Implementation and Operational Research: Integration of PMTCT and Antenatal Services Improves Combination Antiretroviral Therapy Uptake for HIV-Positive Pregnant Women in Southern Zambia: A Prototype for Option B+?

BACKGROUND: Early initiation of combination antiretroviral therapy (cART) for HIV-positive pregnant women can decrease vertical transmission to less than 5%. Programmatic barriers to early cART include decentralized care, disease-stage assessment delays, and loss to follow-up. INTERVENTION: Our intervention had 3 components: integrated HIV and antenatal services in 1 location with 1 provider, laboratory courier to expedite CD4 counts, and community-based follow-up of women-infant pairs to improve prevention of mother-to-child transmission attendance. Preintervention HIV-positive pregnant women were referred to HIV clinics for disease-stage assessment and cART initiation for advanced disease (CD4 count <350 cells/µL or WHO stage >2). METHODS: We used a quasi-experimental design with preintervention/postintervention evaluations at 6 government antenatal clinics (ANCs) in Southern Province, Zambia. Retrospective clinical data were collected from clinic registers during a 7-month baseline period. Postintervention data were collected from all antiretroviral therapy-naive, HIV-positive pregnant women and their infants presenting to ANC from December 2011 to June 2013. RESULTS: Data from 510 baseline women-infant pairs were analyzed and 624 pregnant women were enrolled during the intervention period. The proportion of HIV-positive pregnant women receiving CD4 counts increased from 50.6% to 77.2% [relative risk (RR) = 1.81; 95% confidence interval (CI): 1.57 to 2.08; P < 0.01]. The proportion of cART-eligible pregnant women initiated on cART increased from 27.5% to 71.5% (RR = 2.25; 95% CI: 1.78 to 2.83; P < 0.01). The proportion of eligible HIV-exposed infants with documented 6-week HIV PCR test increased from 41.9% to 55.8% (RR = 1.33; 95% CI: 1.18 to 1.51; P < 0.01). CONCLUSIONS: Integration of HIV care into ANC and community-based support improved uptake of CD4 counts, proportion of cART-eligible women initiated on cART, and infants tested.

Can traditional birth attendants be trained to accurately identify septic infants, initiate antibiotics, and refer in a rural African setting?

BACKGROUND: Neonatal sepsis is a major cause of neonatal mortality. In populations with limited access to health care, early identification of bacterial infections and initiation of antibiotics by community health workers (CHWs) could be lifesaving. It is unknown whether this strategy would be feasible using traditional birth attendants (TBAs), a cadre of CHWs who typically have limited training and educational backgrounds. METHODS: We analyzed data from the intervention arm of a cluster-randomized trial involving TBAs in Lufwanyama District, Zambia, from June 2006 to November 2008. TBAs followed neonates for signs of potential infection through 28 days of life. If any of 16 criteria were met, TBAs administered oral amoxicillin and facilitated referral to a rural health center. RESULTS: Our analysis included 1,889 neonates with final vital status by day 28. TBAs conducted a median of 2 (interquartile range 2-6) home visits (51.4% in week 1 and 48.2% in weeks 2-4) and referred 208 neonates (11%) for suspected sepsis. Of referred neonates, 176/208 (84.6%) completed their referral. Among neonates given amoxicillin, 171/183 (93.4%) were referred; among referred neonates, 171/208 (82.2%) received amoxicillin. Referral and/or initiation of antibiotics were strongly associated with neonatal death (for referral, relative risk [RR] = 7.93, 95% confidence interval [CI] = 4.4-14.3; for amoxicillin administration, RR = 4.7, 95% CI = 2.4-8.7). Neonates clinically judged to be "extremely sick" by the referring TBA were at greatest risk of death (RR = 8.61, 95% CI = 4.0-18.5). CONCLUSION: The strategy of administering a first dose of antibiotics and referring based solely on the clinical evaluation of a TBA is feasible and could be effective in reducing neonatal mortality in remote rural settings.

Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP).

OBJECTIVE: To provide relevant details on how interventions in the Lufwanyama Neonatal Survival Project (LUNESP) were developed and how Zambian traditional birth attendants (TBAs) were trained to perform them. METHODS: The study tested 2 interventions: a simplified version of the American Academy of Pediatrics' neonatal resuscitation protocol (NRP); and antibiotics with facilitated referral (AFR). RESULTS: Key elements that enabled the positive study result were: focusing on common and correctible causes of mortality; selecting a study population with high unmet public health need; early community mobilization to build awareness and support; emphasizing simplicity in the intervention technology and algorithms; using a traditional training approach appropriate to students with low literacy rates; requiring TBAs to demonstrate their competence before completing each workshop; and minimizing attrition of skills by retraining and reassessing the TBAs regularly throughout the study. CONCLUSION: An effective NRP training model was created that is suitable for community-based neonatal interventions, in research or programmatic settings, and by practitioners with limited obstetric skills and low rates of literacy. Clinicaltrials.gov NCT00518856.

Costs and cost-effectiveness of training traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival study (LUNESP).

BACKGROUND: The Lufwanyama Neonatal Survival Project ("LUNESP") was a cluster randomized, controlled trial that showed that training traditional birth attendants (TBAs) to perform interventions targeting birth asphyxia, hypothermia, and neonatal sepsis reduced all-cause neonatal mortality by 45%. This companion analysis was undertaken to analyze intervention costs and cost-effectiveness, and factors that might improve cost-effectiveness. METHODS AND FINDINGS: We calculated LUNESP's financial and economic costs and the economic cost of implementation for a forecasted ten-year program (2011-2020). In each case, we calculated the incremental cost per death avoided and disability-adjusted life years (DALYs) averted in real 2011 US dollars. The forecasted 10-year program analysis included a base case as well as 'conservative' and 'optimistic' scenarios. Uncertainty was characterized using one-way sensitivity analyses and a multivariate probabilistic sensitivity analysis. The estimated financial and economic costs of LUNESP were $118,574 and $127,756, respectively, or $49,469 and $53,550 per year. Fixed costs accounted for nearly 90% of total costs. For the 10-year program, discounted total and annual program costs were $256,455 and $26,834 respectively; for the base case, optimistic, and conservative scenarios, the estimated cost per death avoided was $1,866, $591, and $3,024, and cost per DALY averted was $74, $24, and $120, respectively. Outcomes were robust to variations in local costs, but sensitive to variations in intervention effect size, number of births attended by TBAs, and the extent of foreign consultants' participation. CONCLUSIONS: Based on established guidelines, the strategy of using trained TBAs to reduce neonatal mortality was 'highly cost effective'. We strongly recommend consideration of this approach for other remote rural populations with limited access to health care.

Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study.

OBJECTIVE: To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare. DESIGN: Prospective, cluster randomised and controlled effectiveness study. SETTING: Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers' homes, in rural village settings. PARTICIPANTS: 127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district. INTERVENTIONS: Using an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits). MAIN OUTCOME MEASURES: The primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data. RESULTS: Among 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by intervention birth attendants (0.37, 0.17 to 0.81) and by 81% within the first two days after birth (0.19, 0.07 to 0.52). Stillbirths and deaths from serious infection occurred at similar rates in both groups. CONCLUSIONS: Training traditional birth attendants to manage common perinatal conditions significantly reduced neonatal mortality in a rural African setting. This approach has high potential to be applied to similar settings with dispersed rural populations. Trial registration Clinicaltrials.gov NCT00518856.