Michelle M. Gill

Introduction of rapid syphilis testing within prevention of mother-to-child transmission of HIV programs in Uganda and Zambia: a field acceptability and feasibility study.

Background:Given that integration of syphilis testing into prevention of mother-to-child transmission of HIV (PMTCT) programs can prevent adverse pregnancy outcomes, this study assessed feasibility and acceptability of introducing rapid syphilis testing (RST) into PMTCT services. Methods:RST was introduced into PMTCT programs in Zambia and Uganda. Using a pre–post intervention design, HIV and syphilis testing and treatment rates during the intervention were compared with baseline. Results:In Zambia, comparing baseline and intervention, 12,761 of 15,967 (79.9%) and 11,460 of 11,985 (95.6%) first-time antenatal care (ANC) attendees were tested for syphilis (P < 0.0001), 523 of 12,761 (4.1%) and 1050 of 11,460 (9.2%) women tested positive (P < 0.0001); and 267 of 523 (51.1%) and 1000 of 1050 (95.2%) syphilis-positive women were treated (P < 0.0001), respectively. Comparing baseline and intervention, 7479 of 7830 (95.5%) and 11,151 of 11,409 (97.7%) of ANC attendees were tested for HIV (P < 0.0001) and 1303 of 1326 (98.3%) and 2036 of 2034 (100.1%) of those testing positive received combination antiretroviral drugs or single-dose nevirapine prophylaxis (P < 0.0001). In Uganda, 13,131 of 14,540 (90.3%) women were tested for syphilis during intervention, with 690 of 13,131 (5.3%) positive and 715 of 690 (103.6%) treated. Syphilis baseline data were collected, but not included in analysis, as ANC syphilis testing before the study was not consistently practiced. Comparing baseline and intervention, 6479 of 6776 (95.6%) and 11,192 of 11,610 (96.4%) ANC attendees were tested for HIV (P = 0.0009) and 570 of 726 (78.5%) and 964 of 1153 (83.6%) received combination or single-dose prophylaxis (P = 0.007). In Zambia, 254 of 1050 (24.2%) syphilis-positive pregnant women were HIV-positive and 99 of 690 (14.3%) in Uganda. Conclusions:Integrating RST in PMTCT programs increases screening and treatment for syphilis among HIV-positive pregnant women and does not compromise HIV services.

Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers' Perspectives on Testing, Training and Quality Assurance.

Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues.

The cost-effectiveness of 10 antenatal syphilis screening and treatment approaches in Peru, Tanzania, and Zambia.

Rapid plasma reagin (RPR) is frequently used to test women for maternal syphilis. Rapid syphilis immunochromatographic strip tests detecting only Treponema pallidum antibodies (single RSTs) or both treponemal and non‐treponemal antibodies (dual RSTs) are now available. This study assessed the cost‐effectiveness of algorithms using these tests to screen pregnant women.

Access to HIV prevention and care for HIV-exposed and HIV-infected children: a qualitative study in rural and urban Mozambique

BackgroundFollow-up of HIV-exposed children for the delivery of prevention of mother-to-child transmission services and for early diagnosis and treatment of HIV infection is critical to their survival. Despite efforts, uptake of postnatal care for these children remains low in many sub-Saharan African countries.MethodsA qualitative study was conducted in three provinces in Mozambique to identify motivators and barriers to improve uptake of and retention in HIV prevention, care and treatment services for HIV-exposed and HIV-infected children. Participant recommendations were also gathered. Individual interviews (n = 79) and focus group discussions (n = 32) were conducted with parents/caregivers, grandmothers, community leaders and health care workers. Using a socioecological framework, the main themes identified were organized into multiple spheres of influence, specifically at the individual, interpersonal, institutional, community and policy levels.ResultsStudy participants reported factors such as seeking care outside of the conventional health system and disbelief in test results as barriers to use of HIV services. Other key barriers included fear of disclosure at the interpersonal level and poor patient flow and long waiting time at the institutional level. Key facilitators for accessing care included having hope for children’s future, symptomatic illness in children, and the belief that health facilities were the appropriate places to get care.ConclusionsThe results suggest that individual-level factors are critical drivers that influence the health-seeking behavior of caregivers of HIV-exposed and HIV-infected children in Mozambique. Noted strategies are to provide more information and awareness on the benefits of early pediatric testing and treatment with positive messages that incorporate success stories, to reach more pregnant women and mother-child pairs postpartum, and to provide counseling during tracing visits. Increasing uptake and retention may be achieved by improving patient flow at the institutional level at health facilities, by addressing concerns with family decision makers, and by working with community leaders to support the uptake of services for HIV-exposed children for essential preventive care.

Detectable viral load in late pregnancy among women in the Rwanda option B+ PMTCT program: Enrollment results from the Kabeho Study

There are limited viral load (VL) data available from programs implementing “Option B+,” lifelong antiretroviral treatment (ART) to all HIV-positive pregnant and postpartum women, in resource-limited settings. Extent of viral suppression from a prevention of mother-to-child transmission of HIV program in Rwanda was assessed among women enrolled in the Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV (Kabeho) Study. ARV drug resistance testing was conducted on women with VL>2000 copies/ml. In April 2013-January 2014, 608 pregnant or early postpartum HIV-positive women were enrolled in 14 facilities. Factors associated with detectable enrollment VL (>20 copies/ml) were examined using generalized estimating equations. The most common antiretroviral regimen (56.7%, 344/607) was tenofovir/lamivudine/efavirenz. Median ART duration was 13.5 months (IQR 3.0–48.8); 76.1% of women were on ART at first antenatal visit. Half of women (315/603) had undetectable RNA-PCR VL and 84.6% (510) had <1,000 copies/ml. Detectable VL increased among those on ART > 36 months compared to those on ART 4–36 months (72/191, 37.7% versus 56/187, 29.9%), though the difference was not significant. The odds of having detectable enrollment VL decreased significantly as duration on ART at enrollment increased (AOR = 0.99, 95% CI: 0.9857, 0.9998, p = 0.043). There was a higher likelihood of detectable VL for women with lower gravidity (AOR = 0.90, 95% CI: 0.84, 0.97, p = 0.0039), no education (AOR = 2.25, (95% CI: 1.37, 3.70, p = 0.0004), nondisclosure to partner (AOR = 1.97, 95% CI: 1.21, 3.21, p = 0.0063) and side effects (AOR = 2.63, 95% CI: 1.72, 4.03, p<0.0001). ARV drug resistance mutations were detected in all of the eleven women on ART > 36 months with genotyping available. Most women were receiving ART at first antenatal visit, with relatively high viral suppression rates. Shorter ART duration was associated with higher VL, with a concerning increasing trend for higher viremia and drug resistance among women on ART for >3 years.

The association between HIV status and antenatal care attendance among pregnant women in rural hospitals in Lesotho.

Objective:Early and frequent antenatal clinic (ANC) attendance is important for promotion of healthy outcomes for mother and child. This study explored the relationship between HIV status at the first ANC visit and subsequent ANC attendance among pregnant women in Lesotho. Methods:A retrospective review of ANC records from a cohort of pregnant women attending their first ANC visit in December 2009 to May 2010 in 3 rural hospitals was conducted. Wilcoxon rank sum tests compared the distribution of gestational age (GA) and ANC visit number by HIV status. Results:Records from 728 women were reviewed with mean GA at the first ANC visit of 22.3 weeks (SD = 7.2) and 2.7 (SD = 1.4) mean number of ANC visits per woman. Neither number of visits nor GA at first visit differed between HIV-positive and HIV-negative women. In total, 33.9% of women completed 4 ANC visits. Women with documented HIV-positive status before ANC were more likely to present early to ANC than all other women (18.8 vs. 22.6 weeks, adjusted odds ratio = 2.54, 95% confidence interval: 1.41 to 4.57). Geographical region, increasing maternal age, and lower parity were associated with completion of expected ANC visits among all women. Increasing maternal age and CD4 count were associated with completion of expected visits among HIV-positive women. Conclusions:In Lesotho, number of subsequent visits did not differ between women testing HIV-positive and HIV-negative in ANC. However, women with documented HIV-positive status attended ANC earlier than women who were tested in ANC. HIV testing and counseling, particularly for HIV-positive women before pregnancy, can promote early ANC attendance.

Understanding Antiretroviral Treatment Adherence Among HIV-Positive Women at Four Postpartum Time Intervals: Qualitative Results from the Kabeho Study in Rwanda

&NA; As lifelong antiretroviral therapy (ART) for pregnant women is implemented, it is important to understand the attitudes and norms affecting womens postpartum ART adherence. This is a qualitative cross‐sectional study of HIV‐positive postpartum women (n = 112) enrolled in a 2‐year observational prospective cohort in Rwanda. Informed by the Theory of Reasoned Action (TRA), we conducted in‐depth interviews with women whose children were 0–6, 7–12, 13–18, or 21–24 months of age to describe factors contributing to adherence and changes over time. Positive ART attitudes reported by women included mothers’ health promotion, prevention of infant HIV infection, higher CD4 count, and improved physical appearance. Negative attitudes were few, but included side effects and the lifelong nature of treatment. Learning from people living with HIV (PLHIV) was identified as a norm facilitating adherence; ART adherence was inhibited by fear of disclosure or stigmatization in communities and clinics. Poor adherence behaviors were common immediately after HIV diagnosis, not necessarily during prevention of mother‐to‐child transmission (PMTCT). Women with older children, most of whom stopped breastfeeding by 13–18 months, reported more barriers and missed doses than women with younger children. The TRA was useful in identifying the collective influence of attitudes, norms, and intentions on behavior. Findings suggest that HIV‐positive women are vulnerable to poor adherence following HIV diagnosis and around the time of breastfeeding cessation. Lifelong treatment adherence can be supported through PLHIV exemplifying long‐term ART use, fewer and less stigmatizing clinic visits, and counseling messages highlighting the benefits of drugs on appearance and illness prevention and incorporating biological feedback.

Scaling Down to Scale Up: A Health Economic Analysis of Integrating Point-of-Care Syphilis Testing into Antenatal Care in Zambia during Pilot and National Rollout Implementation.

Maternal syphilis results in an estimated 500,000 stillbirths and neonatal deaths annually in Sub-Saharan Africa. Despite the existence of national guidelines for antenatal syphilis screening, syphilis testing is often limited by inadequate laboratory and staff services. Recent availability of inexpensive rapid point-of-care syphilis tests (RST) can improve access to antenatal syphilis screening. A 2010 pilot in Zambia explored the feasibility of integrating RST within prevention of mother-to-child-transmission of HIV services. Following successful demonstration, the Zambian Ministry of Health adopted RSTs into national policy in 2011. Cost data from the pilot and 2012 preliminary national rollout were extracted from project records, antenatal registers, clinic staff interviews, and facility observations, with the aim of assessing the cost and quality implications of scaling up a successful pilot into a national rollout. Start-up, capital, and recurrent cost inputs were collected, including costs of extensive supervision and quality monitoring during the pilot. Costs were analysed from a provider’s perspective, incremental to existing antenatal services. Total and unit costs were calculated and a multivariate sensitivity analysis was performed. Our accompanying qualitative study by Ansbro et al. (2015) elucidated quality assurance and supervisory system challenges experienced during rollout, which helped explain key cost drivers. The average unit cost per woman screened during rollout (

Conventional early infant diagnosis in Lesotho from specimen collection to results usage to manage patients: Where are the bottlenecks?

11.16) was more than triple the pilot unit cost (

24-month HIV-free survival among infants born to HIV-positive women enrolled in Option B+ program in Kigali, Rwanda: The Kabeho Study

3.19). While quality assurance costs were much lower during rollout, the increased unit costs can be attributed to several factors, including higher RST prices and lower RST coverage during rollout, which reduced economies of scale. Pilot and rollout cost drivers differed due to implementation decisions related to training, supervision, and quality assurance. This study explored the cost of integrating RST into antenatal care in pilot and national rollout settings, and highlighted important differences in costs that may be observed when moving from pilot to scale-up.