Maternal and infant antiretroviral therapy adherence among women living with HIV in rural South Africa: a cluster randomised trial of the role of male partner participation on adherence and PMTCT uptake

‘Mother-to-child transmission of HIV’ can occur during the period of pregnancy, childbirth, or breastfeeding. ‘Prevention of mother-to-child transmission of HIV’ (PMTCT) in Mpumalanga Province, South Africa, is especially vital as the prevalence of HIV is 28.2% in women aged 15–49. PMTCT interventions resulted in a drop of MTCT rates in Mpumalanga from ∼2% in 2015 to 1.3% in 2016. This randomised controlled trial in Mpumalanga examined the potential impact of a lay healthcare worker administered intervention, ‘Protect Your Family’, on maternal and infant adherence, and to assess the relative influence of male partner involvement on infant and maternal adherence. This cluster randomised controlled trial used a two-phase and two-condition (experimental or control) study design where participants (n = 1399) did assessments both during pregnancy and post-postpartum. Only women participated in Phase 1, and both female and male partners participated in Phase 2. Results indicated that male involvement was associated with self-reported maternal or infant antiretroviral therapy (ART) adherence, but the intervention was not associated with ART adherence. Self-reported adherence was associated with depression, age, and partner HIV status. The study results provide support for the involvement of men in the antenatal clinic setting during pregnancy. Results also support further research on the meaning and assessment of male involvement and clarification of the constructs underlying the concept in the sub-Saharan African context. Outcomes provide support for male involvement and treatment of depression as adjuncts to improve uptake of both maternal and infant medication as part of the PMTCT protocol

Distribution of S. mutans and S. sorbinus in Caries Active and Caries Free Children by PCR Approach

Background: Streptococcus mutans (S. mutans) and Streptococcus sorbinus (S. sorbinus) have been considered to be the most important micro-organisms associated with dental caries. Therefore, purpose of this study is to detect and correlate the presence of S. mutans and S. sobrinus in the dental plaque of caries free and caries active children, by using Polymerase chain reaction (PCR) method.Materials and Methods: Twenty patients aged between ages 4-8 years were included in the study. The subjects were divided in two groups: Group A consisting of ten children with early childhood caries and Group B consisting of ten caries-free children. Dental examinations were performed using a plane dental mirror and explorer. Plaque sample was collected from the cervical margin of the teeth by using explorer. PCR testing was performed for S. mutans and S. sorbinus. The data was analyzed by using SPSS software. The caries score data was analyzed among groups by applying Fischer’s exact test. The P value &lt;0.05 was considered as significant.Results: S. mutans was present in all patients, whether they were caries active or caries free. There was no statistically significant difference in the presence of S. sorbinus in caries active patients as compared to caries free patients. It was also noticed that S. sorbinus was found more in male patients as compared to females, the difference being statistically non-significant.Conclusion: Children harbouring both S. mutans and S. sorbinus had a higher incidence of dental caries as compared to the presence of either organism alone.</p

Subversion of host immune responses by otopathogens during otitis media

Otitis media (OM) is one of the most common ear diseases affecting humans. Children are at greater risk and suffer most frequently from OM, which can cause serious deterioration in the quality of life. OM is generally classified into two main types: acute and chronic OM (AOM and COM). AOM is characterized by tympanic membrane swelling or otorrhea and is accompanied by signs or symptoms of ear infection. In COM, there is a tympanic membrane perforation and purulent discharge. The most common pathogens that cause AOM are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis whereas Pseudomonas aeruginosa and Staphylococcus aureus are commonly associated with COM. Innate and adaptive immune responses provide protection against OM. However, pathogens employ a wide arsenal of weapons to evade potent immune responses and these mechanisms likely contribute to AOM and COM. Immunologic evasion is multifactorial, and involves damage to host mucociliary tract, genetic polymorphisms within otopathogens, the number and variety of different otopathogens in the nasopharynx as well as the interaction between the host's innate and adaptive immune responses. Otopathogens utilize host mucin production, phase variation, biofilm production, glycans, as well as neutrophil and eosinophilic extracellular traps to induce OM. The objective of this review article is to discuss our current understanding about the mechanisms through which otopathogens escape host immunity to induce OM. A better knowledge about the molecular mechanisms leading to subversion of host immune responses will provide novel clues to develop effective treatment modalities for OM

Microbial otitis media: recent advancements in treatment, current challenges and opportunities

Otitis media (OM) is a common disease affecting humans, especially paediatric populations. OM refers to inflammation of the middle ear and can be broadly classified into two types, acute and chronic. Bacterial infection is one of the most common causes of OM. Despite the introduction of vaccines, the incidence of OM remains significantly high worldwide. In this mini-review article, we discuss the recent treatment modalities for OM, such as suspension gel, transcutaneous immunization, and intranasal and transtympanic drug delivery, including therapies that are currently undergoing clinical trials. We provide an overview of how these recent advancements in therapeutic strategies can facilitate the circumvention of current treatment challenges involving preadolescence soft palate dysfunction, biofilm formation, tympanic membrane (ear drum) barrier and the attainment of efficacious drug concentrations in the middle ear. While traditional first-line immunization strategies are generally not very efficacious against biofilms, new technologies that use transdermal or intranasal drug delivery via chitosan-PsaA nanoparticles have shown promising results in experimental animal models of OM. Sustained drug delivery systems such as penta-block copolymer poloxamer 407-polybutylphosphoester (P407-PBP) or poloxamer 407 (e.g. OTO-201, with the brand name 'OTIPRIO') have demonstrated that treatments can be reduced to a single topical application. The emergence of effective new treatment modalities opens up promising new avenues for the treatment of OM that could lead to improved quality of life for many children and their families

Blood Pressure, HIV, and Cocaine Use Among Ethnically and Racially Diverse Individuals

Racial minorities are at greater risk of cardiovascular disease (CVD), and CVD is the primary cause of mortality among human immunodeficiency virus (HIV)-infected individuals. Cocaine use also has been associated with hypertension. This study examined the contribution of lifestyle factors to systolic, diastolic, and mean arterial pressure (MAP) among people living with HIV and cocaine users from racially and ethnically diverse backgrounds. Participants (N = 401: 213 men, 188 women) aged 18 to 50 years with no history of CVD were recruited from South Florida. A total of 200 participants were HIV-cocaine-infected, 100 were HIV-infected individuals with no history of cocaine use, and 101 were HIV-uninfected individuals with cocaine abuse or dependence. Carotid intima-media thickness and plaque, blood pressure (BP), and lifestyle risk were assessed. Mean age was 36 years (standard deviation 9.33); the majority (62%) were African American. Carotid plaques were identified in 23% of participants; 42% were obese, 68% engaged in ≥150 minutes of weekly exercise, and 68% were smokers. Sex, body mass index (BMI), and diet were associated with systolic BP. Age, BMI, cannabis use, and diet were associated with diastolic BP and MAP. Age, BMI, cannabis use, and diet were associated with increased diastolic BP and MAP. Cocaine did not emerge as a significant predictor of CVD after controlling for cannabis dependence. Cocaine and HIV lacked significant association with CVD, possibly because the majority of the sample was younger than age 40. Lifestyle modifications and substance abuse counseling may be important in preventing CVD among those without a history of CVD

Implementing an HIV Test and Treat Rapid Response Anti Retroviral Initiation Program in a Southern City with High HIV Incidence

Abstract Background Early initiation of antiretroviral (ART) after HIV diagnosis (Test and Treat Rapid Response, TTRR) is safe and acceptable, shortens the time to virologic suppression, reduces HIV associated morbidity and mortality, and can potentially decrease HIV transmission. Miami Dade County is first in the US for HIV incidence. As with other cities in the South, barriers to routine HIV care result in delays in engagement in care. The average time from HIV diagnosis at the Florida Department of Health (FDOH) STD clinic in Miami to ART initiation is 60 days. The University of Miami, in collaboration with the FDOH, implemented a pilot HIV TTRR program in 2016 whose aim is to speed up the process from initial HIV diagnosis to initiation of ART. This study describes enrolled patients’ demographics and the time to ART initiation in the first year of implementation (March 2016–February 2017). Methods When an individual is diagnosed with HIV at the FDOH STD clinic, a TTRR team consisting of a Disease Intervention Specialist, Patient Navigator, Case Manager, and HIV Provider, is activated. This team ensures that: 1) a visit with an HIV provider occurs within 48 hours; 2) ART is prescribed as soon as possible (1–7 days from diagnosis); and 3) provision of ART and appropriate follow up occurs at the initial visit. Demographics, laboratory results, and time to ART were recorded and summarized Results In one year, 45 patients were enrolled (73% male, 27% female); 70% of male were MSM. A majority were foreign born (32% Cuba, 24% Haiti, 18% other Hispanic countries), and from ethnic minorities (53 % Hispanic, 30% African American). An HIV Provider evaluated 48% of the patients the same day of HIV diagnosis; 88% within 48 hours. The mean time to ART initiation was 6 days (37% same day, 69% <7 days). FTC/TAF/EVG/c was most frequently prescribed (91%). The mean viral load at initial presentation was 4.32 log10 (SD=1.1). The mean CD4 count was 463 cells/mm3 (SD=263); 20% had less than 200 cells/mm3. All but one patient came to the next consecutive appointment. Conclusion Implementation of a TTRR program is feasible in cities with recognized barriers to HIV care. TTRR programs should be essential components of HIV prevention efforts to control the spread of the HIV epidemic in the South. Funding from P30A1073961 and H97HA27433. Disclosures All authors: No reported disclosures

Maternal and infant antiretroviral therapy adherence among women living with HIV in rural South Africa: A cluster randomised trial of the role of male partner participation on adherence and PMTCT uptake

‘Mother-to-child transmission of HIV’ can occur during the period of pregnancy, childbirth, or breastfeeding. ‘Prevention of mother-to-child transmission of HIV’ (PMTCT) in Mpumalanga Province, South Africa, is especially vital as the prevalence of HIV is 28.2% in women aged 15–49. PMTCT interventions resulted in a drop of MTCT rates in Mpumalanga from ∼2% in 2015 to 1.3% in 2016. This randomised controlled trial in Mpumalanga examined the potential impact of a lay healthcare worker administered intervention, ‘Protect Your Family’, on maternal and infant adherence, and to assess the relative influence of male partner involvement on infant and maternal adherence. This cluster randomised controlled trial used a two-phase and two-condition (experimental or control) study design where participants (n = 1399) did assessments both during pregnancy and post-postpartum. Only women participated in Phase 1, and both female and male partners participated in Phase 2. Results indicated that male involvement was associated with self-reported maternal or infant antiretroviral therapy (ART) adherence, but the intervention was not associated with ART adherence. Self-reported adherence was associated with depression, age, and partner HIV status. The study results provide support for the involvement of men in the antenatal clinic setting during pregnancy. Results also support further research on the meaning and assessment of male involvement and clarification of the constructs underlying the concept in the sub-Saharan African context. Outcomes provide support for male involvement and treatment of depression as adjuncts to improve uptake of both maternal and infant medication as part of the PMTCT protocol

Psychological and physical intimate partner violence and sexual risk behavior among South African couples: a dyadic analysis

This study aimed to examine intimate partner violence (IPV) as it relates to both partners' perceptions of IPV and sexual behaviors, considering how their IPV might be interdependent within the relationship dynamics. The sample consisted of 713 female-male dyads in which women were pregnant and living with HIV in rural South Africa. Using an actor-partner interdependence model (APIM), we examined the interdependent influence of psychological and physical IPV on men by their female partners and psychological and physical IPV on women by their male partners on sexual risk behavior. The APIM model found there were no actor (b = −0.06, SE = 0.05, p = .221) or partner (b = −1.2, SE = 0.06, p = .056) effects contributing to protected sex by female IPV victimization. In contrast, significant actor (b = −0.28, SE = 0.06, p < .001) and partner (b = −0.29, SE = 0.06, p < .001) effects for protection were related to male IPV victimization. The model also found that the covariate of female HIV disclosure was associated with both male (b = 0.5, SE = 0.12, p < .001) and female protected sexual intercourse (b = 0.58, SE = 0.1, p < .001). Female HIV disclosure was related to an increased likelihood of protected sex by both male and female partners. As male partners reported more IPV victimization, the likelihood of protected sex between male and female partners decreased.Trial registration: ClinicalTrials.gov identifier: NCT02085356

A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa

Abstract Background We evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes. Methods In a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Africa, were randomized to have pregnant women living with HIV receive either: a standard care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n  = 357), or an enhanced intervention (EI) condition of SC PMTCT plus the “Protect Your Family” intervention (EI; 6 CHCs; n  = 342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions and those in the EI, four antenatal and two postnatal PMTCT plus “Protect Your Family” sessions led by trained lay health workers. Maternal PMTCT and HIV knowledge were assessed. Infant HIV status at 6 weeks postnatal was drawn from clinic PCR records; at 12 months, HIV status was assessed by study administered DNA PCR. Maternal adherence was assessed by dried blood spot at 32 weeks, and infant adherence was assessed by maternal report at 6 weeks. The impact of the EI was ascertained on primary outcomes (infant HIV status at 6 weeks and 12 months and ART adherence for mothers and infants), and secondary outcomes (HIV and PMTCT knowledge and HIV transmission related behaviours). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention on study outcomes. Results In all, 699 women living with HIV were recruited during pregnancy (8–24 weeks), and assessments were completed at baseline, at 32 weeks pregnant (61.7%), and at 6 weeks (47.6%), 6 months (50.6%) and 12 months (59.5%) postnatally. Infants were tested for HIV at 6 weeks and 12 months, 73.5% living infants were tested at 6 weeks and 56.7% at 12 months. There were no significant differences between SC and EI on infant HIV status at 6 weeks and at 12 months, and no differences in maternal adherence at 32 weeks, reported infant adherence at 6 weeks, or PMTCT and HIV knowledge by study condition over time. Conclusion The enhanced intervention administered by trained lay health workers did not have any salutary impact on HIV infant status, ART adherence, HIV and PMTCT knowledge. Trial registration clinicaltrials.gov: number NCT0208535

Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial

Abstract Background “Challenging” HIV-infected patients, those not retained in treatment, represent a critical focus for positive prevention, as linkage to care, early initiation of antiretroviral therapy, adherence and retention in treatment facilitate viral suppression, thus optimizing health and reducing HIV transmission. Argentina was one of the first Latin American countries to guarantee HIV prevention, diagnosis and comprehensive care services, including antiretroviral medication, which removed cost and access as barriers. Yet, dropout occurs at every stage of the HIV continuum. An estimated 110,000 individuals are HIV-infected in Argentina; of these, 70% have been diagnosed and 54% were linked to care. However, only 36% have achieved viral suppression and 31% of those diagnosed delayed entry to care. To achieve meaningful reductions in HIV infection at the community level, innovative strategies must be developed to re-engage patients. Motivational Interviewing (MI) is a patient-centered approach and has been used by therapists in Central and South America to enhance motivation and commitment in substance use and risk reduction. Our pilot feasibility study utilized culturally tailored MI in physicians to target patients not retained in treatment in public and private clinics in Buenos Aires, Argentina. Results demonstrated that a physician-based MI intervention was feasible and effective in enhanced and sustained patient adherence, viral suppression, and patient-physician communication and attitudes about treatment among these patients at 6 and 9 months post baseline. Methods/design This clinical trial seeks to extend these findings in public and private clinics in four urban population centers in Argentina, in which clinics (n = 6 clinics, six MDs per clinic site) are randomized to experimental (physician MI Intervention) (n = 3) or control (physician Standard of Care) (n = 3) conditions in a 3:3 ratio. Using a cluster randomized clinical trial design, the study will test the effectiveness of a physician-based MI intervention to improve and sustain retention, adherence, persistence, and viral suppression among “challenging” patients (n = 420) over 24 months. Discussion Results are anticipated to have significant public health implications for the implementation of MI to re-engage and retain patients in HIV treatment and care and improve viral suppression through high levels of medication adherence. Trial registration ClinicalTrials.gov, ID: NCT02846350. Registered on 1 July 2016