Association of comprehensiveness of antiretroviral care and detectable HIV viral load suppression among pregnant and postpartum women in the Democratic Republic of the Congo: a cross-sectional study.

Introduction: Worldwide, over two-thirds of people living with HIV are on antiretroviral therapy (ART). Despite increased ART access, high virological suppression prevalence remains out of reach. Few studies consider the quality of ART services and their impact on recipients' viral suppression. We assessed the association between ART service readiness and HIV viral load suppression among pregnant and breastfeeding women living with HIV (WLH) receiving ART in maternal and child health (MCH) clinics in Kinshasa, Democratic Republic of Congo. Methods: We performed a cross-sectional analysis leveraging data from a continuous quality improvement intervention on WLH's long-term ART outcomes. From November 2016 to May 2020, we enrolled WLH from the three largest clinics in each of Kinshasa'Ls 35 health zones. We measured clinic's readiness using three WHO-identified ART care quality indicators: relevant guidelines in ART service area, stocks of essential ART medicines, and relevant staff training in ≥24 months, scoring clinics 0-3 based on observed indicators. We defined viral load suppression as ≤1,000 cp/ml. Multilevel mixed-effect logistic models were used to estimate prevalence odds ratios (ORs) measuring the strength of the association between ART service readiness and viral suppression. Results: Of 2,295 WLH, only 1.9% received care from a clinic with a score of 3, 24.1% received care from a 0-scoring clinic, and overall, 66.5% achieved virologically suppression. Suppression increased from 65% among WLH receiving care in 0-scoring clinics to 66.9% in 1-scoring clinics, 65.8% in 2-scoring clinics, and 76.1% in 3-scoring clinics. We did not observe a statistically significant association between ART service readiness score and increased viral suppression prevalence, however we did find associations between other factors, such as the location of the health center and pharmacist availability with suppressed viral load. Discussion: A lack of comprehensive ART care underscores the need for enhanced structural and organizational support to improve virological suppression and overall health outcomes for women living with HIV..

Economic costs and cost-effectiveness of conditional cash transfers for the uptake of services for the prevention of vertical HIV transmissions in a resource-limited setting.

BACKGROUND: Prevention of mother-to-child transmission (PMTCT) is critical for halting the HIV epidemic. However, innovative approaches to improve PMTCT uptake may be resource-intensive. We examined the economic costs and cost-effectiveness of conditional cash transfers (CCTs) for the uptake of PMTCT services in the Democratic Republic of Congo. METHODS: We leveraged data from a randomized controlled trial of CCTs (n = 216) versus standard PMTCT care alone (standard of care (SOC), n = 217). Economic cost data came from multiple sources, with costs analyzed from the societal perspective and reported in 2016 international dollars (I$). Effectiveness outcomes included PMTCT uptake (i.e., accepting all PMTCT visits and services) and retention (i.e., in HIV care at six weeks post-partum). Generalized estimating equations estimated effectiveness (relative risk) and incremental costs, with incremental effectiveness reported as the number of women needing CCTs for an additional PMTCT uptake or retention. We evaluated the cost-effectiveness of the CCTs at various levels of willingness-to-pay and assessed uncertainty using deterministic sensitivity analysis and cost-effectiveness acceptability curves. RESULTS: Mean costs per participant were I$516 (CCTs) and I$431 (SOC), representing an incremental cost of I$85 (95% CI: 59, 111). PMTCT uptake was more likely for CCTs vs SOC (68% vs 53%, p < 0.05), with seven women needing CCTs for each additional PMTCT service uptake; twelve women needed CCTs for an additional PMTCT retention. The incremental cost-effectiveness of CCTs vs SOC was I$595 (95% CI: I$550, I$638) for PMTCT uptake and I$1028 (95% CI: I$931, I$1125) for PMTCT retention. CCTs would be an efficient use of resources if society's willingness-to-pay for an additional woman who takes up PMTCT services is at least I$640. In the worst-case scenario, the findings remained relatively robust. CONCLUSIONS: Given the relatively low cost of the CCTs, policies supporting CCTs may decrease onward HIV transmission and expedite progress toward ending the epidemic.

HIV disclosure and depressive symptoms among pregnant women living with HIV: a cross-sectional study in the Democratic Republic of Congo.

INTRODUCTION: Disclosure of one's HIV status may decrease depression and improve the quality of life among people living with HIV. However, there is mixed evidence on the impact of disclosure to partners for pregnant women living with HIV (WLHIV) in areas of intersecting social concerns over disclosure and high prevalence of intimate partner violence (IPV). We assessed the association between HIV disclosure and depressive symptoms among pregnant WLHIV in the Democratic Republic of Congo (DRC) and examined whether the knowledge of partner's status or recent IPV modified this association. METHODS: We utilized data from participants enrolled in a trial to evaluate the effect of continuous quality interventions on long-term therapy outcomes among HIV-positive pregnant and breastfeeding women in DRC (NCT03048669). Only pregnant women (n = 1392) were included in this cross-sectional analysis. Between November 2016 and June 2019, enrolled participants completed a survey that included the Patient Health Questionnaire-9 (PHQ-9) to screen recent depressive symptoms, questions about disclosure, knowledge of partner's status and IPV. We used linear models to calculate crude and adjusted mean differences (MDs) between disclosure and depressive symptoms. All analyses were stratified by timing of HIV diagnosis. RESULTS: Disclosure was higher among participants diagnosed prior to current pregnancy (41% to their partners and 24% to family, friends or others) relative to those diagnosed during current pregnancy (21% to partners and 12% to family). About one-quarter of women reported any type of IPV in the past 12 months. Disclosure to a partner was associated with lower depressive symptoms among women diagnosed prior to current pregnancy (MD -0.55; 95% CI: -1.06, -0.04) but the opposite was observed among those diagnosed during current pregnancy (MD 0.5; 95% CI: -0.4, 1.4). Adjustment for IPV, knowledge of partner's status, age, number of living children and primigravidae did not change MDs substantially. CONCLUSIONS: Women in our sample mostly disclosed to partners despite high IPV burden. The observed association between disclosure to partners and lower depressive symptoms among women diagnosed prior to current pregnancy is consistent with cross-national evidence. A prospective study among pregnant WLHIV is needed to examine longitudinal effects of HIV status disclosure.

Hepatitis C prevalence and quality of health services among HIV-positive mothers in the Democratic Republic of the Congo.

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.

Arresting vertical transmission of hepatitis B virus (AVERT-HBV) in pregnant women and their neonates in the Democratic Republic of the Congo: a feasibility study.

BACKGROUND: Hepatitis B virus (HBV) remains endemic throughout sub-Saharan Africa despite the widespread availability of effective childhood vaccines. In the Democratic Republic of the Congo, HBV treatment and birth-dose vaccination programmes are not established. We, therefore, aimed to evaluate the feasibility and acceptability of adding HBV testing and treatment of pregnant women as well as the birth-dose vaccination of HBV-exposed infants to the HIV prevention of mother-to-child transmission programme infrastructure in the Democratic Republic of the Congo. METHODS: We did a feasibility study in two maternity centres in Kinshasa: Binza and Kingasani. Using the already established HIV prevention of mother-to-child transmission programme at these two maternity centres, we screened pregnant women for HBV infection at routine prenatal care registration. Those who tested positive and had a gestational age of 24 weeks or less were included in this study. Eligible pregnant women with a high viral load (≥200 000 IU/mL or HBeAg positivity, or both) were considered as having HBV of high risk of mother-to-child transmission and initiated on oral tenofovir disoproxil fumarate (300 mg/day) between 28 weeks and 32 weeks of gestation and continued through 12 weeks post partum. All HBV-exposed infants received a birth-dose of monovalent HBV vaccine (Euvax-B Pediatric: Sanofi Pasteur, Seoul, South Korea; 0·5 mL) within 24 h of life. All women were followed up for 24 weeks post partum, when they completed an exit questionnaire that assessed the acceptability of study procedures. The primary outcomes were the feasibility of screening pregnant women to identify those at high risk for HBV mother-to-child transmission and to provide them with antiviral prophylaxis, the feasibility of administrating the birth-dose vaccine to exposed infants, and the acceptability of this prevention programme. This study is registered with ClinicalTrials.gov, NCT03567382. FINDINGS: Between Sept 24, 2018, and Feb 22, 2019, 4016 women were approached and screened. Of these pregnant women, 109 (2·7%) were positive for HBsAg. Of the 109 women, 91 (83%) met the eligibility criteria for participation. However, only data from 90 women-excluding one woman who had a false pregnancy-were included in the study analysis. The median overall age of the enrolled women was 31 years (IQR 25-34) and the median overall gestational age was 19 weeks (15-22). Ten (11%) of 91 women evaluated had high-risk HBV infection. Nine (90%) of the ten pregnant women with high-risk HBV infection received tenofovir disoproxil fumarate and one (10%) refused therapy and withdrew from the study; five (56%) of the nine women achieved viral suppression (ie, <200 000 IU/mL) on tenofovir disoproxil fumarate therapy by the time of delivery and the remaining four (44%) had decreased viral loads from enrolment to delivery. A total of 88 infants were born to the 90 enrolled women. Of the 88 infants, 60 (68%) received a birth-dose vaccine; of these, 46 (77%) received a timely birth-dose vaccine. No cases of HBV mother-to-child transmission were observed. No serious adverse events associated with tenofovir disoproxil fumarate nor with the birth-dose vaccine were reported. Only one (11%) of nine women reported dizziness during the course of tenofovir disoproxil fumarate therapy. The study procedures were considered highly acceptable (>80%) among mothers. INTERPRETATION: Adding HBV screening and treatment of pregnant women and infant birth-dose vaccination to existing HIV prevention of mother-to-child transmission platforms is feasible in countries such as the Democratic Republic of the Congo. Birth-dose vaccination against HBV infection integrated within the current Expanded Programme on Immunisation and HIV prevention of mother-to-child transmission programme could accelerate progress toward HBV elimination in Africa. FUNDING: Gillings Innovation Laboratory award and the National Institutes of Health. TRANSLATIONS: For the French and Lingala translations of the abstract see Supplementary Materials section.

Role of temporal discounting in a conditional cash transfer (CCT) intervention to improve engagement in the prevention of mother-to-child transmission (PMTCT) cascade.

BACKGROUND: Temporal discounting, the tendency of individuals to discount future costs and benefits relative to the present, is often associated with greater engagement in risky behaviors. Incentives such as conditional cash transfers (CCTs) have the potential to counter the effects of high discount rates on health behaviors. METHODS: With data from a randomized trial of a CCT intervention among 434 HIV-positive pregnant women in the Democratic Republic of Congo, we used binomial models to assess interactions between discount rates (measured using a delay-discounting task) and the intervention. The analysis focused on two outcomes: 1) retention in HIV care, and 2) uptake of prevention of mother-to-child transmission (PMTCT) services. RESULTS: The effect of high discount rates on retention was small, and we did not observe evidence of interaction between high discount rates and CCT on retention. However, our findings suggest that CCT may mitigate the negative effect of high discount rates on uptake of PMTCT services (interaction contrast (IC): 0.18, 95% CI: - 0.09, 0.44). CONCLUSIONS: Our findings provide evidence to support the continued use of small, frequent incentives, to motivate improved uptake of PMTCT services, especially among women exhibiting high rates of temporal discounting. TRIAL REGISTRATION: Clinicaltrials.gov number NCT01838005 , April 23, 2013.

Postpartum depressive symptoms following implementation of the 10 steps to successful breastfeeding program in Kinshasa, Democratic Republic of Congo: A cohort study.

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.

HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI-PMTCT study.

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.

Breastfeeding Support Offered at Delivery is Associated with Higher Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum Among HIV Exposed Infants: A Cross-Sectional Analysis.

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.

Hepatitis B infection among pregnant and post-partum women living with HIV and on antiretroviral therapy in Kinshasa, DR Congo: A cross-sectional study.

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.

Effect of Family Planning Counseling After Delivery on Contraceptive Use at 24 Weeks Postpartum in Kinshasa, Democratic Republic of Congo.

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.

Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.

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 .

Vaccination Coverage and Timelines Among Children 0-6 Months in Kinshasa, the Democratic Republic of Congo: A Prospective Cohort Study.

Objectives The Democratic Republic of Congo (DR Congo) is one of the ten countries, which accounts for 60% of unvaccinated children worldwide. The aim of this study was to assess predictors of incomplete and untimely immunization among a cohort of infants recruited at birth and followed up through 24 weeks in Kinshasa. Methods Complete immunization for each vaccine was defined as receiving all the recommended doses. Untimely immunization was defined as receiving the given dose before (early) or after (delayed) the recommended time window. Infants not immunized by the end of the follow-up time were considered missing. Multivariate hierarchical model and generalized logistic model were used to assess the independent contribution of each socio-economic and demographic factors considered to complete immunization and timeliness, respectively. Results Overall, of 975 infants from six selected clinics included in the analysis 84.7% were fully immunized the three doses of DTP or four doses of Polio by 24 weeks of age. Independently of the vaccine considered, the strongest predictor of incomplete and untimely immunization was the clinic in which the infant was enrolled. This association was strengthened after adjustment for socio-economic and demographic characteristics. Education and the socio-economic status also were predictive of completion and timeliness of immunization in our cohort. Discussion In conclusion, the strongest predictor for incomplete and untimely immunization among infants in Kinshasa was the clinics in which they were enrolled. The association was likely due to the user fee for well-baby clinic visits and its varying structure by clinic.

Conditional Cash Transfers Improve Retention in PMTCT Services by Mitigating the Negative Effect of Not Having Money to Come to the Clinic.

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.

Exclusive Breastfeeding and Clinical Malaria Risk in 6-Month-Old Infants: A Cross-Sectional Study from Kinshasa, Democratic Republic of the Congo.

The World Health Organization recommends exclusive breastfeeding (EBF) for the first 6 months of life. However, the effect of EBF on malaria risk remains unclear. In the present study, 137 EBF infants and 358 non-EBF infants from the Democratic Republic of the Congo were assessed for fever and malaria infections by polymerase chain reaction, at 6 months of age. EBF was associated with a reduced risk of clinical malaria (odds ratio = 0.13; 95% confidence interval = 0.00-0.80), suggesting a protective effect of EBF against malaria.

Conditional Cash Transfers to Increase Retention in PMTCT Care, Antiretroviral Adherence, and Postpartum Virological Suppression: A Randomized Controlled Trial.

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.

Conditional cash transfers and uptake of and retention in prevention of mother-to-child HIV transmission care: a randomised controlled trial.

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.

Implementation and Operational Research: Decentralization Does Not Assure Optimal Delivery of PMTCT and HIV-Exposed Infant Services in a Low Prevalence Setting.

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.