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Quality improvement (QI) methods engage stakeholders in identifying problems, creating strategies called change ideas to address those problems, testing those change ideas and scaling them up where successful. These methods have rarely been used at the community level in low-income country settings. Here we share experiences from rural Tanzania and Uganda, where QI was applied as part of the Expanded Quality Management Using Information Power (EQUIP) intervention with the aim of improving maternal and newborn health. Village volunteers were taught how to generate change ideas to improve health-seeking behaviours and home-based maternal and newborn care practices. Interaction was encouraged between communities and health staff. To describe experiences implementing EQUIP's QI approach at the community level. A mixed methods process evaluation of community-level QI was conducted in Tanzania and a feasibility study in Uganda. We outlined how village volunteers were trained in and applied QI techniques and examined the interaction between village volunteers and health facilities, and in Tanzania, the interaction with the wider community also. Village volunteers had the capacity to learn and apply QI techniques to address local maternal and neonatal health problems. Data collection and presentation was a persistent challenge for village volunteers, overcome through intensive continuous mentoring and coaching. Village volunteers complemented health facility staff, particularly to reinforce behaviour change on health facility delivery and birth preparedness. There was some evidence of changing social norms around maternal and newborn health, which EQUIP helped to reinforce. Community-level QI is a participatory research approach that engaged volunteers in Tanzania and Uganda, putting them in a central position within local health systems to increase health-seeking behaviours and improve preventative maternal and newborn health practices.

ABSTRACTBackground To report the experience of health workers who had played key roles in the early stages of implementing the prevention of mother-to-child HIV transmission services (PMTCT) in Uganda. Methods Interviews were conducted with 15 key informants including counsellors, obstetricians and PMTCT coordinators at the five PMTCT test sites in Uganda to investigate the benefits, challenges and sustainability of the PMTCT programme. Audio-taped interviews were held with each informant between January and June 2003. These were transcribed verbatim and manually analysed using the framework approach. Results The perceived benefits reported by informants were improvement of general obstetric care, provision of antiretroviral prophylaxis for HIV-positive mothers, staff training and community awareness. The main challenges lay in the reluctance of women to be tested for HIV, incomplete follow-up of participants, non-disclosure of HIV status and difficulties with infant feeding for HIV-positive mothers. Key informants thought that the programme's sustainability depended on maintaining staff morale and numbers, on improving services and providing more resources, particularly antiretroviral therapy for the HIV-positive women and their families. Conclusion Uganda's experience in piloting the PMTCT programme reflected the many challenges faced by health workers. Potentially resource-sparing strategies such as the ‘opt-out’ approach to HIV testing required further evaluation.

Background Maternal and perinatal death surveillance and response (MPDSR) was developed as a quality improvement intervention to reduce preventable maternal and newborn deaths and stillbirths. To gain deeper insight into the key components enabling sustained MPDSR implementation, we examined how MPDSR systems are organized and function in Nigeria, North Macedonia, and Sri Lanka. Methods We conducted 61 interviews with participants who were knowledgeable about the MPDSR system of their country, including policymakers, healthcare providers, and public health officials, at the national, subnational and facility levels. We applied content analysis to inductively identify themes and categories. Results Our findings suggest that participants perceive the goal of MPDSR as going beyond local quality improvement to encompass broader healthcare system strengthening. Four enabling components supporting sustained implementation were identified in all three countries: 1. coordination of the MPDSR “programme” through committees across levels; 2. adoption and integration of a data management and analysis system; 3. a confidential, nonpunitive approach supported by committed leadership; and 4. a multilevel, country-specific response strategy integrated with a broader health system strengthening. Sri Lanka demonstrated a highly centralized and structured approach, whereas Nigeria’s federal system showcased more diverse, multilevel stakeholder engagement. North Macedonia’s facility-based approach focused on the immediate implementation of quality improvements. Conclusions The findings reveal that a structured, multilevel approach that is interconnected with the broader health system is supporting sustained MPDSR implementation. The potential of MPDSR as a health system programme that goes beyond facility-level mortality reduction links to an integrated health system strengthening and accountability at multiple levels.

To determine the safety of 0.5% and 2% PRO 2000 gel in terms of local and systemic adverse events (AE) and the acceptability of gel use. A randomised placebo-controlled trial among healthy, sexually active African women aged 18-45 years. Between June 2003 and September 2004, 180 consenting women were randomly assigned to one of four groups: PRO 2000 gel (0.5% or 2%), placebo gel, or condom use only. Participants were screened for sexually transmitted infections, with HIV counselling and testing. Women randomly assigned to gel used this intravaginally twice a day for 28 days. Follow-up visits were fortnightly up to 6 weeks from enrolment, and comprised a physical examination including colposcopy, laboratory testing and questionnaire interviews. Ten women were lost to follow-up, none due to AE. Adherence with total gel doses was 69%. Observed rates of the primary toxicity endpoints, ulceration greater than 2 x 1 cm and clinically relevant coagulation abnormalities were, for PRO 2000 0.5%: 1.6% (95% CI 0.04% to 8.5%) and 0% (97.5% CI 0% to 5.7%), and for PRO 2000 2%: 0% and 0% (97.5% CI 0% to 5.9%). Women randomly assigned to active gels did not show an increased rate of AE. Gel use had no significant effect on haematology and biochemistry results. Women found gel use highly acceptable. Both concentrations of PRO 2000 gel were found to be safe and well tolerated. These data justified testing the gels in large-scale effectiveness trials.

Background Uganda adopted maternal and perinatal death surveillance and response (MPDSR) in 2017 and has put concerted effort into scaling up and using data on MPDSR to avert preventable deaths. However, formal analysis of MPDSR implementation processes among health facilities in Uganda has been limited. The purpose of this study was to assess the implementation of MPDSR processes in referral hospitals in Uganda, using a tested measurement approach. Methods From November to December 2022, a cross-sectional study was conducted to assess MPDSR implementation processes in Uganda’s referral hospitals. The tool, adapted from previous studies, uses a 30-point scoring guide to measure progress markers across six stages of implementation. Data collectors visited 15 regional and national referral hospitals and conducted interviews with two members of the MPDSR committee per facility. Descriptive statistics were used to summarize scores by construct and total scores for the facilities. A content analysis from open-ended questions provided contextual insights. Results The average score for MPDSR implementation among referral hospitals in the study was 20.2 out of 30 (range 16 – 27) possible points, which falls in a category showing evidence of routine practice and integration. Progress markers which had particularly low scores included: written staff agreements about MPDSR and orientation of new staff to death reviews. No hospital reported having a budget to support death review meetings. Almost all committee members listed specific ways that MPDSR led to positive changes in quality of care. Conclusion The overall score of 20.2 was somewhat higher when compared to other countries who have applied this measurement approach (in four countries, average 18.98). Only four of the surveyed hospitals demonstrated sustained practice of MPDSR, suggesting that there is still much work to be done to institutionalize MPDSR in Uganda’s referral hospitals. Specific action areas can be pinpointed using the findings on progress markers. The scored MPDSR implementation assessment tool was easy to use and well accepted. We recommend annually updating the tool to reflect new directions and developments in MPDSR implementation, and routine use to self- or externally assess hospitals’ implementation of MPDSR.

Background. Human immunodeficiency virus (HIV)–infected pregnant women are at increased risk of malaria and its complications. In vitro and in vivo data suggest that the HIV protease inhibitors lopinavir/ritonavir may have potent antimalarial activity. We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy (ART) reduced the risk of placental malaria. Methods. HIV-infected, ART-naive pregnant women were enrolled between gestational weeks 12 and 28 and randomly assigned to receive lopinavir/ritonavir-based or efavirenz-based ART. Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bed nets at enrollment and were followed up to 1 year after delivery. The primary outcome was placental malaria, defined by the detection of malaria parasites, using microscopy or polymerase chain reaction (PCR) analysis of placental blood specimens. Secondary outcomes included placental malaria, defined by histopathologic results; adverse birth outcomes; incidence of malaria; and prevalence of asymptomatic parasitemia. Analyses were done using an intention-to-treat approach. Results. Of 389 subjects randomly assigned to a treatment group, 377 were followed through to delivery. There was no significant difference in the risk of placental malaria, as defined by thick smear or PCR findings, between the lopinavir/ritonavir-based and efavirenz-based ART arms (7.4% vs 9.8%; P = .45). Similarly, there were no differences in secondary outcomes between the 2 treatment arms. Conclusions. Lopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes, compared with efavirenz-based ART.

Background The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60–70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. Objective The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. Methods A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour. The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000 ml or more at one hour and up to two hours for women who continue to bleed after one hour. The secondary outcomes are blood transfusion, the use of additional uterotonics and measure of severe morbidity and maternal death. We aim to recruit 25,000 women delivering vaginally in health facilities in eight countries within a 12 month recruitment period. Management Overall trial management will be from HRP/RHR in Geneva. There will be eight centres located in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda. There will be an online data entry system managed from HRP/RHR. The trial protocol was developed following a technical consultation with international organizations and leading researchers in the field. Expected outcomes The main objective of this trial is to investigate whether a simplified package of third stage management can be recommended without increasing the risk of PPH. By avoiding the need for a manual procedure that requires training, the third stage management can be implemented in a more widespread and cost-effective way around the world even at the most peripheral levels of the health care system. This trial forms part of the programme of work to reduce maternal deaths due to postpartum haemorrhage within the RHR department in collaboration with other research groups and organizations active in the field. Trial Registration ACTRN12608000434392

Background. The objective of the present study was to assess whether the high-density lipoprotein cholesterol (HDL-c)-increasing effect of nevirapine (NVP), as observed in human immunodeficiency virus type 1 (HIV-1)- infected subjects, at least in part may relate to intrinsic properties of NVP. Methods. At 2, 6, and 12 weeks after birth, complete lipid profiles as well as plasma apolipoproteins levels were assessed in 80 HIV-uninfected newborns, half of whom received NVP and half lamivudine (3TC), respectively. Newborns were randomly selected from a randomized trial in which NVP or 3TC had been administered to HIVuninfected infants born to HIV-infected mothers to try and prevent HIV-1 transmission from occurring during breast-feeding. Results. After 6 weeks of therapy, the expected physiological decline in HDL-c levels in the newborns was attenuated in infants treated with NVP, compared with levels in those treated with 3TC. Apolipoprotein A-I (apoA-I) levels were higher at all time points in the NVP arm than they were in the 3TC arm (P = .02), reaching peak levels at 6 weeks. The difference in HDL-c was no longer significant at 12 weeks. Conclusions. apoA-I levels and HDL-c were elevated in HIV-1-uninfected newborns receiving NVP, compared with those receiving 3TC. These data support that NVP may indeed have intrinsic apoA-I and HDL-c elevating properties in humans.

Background Oxidative stress plays a role in the pathogenesis of pre-eclampsia. Supplementing women with antioxidants during pregnancy may reduce oxidative stress and thereby prevent or delay the onset pre-eclampsia. The objective of this study was to evaluate the effect of supplementing vitamin C in pregnancy on the incidence of pre-eclampsia, at Mulago hospital, Kampala, Uganda. Methods This was a (parallel, balanced randomization, 1:1) placebo randomized controlled trial conducted at Mulago hospital, Department of Obstetrics and Gynecology. Participants included in this study were pregnant women aged 15-42 years, who lived 15 km or less from the hospital with gestational ages between 12-22 weeks. The women were randomized to take 1000mg of vitamin C (as ascorbic acid) or a placebo daily until they delivered. The primary outcome was pre-eclamsia. Secondary outcomes were: severe pre-eclampsia, gestational hypertension, preterm delivery, low birth weight and still birth delivery. Participants were 932 pregnant women randomized into one of the two treatment arms in a ratio of 1:1. The participants, the care providers and those assessing the outcomes were blinded to the study allocation. Results Of the 932 women recruited; 466 were randomized to the vitamin and 466 to the placebo group. Recruitment of participants was from November 2011 to June 2012 and follow up was up to January 2013. Outcome data was available 415 women in the vitamin group and 418 women in the placebo group. There were no differences in vitamin and placebo groups in the incidence of pre-eclampsia (3.1% versus 4.1%; RR 0.77; 95% CI: 0.37-1.56), severe pre-eclampsia (1.2% versus 1.0%; RR 1.25; 95% CI: 0.34-4.65), gestational hypertension(7.7% versus 11.5%; RR 0.67; 95% CI: 0.43-1.03), preterm delivery (11.3% versus 12.2%; RR 0.92; 95% CI: 0.63-1.34), low birth weight (11.1% versus 10.3%; RR 1.07; 95% CI: 0.72-1.59) and still birth delivery (4.6% versus 4.5%; RR 1.01; 95% CI: 0.54-1.87). Conclusions Supplementation with vitamin C did not reduce the incidence of pre-eclampsia nor did it reduce the adverse maternal or neonatal outcomes. We do not recommend the use of vitamin C in pregnancy to prevent pre-eclampsia. Trial registration This study was registered at the Pan African Clinical Trial Registry, PACTR201210000418271 on 25 th October 2012.