Using Implementation Mapping to increase uptake and use of Salud en Mis Manos: A breast and cervical cancer screening and HPV vaccination intervention for Latinas.

Background: Despite CDC recommendations for breast and cervical cancer screening and HPV vaccination, cancer control behaviors are underutilized among low-income Latinas. Salud en Mis Manos (SEMM), adapted from Cultivando La Salud, is a community health worker- (CHW-) delivered evidence-based intervention (EBI), shown to increase breast and cervical cancer screening. Methods: We used Implementation Mapping to create SEMM-Dissemination and Implementation Assistance (SEMM-DIA), a set of implementation strategies designed to support implementation and maintenance of SEMM in clinic settings. Specifically, we used Implementation Mapping's five iterative tasks to guide the use of theories and frameworks, evidence, new data, and stakeholder input to develop strategies to accelerate and improve implementation fidelity, reach, and maintenance of the SEMM intervention. The resulting implementation mapping logic model also guides the SEMM-DIA evaluation plan to assess reach, effectiveness, implementation, and maintenance. Discussion: Increased use of implementation planning frameworks is necessary to accelerate the translation of EBIs to public health practice. This work demonstrates the application of Implementation Mapping to develop SEMM-DIA, providing a model for the development of other implementation strategies to support translation of evidence-based health promotion interventions into clinic settings.

Qualitative Exploration of Family Influences on Physical Activity in Hispanic Families.

BACKGROUND: Limited information exists on how the family unit aids or impedes physical activity (PA) engagement within Hispanic populations. This qualitative study explored family-level influences on PA in dyads of adult Hispanic family members (eg, parent-adult child, siblings, spouses). METHODS: In-person interviews and brief surveys were conducted together with 20 dyads lasting 1.5 hours each. Two researchers coded and analyzed text using thematic analysis in NVivo (version 11.0). They resolved discrepancies through consensus and used matrix coding analysis to examine themes by participants' demographics. RESULTS: The participants were mainly women (70%), from Mexico (61.5%), and they reported low levels of acculturation (87.5%). Themed facilitators for PA included "verbal encouragement," "help with responsibilities," "exercising with someone," and "exercising to appease children." Themed challenges included "lack of support," "challenges posed by children," "sedentary behaviors," and "competing responsibilities." Women more so than men described family-level challenges and facilitators, and dyads where both study partners were physically active provided more positive partner interaction descriptions for PA support than other dyads. CONCLUSIONS: This study suggests that leveraging family support may be an important approach to promote and sustain PA, and that family-focused interventions should integrate communication-building strategies to facilitate family members' ability to solicit support from each other.

The novel tuberculosis vaccine, AERAS-402, induces robust and polyfunctional CD4+ and CD8+ T cells in adults.

RATIONALE: AERAS-402 is a novel tuberculosis vaccine designed to boost immunity primed by bacillus Calmette-Guérin (BCG), the only licensed vaccine. OBJECTIVES: We investigated the safety and immunogenicity of AERAS-402 in healthy Mycobacterium tuberculosis-uninfected BCG-vaccinated adults from a tuberculosis-endemic region of South Africa. METHODS: Escalating doses of AERAS-402 vaccine were administered intramuscularly to each of three groups of healthy South African BCG-vaccinated adults, and a fourth group received two injections of the maximal dose. Participants were monitored for 6 months, with all adverse effects documented. Vaccine-induced CD4(+) and CD8(+) T-cell immunity was characterized by an intracellular cytokine staining assay of whole blood and peripheral blood mononuclear cells. MEASUREMENTS AND MAIN RESULTS: AERAS-402 was well tolerated, and no vaccine-related serious adverse events were recorded. The vaccine induced a robust CD4(+) T-cell response dominated by cells coexpressing IFN-gamma, tumor necrosis factor-alpha, and IL-2 ("polyfunctional" cells). AERAS-402 also induced a potent CD8(+) T-cell response, characterized by cells expressing IFN-gamma and/or tumor necrosis factor-alpha, which persisted for the duration of the study. CONCLUSIONS: Vaccination with AERAS-402 is safe and immunogenic in healthy adults. The immunity induced by the vaccine appears promising: polyfunctional T cells are thought to be important for protection against intracellular pathogens such as Mycobacterium tuberculosis, and evidence is accumulating that CD8(+) T cells are also important. AERAS-402 induced a robust and durable CD8(+) T-cell response, which appears extremely promising. Clinical trial registered with www.sanctr.gov.za (NHREC no. 1381).

Non-clinical efficacy and safety of HyVac4:IC31 vaccine administered in a BCG prime-boost regimen.

Despite the extensive success with the introduction of M. bovis Bacille Calmette-Guérin (BCG), tuberculosis (TB) remains a major global epidemic infecting between 8 and 9 million people annually with an estimated 1.7 million deaths each year. However, because of its demonstrated effectiveness against some of the most severe forms of childhood TB, it is now realized that BCG vaccination of newborns is unlikely to be replaced. Therefore, BCG or an improved BCG will continue to be used as a prime TB vaccine and there is a need to develop effective boost vaccines that would enhance and prolong the protective immunity induced by BCG prime immunization. We report on a heterologous booster approach using two highly immunogenic TB antigens comprising Ag85B and TB10.4 (HyVac4) delivered as a fusion molecule and formulated in the proprietary adjuvant IC31. This vaccine was found to be immunogenic and demonstrated greater protection in the more stringent guinea pig model of pulmonary tuberculosis than BCG alone when used in a prime/boost regimen. Significant difference in lung involvement was observed for all animals in the HyVac4 boosted group compared to BCG alone regardless of time to death or sacrifice. A vaccine toxicology study of the HyVac4:IC31 regimen was performed and it was judged safe to advance the vaccine into clinical trials. Therefore, all non-clinical data supports the suitability of HyVac4 as a safe, immunogenic, and effective vaccination in a prime-boost regimen with BCG.

Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial.

OBJECTIVE: To compare the incidence of tuberculosis over two years in infants vaccinated at birth with intradermal BCG or with percutaneous BCG. DESIGN: Randomised trial. SETTING: South Africa. PARTICIPANTS: 11,680 newborn infants. INTERVENTIONS: Infants were randomised by week of birth to receive Tokyo 172 BCG vaccine through the percutaneous route (n=5775) or intradermal route (n=5905) within 24 hours of birth and followed up for two years. MAIN OUTCOME MEASURES: The primary outcome measure was documented Mycobacterium tuberculosis infection or radiological and clinical evidence of tuberculosis disease. Secondary outcome measures were rates of adverse events, all cause and tuberculosis specific admissions to hospital, and mortality. RESULTS: The difference in the cumulative incidence of definite, probable, and possible tuberculosis between the intradermal group and the percutaneous group, as defined using study definitions based on microbiological, radiological, and clinical findings was -0.36% (95.5% confidence interval -1.27% to 0.54%). No significant differences were found between the routes in the cumulative incidence of tuberculosis using a range of equivalence of "within 25%." Additionally, no significant differences were found between the routes in the cumulative incidence of adverse events (risk ratio 0.98, 95% confidence interval 0.91 to 1.06), including deaths (1.19, 0.89 to 1.58). CONCLUSION: Equivalence was found between intradermal BCG vaccine and percutaneous BCG in the incidence of tuberculosis in South African infants vaccinated at birth and followed up for two years. The World Health Organization should consider revising its policy of preferential intradermal vaccination to allow national immunisation programmes to choose percutaneous vaccination if that is more practical. Trial registration ClinicalTrials.gov NCT00242047.