported being sexually active at 24-weeks post-partum. Modern contraceptive methods included intrauterine devices, injectables, implants, and contraception pills. Logistic regression models were used to estimate odd ratios (OR) and 95% confidence intervals (CI) for the impact of nurse counseling on use of modern birth control methods. Results Of 522 participants who reported being sexually active, 251 (48.0%) reported doing at least one thing to avoid pregnancy and were included in this analysis. Of these 251, 14.3% were using a modern contraceptive method, despite availability at the clinic. Discussion with a nurse about family planning was associated with increased odds of using modern birth control relative to other methods (OR 4.0, 95% CI 1.9, 8.6). Discussion Discussion of family planning with a nurse increased the odds of using a modern contraceptive among postpartum women. Integration of family planning counseling into postpartum services offers a potential avenue to increase modern contraceptive use among women with access.

Intimate partner violence (IPV) is a risk factor for non-adherence to HIV treatment for women, however the evidence on the impact of IPV on uptake of the prevention of mother to child transmission of HIV (PMTCT) cascade is inconclusive. We examined data from 433 HIV positive pregnant women in Kinshasa, Democratic Republic of Congo, enrolled between April 2013 and August 2014 and followed-up through 6 weeks postpartum. Participants were asked about their IPV experiences in a face-to-face interview at enrollment. Measures of PMTCT cascade included: uptake of clinical appointments and services, viral suppression, and adherence to antiretrovirals (ARV). Approximately half of the sample (51%) had experienced some form of IPV; 35% had experienced emotional abuse, 29% physical abuse, and 19% sexual abuse. There were no statistically significant associations between experiencing any form of IPV and uptake of clinical appointments and services (Adjusted Prevalence Ratio [aPR] = 1.02; 95% [CI]: 0.89-1.17), viral load suppression (aPR = 1.07, 95% CI:0.96-1.19) and ARV adherence (aPR = 1.01, 95% CI: 0.87-1.18). Findings from this study indicate that, among HIV-infected pregnant women enrolled in PMTCT care, experiencing IPV does not reduce adherence to clinic visits and services, adherence to ARV. The high prevalence of IPV in this population suggests that IPV screening and intervention should be included as part of standard care for PMTCT., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Global initiatives to improve breastfeeding practices have focused on the Ten Steps to Successful Breastfeeding. The aim of this study was to assess the effect of implementing Baby-Friendly Hospital Initiative (BFHI) steps 1-9 and BFHI steps 1-10 on incidence of diarrhea and respiratory illnesses in the first 6 months of life., Methods: We reanalyzed a cluster randomized trial in which health-care clinics in Kinshasa, Democratic Republic of Congo, were randomly assigned to standard care (control group), BFHI steps 1-9, or BFHI steps 1-10. Outcomes included episodes of diarrhea and respiratory illness. Piecewise Poisson regression with generalized estimation equations to account for clustering by clinic was used to estimate incidence rate ratios (IRR) and 95% confidence intervals (CI)., Results: Steps 1-9 was associated with a decreased incidence of reported diarrhea (IRR 0.72, 95% CI 0.53, 0.99) and respiratory illness (IRR 0.48, 95% CI 0.37, 0.63), health facility visits due to diarrhea (IRR 0.60, 95% CI 0.42, 0.85) and respiratory illness (IRR 0.47, 95% CI 0.36, 0.63), and hospitalizations due to diarrhea (IRR 0.42, 95% CI 0.17, 1.06) and respiratory illness (IRR 0.33, 95% CI 0.11, 0.98). Addition of Step 10 attenuated this effect: episodes of reported diarrhea (IRR 1.24, 95% CI 0.93, 1.68) and respiratory illness (IRR 0.77, 95% CI 0.60, 0.99), health facility visits due to diarrhea (IRR 0.76, 95% CI 0.54, 1.08) and respiratory illness (IRR 0.75 95% CI 0.57, 0.97), and hospitalizations due to respiratory illness (IRR 0.48 95% CI 0.16, 1.40); but strengthened the effect against hospitalizations due to diarrhea (IRR 0.14, 95% CI 0.03, 0.60)., Conclusions: Implementation of steps 1-9 significantly reduced incidence of mild and severe episodes of diarrhea and respiratory infection in the first 6 months of life, addition of step 10 appeared to lessen this effect., Trial Registration: NCT01428232.

Background: Loss to care is high among asymptomatic HIV-infected women initiated on antiretroviral therapy (ART) during pregnancy or in the postpartum period. However, whether pregnancy itself plays a role in the high loss to care rate is uncertain. We compared loss to care over seven years between pregnant and non-pregnant women at enrollment into HIV care in the Democratic Republic of Congo (DRC)., Methods: We conducted a retrospective analysis of all ART-naive women aged 15-45 initiating HIV care at two large clinics in Kinshasa, DRC, from 2007-2013. Pregnancy status was recorded at care enrollment. Patients were classified as having no follow-up if they did not return to care after the initial enrollment visit. Among those with at least one follow-up visit after enrollment, we classified patients as lost to care if more than 365 days had passed since their last clinic visit. We used logistic regression to model the association between pregnancy status and no follow-up, and Cox proportional hazards regression to model the association between pregnancy status and time to loss to care., Results: Of 2175 women included in the analysis, 1497 (68.8%) were pregnant at enrollment. Compared to non-pregnant women, pregnant women were less likely to be over 35 years of age (19.1% vs. 31.9%, p<0.0001) and less likely to be in WHO stage III or IV (9.0% vs. 26.3%, p<0.0001). Among pregnant women, 106 (7.1%) were not seen after enrollment, versus 25 (3.7%) non-pregnant women (adjusted odds ratio 2.01, 95% CI 1.24-3.24). Of the 2,044 women with at least one follow-up visit, 46.5% of pregnant women and 46.7% of non-pregnant women were lost to care by 5 years; hazards of loss to care were similar for pregnant and non-pregnant women (adjusted hazard ratio 1.08, 95% CI 0.93-1.26)., Conclusions: In this large cohort of HIV-infected women, patients pregnant at care enrollment were more likely to never return for follow-up. Among those who attended at least one follow-up visit, loss to care was not different between pregnant and non-pregnant women, suggesting that pregnancy itself may not be the main driver of the high attrition observed in this cohort.

Background: Based on clinical trial results, the World Health Organization recommends infant HIV testing at age 4-6 weeks and immediate antiretroviral therapy (ART) initiation in all HIV-infected infants. Little is known about the outcomes of HIV-infected infants diagnosed with HIV in the first weeks of life in resource-limited settings. We assessed ART initiation and mortality in the first year of life among infants diagnosed with HIV by 12 weeks of age., Methods: Cohort of HIV-infected infants in Kinshasa and Blantyre diagnosed before 12 weeks to estimate 12-month cumulative incidences of ART initiation and mortality, accounting for competing risks. Multivariate models were used to estimate associations between infant characteristics and timing of ART initiation., Results: One hundred and twenty-one infants were diagnosed at a median age of 7 weeks (interquartile range, 6-8). The cumulative incidence of ART initiation was 46% [95% confidence interval (CI), 36%, 55%] at 6 months and 70% (95% CI 60%, 78%) at 12 months. Only age at HIV diagnosis was associated with ART initiation by age 6 months, with a subdistribution hazard ratio of 0.70 (95% CI 0.52, 0.91) for each week increase in age at DNA polymerase chain reaction test. The 12-month cumulative incidence of mortality was 20% (95% CI 13%, 28%)., Conclusions: Despite early diagnosis of HIV, ART initiation was slow and mortality remained high, underscoring the complexity in translating clinical trial findings and World Health Organization's guidance into real-life practice. Novel and creative health system interventions will be required to ensure that all HIV-infected infants achieve optimal treatment outcomes under routine care settings.

Background: Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum., Methods: The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics., Discussion: If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation., Trial Registration: The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .

Objective: To elucidate the mechanisms by which a cash incentive intervention increases retention in prevention of mother-to-child transmission services., Methods: We used data from a randomized controlled trial in Kinshasa, Democratic Republic of Congo. Perceptual factors associated with loss to follow-up (LTFU) through 6 weeks postpartum were first identified. Then, binomial models were used to assess interactions between LTFU and identified factors, and the cash incentive intervention., Results: Participants were less likely to be LTFU if they perceived HIV as a "very serious" health problem for their baby vs. not [risk difference (RD), -0.13; 95% confidence interval (CI): -0.30 to 0.04], if they believed it would be "very likely" to pass HIV to their baby if they did not take any HIV drug vs. not (RD, -0.15; 95% CI: -0.32 to 0.02), and if they anticipated that not having money would make it difficult for them to come to the clinic vs. not (RD, 0.12; 95% CI: -0.07 to 0.30). The effect of each of the 3 factors on LTFU was antagonistic to that of receiving the cash incentive intervention. The excess risk due to interaction between the cash incentive intervention and the anticipated difficulty of "not having money" to come to the clinic was exactly equal to the effect of removing this perceived barrier (excess risk due to interaction, -0.12; 95% CI: -0.35 to 0.10)., Conclusions: Our analyses show that cash transfers improve retention in prevention of mother-to-child transmission services mainly by mitigating the negative effect of not having money to come to the clinic.

Background: Syphilis management is complex and demonstration of treatment response requires monitoring of nontreponemal antibody titers for a ≥ 4-fold decline and/or seroreversion to nonreactive titers., Methods: We evaluated data from a multicenter clinical trial of syphilis treatment conducted from 2000 to 2009 involving human immunodeficiency virus (HIV)-negative patients 18 years or older with early syphilis. To assess the rate of titer decline and seroreversion after effective therapy, rapid plasma reagin (RPR) titers were analyzed at 1, 3, 6, 9, and 12 months among patients with an appropriate treatment response. We plotted the rate of RPR titer decline after treatment, estimated the frequency of seroreversion, and conducted multivariate analyses to assess characteristics associated with seroreversion., Results: Among 369 (79.4%) of 465 HIV-negative patients with early syphilis who had an appropriate treatment response, 333 participants had complete RPR data over 12 months. Although the decline in RPR titers was ≥ 4-fold among 88.0% (293/333) of participants at 3 months and ≥ 8-fold among 77.8% at 6 months, only 9.6% achieved complete RPR seroreversion at 6 months and 17.1% at 12 months after therapy. Male sex (adjusted odds ratio, 4.3; 95% confidence interval, 1.8-10.5) and baseline RPR titers ≤ 1:32 (adjusted odds ratio, 14.5; 95% confidence interval, 6.8-31.2) were associated with higher odds of seroreversion compared with females and titers > 1:32, respectively., Conclusions: Despite a ≥ 4-fold RPR titer decline after treatment, the majority of HIV-negative patients with early syphilis failed to have seroreversion at 12 months. Nontreponemal antibody titers often persist despite an appropriate treatment response., Competing Interests: Dr. Hook reports personal fees from Rib-X (Melinta), grants from Cempra, grants from Becton Dickinson, grants from Hologic, personal fees from Roche Molecular, personal fees from McGraw Hill, personal fees from Cepheid, outside the submitted work. All other authors declare no conflict of interests.

Introduction: Provider-initiated HIV testing and counseling (PITC) of patients with presumptive tuberculosis (TB) is not widely implemented and the burden of HIV among them is not well characterized. We assessed the uptake of PITC and prevalence of HIV among patients with presumptive TB in primary care settings in the Democratic Republic of Congo., Methods: PITC was implemented in primary care TB clinics in Kinshasa and Kisangani, respectively. In each of the clinics, all patients presenting with cough lasting more than two weeks or any other symptom suggestive of TB were offered HIV testing and counseling and those found to be HIV+ were linked to HIV care and treatment., Results: Between November 2011 and June 2013, 43,145 patients with presumptive TB were registered in 65 clinics in Kinshasa of whom 84.0% were counseled; 92.4% of those counseled were tested and 4,320 (12.9%) were found to be HIV+. Similarly, in Kisangani, of the 6,687 patients with presumptive TB were registered in 13 clinics, 80.5% were counseled; 99.3% were tested for HIV and 619 (11.6%) were found to be HIV+., Conclusion: Implementation of PITC among patients with presumptive TB in primary care clinics was associated with high uptake of HIV testing and identification of high number of HIV+ patients., Competing Interests: The authors declare no competing interest.

Background: Novel strategies are needed to increase retention in prevention of mother-to-child HIV transmission (PMTCT) services. We have recently shown that small, incremental cash transfers conditional on attending clinic resulted in increased retention along the PMTCT cascade. However, whether women who receive incentives to attend clinic visits are as adherent to antiretrovirals (ARV) as those who do not was unknown., Objective: To determine whether HIV-infected women who received incentives to remain in care were as adherent to antiretroviral treatment and achieved the same level of viral suppression at 6 weeks postpartum as those who did not receive incentives but also remained in care., Methods: Newly diagnosed HIV-infected women at ≤32 weeks gestational age were recruited at antenatal care clinics in Kinshasa, Democratic Republic of Congo. Women were randomized in a 1:1 ratio to an intervention or control group. The intervention group received compensation ($5, plus $1 increment at each subsequent visit) conditional on attending scheduled clinic visits and accepting offered PMTCT services, whereas the control group received usual care. The proportion of participants who remained in care, were fully adherent (took all their pills at each visit) or with undetectable viral load at 6 weeks postpartum were compared across group., Results: Among 433 women randomized (216 in intervention group and 217 in control group), 332 (76.7%) remained in care at 6 weeks postpartum, including 174 (80.6%) in the intervention group and 158 (72.8%) in the control group, (P = 0.04). Data on pill count were available for 297 participants (89.5%), including 156 (89.7%) and 141 (89.2%) in the intervention and control groups, respectively; 69.9% (109/156) and 68.1% (96/141) in the intervention and control groups had perfect adherence [risk difference, 0.02; 95% CI: -0.06 to 0.09]. Viral load results were available for 171 (98.3%) and 155 (98.7%) women in the intervention and control groups, respectively; 66.1% (113/171) in the intervention group and 69.7% (108/155) in the control group had an undetectable viral load (risk difference, -0.04; 95% CI: -0.14 to 0.07). Results were similar after adjusting for marital status, age, education, baseline CD4 count, viral load, gestational age, and initial ARV regimen., Conclusions: Although the provision of cash incentives to HIV-infected pregnant women led to higher retention in care at 6 weeks postpartum, among those retained in care, adherence to ARVs and virologic suppression did not differ by study group., Competing Interests: The authors have no conflicts of interest to disclose.

Background: The human immunodeficiency virus type 1 (HIV-1) pandemic was ignited in Léopoldville (now known as Kinshasa), in the former Belgian Congo. Factors that jump-started its early expansion remain unclear. Nonlethal hepatitis C virus (HCV) and human T-cell lymphotropic virus (HTLV-1) can be used to investigate past iatrogenic transmission., Methods: We undertook a cross-sectional study of elderly inhabitants of Kinshasa, with serological assays, amplification, and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods reconstructed the genetic history of HCV., Results: A total of 217 of 839 participants (25.9%) were HCV seropositive; 26 (3.1%) were HTLV-1-seropositive. Amplification products were obtained from 118 HCV-seropositive participants; subtypes 4k (in 47 participants) and 4r (in 38) were most common. Independent risk factors for HCV subtype 4r seropositivity were intramuscular tuberculosis therapy, intravenous injections at hospital A, intravenous injections before 1960, and injections at a colonial-era venereology clinic. Intravenous injections at hospital B and antimalarials were associated with HCV subtype 4k seropositivity. Risk factors for HTLV-1 seropositivity included intravenous injections at hospitals C or D and transfusions. Evolutionary analysis of viral sequences revealed independent exponential amplification of HCV subtypes 4r and 4k from the 1950s onward., Conclusions: Iatrogenic transmission of HCV and HTLV-1 occurred in mid-20th century Kinshasa, at the same time and place HIV-1 emerged. Iatrogenic routes may have contributed to the early establishment of the pandemic., (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.)

Background: Novel strategies are needed to increase retention in and uptake of prevention of mother-to-child HIV transmission (PMTCT) services in sub-Saharan Africa. We aimed to determine whether small, increasing cash payments, which were conditional on attendance at scheduled clinic visits and receipt of proposed services can increase the proportions of HIV-infected pregnant women who accept available PMTCT services and remain in care., Methods: In this randomised controlled trial, we recruited newly diagnosed HIV-infected women, who were 32 or less weeks pregnant, from 89 antenatal care clinics in Kinshasa, Democratic Republic of Congo, and randomly assigned (1:1) them to either the intervention group or the control group using computer-based randomisation with varying block sizes of four, six, and eight. The intervention group received compensation on the condition that they attended scheduled clinic visits and accepted offered PMTCT services (US$5, plus US$1 increment at every subsequent visit), whereas the control group received usual care. Outcomes assessed included retention in care at 6 weeks' post partum and uptake of PMTCT services, measured by attendance of all scheduled clinic visits and acceptance of proposed services up to 6 weeks' post partum. Analyses were by intention to treat. This trial is registered with ClinicalTrials.org, number NCT01838005., Findings: Between April 18, 2013, and Aug 30, 2014, 612 potential participants were identified, 545 were screened, and 433 were enrolled and randomly assigned; 217 to the control group and 216 to the intervention group. At 6 weeks' post partum, 174 participants in the intervention group (81%) and 157 in the control group (72%) were retained in care (risk ratio [RR] 1·11; 95% CI 1·00-1·24). 146 participants in the intervention group (68%) and 116 in the control group (54%) attended all clinic visits and accepted proposed services (RR 1·26; 95% CI 1·08-1·48). Results were similar after adjustment for marital status, age, and education., Interpretation: Among women with newly diagnosed HIV, small, incremental cash incentives resulted in increased retention along the PMTCT cascade and uptake of available services. The cost-effectiveness of these incentives and their effect on HIV-free survival warrant further investigation., Funding: President's Emergency Plan for AIDS Relief and the National Institute of Health and Child Development., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background. We assessed the impact of WHO's 2010 guidelines that removed the requirement of CD4 count before ART, on timely initiation of ART among HIV/TB patients in the Democratic Republic of Congo (DRC). Methods. Data collected to monitor implementation of provider initiated HIV testing and counseling (PITC) and linkage to HIV care from 65 and 13 TB clinics in Kinshasa and Kisangani, respectively, between November 2010 and June 2013. Results. Prior to the WHO's 2010 guidelines, in Kinshasa, 79.1% (401/507) of HIV/TB patients referred for HIV services were initiated on ART in clinics with onsite ART services compared to 50.0% (63/123) in clinics without. Following the implementation of the new guidelines, 89.8% (714/795) and 93.0% (345/371) of HIV/TB patients referred for HIV services were initiated on ART, respectively, in clinics with onsite and without onsite ART services. Similarly, in Kisangani, 69.7% (53/120) and 36.4% (16/44) in clinics with and without onsite ART service, respectively, were initiated on ART prior to the 2010 guidelines and 88.8% (135/152) and 72.6% (106/146), respectively, after the new guidelines. Conclusion. Though implementation of the 2010 guidelines increased the proportion of HIV/TB patients initiated on ART substantially, it remained below the 100% target, particularly in clinics without onsite ART services.

Background: The consequences of decentralizing prevention of mother-to-child HIV transmission and HIV-exposed infant services to antenatal care (ANC)/labor and delivery (L&D) sites from dedicated HIV care and treatment (C&T) centers remain unknown, particularly in low prevalence settings., Methods: In a cohort of mother-infant pairs, we compared delivery of routine services at ANC/L&D and C&T facilities in Kinshasa, Democratic Republic of Congo from 2010-2013, using methods accounting for competing risks (eg, death). Women could opt to receive interventions at 90 decentralized ANC/L&D sites, or 2 affiliated C&T centers. Additionally, we assessed decentralization's population-level impacts by comparing proportions of women and infants receiving interventions before (2009-2010) and after (2011-2013) decentralization., Results: Among newly HIV-diagnosed women (N = 1482), the 14-week cumulative incidence of receiving the package of CD4 testing and zidovudine or antiretroviral therapy was less at ANC/L&D [66%; 95% confidence interval (CI): 63% to 69%] than at C&T (88%; 95% CI: 83% to 92%) sites (subdistribution hazard ratio, 0.62; 95% CI: 0.55 to 0.69). Delivery of cotrimoxazole and DNA polymerase chain reaction testing to HIV-exposed infants (N = 1182) was inferior at ANC/L&D sites (subdistribution hazard ratio, 0.84; 95% CI: 0.76 to 0.92); the 10-month cumulative incidence of the package at ANC/L&D sites was 89% (95% CI: 82% to 93%) versus 97% (95% CI: 93% to 99%) at C&T centers. Receipt of the pregnancy (20% of 1518, to 64% of 1405) and infant (16%-31%) packages improved post decentralization., Conclusions: Services were delivered less efficiently at ANC/L&D sites than C&T centers. Although access improved with decentralization, its potential cannot be realized without sufficient and sustained support.

We assessed isoniazid preventive therapy (IPT) completion and predictors among HIV-infected children and adults in two HIV clinics in Kinshasa, Democratic Republic of Congo. Between 1 September 2012 and 15 June 2013, 546 children (1-15 years) and 1532 adults (>15 years) were initiated on IPT; 86.6% (408/470) of the children and 88.2% (1129/1280) of the adults with an IPT outcome completed their therapy. Patients on antiretroviral therapy at IPT initiation were more likely to complete IPT.

The Garífuna, an ethnic minority group in Honduras, have been disproportionately affected by HIV. Previous research suggests that migration and high rates of multiple sexual partnerships are major drivers of the epidemic. Using data from a 2012 population-based survey, we assessed whether temporary migration was associated with (1) multiple sexual partnerships and (2) sexual concurrency among Garífuna men and women in Honduras. Among both men and women, temporary migration in the last year was associated with an increased likelihood of multiple sexual partnerships and with concurrency, though only the association between migration and multiple sexual partnerships among men was statistically significant (Adjusted Prevalence Ratio 1.7, 95 % CI 1.2-2.4). Migration may contribute to HIV/STI vulnerability among Garífuna men and women via increases in these sexual risk behaviors. Research conducted among men and women at elevated risk of HIV should continue to incorporate measures of mobility, including history of internal migration.

Background: Optimisation of breastfeeding practices could reduce high mortality rates in children younger than 5 years, but in DR Congo, despite near-universal breastfeeding initiation and nine of ten children still breastfeeding at 1 year of age, exclusivity remains a difficulty. We assessed the effect on breastfeeding outcomes of a short-cut implementation of a programme called the Ten Steps to Successful Breastfeeding, the key component of the Baby-Friendly Hospital Initiative (BFHI)., Methods: We did a cluster-randomised controlled trial and randomly assigned health-care clinics in Kinshasa, DR Congo, to standard care (control group), BFHI steps 1-9 (steps 1-9 group), or BFHI steps 1-9 plus additional support during well-child visits (steps 1-10 group) with computer-generated random numbers used to assign matched pairs to study groups. Mothers at these clinics who had given birth to one healthy baby during enrolment, and who expressed their intentions of visiting a well-baby session at the same clinic, were eligible and received the treatment assigned to their clinic. Mother-infant pairs were excluded if the mothers intended to attend well-baby clinic visits at a different health facility, or to travel before the child was aged at least 6 months. Participants and independent interviewers were masked to group assignment (ie, they were recruited after randomisaion and training of the clinic staff and were not informed of the study scheme), but clinical staff were unmasked. BFHI steps 1-9 and 1-10 were given by health-care staff trained with the WHO/UNICEF BFHI course. The primary outcomes were breastfeeding initiation within 1 h of birth and exclusive breastfeeding at age 14 and 24 weeks, assessed at face-to-face interviews in the clinic. Analysis was by intention to treat. Prevalence ratios (PR) were adjusted for cluster effects and baseline characteristics. This trial is registered at ClinicalTrials.gov, number NCT01428232, and is closed to new participants., Findings: Between May 24, and Aug 25, 2012, we randomly assigned two eligible clinics to control, two to BFHI steps 1-9, and two to BFHI steps 1-10. We enrolled 975 eligible mother-infant pairs (304 in the control group, 363 in the steps 1-9 group, and 308 in the steps 1-10 group). 230 (76%) of infants in the control group, 263 (72%) in the steps 1-9 group, and 220 (71%) in the steps 1-10 group were breastfed within 1 h of birth; these results did not differ significantly between groups. Prevalence of exclusive breastfeeding at age 14 weeks was 89 (29%) in the control group, 237 (65%) in the steps 1-9 group (adjusted PR 2·20, 95% CI 1·73-2·77), and 129 (42%) in the steps 1-10 group (1·40, 1·13-1·74). At age 24 weeks, the prevalence of exclusive breastfeeding was 36 (12%) in the control group, 131 (36%) in the steps 1-9 group (3·50, 2·76-4·43), and 43 (14%) in the steps 1-10 group (1·31, 0·91-1·89)., Interpretation: In the setting of health-care clinics in DR Congo with a high proportion of mothers initiating breastfeeding, implementation of basic training in BFHI steps 1-9 had no additional effect on initiation of breastfeeding but significantly increased exclusive breastfeeding at 6 months of age. Additional support based on the same training materials and locally available breastfeeding support materials, offered during well-child visits (ie, step 10) did not enhance this effect, and might have actually lessened it., (Copyright © 2015 Yotebieng et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.)

Background: Programs to prevent mother-to-child HIV transmission are plagued by loss to follow-up (LTFU) of HIV-exposed infants. We assessed if providing combination antiretroviral therapy (cART) to HIV-infected mothers was associated with reduced LTFU of their HIV-exposed infants in Kinshasa, DR Congo., Methods: We constructed a cohort of mother-infant pairs using routinely collected clinical data. Maternal cART eligibility was based on national guidelines in effect at the time. Infants were considered LTFU after 3 failed tracking attempts after a missed visit or if more than 6 months passed since they were last seen in clinic. Statistical methods accounted for competing risks (eg, death)., Results: A total of 1318 infants enrolled at a median age of 2.6 weeks (interquartile range: 2.1-6.9), at which point 24% of mothers were receiving cART. Overall, 5% of infants never returned to care after enrollment and 18% were LTFU by 18 months. The 18-month cumulative incidence of LTFU was 8% among infants whose mothers initiated cART by infant enrollment and 20% among infants whose mothers were not yet on cART. Adjusted for baseline factors, infants whose mothers were not on cART were over twice as likely to be LTFU, with a subdistribution hazard ratio of 2.75 (95% confidence limit: 1.81 to 4.16). The association remained strong regardless of maternal CD4 count at infant enrollment., Conclusions: Increasing access to cART for pregnant women could improve retention of HIV-exposed infants, thereby increasing the clinical and population-level impacts of prevention of mother-to-child HIV transmission interventions and access to early cART for HIV-infected infants.

Among patients with tuberculosis and human immunodeficiency virus type 1, CD4-stratified initiation of antiretroviral therapy (ART) is recommended, with earlier ART in those with low CD4 counts. However, the impact of implementation fidelity to this recommendation is unknown. We examined a prospective cohort study of 395 adult patients diagnosed with tuberculosis and human immunodeficiency virus between August 2007 and November 2009 in Kinshasa, Democratic Republic of the Congo. ART was to be initiated after 1 month of tuberculosis treatment at a CD4 count of <100 cells/mm(3) or World Health Organization stage 4 (other than extrapulmonary tuberculosis) and after 2 months of tuberculosis treatment at a CD4 count of 100-350 cells/mm(3). We used the parametric g-formula to estimate the impact of implementation fidelity on 6-month mortality. Observed implementation fidelity was low (46%); 54% of patients either experienced delays in ART initiation or did not initiate ART, which could be avoided under perfect implementation fidelity. The observed mortality risk was 12.0% (95% confidence interval (CI): 8.2, 15.7); under complete (counterfactual) implementation fidelity, the mortality risk was 7.8% (95% CI: 2.4, 12.3), corresponding to a risk reduction of 4.2% (95% CI: 0.3, 8.1) and a preventable fraction of 35.1% (95% CI: 2.9, 67.9). Strategies to achieve high implementation fidelity to CD4-stratified ART timing are needed to maximize survival benefit., (© The Author 2015. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: We assessed the fertility desires, utilization of family planning (FP) methods, and incidence of pregnancies among HIV-infected women receiving care in an HIV clinic with an onsite FP services in Kinshasa, Democratic Republic of Congo., Methods: Between November 2011 and May 2012, all HIV-infected women who attended a routine visit at the clinic were interviewed about their fertility desires and utilization of contraceptive methods using a structured questionnaire. Routine follow-up visit data were used to identify pregnancies recorded between the interview and June 2013., Results: Overall, of the 699 HIV-infected women interviewed. 249 (35.7%) reported not wanting another child. Of the 499 (72.2%) participants who were sexually active at the time of interview, 177 (35.5%) were using an effective contraceptive method, including 70 (14.0%) women who reported using condoms consistently and 104 (20.8%) who were using injectable contraception. Overall, 88 (17.6%) sexually active participants who did not want another child were not using an effective FP method, and thus are considered to have had unmet need. During the median follow-up time of 22.2 (IQR: 20.2, 23.6) months, among all women interviewed, 96 (14.1%) became newly pregnant [pregnancy rate 9.3 (95%CI: 7.6, 11.4) per 100 women-years] including 21 (8.7%) among women who initially reported not wanting another child [unwanted pregnancy rate 5.8 (95%CI: 3.6, 9.3) per 100 women-years]., Conclusion: The persistence of relatively high unmet need among women receiving HIV care in a clinic with onsite FP services suggests the existence of barriers that must be identified and addressed.

Background: Viral load and CD4% are often not available in resource-limited settings for monitoring children's responses to antiretroviral therapy (ART). We aimed to construct normative curves for weight gain at 6, 12, 18, and 24 months following initiation of ART in children, and to assess the association between poor weight gain and subsequent responses to ART., Design: Analysis of data from HIV-infected children younger than 10 years old from African and Asian clinics participating in the International epidemiologic Databases to Evaluate AIDS., Methods: The generalized additive model for location, scale, and shape was used to construct normative percentile curves for weight gain at 6, 12, 18, and 24 months following ART initiation. Cox proportional models were used to assess the association between lower percentiles (< 50th) of weight gain distribution at the different time points and subsequent death, virological suppression, and virological failure., Results: Among 7173 children from five regions of the world, 45% were underweight at baseline. Weight gain below the 50th percentile at 6, 12, 18, and 24 months of ART was associated with increased risk of death, independent of baseline characteristics. Poor weight gain was not associated with increased hazards of virological suppression or virological failure., Conclusion: Monitoring weight gain on ART using age-specific and sex-specific normative curves specifically developed for HIV-infected children on ART is a simple, rapid, sustainable tool that can aid in the identification of children who are at increased risk of death in the first year of ART.

Background: While highly active antiretroviral therapy (HAART) programs have been scaled up across sub-Saharan Africa, no prognostic models for the prediction of mortality risk for children initiating HAART are widely available. Current clinical prediction tools for human immunodeficiency virus (HIV)-infected children are derived from pre-HAART data and therefore cannot predict mortality for children initiating HAART. The purpose of this study was to develop a mortality risk scoring system for HIV-infected children beginning HAART in a resource-deprived setting., Methods: Observational data from HIV-infected children initiating HAART from December 2004 through March 2012 in Kinshasa, Democratic Republic of Congo, were analyzed. Cox proportional hazards models were constructed to assess associations between demographic and clinical characteristics at the time of HAART initiation and mortality. Each child received a model-based risk score predicting mortality after HAART initiation., Results: By 31 March 2012, 1010 children had started HAART. One hundred three children (10.2%) died at a median of 5.3 months post-HAART initiation, yielding a mortality rate of 3.4 deaths per 100 child-years. The final mortality prediction model included undernutrition, low CD4 count, HIV symptoms, and low total lymphocyte count. These factors were highly predictive of mortality in the study population (C statistic = 0.79) and performed well when applied to the validation population (C statistic = 0.77)., Conclusions: Mortality among children starting HAART in resource-deprived settings can be predicted using a simple scoring system incorporating several readily available factors. Identifying predictors of mortality will help clinicians target modifiable risk factors, such as undernutrition, which are not directly addressed by HAART.

The prevalence of Mycoplasma genitalium is high in vulnerable populations of women in low-resource settings. However, the epidemiology of infection in these populations is not well established. To determine the prevalence of Mycoplasma genitalium and its association with cervical cytology and other correlates, we recruited 350 female sex workers (FSW) who were 18 to 50 years old in Nairobi, Kenya, for a cross-sectional study. A questionnaire was administered at baseline to obtain information on sociodemographics and sexual behaviors. Women underwent a pelvic exam, during which a physician collected cervical-exfoliation samples for conventional cytology and sexually transmitted infection (STI) testing. Samples were tested for M. genitalium and other STI organisms (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis) and the E6/E7 mRNA of human papillomavirus (HPV) by Aptima nucleic amplification assays. The prevalence of M. genitalium was 12.9%. FSW who engaged in sexual intercourse during menses were less likely to have M. genitalium infection than those who did not (odds ratio [OR], 0.3; 95% confidence interval [95% CI], 0.1, 0.9). M. genitalium was also less prevalent among FSW who had worked in prostitution for >5 years (6.2%) than among those who had worked for <3 years (17.6%) (OR, 0.3; 95% CI, 0.1, 0.8). FSW who reported more frequent condom use were more likely to be infected with M. genitalium than those who reported less frequent use (OR, 3.8; 95% CI, 1.2, 11.6). These correlates differ from those found in M. genitalium studies conducted with FSW from West Africa and China. Further longitudinal analyses assessing associations with persistent M. genitalium infection are needed., (Copyright © 2014, American Society for Microbiology. All Rights Reserved.)

Objective: Guidelines for prevention of mother-to-child transmission of HIV have developed rapidly, yet little is known about how outcomes of HIV-exposed infants have changed over time. We describe HIV-exposed infant outcomes in Kinshasa, Democratic Republic of Congo, between 2007 and 2013., Design: Cohort study of mother-infant pairs enrolled in family-centered comprehensive HIV care., Methods: Accounting for competing risks, we estimated the cumulative incidences of early infant diagnosis, HIV transmission, death, loss to follow-up, and combination antiretroviral therapy (cART) initiation for infants enrolled in three periods (2007-2008, 2009-2010, and 2011-2012)., Results: 1707 HIV-exposed infants enrolled at a median age of 2.6 weeks. Among infants whose mothers had recently enrolled into HIV care (N = 1411), access to EID by age two months increased from 28% (95% confidence limits [CL]: 24,34%) among infants enrolled in 2007-2008 to 63% (95% CL: 59,68%) among infants enrolled in 2011-2012 (Gray's p-value <0.01). The 18-month cumulative incidence of HIV declined from 16% (95% CL: 11,22%) for infants enrolled in 2007-2008 to 11% (95% CL: 8,16%) for infants enrolled in 2011-2012 (Gray's p-value = 0.19). The 18-month cumulative incidence of death also declined, from 8% (95% CL: 5,12%) to 3% (95% CL: 2,5%) (Gray's p-value = 0.02). LTFU did not improve, with 18-month cumulative incidences of 19% (95% CL: 15,23%) for infants enrolled in 2007-2008 and 22% (95% CL: 18,26%) for infants enrolled in 2011-2012 (Gray's p-value = 0.06). Among HIV-infected infants, the 24-month cumulative incidence of cART increased from 61% (95% CL: 43,75%) to 97% (95% CL: 82,100%) (Gray's p-value <0.01); the median age at cART decreased from 17.9 to 9.3 months. Outcomes were better for infants whose mothers enrolled before pregnancy., Conclusions: We observed encouraging improvements, but continued efforts are needed.

Background: A crucial question in managing HIV-infected patients with tuberculosis (TB) concerns when and how to initiate antiretroviral therapy (ART). The effectiveness of CD4-stratified ART initiation in a nurse-centered, integrated TB/HIV program at primary care in Kinshasa, Democratic Republic of Congo, was assessed., Methods: Prospective cohort study was conducted to assess the effect of CD4-stratified ART initiation by primary care nurses (513 TB patients, August 2007 to November 2009). ART was to be initiated at 1 month of TB treatment if CD4 count is <100 cells per cubic millimeter, at 2 months if CD4 count is 100-350 cells per cubic millimeter, and at the end of TB treatment after CD4 count reassessment if CD4 count is >350 cells per cubic millimeter. ART uptake and mortality were compared with a historical prospective cohort of 373 HIV-infected TB patients referred for ART to a centralized facility and 3577 HIV-negative TB patients (January 2006 to May 2007)., Results: ART uptake increased (17%-69%, P < 0.0001) and mortality during TB treatment decreased (20.1% vs 9.8%, P < 0.0003) after decentralized, nurse-initiated, CD4-stratified ART. Mortality among TB patients with CD4 count >100 cells per cubic millimeter was similar to that of HIV-negative TB patients (5.6% vs 6.3%, P = 0.65), but mortality among those with CD4 count <100 cells per cubic millimeter remained high (18.8%)., Conclusions: Nurse-centered, CD4-stratified ART initiation at primary care level was effective in increasing timely ART uptake and reducing mortality among TB patients but may not be adequate to prevent mortality among those presenting with severe immunosuppression. Further research is needed to determine the optimal management at primary care level of TB patients with CD4 counts <100 cells per cubic millimeter.

For this study we conducted in-depth interviews with 29 youth living with HIV (YLWH) and key informant interviews with 8 HIV care/support providers. We describe terms used to portray people living with HIV (PLWH) in Kinshasa, Democratic Republic of the Congo. Labels commonly used, mostly derogatory, described PLWH as walking corpses, dangers to others, or people deserving to die before others get infected. Blame and other accusations were directed at PLWH through anchoring or objectification. Being labeled sometimes made these youth suffer in silence, afraid to disclose their status, or avoid performing actions in public, preferring to let others do them. YLWH need psychosocial support to mitigate the harmful effects of these labels and strengthen their coping skills, whereas community, institutional, and national efforts are needed for stigma reduction.

Objective: Youth aged 15-24 years in sub-Saharan Africa are at a high risk for HIV acquisition and urgently need HIV prevention interventions. HIV counselling and testing (HCT) is designed to promote HIV prevention. However the impact of HCT on HIV acquisition has never been assessed among youth. We assess the impact of HCT on HIV acquisition among South African youth., Design: Data came from an annual HIV survey for persons aged 15 years and over, nested within a socio-demographic household surveillance in a geographically defined area of KwaZulu-Natal. Within this population, we used data from 2006 to 2011 to construct a cohort of HIV-uninfected youth aged 15-24 years., Methods: We compared youth who reported knowing their HIV status from HCT with those who reported not knowing their HIV status for time to HIV seroconversion using time-varying marginal structural Cox proportional hazards models., Results: The cohort included 3959 HIV-uninfected youth, of whom 1167 (29%) reported HCT at baseline and an additional 1064 (27%) reported HCT during follow up. Youth experienced 248 seroconversions over 8536 person-years, an incidence rate of 2.91 per 100 person-years [95% confidence interval (CI) 2.56-3.28]. In crude analysis, HCT was not associated with HIV incidence (hazard ratio 1.02, 95% CI 0.79-1.31], but in marginal structural models weighted for risk factors, HCT was protective (hazard ratio 0.59, 95% CI 0.45-0.78)., Conclusion: In this high-risk population, after accounting for differences in underlying HIV acquisition risk, HCT was associated with lower HIV incidence. HCT scale-up may have prevention benefits for HIV-uninfected youth.

A better understanding of the factors influencing use of family planning has the potential to increase contraceptive prevalence and improve the ability of women and their partners to freely choose the number and spacing of their children. Investigations into factors contributing to unmet need frequently rely on data collected using household surveys or interviews with family planning clients and providers. This research utilizes qualitative information resulting from simulated client visits to investigate programmatic barriers to contraceptive use in a sample of 19 health care facilities in Kisumu East District, a city in Western Kenya. Simulated client reports indicate deficiencies in provider competence as well as tenuous relations between providers and clients. In addition, simulated client data reveal occasional absences of providers during normal facility hours of operation and requests of informal fees for services. Trainings that address specific gaps in provider medical knowledge and counseling skills as well as client-provider relations may reduce programmatic barriers to contraceptive use. In addition, improved supervision and oversight at facilities may increase physical and financial access to services. Future research investigating provider motivations may illuminate root causes of programmatic barriers.

Background: Although breastfeeding is almost universally accepted in the Democratic Republic (DR) of Congo, by the age of 2 to 3 months 65% of children are receiving something other than human milk. We sought to describe the infant feeding practices and determinants of suboptimal breastfeeding behaviors in DR Congo., Methods: Survey questionnaire administered to mothers of infants aged ≤ 6 months and healthcare providers who were recruited consecutively at six selected primary health care facilities in Kinshasa, the capital., Results: All 66 mothers interviewed were breastfeeding. Before initiating breastfeeding, 23 gave their infants something other than their milk, including: sugar water (16) or water (2). During the twenty-four hours prior to interview, 26 (39%) infants were exclusively breastfed (EBF), whereas 18 (27%), 12 (18%), and 10 (15%) received water, tea, formula, or porridge, respectively, in addition to human milk. The main reasons for water supplementation included "heat" and cultural beliefs that water is needed for proper digestion of human milk. The main reason for formula supplementation was the impression that the baby was not getting enough milk; and for porridge supplementation, the belief that the child was old enough to start complementary food. Virtually all mothers reported that breastfeeding was discussed during antenatal clinic visit and half reported receiving help regarding breastfeeding from a health provider either after birth or during well-child clinic visit. Despite a median of at least 14 years of experience in these facilities, healthcare workers surveyed had little to no formal training on how to support breastfeeding and inadequate breastfeeding-related knowledge and skills. The facilities lacked any written policy about breastfeeding., Conclusion: Addressing cultural beliefs, training healthcare providers adequately on breastfeeding support skills, and providing structured breastfeeding support after maternity discharge is needed to promote EBF in the DR Congo.

Objectives: Increasing coverage of quality reproductive health services, including prevention of mother-to-child transmission services, requires understanding where and how these services are provided. To inform scale-up, we conducted a population-based survey in Kinshasa, Democratic Republic of Congo., Methods: Stratified two-stage cluster sampling was used to select women ≥18 years old who had been pregnant within the prior three years. Participants were interviewed about their reproductive healthcare utilization and impressions of services received., Results: We interviewed 1221 women, 98% of whom sought antenatal care (ANC). 78% of women began ANC after the first trimester and 22% reported <4 visits. Reasons for choosing an ANC facility included reputation (51%), friendly/accessible staff (39%), availability of comprehensive services (29%), medication access (26%), location (26%), and cost (21%). Most women reported satisfactory treatment by staff, but 47% reported that the ANC provider ignored their complaints, 23% had difficulty understanding responses to their questions, 22% wanted more time with the provider, 21% wanted more privacy, and 12% felt uncomfortable asking questions. Only 56% reported someone talked to them about HIV/AIDS. Strongest predictors of seeking inadequate ANC included low participant and partner education and lack of certain assets. Only 32% of women sought postnatal care. Some results varied by health zone., Conclusions: Scaling-up interventions to improve reproductive health services should include broad-based health systems strengthening and promote equitable access to quality ANC, delivery, and postnatal services. Personal and structural-level barriers to seeking ANC need to be addressed, with consideration given to local contexts., (© 2013 John Wiley & Sons Ltd.)

Objective: In August 2011, South Africa expanded its adult antiretroviral therapy (ART) guidelines to allow treatment initiation at CD4 cell values 350 cells/μl or less. Mortality and morbidity are known to be reduced when initiating at higher CD4 levels; we explored the impact on patient loss to follow-up., Design: An observational cohort study., Methods: We analyzed routine data of 1430 adult patients initiating ART from April to December 2010 from a Johannesburg primary healthcare clinic offering ART initiation at CD4 cell count 350 cells/μl or less since 2010. We compared loss to follow-up (≥3 months late for the last scheduled visit), death, and incident tuberculosis within 1 year of ART initiation for those initiating at CD4 cell values 200 or less versus 201-350 cells/μl., Results: : Half (52.0%) of patients presented in the lower CD4 cell group [≤200 cells/μl, median: 105 cells/μl, interquartile range (IQR): 55-154] and initiated ART, and 48.0% in the higher group (CD4 cell count 201-350 cells/μl, median: 268 cells/μl, IQR: 239-307). The proportion of women and pregnant women was greater in the high CD4 cell group; the lower CD4 cell group included more patients with prevalent tuberculosis. Among men and nonpregnant women, initiating at 201-350 cells/μl was associated with 26-42% reduced loss to follow-up compared to those initiating 200 cells/μl or less. We found no CD4 cell effect among pregnant women. Risk of mortality [adjusted hazard ratio (aHR) 0.34, 95% confidence interval (CI) 0.13-0.84] and incident tuberculosis (aHR 0.44, 95% CI 0.23-0.85) was lower among the higher CD4 cell group., Conclusion: This is one of the first studies from a routine clinical setting to demonstrate South Africa's 2011 expansion of ART treatment guidelines can be enacted without increasing program attrition.

Objective: Effective behavioral HIV prevention is needed for stable HIV-discordant couples at risk for HIV, especially those without access to biomedical prevention. This analysis addressed whether HIV testing and counseling with ongoing counseling and condom distribution lead to reduced unprotected sex in HIV-discordant couples., Methods: Partners in Prevention HSV/HIV Transmission Study was a randomized trial conducted from 2004 to 2008 assessing whether acyclovir reduced HIV transmission from HSV-2/HIV-1-coinfected persons to HIV-uninfected sex partners. This analysis relied on self-reported behavioral data from 508 HIV-infected South African participants. The exposure was timing of first HIV testing and counseling: 0-7, 8-14, 15-30, or >30 days before baseline. In each exposure group, predicted probabilities of unprotected sex in the last month were calculated at baseline, month 1, and month 12 using generalized estimating equations with a logit link and exchangeable correlation matrix., Results: At baseline, participants who knew their HIV status for less time experienced higher predicted probabilities of unprotected sex in the last month: 0-7 days, 0.71; 8-14 days, 0.52; 15-30 days, 0.49; >30 days, 0.26. At month 1, once all participants had been aware of being in HIV-discordant relationships for ≥1 month, predicted probabilities declined: 0-7 days, 0.08; 8-14 days, 0.08; 15-30 days, 0.15; >30 days, 0.14. Lower predicted probabilities were sustained through month 12: 0-7 days, 0.08; 8-14 days, 0.11; 15-30 days, 0.05; >30 days, 0.19., Conclusions: Unprotected sex declined after HIV-positive diagnosis and declined further after awareness of HIV discordance. Identifying HIV-discordant couples for behavioral prevention is important for reducing HIV transmission risk.

Persistent nontreponemal titers after treatment are common among patients with early syphilis. We retreated 82 human immunodeficiency virus-negative early syphilis participants who were serofast at 6 months using benzathine penicillin. Only 27% exhibited serological response after retreatment and after an additional 6 months of follow-up.

Objective: To compare patient retention at 3 stages of pre-antiretroviral (ART) care and 2 stages of post-ART care to identify when greatest attrition occurs., Design: An observational cohort study., Methods: We reviewed files of all adult nonpregnant individuals testing HIV-positive January 1-June 30, 2010, at a primary health clinic in Johannesburg, South Africa (N = 842). We classified retention in pre-ART stage 1 (HIV diagnosis to CD4 results notification in ≤3 months), pre-ART stage 2 (initially ineligible for ART with repeat CD4 test ≤1 year of prior CD4), pre-ART stage 3 (initiating ART ≤3 months after first eligible CD4 result), and at 0-6 and 6-12 months post-ART., Results: Retention among all patients during pre-ART stage 1 was 69.8% [95% confidence interval (CI): 66.7% to 72.9%]. For patients initially ART ineligible (n = 221), 57.4% (95% CI: 49.5% to 65.0%) returned for a repeat CD4 during pre-ART stage 2. Among those who were ART eligible (n = 589), 73.5% (95% CI: 69.0% to 77.6%) were retained during pre-ART stage 3. Retention increased with time on ART, from 80.2% (95% CI: 75.3% to 84.5%) at 6 months to 95.3% (95% CI: 91.7% to 97.6%) between 6 and 12 months. Cumulative retention from diagnosis to 12 months on ART was 36.9% (95% CI: 33.0% to 41.1%) for those ART eligible and 43.0% (95% CI: 36.4% to 49.8%) from diagnosis to repeat CD4 testing within one year among those ART ineligible., Conclusions: Patient attrition in the first year after HIV diagnosis was greatest before ART initiation: more than 25% at each of 3 pre-ART stages. As countries expand HIV testing and ART programs, success will depend on linkage to care, especially before ART eligibility and initiation.

Background: The long-term effects of combined antiretroviral therapy (cART) on CD4 percentage in HIV-infected children are incompletely understood, with evidence from resource-deprived areas particularly scarce even though most children with HIV live in such settings. We sought to describe this relationship., Methods: Observational longitudinal data from cART-naive children enrolled between December 2004 and May 2010 into an HIV care and treatment program in Kinshasa, Democratic Republic of Congo were analyzed. To estimate the effect of cART on CD4 percentage while accounting for time-dependent confounders affected by prior exposure to cART, a marginal structural linear mean model was used., Results: Seven hundred ninety children were active for 2090 person-years and a median of 31 months; 619 (78%) initiated cART. At baseline, 405 children (51%) were in HIV clinical stage 3 or 4; 528 (67%) had advanced or severe immunodeficiency. Compared with no cART, the estimated absolute rise in CD4 percentage was 6.8% [95% confidence interval (CI), 4.7% to 8.9%] after 6 months of cART, 8.6% (95% CI, 7.0% to 10.2%) after 12 months, and 20.5% (95% CI, 16.1% to 24.9%) after 60 months. cART-mediated CD4 percentage gains were slowest but greatest among children with baseline CD4 percentage <15. The cumulative incidence of recovery to "not significant" World Health Organization age-specific immunodeficiency was lower if cART was started when immunodeficiency was severe rather than mild or advanced., Conclusions: cART increased CD4 percentages among HIV-infected children in a resource-deprived setting, as previously noted among children in the United States. More gradual and protracted recovery in children with lower baseline CD4 percentages supports earlier initiation of pediatric cART.

Background: Serologic tests for syphilis results at the time of diagnosis are the basis for evaluating response to syphilis therapy. After treatment, however, serologic tests for syphilis titers may continue to increase for several weeks. We evaluated rapid plasma reagin (RPR) titer variation during the 14 days after therapy using data from a recent large, prospective randomized controlled trial., Methods: Prospectively enrolled participants in North America and Madagascar with primary, secondary, or early latent syphilis were randomly assigned to penicillin, doxycycline (in the case of penicillin allergy), or azithromycin treatment. Blood for RPR analysis was drawn at days 0, 7, and 14 posttreatment. All RPR titers were determined simultaneously at a central laboratory., Results: Four hundred and seventy patients had data available for at least 2 of 3 RPR measurements. Overall, 20% of patients showed a titer increase of at least 1 dilution in the 14 days after therapy. The greatest proportion of titer increases following therapy was observed in patients with primary syphilis. Comparing outcome of therapy using the initial (day 0) RPR titer versus the maximal RPR titer (during 14 days) resulted in outcome reclassification in 2.98% of participants., Conclusions: Despite the fact that about 20% of early syphilis patients had increases in RPR titers immediately after treatment, these changes rarely influenced assessment of therapeutic outcome. Only 3% of patients treated would have been reclassified.

Background: Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials., Study Design: Qualitative research was conducted in Madagascar, South Africa, and the United States to explore the acceptability of three potential true contraceptive efficacy study designs and the feasibility of recruitment for such trials, including characteristics of potential participants who may be willing to join., Results: Participants preferred the study design with the least restrictive sex criteria: participants have sex with assigned contraceptive method/no method on days around ovulation and use condoms on other days. Participants suggested that condom adherence would be low. Differences were noted across sites on whether female participants should be actively seeking pregnancy or not actively seeking pregnancy but willing to accept a pregnancy. Recruitment of participants was expected to be difficult., Conclusions: Data suggest that a true contraceptive efficacy clinical trial may not be feasible at this time in these settings., (Copyright © 2012 Elsevier Inc. All rights reserved.)

HIV transmission through breastfeeding is a significant public health challenge. While breastfeeding provides important nutrition, and results in reduced morbidity and mortality, there is a risk of HIV transmission through breastfeeding. International prevention of mother-to-child transmission (PMTCT) guidelines recommend exclusive breastfeeding for six months among HIV-infected women on antiretroviral therapy. Promoting exclusive feeding has proved difficult in settings where mixed feeding is a cultural norm. Understanding the factors that influence HIV infected women's infant feeding choices and practices is critical to promoting adherence to PMTCT guidelines. We conducted in-depth interviews with 40 HIV+ pregnant and post-partum women in Kinshasa, Democratic Republic of Congo to understand their infant feeding experiences. Interviews were conducted in Lingala, and transcribed and translated into French for analysis. Deductive and inductive codes were applied, and matrices were created to facilitate cross-case analysis. Women had limited understanding of the specific mechanisms through which their infant feeding practices influenced HIV transmission risk. Clinical staff was the primary source of women's knowledge of HIV mother-to-child-transmission. Among the 24 post-partum women in the sample, seven women adhered to exclusive breastfeeding and two women to exclusive formula feeding for at least six months. Women's beliefs and awareness about HIV transmission through breastfeeding, as well as the information and support from clinical staff and other members of their support networks positively influenced their exclusive feeding. Common barriers to exclusive feeding included financial constraints, breast health problems, misinformation about HIV transmission, local norms, and prior feeding experiences. Health care workers play a key role in providing correct information on PMTCT and supporting women's infant feeding choices to adhere to guidelines of exclusive infant feeding. Optimizing provider-patient communication and creating a supportive environment surrounding infant feeding is critical.

Background: Syphilis management requires serological monitoring after therapy. We compared factors associated with serological response after treatment of early (ie, primary, secondary, or early latent) syphilis., Methods: We performed secondary analyses of data from a prospective, randomized syphilis trial conducted in the United States and Madagascar. Human immunodeficiency virus (HIV)-negative participants aged ≥ 18 years with early syphilis were enrolled from 2000-2009. Serological testing was performed at baseline and at 3 and 6 months after treatment. At 6 months, serological cure was defined as a negative rapid plasma reagin (RPR) test or a ≥4-fold decreased titer, and serofast status was defined as a ≤ 2-fold decreased titer or persistent titers that did not meet criteria for treatment failure., Results: Data were available from 465 participants, of whom 369 (79%) achieved serological cure and 96 (21%) were serofast. In bivariate analysis, serological cure was associated with younger age, fewer sex partners, higher baseline RPR titers, and earlier syphilis stage (P ≤ .008). There was a less significant association with Jarisch-Herxheimer reaction after treatment (P = .08). Multivariate analysis revealed interactions between log-transformed baseline titer with syphilis stage, in which the likelihood of cure was associated with increased titers among participants with primary syphilis (adjusted odds ratio [AOR] for 1 unit change in log(2) titer, 1.83; 95% confidence interval [CI], 1.25-2.70), secondary syphilis (AOR, 3.15; 95% CI, 2.14-4.65), and early latent syphilis (AOR, 1.86; 95% CI, 1.44-2.40)., Conclusions: Serological cure at 6 months after early syphilis treatment is associated with age, number of sex partners, Jarisch-Herxheimer reaction, and an interaction between syphilis stage and baseline RPR titer.

Despite the need for HIV-positive children to adhere effectively to antiretroviral treatment (ART), a guiding theory for pediatric ART in resource-limited settings is still missing. Understanding factors that influence pediatric ART adherence is critical to developing adequate strategies. In-depth qualitative interviews were undertaken in Kinshasa, Democratic Republic of the Congo, with 20 sets of HIV disclosed and nondisclosed children along with respective caregivers to better characterize barriers, facilitators, and adherence experiences in children taking ART. Commonly cited barriers included lack of food or nutritional support, lack of assistance or supervision for children, lack of assistance for caregivers, and being unable to remember to take medicines on a consistent basis. Facilitators included having a strong caregiver-child relationship and support system along with strategies for maintaining adherence. Similar themes arose within the child-caregiver sets, but were often characterized differently between the two. Children who were aware of their HIV status displayed fewer instances of frustration and conflict concerning taking medicines and within the child-caregiver relationship. Continued study on pediatric ART adherence should account for differing perspectives of children and caregivers, as well as between status disclosed and nondisclosed children. Areas of future intervention should focus on child-caregiver relationships, disclosure of HIV status, and available nutritional and psychosocial support for children and their caregivers.

Background: The effect of highly active antiretroviral therapy (HAART) on the survival of HIV-infected children has not been well quantified. Because most pediatric HIV occurs in low- and middle-income countries, our objective was to provide a first estimate of this effect among children living in a resource-deprived setting., Methods and Findings: Observational data from HAART-naïve children enrolled into an HIV care and treatment program in Kinshasa, Democratic Republic of the Congo, between December 2004 and May 2010 were analyzed. We used marginal structural models to estimate the effect of HAART on survival while accounting for time-dependent confounders affected by exposure. At the start of follow-up, the median age of the 790 children was 5.9 y, 528 (66.8%) had advanced or severe immunodeficiency, and 405 (51.3%) were in HIV clinical stage 3 or 4. The children were observed for a median of 31.2 mo and contributed a total of 2,089.8 person-years. Eighty children (10.1%) died, 619 (78.4%) initiated HAART, six (0.8%) transferred to a different care provider, and 76 (9.6%) were lost to follow-up. The mortality rate was 3.2 deaths per 100 person-years (95% confidence interval [CI] 2.4-4.2) during receipt of HAART and 6.0 deaths per 100 person-years (95% CI 4.1-8.6) during receipt of primary HIV care only. The mortality hazard ratio comparing HAART with no HAART from a marginal structural model was 0.25 (95% CI 0.06-0.95)., Conclusions: HAART reduced the hazard of mortality in HIV-infected children in Kinshasa by 75%, an estimate that is similar in magnitude but with lower precision than the reported effect of HAART on survival among children in the United States. Please see later in the article for the Editors' Summary.