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South Africa has one of the highest child mortality and stunting rates in the world. Flexible geoadditive models were used to investigate the geospatial variations in child mortality and stunting in South Africa. We used consecutive rounds of national surveys (2008-2017). The child mortality declined from 31 % to 24 % over time. Lack of medical insurance, black ethnicity, low-socioeconomic conditions, and poor housing conditions were identified as the most significant correlates of child mortality. The model predicted degrees of freedom which was estimated as 19.55 (p < 0.001), provided compelling evidence for sub-geographical level variations in child mortality which ranged from 6 % to 35 % across the country. Population level impact of the distal characteristics on child mortality and stunting exceeded that of other risk factors. Geospatial analysis can help in monitoring trends in child mortality over time and in evaluating the impact of health interventions.
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Mortalidad del Niño , Trastornos del Crecimiento , Humanos , Sudáfrica/epidemiología , Mortalidad del Niño/tendencias , Trastornos del Crecimiento/epidemiología , Trastornos del Crecimiento/mortalidad , Preescolar , Masculino , Lactante , Femenino , Factores de Riesgo , Factores Socioeconómicos , Niño , Análisis Espacio-Temporal , Recién Nacido , Análisis EspacialRESUMEN
BACKGROUND: South African women have the highest burden of HIV infections globally. We investigated the temporal trends and the impact of key factors associated with HIV diagnosis among a nationally representative cohort of South African women. METHODS: Total of 24,657 women who participated in the National HIV, Behaviour and Health Surveys conducted from 2002-to-2017. RESULTS: Despite decades-long prevention efforts, we observed a significant increase in HIV prevalence over time (22% in 2002 to 21% in 2005-2008 and 29% in 2012-2017). Overall, 46% of the women living with HIV were not aware of their risk of HIV with age-specific disparities. Our findings revealed compelling evidence between HIV seropositivity and high HIV risk-perception (adjusted Odds Ratio (aOR):1.47 to 3.29) which increased overtime and exceeded the other factors. At a population-level, 45% of the HIV diagnoses were exclusively associated with women who believed they were at risk of HIV in 2012-2017. Women who reported using condoms at last sexual act were also at increased risk of HIV infection, with a population attributable risk of 18% (2002) to 21% (2012-2017). CONCLUSION: There is an urgent need for culturally, socially, and linguistically appropriate prevention and awareness campaigns with realistic, non-confrontational messages.
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Infecciones por VIH , Conocimientos, Actitudes y Práctica en Salud , Humanos , Femenino , Sudáfrica/epidemiología , Infecciones por VIH/epidemiología , Infecciones por VIH/diagnóstico , Infecciones por VIH/psicología , Adulto , Prevalencia , Persona de Mediana Edad , Adolescente , Adulto Joven , Conducta Sexual/estadística & datos numéricos , Factores de Riesgo , Condones/estadística & datos numéricos , Encuestas Epidemiológicas , PercepciónRESUMEN
More than 140 million children under five suffered from stunting in 2020. This highlights the ongoing challenge of addressing childhood malnutrition globally. We utilized data from a nationally representative sample of children under five years of age (n = 14,151) who participated in five cycles of the South African National Income Dynamics Study (SA-NIDS) (2008-2017). We estimated the proportion of stunted children attributed to the mothers' anthropometric characteristics and socioeconomic conditions. We also quantified the population-level burden of low-socioeconomic conditions on hunger/food insecurity among pregnant women (n = 22,814) who participated in the nine rounds of the South African General Household Surveys (GHS) (2008-2021). Results from weighted-multivariate logistic regression were incorporated into the population-level impacts of correlates of stunting and low-socioeconomic conditions. The prevalence of stunting declined from 25% in 2008 to 23% in 2017. Mothers' anthropometric measures (underweight/height < 160 cm), marital status, low education, absence of medical insurance and low-socioeconomic conditions were all identified as the most influential risk factors for stunting. Their population-level impacts on stunting increased substantially from 34% (in 2008) to 65% (in 2017). Comprehensive strategies emphasizing enhanced food security, extended breastfeeding, appropriate nutrition, and access to adequate healthcare and education are urgently needed to reduce the burden of food insecurity low-socioeconomic, malnutrition, and its long-term consequences.
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Trastornos del Crecimiento , Madres , Factores Socioeconómicos , Humanos , Trastornos del Crecimiento/epidemiología , Trastornos del Crecimiento/prevención & control , Sudáfrica/epidemiología , Femenino , Preescolar , Lactante , Masculino , Madres/estadística & datos numéricos , Inseguridad Alimentaria , Adulto , Prevalencia , Embarazo , Factores de Riesgo , Pobreza/estadística & datos numéricosRESUMEN
Open-Label Extension (OLE) studies are important in the drug development process and are used to further support the licensing applications and regulatory approvals of products. We aimed to understand why women chose to join the HOPE OLE study - where women were offered the dapivirine vaginal ring after two pivotal trials were completed - through data collected from individual in-depth interviews. Ten women at each of the six HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled (n = 60). Access to an effective user-initiated HIV prevention product was one of the main reasons women joined HOPE. Although many participants worried that their male partners might expose them to HIV, they chose to remain in their relationships and avoid conflict or confrontation with their partners by discreetly using the ring to protect themselves. Other reasons for joining were quality healthcare, reimbursement and altruism. Researchers should better understand social and personal motivators behind research participation in order to recognize community sociocultural norms and its influences on product acceptability and adherence challenges.
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Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Pirimidinas , Humanos , Masculino , Femenino , Sudáfrica , Motivación , Uganda , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéuticoRESUMEN
Background: Optimal adherence to antiretroviral therapy (ART) is crucial for the effective management of HIV. Mental disorders often co-occur with HIV infection which often compromises ART adherence. Little is known about ART adherence in psychiatric settings in sub-Saharan Africa.Aims: This study aimed at exploring the health care providers' perspectives on ART adherence among psychiatric inpatients. The study further assessed the facilitators and strategies enhancing ART adherence in hospitalised psychiatric patients.Methods: In-depth interviews were conducted with 25 health care providers at the Sbrana Psychiatric Hospital in Botswana. Interviews were focused on barriers and facilitators to psychiatric inpatients' adherence to ART, and strategies and recommendations to support adherence. Data were manually analysed using a thematic analysis approach.Results: Key barriers were lack of insight, HIV-related stigma, lack of HIV-related knowledge, antiretroviral side effects and delays in re-initiating ART. Facilitators of ART adherence included motivation to be discharged from the hospital, fear of being sick, peer support, longer duration of hospitalisation, good provider-patient relationships, good diet, privacy and confidentiality and a single-tablet regimen. Health care providers described the various strategies currently used to support adherence, including directly observed therapy and family support, and recommended potential approaches to enhance psychiatric inpatient adherence to ART, including the use of injectable antiretrovirals and the introduction of halfway house centres.Conclusions: Findings from this study revealed unique insights into the numerous factors that influence ART adherence among psychiatric inpatients, and underscore the need to implement tailored strategies to support ART adherence in this population with complex health needs.
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Infecciones por VIH , Humanos , Infecciones por VIH/epidemiología , Pacientes Internos , Cumplimiento de la Medicación/psicología , Botswana , Investigación Cualitativa , Antirretrovirales/uso terapéuticoRESUMEN
Background: The high prevalence of HIV among psychiatric inpatients is well-documented, yet little is known about the provision of HIV services for these patients. Aim: This qualitative study aimed to explore and understand healthcare providers' challenges with providing HIV services to psychiatric inpatients. Setting: This study was conducted at the national psychiatric referral hospital in Botswana. Methods: The authors conducted in-depth interviews with 25 healthcare providers serving HIV-positive psychiatric inpatients. Data analysis was performed using a thematic analysis approach. Results: Healthcare providers reported challenges with transporting patients to access off-site HIV services, longer waiting periods for antiretroviral therapy (ART) initiation, patient confidentiality, fragmented services for treatment of comorbidities, and a lack of patient data integration between the national psychiatric referral hospital and other facilities such as the Infectious Diseases Care Clinic (IDCC) at the nearby district hospital. Providers' recommendations for addressing these challenges included the establishment of an IDCC at the national psychiatric referral hospital, connecting the psychiatric facility to the patient data management system to ensure integration of patient data, and provision of HIV-related in-service training to nurses. Conclusion: Psychiatric healthcare providers advocated for on-site integration of care for psychiatric illness and HIV among inpatients to address the challenges of ART provision. Contribution: The findings suggest the need to improve the provision of HIV services in the psychiatric hospitals in order to ensure better outcomes for this often-overlooked population. These findings are useful in improving clinical practice for HIV in psychiatric settings.
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INTRODUCTION: South Africa has the highest obesity and hypertension rates in the African region. In this cross-sectional study, we aimed to quantify the correlates and burden of obesity and their impacts on cardiometabolic conditions. METHODS: The study population was 80,270 men(41 %) and women(59 %) who participated in South African national surveys (2008-to-2017). Weighted-logistic regression models and the population attributable risk (PAR %) were used after accounting for the correlation structure of the risk factors in a multifactorial setting. RESULTS: Overall, 63 % of the women and 28 % of the men were either overweight or obese. Parity was identified as the most influential factor and exclusively associated with 62 % of the obesity in women; being married/cohabiting had the highest impact on obesity in men and associated with 37 % of the obesity. Overall, 69 % of them had comorbidities including hypertension, diabetes and heart disease. More than 40 % of the comorbidities were attributed to overweight/obesity. CONCLUSION: Developing culturally appropriate prevention programs are urgently needed to raise awareness of obesity, hypertension and their impacts on severe cardiometabolic diseases. This approach would also significantly reduce COVID-19 related poor health outcomes and premature deaths.
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COVID-19 , Hipertensión , Masculino , Humanos , Femenino , Sobrepeso/epidemiología , Sudáfrica/epidemiología , Estudios Transversales , Obesidad/complicaciones , Obesidad/epidemiología , Factores de Riesgo , Hipertensión/epidemiología , PrevalenciaRESUMEN
After decades of research, South African women continue to have the highest burden of HIV in the world. The aim of the study is to investigate the impact of marital status on HIV using population and community-level data sources. We included data 13,469 and 5682 South African women who participated to South African HIV behavioural surveys in 2002-2012 and 2017, respectively. HIV prevalence and incidence rates were significantly higher among single/not-cohabiting women compared to those married/cohabiting with a partner in all survey participants (adjusted odds ratio (aOR): 1.60 and 1.58 in 2002-2012 and 2017, respectively). A quarter of the HIV diagnoses were attributed to those who were single/not-cohabiting women (population attributable risk (PAR%): 25% and 24%, respectively). More than 40% of the HIV infections were exclusively associated with single women (PAR%: 42%, 95% CI: 33%, 51%). Our results provided strong evidence for the profound impact of marital status on excess HIV infection rates. Targeting and reaching single/not-cohabiting women with multiple risk factors can potentially play a crucial role in the trajectories of the epidemic.
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Infecciones por VIH , Humanos , Femenino , Infecciones por VIH/epidemiología , Sudáfrica/epidemiología , Estado Civil , Factores de Riesgo , Encuestas y Cuestionarios , PrevalenciaRESUMEN
BACKGROUND: The dapivirine vaginal ring ("the ring") reduced HIV acquisition by about 35% in phase III trials, with modeling from open-label extension trials estimating 50% HIV protection with consistent use. The ring may be used without male partner knowledge. The Assessment of ASPIRE and HOPE Adherence (AHA) substudy aimed to understand the impact of sociocontextual issues on ring adherence. This subanalysis provides insight into disclosure and male partner influence on ring acceptability. METHODS: Data were collected using 4 focus group discussions with 18 male partners of phase III trial participants at 2 sites in KwaZulu-Natal, South Africa. Qualitative data were coded, summarized by urban vs. rural location, and analyzed thematically. RESULTS: Male partners aged 23-49 years wanted to be informed about the ring use to maintain the trust in their relationships. Their initial response to the ring was characterized by fear due to perceived impact of the ring on their female partner's reproductive system, their penile safety, and that the ring would encourage women to engage in unprotected sex and infidelity. Over time and with information and experience with having a partner who had used the vaginal ring, this fear transformed to support for women to have their own HIV prevention option. CONCLUSION: Male partners supported the ring as an HIV prevention method for women but wanted to be informed about its use. Engaging male partners on female-initiated HIV prevention methods and increased education among rural men may contribute to improved partner support and facilitate women's consistent use.
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Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Adulto , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Fármacos Anti-VIH/uso terapéutico , Ensayos Clínicos Fase III como Asunto , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Estudios Multicéntricos como Asunto , Pirimidinas , SudáfricaRESUMEN
South Africa also has the highest burden of coronavirus disease 2019 (COVID-19) related comorbidities in Africa. We aimed to quantify the temporal and geospatial changes in unemployment, food insecurity, and their combined impact on depressive symptoms among South Africans who participated into several rounds of national surveys. We estimated the population-attributable risk percent (PAR%) for the combinations of the risk factors after accounting for their correlation structure in multifactorial setting. Our study provided compelling evidence for immediate and severe effect of the pandemic where 60% of South Africans reported household food insecurity or household hunger, shortly after the pandemic emerged in 2020. Despite the grants provided by the government, these factors were also identified as the most influential risk factors (adjusted odds ratios (aORs) ranged from 2.06 to 3.10, p < 0.001) for depressive symptoms and collectively associated with 62% and 53% of the mental health symptoms in men and women, respectively. Similar pattern was observed among pregnant women and 41% of the depressive symptoms were exclusively associated with those who reported household hunger. However, aORs associated with the concerns around pandemic and vaccine were mostly not significant and ranged from 1.12 to 1.26 which resulted substantially lower impacts on depressive symptoms (PAR%:7%-and-14%). Our findings suggest that South Africa still has unacceptably high rates of hunger which is accelerated during the pandemic. These results may have significant clinical and epidemiological implications and may also bring partial explanation for the low vaccine coverage in the country, as priorities and concerns are skewed towards economic concerns and food insecurity.
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INTRODUCTION: There is compelling evidence of significant country-level disparities where African countries, particularly South Africa, have the highest hypertension rates in the world. AIM: To develop and validate a simple risk scoring algorithm for hypertension in a large cohort (80,270) of South African men and women. METHODS: Multivariable logistic regression models were used to build our hypertension risk scoring algorithm and validated externally and internally using the standard statistical techniques. We also compared our risk scores with the results from the Framingham risk prediction model for hypertension. RESULTS: Six factors were identified as the significant correlates of hypertension: age, education, obesity, smoking, alcohol intake and exercise. A score of ≥ 25 (out of 57) for men and ≥ 35 (out of 75) for women were selected as the optimum cut-points with 82% (43%) and 83% (49%) sensitivity (specificity) for males and females, respectively in the development datasets. We estimated probabilities of developing hypertension using the Framingham risk prediction model, which were higher among those with higher scores for hypertension. CONCLUSIONS: Identifying, targeting and prioritising individuals at highest risk of hypertension will have significant impact on preventing severe cardiometabolic diseases by scaling up healthy diet and life-style factors. Our six-item risk scoring algorithm may be included as part of hypertension prevention and treatment programs by targeting older individuals with high body fat measurements who are at highest risk of developing hypertension.
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Hipertensión , Algoritmos , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/epidemiología , Masculino , Obesidad/diagnóstico , Obesidad/epidemiología , Prevalencia , Factores de Riesgo , Sudáfrica/epidemiologíaRESUMEN
South Africa has one of the world's highest proportions of hypertensive individuals, which has become a major public health problem. Understanding the temporal and spatial patterns in hypertension rates is crucial for evaluating the existing prevention and care models, which have not been fully understood in South Africa. The geoadditive models were used to quantify the geographical clustering of hypertension in the Black South African population enrolled in the most recent cross-sectional national surveys (2008-2017). Population-attributable risks were calculated for modifiable risk factors. 80,270 men (41%) and women (59%) aged 15+ were included. Using the 2017 guidelines, 52% of the men and 51% of the women were classified as hypertensive. As expected, these proportions were slightly lower when we used the previous guidelines (48% and 47% for men and women, respectively). There was significant geospatial heterogeneity in hypertension prevalence with substantial province-specific disparities. Western, Northern, and Eastern Capes were the most significant provinces, with >50% of the hypertensive men and women. The population-level impact of obesity remained high in all provinces, where 33%-to-57% and 47%-to-65% of hypertensives were exclusively associated with obese/overweight men and women respectively. Despite some improvements in certain areas, most of the country is behind the targeted levels set in 2011/2013. Identifying the most relevant risk factors and their sub-geographical-level contributions to hypertension may have significant public health implications for developing and implementing cost-effective prevention programs to raise awareness of healthy diet and lifestyle behaviours.
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Hipertensión , Estudios Transversales , Femenino , Humanos , Hipertensión/epidemiología , Estilo de Vida , Masculino , Obesidad/epidemiología , Prevalencia , Factores de RiesgoRESUMEN
Women account for a disproportionate percentage of new HIV infections in sub-Saharan Africa indicating a need for female-initiated HIV prevention options congruent with their lifestyles. The dapivirine vaginal ring for HIV prevention is one such option. We explored the interest of women, who used this ring during the Microbicide Trials Network's ASPIRE and HOPE studies, in using the ring post-licensure and what they perceived as important considerations for future use. We also explored perspectives of HOPE participants' male partners on their involvement in their partners' future ring use. Women appeared keen to use the ring in the future and expressed desires for easy access, support for both ongoing and new users and intense community engagement. In parallel, male partners indicated high levels of interest in supporting their partners' ring use and being involved in ring use decision making. These data offer important insights for ring rollout planning and engagement activities.
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Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , Masculino , Pirimidinas/uso terapéuticoRESUMEN
As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3 months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential.
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Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , PirimidinasRESUMEN
Body mapping methods are used in sexual and reproductive health studies to encourage candid discussion of sex and sexuality, pleasure and pain, sickness and health, and to understand individuals' perceptions of their bodies. VOICE-D, a qualitative follow-up study to the VOICE trial, developed and used a body map tool in the context of individual in-depth interviews with women in South Africa, Uganda, and Zimbabwe. The tool showed the outline of a nude female figure from the front and back perspective. We asked women to identify, label, and discuss genitalia and other body parts associated with sexual behaviors, pain, and pleasure. Respondents could indicate body parts without having to verbalize potentially embarrassing anatomical terms, enabling interviewers to clarify ambiguous terminology that may have otherwise been open to misinterpretation. Body maps provided women with a non-intimidating way of discussing and disclosing their sexual practices, and minimized miscommunication of anatomical and behavioral terminology.
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After several decades of research, South Africa is still considered to be the epicentre of HIV epidemic. The country also has the highest burden of sexually transmitted infections (STIs) which have been frequently linked to increasing rates of HIV transmission due to biological and behavioural associations between these two pathogeneses. We investigated the cumulative impact of recurrent STIs on subsequent HIV seroconversion among a cohort of South African women. We used the 'frailty' models which can account for the heterogeneity due to the recurrent STIs in a longitudinal setting. The lowest HIV incidence rate was 5.0/100 person-year among women who had no baseline STI and remained negative during the follow-up. This estimate was three times higher among those who had recurrent STIs in the follow-up period regardless of their STI status at baseline (15.8 and 14.0/100 person-year for women with and without STI diagnosis at baseline, respectively). Besides younger age and certain partnership characteristics, our data provided compelling evidence for the impact of recurrent STI. diagnoses on increasing rates of HIV. At the population-level, 65% of HIV infections collectively associated with recurrent STIs. These results have significant clinical and epidemiological implications and may play critical role in the trajectory of the infections in the region.
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Fragilidad , Infecciones por VIH , Seropositividad para VIH , Enfermedades de Transmisión Sexual , Femenino , Infecciones por VIH/epidemiología , Humanos , Incidencia , Seroconversión , Enfermedades de Transmisión Sexual/epidemiologíaRESUMEN
The dapivirine vaginal ring has been well-tolerated and shown to prevent HIV in clinical trials. The ring is female initiated, yet endorsement for use is sought from male partners in many relationships. In clinical studies, participants have expressed worries about men detecting rings during vaginal sex, which introduces concerns about product use disclosure, sexual pleasure, penile harm, inter-partner dynamics, and ring removals. This study reports African men's firsthand sexual experiences with the ring. Qualitative data were captured through 11 focus group discussions and one in-depth interview with 54 male partners of ring-users at six research sites in Malawi, South Africa, Uganda and Zimbabwe. Following a semi-structured guide, and using demonstration rings, vulva and penis models, men were asked to discuss the ring's impact on sex and views on male engagement and ring use. Interviews were facilitated by local male social scientists, audio-recorded, translated into English, and analyzed thematically. 22 (41%) of the male partners reported feeling the ring during sex, often attributed to perceived incorrect insertion. Many men described the ring as "scratching" the tip of their penises, and sensations of "prodding" something that "blocked" the vagina and prohibited "full entry". In most cases, feelings dissipated with time or when sexual fluids increased. Less common descriptions included perceiving the vaginal texture, wetness and size as different, which increased pleasure for some, and decreased for others. Over half (59%) never noticed the ring; some attempting and failing to feel it during intercourse. A majority of men reported that the ring did not lead to changes in sexual positions, feelings, frequency or experience of sex, although some were initially afraid that the ring was a "magic snake" or "potion". Male partners expressed strong opinions that ring use was a shared prevention responsibility that men should be engaged in, especially for maintaining trust and open communication in relationships. The ring was noticed by many male partners, particularly during women's initial stages of ring use, although this led to few sexual problems or changes. Nevertheless, results suggest that risk of ring discovery should be discussed with women to mitigate any potential negative reactions or social harm. Strategies to increase male partner engagement will enhance support of this prevention method for women.
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Fármacos Anti-VIH , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH , Fármacos Anti-VIH/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , Malaui , Masculino , Pirimidinas , Conducta Sexual , Parejas Sexuales , Sudáfrica , Uganda , ZimbabweRESUMEN
BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. METHODS: In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1-uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. RESULTS: All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P = .02), but not in the coadministration regimen (43.3% vs 48.3%; P = .61). CONCLUSIONS: Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
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Vacunas contra el SIDA , Infecciones por VIH , VIH-1 , Vacunas contra el SIDA/uso terapéutico , Adulto , ADN , Anticuerpos Anti-VIH , Infecciones por VIH/prevención & control , VIH-1/genética , Humanos , Inmunización Secundaria , Inmunogenicidad Vacunal , Polisorbatos , Sudáfrica , Escualeno , Tanzanía , ZambiaRESUMEN
BACKGROUND: There continues to be a need for HIV prevention options that women can initiate and use autonomously. The dapivirine vaginal ring (VR) has been shown to have a favorable safety profile and reduce the risk of HIV-1 acquisition. We report on women's experiences with VR adherence during the MTN-025/HIV Open-label Prevention Extension (HOPE) study and responses to Residual Drug Level (RDL) results. SETTING: Ten women at each of the 6 HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were randomly selected (n = 60). METHODS: After confirmation of eligibility criteria, in-depth interviews were conducted where available RDL results were presented. RESULTS: Many women with low RDL release measurements deflected blame onto other factors (the ring, the drug, and faulty testing machines) and distrust of the testing method. The disclosure of RDL results enabled some users to discuss their challenges experienced (fear of partner objections, perceived side effects, and removals during menses). Consistent users reported important motivators (support from others, protection from HIV, and enhanced sexual experiences from the VR). CONCLUSION: The VR provided a sense of security for some women; however, adherence was still challenging for others regardless of it being a female controlled, long-acting HIV prevention technology. Adherence measurements may not be sustainable in the real-world implementation of the VR, although they can be seen as a benefit as they provide a better understanding of actual product use and provide women with a platform to discuss their experiences.
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Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , VIH-1 , Cumplimiento de la Medicación , Pirimidinas/uso terapéutico , Administración Intravaginal , Adulto , África del Sur del Sahara/epidemiología , Fármacos Anti-VIH/administración & dosificación , Fármacos Anti-VIH/sangre , Dispositivos Anticonceptivos Femeninos , Infecciones por VIH/epidemiología , Humanos , Persona de Mediana Edad , Pirimidinas/administración & dosificación , Pirimidinas/sangreRESUMEN
Medical male circumcision is a proven method of HIV risk reduction in men with no known direct benefit to women. We investigated the benefit of partner circumcision on women's health. We conducted a secondary analysis of 5,029 women enrolled in the Vaginal and Oral Interventions to Control the Epidemic trial across 15 African sites, to look at the impact of partner circumcision status on sexually transmitted infections, pregnancy, frequency of sex, and condom use in women. Of 4,982 participants with a baseline response, 31% had circumcised partners. Women with circumcised partners had a significantly reduced risk of syphilis acquisition, hazard ratio 0.51 (0.26, 1.00), p value = .05. Participants with uncircumcised partners were significantly less likely to have used a condom at the last sex act than the other two groups, adj. relative risk 0.86 (0.80, 0.92), adj. p value < .0001. We found no evidence of sexual risk compensation in women with circumcised partners.