Amynah Janmohamed

Human papillomavirus vaccine delivery strategies that achieved high coverage in low- and middle-income countries

OBJECTIVE To assess human papillomavirus (HPV) vaccination coverage after demonstration projects conducted in India, Peru, Uganda and Viet Nam by PATH and national governments and to explore the reasons for vaccine acceptance or refusal. METHODS Vaccines were delivered through schools or health centres or in combination with other health interventions, and either monthly or through campaigns at fixed time points. Using a two-stage cluster sample design, the authors selected households in demonstration project areas and interviewed over 7000 parents or guardians of adolescent girls to assess coverage and acceptability. They defined full vaccination as the receipt of all three vaccine doses and used an open-ended question to explore acceptability. FINDINGS Vaccination coverage in school-based programmes was 82.6% (95% confidence interval, CI: 79.3-85.6) in Peru, 88.9% (95% CI: 84.7-92.4) in 2009 in Uganda and 96.1% (95% CI: 93.0-97.8) in 2009 in Viet Nam. In India, a campaign approach achieved 77.2% (95% CI: 72.4-81.6) to 87.8% (95% CI: 84.3-91.3) coverage, whereas monthly delivery achieved 68.4% (95% CI: 63.4-73.4) to 83.3% (95% CI: 79.3-87.3) coverage. More than two thirds of respondents gave as reasons for accepting the HPV vaccine that: (i) it protects against cervical cancer; (ii) it prevents disease, or (iii) vaccines are good. Refusal was more often driven by programmatic considerations (e.g. school absenteeism) than by opposition to the vaccine. CONCLUSION High coverage with HPV vaccine among young adolescent girls was achieved through various delivery strategies in the developing countries studied. Reinforcing positive motivators for vaccine acceptance is likely to facilitate uptake.

Immunogenicity and Reactogenicity of Alternative Schedules of HPV Vaccine in Vietnam: A Cluster Randomized Noninferiority Trial

CONTEXT Human papillomavirus (HPV) vaccine programs may decrease the morbidity and mortality due to cervical cancer seen among women in low-resource countries. However, the 3-dose schedule over a 6-month period is a potential barrier to vaccine introduction in such settings. OBJECTIVE To determine the immunogenicity and reactogenicity of different dosing schedules of quadrivalent HPV vaccine in adolescent girls in Vietnam. DESIGN, SETTING, AND PARTICIPANTS Open-label, cluster randomized, noninferiority study (conducted between October 2007 and January 2010) assessing 4 schedules of an HPV vaccine delivered in 21 schools to 903 adolescent girls (aged 11-13 years at enrollment) living in northwestern Vietnam. INTERVENTION Intramuscular injection of 3 doses of quadrivalent HPV vaccine delivered on a standard dosing schedule (at 0, 2, and 6 months) and 3 alternative dosing schedules (at 0, 3, and 9 months; at 0, 6, and 12 months; or at 0, 12, and 24 months). MAIN OUTCOME MEASURES Serum anti-HPV geometric mean titers (GMT) measured 1 month after the third dose of the HPV vaccine was administered; GMT was determined by type-specific competitive immunoassay. Noninferiority of each alternative vaccination dosing schedule was achieved if the lower bound of the multiplicity-adjusted confidence interval (CI) of the type-specific GMT ratio for HPV-16 and HPV-18 was greater than 0.5 (primary outcome). Safety outcomes were immediate reactions, local reactions, fever within 7 days after each dose, and serious adverse events up to 30 days following the last dose. RESULTS In the intention-to-treat analysis, 809 girls who received at least 1 HPV vaccine dose had valid serum measurements 1 month after the third dose. After the third dose, the GMTs for those in the standard schedule group who received doses at 0, 2, and 6 months were 5808.0 (95% CI, 4961.4-6799.0) for HPV-16 and 1729.9 (95% CI, 1504.0-1989.7) for HPV-18; 5368.5 (95% CI, 4632.4-6221.5) and 1502.3 (95% CI, 1302.1-1733.2), respectively, for those whose received doses at 0, 3, and 9 months; 5716.4 (95% CI, 4876.7-6700.6) and 1581.5 (95% CI, 1363.4-1834.6), respectively, for those who received doses at 0, 6, and 12 months; and 3692.5 (95% CI, 3145.3-4334.9) and 1335.7 (95% CI, 1191.6-1497.3), respectively, for those who received doses at 0, 12, and 24 months. Noninferiority criteria were met for the alternative schedule groups that received doses at 0, 3, and 9 months (HPV-16 GMT ratio: 0.92 [95% CI, 0.71-1.20]; HPV-18 GMT ratio: 0.87 [95% CI, 0.68-1.11]) and at 0, 6, and 12 months (HPV-16 GMT ratio: 0.98 [95% CI, 0.75-1.29]; HPV-18 GMT ratio: 0.91 [95% CI, 0.71-1.17]). Prespecified noninferiority criteria were not met for the alternative schedule group that received doses at 0, 12, and 24 months (HPV-16 GMT ratio: 0.64 [95% CI, 0.48-0.84]; HPV-18 GMT ratio: 0.77 [95% CI, 0.62-0.96]). Pain at the injection site was the most common adverse event. CONCLUSIONS Among adolescent girls in Vietnam, administration of the HPV vaccine on standard and alternative schedules was immunogenic and well tolerated. The use of 2 alternative dosing schedules (at 0, 3, and 9 months and at 0, 6, and 12 months) compared with a standard schedule (at 0, 2, and 6 months) did not result in inferior antibody concentrations. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00524745.

Strategies to vaccinate against cancer of the cervix: feasibility of a school-based HPV vaccination program in Peru.

Operational research using a mixed method, cross-sectional, case-study approach assessed the feasibility and health system impact of large-scale implementation of human papillomavirus (HPV) vaccination into routine vaccine delivery by the Ministry of Health in Peru. The strategy was school-based vaccination of fifth grade girls in 527 primary schools in Piura region. Our evaluation showed that school-based HPV vaccination is feasible without major changes in existing health systems. This was reflected in the opinions of health personnel, the lack of impact on other vaccine coverage, and the high HPV vaccine coverage documented in routine records and by an independent community-based survey.

An Approach to Formative Research in HPV Vaccine Introduction Planning in Low-Resource Settings

Introduction: Formative research can inform country-level HPV vaccine delivery strategies, communication messages, and advocacy plans. This paper describes our formative researchs conceptual framework; details our applied methodology; summarizes our field experience and challenges; and outlines best practices for formative research in vac- cine introduction. Methods: From 2006-2008, literature reviews, stakeholder mapping, sociocultural studies, health system assessments, and policy reviews were conducted. Data collection at individual, interpersonal, community, institutional, and policy levels in- cluded in-depth interviews, focus groups, surveys, observations, secondary data, and facility audits. Data were analyzed thematically using an iterative process. Discussion: Integrated formative research can be implemented in low-resource settings, but may require overcoming op- erational challenges. Best practices in applied formative research include a conceptual framework, multidisciplinary ap- proach, and rapid dissemination of results.

Evaluation of two methods to measure hemoglobin concentration among women with genetic hemoglobin disorders in Cambodia: a method-comparison study.

BACKGROUND Genetic hemoglobin (Hb) E variants are common in Cambodia and result in an altered and unstable Hb molecule. We evaluated two methods to measure Hb concentration among individuals with and without Hb variants using a hemoglobinometer (HemoCue) and a hematology analyzer (Sysmex XT-1800i). METHODS We determined the bias and concordance between the methods among 420 Cambodian women (18-45 y). RESULTS Bias and concordance appeared similar between methods among women with no Hb disorders (n=195, bias=2.5, ρc=0.68), women with Hb E variants (n=133, bias=2.5, ρc=0.78), and women with other Hb variants (n=92, bias=2.7, ρc=0.73). The overall bias was 2.6g/l, resulting in a difference in anemia prevalence of 11.5% (41% using HemoCue and 29.5% using Sysmex, p<0.001). Based on visual interpretation of the concordance plots, the HemoCue device appears to underestimate Hb concentrations at lower Hb concentrations and to overestimate Hb concentrations at higher Hb concentrations (in comparison to the Sysmex analyzer). CONCLUSIONS Bias and concordance were similar across groups, suggesting the two methods of Hb measurement were comparable. We caution field staff, researchers and policy makers in the interpretation of data and the impact that bias between methods can have on anemia prevalence rates.

Performance of cryotherapy devices using nitrous oxide and carbon dioxide

To compare temperatures reached by 4 different cryotherapy devices commonly used to treat precancerous cervical lesions in low‐resource countries using nitrous oxide (N2O) and carbon dioxide (CO2) as well as with and without a gas conditioner.

Effect of the “cough technique” on cryotherapy freezing temperature

To assess the impact of the cough technique on the tip temperature reached in a cryotherapy device commonly used to treat precancerous cervical lesions.

Comparison of administrative and survey data for estimating vitamin A supplementation and deworming coverage of children under five years of age in sub-Saharan Africa

To compare administrative coverage data with results from household coverage surveys for vitamin A supplementation (VAS) and deworming campaigns conducted during 2010–2015 in 12 African countries.

Factors affecting the acceptability and consumption of Corn Soya Blend Plus as a prenatal dietary supplement among pregnant women in rural Cambodia.

OBJECTIVE Undernutrition is prevalent among pregnant women in Cambodia. The provision of fortified dietary supplements is one strategy to help pregnant women meet their nutritional needs. Corn Soya Blend Plus (CSBP) is a widely used prenatal dietary supplement in areas with high rates of undernutrition and food insecurity. However, little is known about its acceptability during pregnancy. The present study aimed to identify factors that affected the acceptability and consumption of CSBP supplements among pregnant women. DESIGN Women completed a structured interview designed to provide information on facilitators of and barriers to utilization. In addition, six focus groups were conducted with a subset of women (n 70) to further explore attitudes, perceptions and experiences related to CSBP use. SETTING Two districts in Kampong Chhnang Province, Cambodia. SUBJECTS Pregnant women (n 288) participating in a cluster-randomized trial of CSBP. RESULTS The acceptability of CSBP was influenced by sensory attributes, family support, peer influences, and attitudes related to diet, nutritional status and weight gain in pregnancy. Attaining adequate nutrition was considered less important than other concerns during pregnancy, particularly anxiety related to the costs of delivery and postpartum care. Acceptance was lower among new mothers due to fears of weight gain. Health benefits were common reasons for continued use and minor side-effects, such as nausea, were not major barriers to consumption. CONCLUSIONS CSBP was generally well accepted in this population. However, organoleptic factors and perceptions regarding nutrition and weight gain in pregnancy, particularly for first-time mothers, were barriers to increasing acceptance among Cambodian women.

Determinants of successful vitamin A supplementation coverage among children aged 6–59 months in thirteen sub-Saharan African countries

OBJECTIVE Vitamin A supplementation (VAS) for children aged 6-59 months occurs regularly in most sub-Saharan African countries. The present study aimed to explore child, household and delivery platform factors associated with VAS coverage and identify barriers to compliance in thirteen African countries. DESIGN We pooled data (n ~60 000) from forty-four household coverage surveys and used bivariate and multivariable regression analyses to assess the effects of supplementation strategy, rural v. urban residence, child sex, child age, caregiver education and campaign awareness on child VAS status. Setting/Subjects Primary caregivers of children aged 6-59 months in thirteen countries. RESULTS Door-to-door distribution resulted in higher VAS coverage than fixed-site plus outreach approaches (91 v. 63 %) and was a significant predictor of supplementation in the adjusted model (OR=19·0; 95 % CI 17·2, 21·1; P<0·001). Having been informed about the campaign was the main predictor of VAS in the door-to-door (OR=6·8; 95 % CI 5·8, 7·9; P<0·001) and fixed-site plus outreach (OR=72·5; 95 % CI 66·6, 78·8; P<0·001) groups. CONCLUSIONS Door-to-door provision of VAS may achieve higher coverage than fixed-site models in the African context. However, the phase-out of door-to-door polio immunization campaigns in most sub-Saharan African countries threatens the main distribution vehicle for VAS. Our findings suggest well-informed communities are key to attaining higher coverage using fixed-site delivery alternatives.