Does quality influence utilization of primary health care? Evidence from Haiti.

BACKGROUND: Expanding coverage of primary healthcare services such as antenatal care and vaccinations is a global health priority; however, many Haitians do not utilize these services. One reason may be that the population avoids low quality health facilities. We examined how facility infrastructure and the quality of primary health care service delivery were associated with community utilization of primary health care services in Haiti. METHODS: We constructed two composite measures of quality for all Haitian facilities using the 2013 Service Provision Assessment survey. We geographically linked population clusters from the Demographic and Health Surveys to nearby facilities offering primary health care services. We assessed the cross-sectional association between quality and utilization of four primary care services: antenatal care, postnatal care, vaccinations and sick child care, as well as one more complex service: facility delivery. RESULTS: Facilities performed poorly on both measures of quality, scoring 0.55 and 0.58 out of 1 on infrastructure and service delivery quality respectively. In rural areas, utilization of several primary cares services (antenatal care, postnatal care, and vaccination) was associated with both infrastructure and quality of service delivery, with stronger associations for service delivery. Facility delivery was associated with infrastructure quality, and there was no association for sick child care. In urban areas, care utilization was not associated with either quality measure. CONCLUSIONS: Poor quality of care may deter utilization of beneficial primary health care services in rural areas of Haiti. Improving health service quality may offer an opportunity not only to improve health outcomes for patients, but also to expand coverage of key primary health care services.

Assessing the quality of primary care in Haiti.

OBJECTIVE: To develop a composite measure of primary care quality and apply it to Haiti's primary care system. METHODS: Using the Primary Health Care Performance Initiative's framework, we defined four domains of primary care service delivery: (i) accessible care; (ii) effective service delivery; (iii) management and organization; and (iv) primary care functions. We gave each primary care facility in Haiti a quality score for each domain and overall, with poor, fair and good quality indicated by scores of 0.00-0.49, 0.50-0.74 and 0.75-1.00, respectively. We quantified access and effective access to primary care as the proportions of the population within 5 km of any primary care facility and a good facility, respectively. FINDINGS: Of the 786 primary care facilities in Haiti in 2013, only 332 (43%) facilities were classified as good for accessible care. Fewer facilities were classified as good in the domains of effective service delivery (30; 4%), management and organization (91; 12%) and primary care functions (43; 5%). Although about 91% of the population lived within 5 km of a primary care facility, only an estimated 23% of the entire population - including just 5% of the rural population - had access to primary care of good quality. CONCLUSION: Despite an extensive network of health facilities, a minority of Haitians had access to a primary care facility of good quality. Such facilities were especially scarce in rural areas. Similar systematic analyses of the quality of primary care could inform national efforts to strengthen health systems.

Acceptability and use of ready-to-use supplementary food compared to corn-soy blend as a targeted ration in an HIV program in rural Haiti: a qualitative study.

BACKGROUND: Ready-to-use supplementary food (RUSF) is increasingly used as a component of food rations for adults with HIV. METHODS: We undertook a qualitative study to evaluate the acceptability and use of peanut-based RUSF compared to corn-soy blend (CSB) among adults living with HIV in rural Haiti who had been enrolled in a prospective, randomized trial comparing the impact of those rations. A total of 13 focus groups were conducted with 84 participants-42 selected from the RUSF arm of the study, and 42 from the CSB arm-using a guide with pre-designated core topics and open-ended questions. RESULTS: We found that RUSF was highly acceptable in terms of taste, preparation, and packaging. Both types of food ration were widely shared inside and outside households, especially with children. However, while CSB was without exception stored with the communal household food supply, RUSF was frequently separated from the household food supply and was more often reserved for consumption by individuals with HIV. CONCLUSIONS: RUSF was a highly acceptable food ration that, compared to CSB, was more often reserved for use by the individual with HIV. Qualitative examination of the perceptions, use, and sharing of food rations is critical to understanding and improving the efficacy of food assistance for food-insecure people living with HIV.

Immunogenicity of the Bivalent Oral Cholera Vaccine Shanchol in Haitian Adults With HIV Infection.

We evaluated immune responses following bivalent oral cholera vaccination (Shanchol [Shantha Biotechnics]; BivWC) in a cohort of 25 human immunodeficiency virus (HIV)-infected adults in Haiti. Compared with adults without HIV infection, vaccination in HIV-infected individuals resulted in lower vibriocidal responses against Vibrio cholerae O1, and there was a positive relationship between the CD4(+) T-cell count and vibriocidal responses following vaccination. Nevertheless, seroconversion occurred at a rate of 65% against the Ogawa serotype and 74% against the Inaba serotype in adults with HIV infection. These results suggest that the vaccine retains substantial immunogenicity in adults with HIV infection and may benefit this population by protecting against cholera.

A randomized trial of ready-to-use supplementary food versus corn-soy blend plus as food rations for HIV-infected adults on antiretroviral therapy in rural Haiti.

BACKGROUND: The epidemics of food insecurity, malnutrition, and human immunodeficiency virus (HIV) frequently overlap. HIV treatment programs increasingly provide nutrient-dense ready-to-use supplementary foods (RUSFs) to patients living with HIV and food insecurity, but in the absence of wasting, it is not known if RUSF confers benefit above less costly food commodities. METHODS: We performed a randomized trial in rural Haiti comparing an RUSF with less costly corn-soy blend plus (CSB+) as a monthly supplement to patients with HIV infection who were on antiretroviral therapy (ART) <24 months prior to study start. We compared 6- and 12-month outcomes by ration type in terms of immunologic response, body mass index (BMI), adherence to ART, general health quality of life, household food insecurity, and household wealth. RESULTS: A cohort of 524 patients with HIV receiving ART was randomized and followed over time. Median CD4 cell count at baseline was 339 cells/µL (interquartile range [IQR], 197-475 cells/µL) for the CSB+ group, and 341 cells/µL (IQR, 213-464/µL) for the RUSF group. Measured outcomes improved from baseline over time, but there were no statistically significant differences in change for BMI, household wealth index, hunger, general health perception score, or adherence to ART by ration type at 6 or 12 months. The RUSF group had higher CD4 count at 12 months, but this was also not statistically significant. CONCLUSIONS: In 12 months of follow-up, there was no statistically significant difference in outcomes between those receiving RUSF-based compared with CSB+-based rations in a cohort of HIV-infected adults on ART in rural Haiti.

HIV-free survival and morbidity among formula-fed infants in a prevention of mother-to-child transmission of HIV program in rural Haiti.

BACKGROUND: Partners In Health (PIH) works with the Ministry of Health to provide comprehensive health services in Haiti. Between 1994 and 2009, PIH recommended exclusive formula feeding in the prevention of mother-to-child transmission (PMTCT) of HIV program and provided support to implement this strategy. We conducted this study to assess HIV-free survival and prevalence of diarrhea and malnutrition among infants in our PMTCT program in rural Haiti where exclusive formula feeding was supported. METHODS: We reviewed medical charts of PMTCT mother-infant pairs at PIH between November 2004 and August 2006 through a retrospective longitudinal study and cross-sectional survey. We performed household surveys for each pair and at control households matched by infant's age and gender. RESULTS: 254 mother-infant pairs were included. 15.3% of infants were low birth weight; most births occurred at home (68.8%). 55.9% of households had no latrine; food insecurity was high (mean score of 18; scale 0-27, SD = 5.3). HIV-free survival at 18 months was 90.6%. Within the cohort, 9 children (3.5%) were HIV-infected and 17 (6.7%) died. Community controls were more likely to be breastfed (P = 0.003) and more likely to introduce food early (P = 0.003) than PMTCT-program households. There was no difference in moderate malnutrition (Z score ≤ 2 SD) between PMTCT and community groups after controlling for guardian's education, marital status, and food insecurity (OR = 1.05; 95% CI: 0.67, 1.64; P = 0.84). Diarrhea was 2.9 times more prevalent among community children than PMTCT infants (30.3% vs. 12.2%; P < 0.0001). CONCLUSIONS: In a PIH-supported program in rural Haiti that addressed socioeconomic barriers to ill-health, breast milk substitution was safe, acceptable and feasible for PMTCT for HIV-infected women choosing this option.

Mortality Over Long-term Follow-up for People With HIV Receiving Longitudinal Care and Antiretroviral Therapy in Rural Haiti.

BACKGROUND: Deaths from HIV have fallen dramatically with the increasing availability of fully suppressive antiretroviral therapy (ART), and yet HIV remains the ninth leading cause of death in low-income countries. As more people with HIV enter care and receive ART, the focus will need to shift from expanding ART to including long-term program effectiveness and outcomes for people with HIV already engaged in care. METHODS: We evaluated risk factors for mortality among people with HIV on ART receiving longitudinal care in rural Haiti. We assessed baseline characteristics using a household survey and abstracted clinical characteristics from the electronic record. We used multivariable Cox regression models to identify risk factors for mortality. RESULTS: There were 464 people included in this study with a median follow-up (interquartile range [IQR]) of 69 (44-77) months, during which time 37 (8%) were lost to follow-up and 118 (25%) died (median time to death [IQR], 29 [12-53] months). After adjustment, poverty (adjusted hazard ratio [AHR], 1.12 per 10-percentage point increased probability; 95% CI, 1.01-1.24) and single marital status (AHR, 1.59; 95% CI, 1.08-2.36) were associated with increased mortality. Age (AHR, 0.78 per 10-year increase; 95% CI, 0.64-0.94), role function quality of life (AHR, 0.75 per quintile increase; 95% CI, 0.62-0.90), and CD4 count (AHR, 0.66 per 100 cells/µL; 95% CI, 0.58-0.75) were associated with decreased mortality. CONCLUSIONS: Poverty, marital status, and quality of life were associated with mortality. Social protection should be evaluated as a strategy to reduce mortality for people with HIV in concert with increasing access to ART.

Bivalent oral cholera vaccination induces a memory B cell response to the V. cholerae O1-polysaccharide antigen in Haitian adults.

The bivalent killed whole-cell oral cholera vaccine (BivWC) is being increasingly used to prevent cholera. The presence of O-antigen-specific memory B cells (MBC) has been associated with protective immunity against cholera, yet MBC responses have not been evaluated after BivWC vaccination. To address this knowledge gap, we measured V. cholerae O1-antigen MBC responses following BivWC vaccination. Adults in St. Marc, Haiti, received 2 doses of the BivWC vaccine, Shanchol, two weeks apart. Participants were invited to return at days 7, 21, 44, 90, 180 and 360 after the initial vaccination. Serum antibody and MBC responses were assessed at each time-point before and following vaccination. We observed that vaccination with BivWC resulted in significant O-antigen specific MBC responses to both Ogawa and Inaba serotypes that were detected by day 21 and remained significantly elevated over baseline for up to 12 months following vaccination. The BivWC oral cholera vaccine induces durable MBC responses to the V. cholerae O1-antigen. This suggests that long-term protection observed following vaccination with BivWC could be mediated or maintained by MBC responses.

Long-term effectiveness of one and two doses of a killed, bivalent, whole-cell oral cholera vaccine in Haiti: an extended case-control study.

BACKGROUND: No study of long-term protection following killed oral cholera vaccination has been done outside of the historically cholera-endemic areas of south Asia, or has examined protection after a single-dose vaccination regimen. To address this, we examined the duration of protection of the standard two-dose regimen and an incomplete regimen of one dose up to 4 years after vaccination in Haiti. METHODS: In the setting of two-dose vaccination campaigns with a killed, bivalent, whole-cell oral cholera vaccination, we did a case-control study from October, 2012 through November, 2016. Eligible participants were required to be resident in the vaccine catchment area (Artibonite Department or Central Department) where they were recruited at the start of the study; and be eligible for the vaccination campaign (ie, aged ≥12 months, not pregnant, and living in the region at the time of the vaccine campaign). Patients with cholera had a positive stool culture and were recruited from cholera treatment centres. Community controls were matched to people with cholera by age group, time, and neighbourhood. We did adjusted matched regression analyses to calculate vaccine effectiveness and examine heterogeneity in effectiveness over time. The primary outcome was the effectiveness of one and two oral cholera doses as compared with zero doses from 2 months to 48 months after vaccination, measured by self reporting. FINDINGS: Among 178 people assigned to the case group and 706 people assigned to the control group, we found no evidence that two-dose effectiveness decreased during follow-up. In adjusted analyses, the average cumulative 4 year effectiveness for two doses was 76% (95% CI 59-86). In contrast, single-dose effectiveness decreased over time in a log-linear fashion, with a predicted vaccine effectiveness of 79% at the end of 12 months (95% CI 43-93), which declined to zero before the end of the second year. INTERPRETATION: In a setting of epidemic and newly endemic cholera in Haiti, single-dose vaccination with killed, bivalent, whole-cell oral cholera vaccination provided short-term protection; however, vaccination with two doses was required for long-term protection, which lasted up to 4 years after vaccination. These results add to the evidence in support of the use of killed, bivalent, whole-cell oral cholera vaccination as part of comprehensive cholera control plans. FUNDING: US National Institute of Allergy and Infectious Diseases of the National Institutes of Health and the Bill & Melinda Gates Foundation.

Comparison of two control groups for estimation of oral cholera vaccine effectiveness using a case-control study design.

BACKGROUND: Case-control studies to quantify oral cholera vaccine effectiveness (VE) often rely on neighbors without diarrhea as community controls. Test-negative controls can be easily recruited and may minimize bias due to differential health-seeking behavior and recall. We compared VE estimates derived from community and test-negative controls and conducted bias-indicator analyses to assess potential bias with community controls. METHODS: From October 2012 through November 2016, patients with acute watery diarrhea were recruited from cholera treatment centers in rural Haiti. Cholera cases had a positive stool culture. Non-cholera diarrhea cases (test-negative controls and non-cholera diarrhea cases for bias-indicator analyses) had a negative culture and rapid test. Up to four community controls were matched to diarrhea cases by age group, time, and neighborhood. RESULTS: Primary analyses included 181 cholera cases, 157 non-cholera diarrhea cases, 716 VE community controls and 625 bias-indicator community controls. VE for self-reported vaccination with two doses was consistent across the two control groups, with statistically significant VE estimates ranging from 72 to 74%. Sensitivity analyses revealed similar, though somewhat attenuated estimates for self-reported two dose VE. Bias-indicator estimates were consistently less than one, with VE estimates ranging from 19 to 43%, some of which were statistically significant. CONCLUSIONS: OCV estimates from case-control analyses using community and test-negative controls were similar. While bias-indicator analyses suggested possible over-estimation of VE estimates using community controls, test-negative analyses suggested this bias, if present, was minimal. Test-negative controls can be a valid low-cost and time-efficient alternative to community controls for OCV effectiveness estimation and may be especially relevant in emergency situations.

Effectiveness of reactive oral cholera vaccination in rural Haiti: a case-control study and bias-indicator analysis.

BACKGROUND: Between April and June, 2012, a reactive cholera vaccination campaign was done in Haiti with an oral inactivated bivalent whole-cell vaccine. We aimed to assess the effectiveness of the vaccine in a case-control study and to assess the likelihood of bias in that study in a bias-indicator study. METHODS: Residents of Bocozel or Grand Saline who were eligible for the vaccination campaign (ie, age ≥12 months, not pregnant, and living in the region at the time of the vaccine campaign) were included. In the primary case-control study, cases had acute watery diarrhoea, sought treatment at one of three participating cholera treatment units, and had a stool sample positive for cholera by culture. For each case, four control individuals who did not seek treatment for acute watery diarrhoea were matched by location of residence, enrolment time (within 2 weeks of the case), and age (1-4 years, 5-15 years, and >15 years). Cases in the bias-indicator study were individuals with acute watery diarrhoea with a negative stool sample for cholera. Controls were selected in the same manner as in the primary case-control study. Trained staff used standard laboratory procedures to do rapid tests and stool cultures from study cases. Participants were interviewed to collect data on sociodemographic characteristics, risk factors for cholera, and self-reported vaccination. Data were analysed by conditional logistic regression, adjusting for matching factors. FINDINGS: From Oct 24, 2012, to March 9, 2014, 114 eligible individuals presented with acute watery diarrhoea and were enrolled, 25 of whom were subsequently excluded. 47 participants were analysed as cases in the vaccine effectiveness case-control study and 42 as cases in the bias-indicator study. 33 (70%) of 47 cholera cases self-reported vaccination versus 167 (89%) of 188 controls (vaccine effectiveness 63%, 95% CI 8-85). 27 (57%) of 47 cases had certified vaccination versus 147 (78%) of 188 controls (vaccine effectiveness 58%, 13-80). Neither self-reported nor verified vaccination was significantly associated with non-cholera diarrhoea (vaccine effectiveness 18%, 95% CI -208 to 78 by self-report and -21%, -238 to 57 by verified vaccination). INTERPRETATION: Bivalent whole-cell oral cholera vaccine effectively protected against cholera in Haiti from 4 months to 24 months after vaccination. Vaccination is an important component of efforts to control cholera epidemics. FUNDING: National Institutes of Health, Delivering Oral Vaccines Effectively project, and Department of Global Health and Social Medicine at Harvard Medical School.

Immunogenicity of a killed bivalent (O1 and O139) whole cell oral cholera vaccine, Shanchol, in Haiti.

BACKGROUND: Studies of the immunogenicity of the killed bivalent whole cell oral cholera vaccine, Shanchol, have been performed in historically cholera-endemic areas of Asia. There is a need to assess the immunogenicity of the vaccine in Haiti and other populations without historical exposure to Vibrio cholerae. METHODOLOGY/PRINCIPAL FINDINGS: We measured immune responses after administration of Shanchol, in 25 adults, 51 older children (6-17 years), and 47 younger children (1-5 years) in Haiti, where cholera was introduced in 2010. A≥4-fold increase in vibriocidal antibody titer against V. cholerae O1 Ogawa was observed in 91% of adults, 74% of older children, and 73% of younger children after two doses of Shanchol; similar responses were observed against the Inaba serotype. A≥2-fold increase in serum O-antigen specific polysaccharide IgA antibody levels against V. cholerae O1 Ogawa was observed in 59% of adults, 45% of older children, and 61% of younger children; similar responses were observed against the Inaba serotype. We compared immune responses in Haitian individuals with age- and blood group-matched individuals from Bangladesh, a historically cholera-endemic area. The geometric mean vibriocidal titers after the first dose of vaccine were lower in Haitian than in Bangladeshi vaccinees. However, the mean vibriocidal titers did not differ between the two groups after the second dose of the vaccine. CONCLUSIONS/SIGNIFICANCE: A killed bivalent whole cell oral cholera vaccine, Shanchol, is highly immunogenic in Haitian adults and children. A two-dose regimen may be important in Haiti, and other populations lacking previous repeated exposures to V. cholerae.

Use of oral cholera vaccine in Haiti: a rural demonstration project.

A cholera epidemic has claimed the lives of more than 8,000 Haitians and sickened 650,000 since the outbreak began in October 2010. Early intervention in the epidemic focused on case-finding, treatment, and water and sanitation interventions for prevention of transmission. Use of oral cholera vaccine (OCV) as part of a complementary set of control activities was considered but initially rejected by policymakers. In December 2011, the Minister of Health of Haiti called for a demonstration of the acceptability and feasibility of the use of OCV in urban and rural Haiti. This paper describes the collaborative activity that offered OCV to one region of the Artibonite Department of rural Haiti in addition to other ongoing treatment and control measures. Despite logistics and cold chain challenges, 45,417 persons were successfully vaccinated with OCV in the region, and 90.8% of these persons completed their second dose.