Prevalence of gestational diabetes mellitus based on various screening strategies in western Kenya: a prospective comparison of point of care diagnostic methods.

BACKGROUND: Early diagnosis of gestational diabetes mellitus (GDM) is crucial to prevent short term delivery risks and long term effects such as cardiovascular and metabolic diseases in the mother and infant. Diagnosing GDM in Sub-Saharan Africa (SSA) however, remains sub-optimal due to associated logistical and cost barriers for resource-constrained populations. A cost-effective strategy to screen for GDM in such settings are therefore urgently required. We conducted this study to determine the prevalence of gestational diabetes mellitus (GDM) and assess utility of various GDM point of care (POC) screening strategies in a resource-constrained setting. METHODS: Eligible women aged ≥18 years, and between 24 and 32 weeks of a singleton pregnancy, prospectively underwent testing over two days. On day 1, a POC 1-h 50 g glucose challenge test (GCT) and a POC glycated hemoglobin (HbA1c) was assessed. On day 2, fasting blood glucose, 1-h and 2-h 75 g oral glucose tolerance test (OGTT) were determined using both venous and POC tests, along with a venous HbA1c. The International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria was used to diagnose GDM. GDM prevalence was reported with 95% confidence interval (CI). Specificity, sensitivity, positive predictive value, and negative predictive value of the various POC testing strategies were determined using IADPSG testing as the standard reference. RESULTS: Six hundred-sixteen eligible women completed testing procedures. GDM was diagnosed in 18 women, a prevalence of 2.9% (95% CI, 1.57% - 4.23%). Compared to IADPSG testing, POC IADPSG had a sensitivity and specificity of 55.6% and 90.6% respectively while that of POC 1-h 50 g GCT (using a diagnostic cut-off of ≥7.2 mmol/L [129.6 mg/dL]) was 55.6% and 63.9%. All other POC tests assessed showed poor sensitivity. CONCLUSIONS: POC screening strategies though feasible, showed poor sensitivity for GDM detection in our resource-constrained population of low GDM prevalence. Studies to identify sensitive and specific POC GDM screening strategies using adverse pregnancy outcomes as end points are required. TRIALS REGISTRATION: Clinical trials.gov : NCT02978807 , Registered 29 November 2016.

A Cervical Cancer Screening Toolkit for Somali Women: A Pilot Randomized Controlled Trial.

This study aims to determine whether a novel cervical cancer screening toolkit will increase rates of pap test completion and HPV vaccination among Somali women living in the United States. We conducted a randomized controlled, pilot trial from June 2021 to February 2022. Somali women aged 21 to 70 were randomized to either receive a toolkit (infographic, video and an in-person health seminar) or not. Health passports confirming a completed pap test and/or HPV vaccination by clinician signature were used to measure outcomes. The primary outcome was pap test completion and the secondary outcome was HPV vaccination. We enrolled 57 participants. Patients randomized to the treatment arm were significantly more likely to have had a pap test (53.7% vs. 3.7%, p < 0.0001) and were also more likely to have received the HPV vaccine (10.7% vs. 3.7%, p = 0.6110). This toolkit increased rates of pap test completion and more participants in the intervention arm received HPV vaccination, though numbers were low. The study design may serve as a reproducible model to determine the effectiveness of patient education materials.

Patient satisfaction with integrated HIV and antenatal care services in rural Kenya.

A cluster randomized controlled trial was initiated in Kenya to determine if full integration (FI) of HIV care, including HAART, into antenatal care (ANC) clinics improves health outcomes among HIV-infected women and exposed infants, compared to a non-integrated (NI) model. This article examines ANC clients' satisfaction with and preferences regarding HIV-integrated services. In this cross-sectional study, pregnant women attending five FI clinics (n=185) and four NI clinics (n=141) completed an interviewer-administered questionnaire following an ANC visit. By self-report, 55 women (17%) were HIV(+), 230 (71%) were HIV(-), and 40 (12%) did not know their HIV status. Among HIV-infected women, 79% attending FI clinics were very satisfied with their clinic visit compared to 54% of women attending NI clinics (P=0.044); no such difference was found among HIV-uninfected women. In multivariate analysis, overall satisfaction was also independently associated with satisfaction with administrative staff, satisfaction with health care providers, positive evaluation of wait time, and having encountered a receptionist. Full integration of HIV care into antenatal clinics can significantly increase overall satisfaction with care for HIV-infected women, with no significant decrease in satisfaction for HIV-uninfected women served in the same clinics.

Racial and ethnic differences in indication for primary cesarean delivery at term: experience at one U.S. Institution.

BACKGROUND: Black and Latina women in the United States are known to undergo cesarean delivery at a higher rate than other women. We sought to explore the role of medical indications for cesarean delivery as a potential explanation for these differences. METHODS: A retrospective cohort study was conducted of 11,034 primiparas delivering at term at the University of California, San Francisco, between 1990 and 2008. We used multivariable analyses to evaluate racial and ethnic differences in risks of, and indications for, cesarean delivery. RESULTS: The overall rate of cesarean delivery in our cohort was 21.9 percent. Black and Latina women were at significantly higher odds of undergoing cesarean delivery than white women (adjusted odds ratio or AOR: 1.54; 95% CI: 1.30, 1.83, and 1.21; 95% CI: 1.03, 1.43, respectively). Black women were at significantly higher odds of undergoing cesarean delivery for nonreassuring fetal heart tracings than white women (AOR: 2.19; 95% CI: 1.55, 3.09), and black women (AOR: 1.55; 95% CI: 1.21, 1.98), Latina women (AOR: 1.48; 95% CI: 1.19, 1.85), and Asian women (AOR: 1.47; 95% CI: 1.22, 1.85) were at significantly higher odds of undergoing cesarean delivery for failure to progress. Black, Latina, and Asian women were at significantly lower odds of undergoing cesarean delivery for malpresentation than white women (AOR: 0.56; 95% CI: 0.34, 0.89, 0.66; 95% CI: 0.44, 0.98, and 0.55; 95% CI: 0.40, 0.76, respectively). CONCLUSIONS: Racial and ethnic differences exist in specific indications for cesarean delivery among primiparas. Clarifying the possible reasons for increased cesareans for nonreassuring fetal heart tracing in black women, in particular, may help to decrease excess cesarean deliveries in this racial and ethnic group. (BIRTH 39:2 June 2012).

Quality and equality in obstetric care: racial and ethnic differences in caesarean section delivery rates.

We sought to examine racial/ethnic differences in deliveries by caesarean section (CS) over time, particularly among women at low risk for this procedure. To do so, we conducted a retrospective cohort study at the University of California, San Francisco, a tertiary care academic centre. Births occurring between 1980 and 2001 were included in the analyses. Women with multiple gestations, fetuses in other than the cephalic presentation or with other known contraindications to vaginal birth were excluded. A total of 28 493 African American, Asian, Latina and White women were studied. Risk-adjusted models were created to explore differences in CS risk by race/ethnicity. We also performed analyses of subgroups of women at relatively low risk of CS, and explored changes in observed disparities over time. The overall CS rate was 15.8%. The absolute rate was highest among Latinas (16.7%) and lowest among Asians (14.7%). After adjustment for known risk factors, African American women had a 1.48 times greater odds of having a CS than did White women [95% confidence interval (CI) 1.31, 1.68], and Latina women had a 1.19 times greater odds [95% CI 1.05, 1.34]. Stepwise adjustment for confounders showed that this variation is not entirely explained by known risk factors. These differences exist even for women at low risk of CS, and have persisted over time. We conclude that racial and ethnic disparities in CS delivery exist, even among women presumed to be at lower risk of CS; rates have not improved with time. Disparities in risk-adjusted CS should be considered as a quality metric for obstetric care, whether at the national, state, hospital or provider level.

Use of visual inspection with acetic acid, Pap smear, or high-risk human papillomavirus testing in women living with HIV/AIDS for posttreatment cervical cancer screening: same tests, different priorities.

OBJECTIVES: Few studies have addressed optimal follow-up for HIV-infected women after cervical treatment. This study aimed to compare performance of three available tests to detect posttreatment cervical disease in HIV-infected women in Kenya. DESIGN: This is a prospective cohort study. METHODS: At least 6 months following cryotherapy, 517 HIV-infected women were evaluated concurrently with visual inspection with acetic acid (VIA), papanicolaou (Pap) smear, and high-risk human papillomavirus (HR-HPV) testing. Women positive by any test (≥low-grade squamous intraepithelial lesion for Pap) were scheduled for colposcopy and biopsy. Among 248 with histological confirmation [and 174 assumed to be truly negative for cervical intraepithelial neoplasia (CIN)2+ after testing negative by all three tests], the ability of each test alone, or in combination, to detect CIN2+ was calculated to determine their utility in posttreatment follow-up. RESULTS: The median age of women was 35 years, 68% were WHO stage 1-2, with a median CD4 cell count of 410 cells/µl, and 87% were on combination antiretroviral therapy. At a median of 6.3 months posttreatment, 64% had an abnormal screen by VIA, Pap, and/or HR-HPV. Among women with histological confirmation, 72 (30%) had persistent/recurrent CIN2+. As single tests, Pap correctly classified the most cases (83%) and had the highest specificity [91% (88 and 95%); sensitivity 44% (35 and 53%)], whereas HR-HPV had the highest sensitivity [85% (75 and 96%); specificity 54% (49 and 58%)]. VIA was not sensitive [27% (18 and 36%)] for the detection of posttreatment CIN2+ [specificity 82% (79 and 86%)]. CONCLUSION: With the goal to minimize the number of false negatives (e.g. not miss CIN2+ posttreatment) in this population that is high-risk due to both prior cervical disease and HIV infection, HR-HPV-based algorithms are recommended.

HIV Prevalence and Antenatal Care Attendance among Pregnant Women in a Large Home-Based HIV Counseling and Testing Program in Western Kenya.

OBJECTIVE: To describe the uptake of and factors associated with HIV prevalence among pregnant women in a large-scale home-based HIV counseling and testing (HBCT) program in western Kenya. METHODS: In 2007, the Academic Model Providing Access to Healthcare Program (AMPATH) initiated HBCT to all individuals aged ≥13 years and high-risk children <13 years. Included in this analysis were females aged 13-50 years, from 6 catchment areas (11/08-01/12). We used descriptive statistics and logistic regression to describe factors associated with HIV prevalence. RESULTS: There were 119,678 women eligible for analysis; median age 25 (interquartile range, IQR: 18-34) years. Of these, 7,396 (6.2%) were pregnant at the time of HBCT; 4,599 (62%) had ever previously tested for HIV and 2,995 (40.5%) had not yet attended ANC for their current pregnancy. Testing uptake among pregnant women was high (97%). HBCT newly identified 241 (3.3%) pregnant HIV-positive women and overall HIV prevalence among all pregnant women was 6.9%. HIV prevalence among those who had attended ANC in this pregnancy was 5.4% compared to 9.0% among those who had not. Pregnant women were more likely to newly test HIV-positive in HBCT if they had not attended ANC in the current pregnancy (AOR: 6.85, 95% CI: 4.49-10.44). CONCLUSIONS: Pregnant women who had never attended ANC were about 6 times more likely to newly test HIV-positive compared to those who had attended ANC, suggesting that the cascade of services for prevention of mother-to-child HIV transmission should optimally begin at the home and village level if elimination of perinatal HIV transmission is to be achieved.

Implementation and Operational Research: Effect of Integration of HIV Care and Treatment Into Antenatal Care Clinics on Mother-to-Child HIV Transmission and Maternal Outcomes in Nyanza, Kenya: Results From the SHAIP Cluster Randomized Controlled Trial.

BACKGROUND: Many HIV-infected pregnant women identified during antenatal care (ANC) do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. METHODS: We performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, prevention of mother-to-child transmission, and HIV care delivered in the ANC clinic; n = 6 intervention facilities) or standard ANC services (including prevention of mother-to-child transmission and referral to a separate clinic for HIV care; n = 6 control facilities). RESULTS: There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was 12-month follow-up data for 256 of 611 (41.8%) women and postpartum data for only 325 of 1172 (28%) women. By 9 months of age, 382 of 568 (67.3%) infants at intervention sites and 338 of 594 (57.0%) at control sites had tested for HIV [odds ratio (OR) 1.45, 95% confidence interval (CI): 0.71 to 2.82]; 7.3% of infants tested HIV positive at intervention sites compared with 8.0% of infants at control sites (OR 0.89, 95% CI: 0.56 to 1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1%, OR 0.83, 95% CI: 0.41 to 1.68). CONCLUSIONS: Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes.

Implementation and Operational Research: Effects of Antenatal Care and HIV Treatment Integration on Elements of the PMTCT Cascade: Results From the SHAIP Cluster-Randomized Controlled Trial in Kenya.

BACKGROUND: Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes. METHODS: ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or nonintegrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. RESULTS: HIV care enrollment was higher in intervention compared with control clinics [69% versus 36%; odds ratio = 3.94, 95% confidence interval (CI): 1.14 to 13.63]. Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, hazard ratio = 2.20, 95% CI: 1.62 to 3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%; odds ratio = 3.22, 95% CI: 1.81 to 5.72). Infant testing was more common in the intervention arm (25% versus 18%), however, not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. CONCLUSIONS: Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions.

Successes and challenges of establishing a cervical cancer screening and treatment program in western Kenya.

OBJECTIVE: To describe the challenges and successes of integrating a public-sector cervical screening program into a large HIV care system in western Kenya. METHODS: The present study was a programmatic description and a retrospective chart review of data collected from a cervical screening program based on visual inspection with acetic acid (VIA) between June 2009 and October 2011. RESULTS: In total, 6787 women were screened: 1331 (19.6%) were VIA-positive, of whom 949 (71.3%) had HIV. Overall, 206 women underwent cryotherapy, 754 colposcopy, 143 loop electrical excision procedure (LEEP), and 27 hysterectomy. Among the colposcopy-guided biopsies, 27.9% had severe dysplasia and 10.9% had invasive cancer. There were 68 cases of cancer, equating to approximately 414 per 100000 women per year. Despite aggressive strategies, the overall loss to follow-up was 31.5%: 27.9% were lost after a positive VIA screen, 49.3% between biopsy and LEEP, and 59.6% between biopsy and hysterectomy/chemotherapy. CONCLUSION: The established infrastructure of an HIV treatment program was successfully used to build capacity for cervical screening in a low-resource setting. By using task-shifting and evidence-based, low-cost approaches, population-based cervical screening in a rural African clinical network was found to feasible; however, loss to follow-up and poor pathology infrastructure remain important obstacles.

Pilot study of single-use obstetric emergency medical kits to reduce maternal mortality.

OBJECTIVE: To describe the experience at a single facility regarding single-use emergency medication kits to treat obstetric emergencies in a resource-poor setting. METHODS: A retrospective study was conducted between October 2009 and October 2010 using data from the medical records of all patients treated with a single-use obstetric emergency medical kit (E-kit) during admission at the Riley Mother and Baby Hospital Wing, Eldoret, Kenya. Descriptive analyses were performed to quantify proportions of emergencies treated using E-kits in the first year of implementation. Summary statistics regarding maternal mortality from October 2008 to October 2010 were also retrieved to evaluate differences in the maternal mortality rates in the year of E-kit implementation and the year preceding implementation in order to estimate maternal mortalities averted with E-kit implementation. RESULTS: In the first year of implementation, 192 patients were treated using E-kits. Overall, 144 kits were used for treating postpartum hemorrhage, 52 for treating severe pre-eclampsia/eclampsia, and 1 for treating cardiopulmonary shock. There was a 30% reduction in maternal mortality ratio with E-kit implementation; however, results did not reach statistical significance. CONCLUSION: The results indicate that single-use E-kits may help to achieve a significant reduction in hospital rates of maternal mortality.

The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial.

BACKGROUND: Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. METHODOLOGY/PRINCIPAL FINDINGS: A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. CONCLUSIONS/SIGNIFICANCE: This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health. TRIAL REGISTRATION: ClinicalTrials.gov NCT00931216 http://clinicaltrials.gov/ct2/show/NCT00931216.

Patient perspectives with abbreviated versus standard pre-test HIV counseling in the prenatal setting: a randomized-controlled, non-inferiority trial.

BACKGROUND: In the US, an unacceptably high percentage of pregnant women do not undergo prenatal HIV testing. Previous studies have found increased uptake of prenatal HIV testing with abbreviated pre-test counseling, however little is known about patient decision making, testing satisfaction and knowledge in this setting. METHODOLOGY/FINDINGS: A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco. A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit. Patient decision making experience was compared between abbreviated versus standard HIV counseling strategies among a sample of low-income, urban, ethnically diverse prenatal patients. The primary outcome was the decisional conflict score (DCS) using O'Connor low-literacy scale and secondary outcomes included satisfaction with test decision, basic HIV knowledge and HIV testing uptake. We conducted an intention-to-treat analysis of 278 women--134 (48.2%) in the abbreviated arm (AA) and 144 (51.8%) in the standard arm (SA). There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: -0.65, 8.41) did not exceed the non-inferiority margin. HIV testing uptake was very high (97. 8%) and did not differ significantly between the 2 groups (99.3% in AA vs. 96.5% in SA, p = .12). Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36). However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p<0.01). CONCLUSIONS/SIGNIFICANCE: This study suggests that streamlining the pre-test counseling process, while associated with slightly lower knowledge, does not compromise patient decision making or satisfaction regarding HIV testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT00503308.

A pilot study of food supplementation to improve adherence to antiretroviral therapy among food-insecure adults in Lusaka, Zambia.

BACKGROUND: The provision of food supplementation to food-insecure patients initiating antiretroviral therapy (ART) may improve adherence to medications. METHODS: A home-based adherence support program at 8 government clinics assessed patients for food insecurity. Four clinics provided food supplementation, and 4 acted as controls. The analysis compared adherence (assessed by medication possession ratio), CD4, and weight gain outcomes among food-insecure patients enrolled at the food clinics with those enrolled at the control clinics. RESULTS: Between May 1, 2004, and March 31, 2005, 636 food- insecure adults were enrolled. Food supplementation was associated with better adherence to therapy. Two hundred fifty-eight of 366 (70%) patients in the food group achieved a medication possession ratio of 95% or greater versus 79 of 166 (48%) among controls (relative risk = 1.5; 95% confidence interval: 1.2 to 1.8). This finding was unchanged after adjustment for sex, age, baseline CD4 count, baseline World Health Organization stage, and baseline hemoglobin. We did not observe a significant effect of food supplementation on weight gain or CD4 cell response. CONCLUSIONS: This analysis suggests that providing food to food-insecure patients initiating ART is feasible and may improve adherence to medication. A large randomized study of the clinical benefits of food supplementation to ART patients is urgently needed to inform international policy.