Study finds adolescent girls and young women in Africa will use HIV prevention products

Interim results of the REACH study of daily oral PrEP and monthly dapivirine vaginal ring presented at IAS 2021 - the 11th IAS Conference on HIV Science

MICROBICIDE TRIALS NETWORK

Research News

Adolescent girls and young women can and will use HIV prevention products with consistency, according to interim results of a study of two different methods: daily use of the antiretroviral (ARV) tablet Truvada® as oral pre-exposure prophylaxis (PrEP) and the monthly dapivirine vaginal ring, a new HIV prevention product currently under regulatory review in several countries.

To provide protection against HIV, both must be used consistently- daily, for oral PrEP, and for the ring, a full month at a time - which previous studies of these products found to be especially challenging for younger women.

This was not the case in an ongoing study, known as REACH (Reversing the Epidemic in Africa with Choices in HIV prevention), being conducted at four clinical research sites in Uganda, South Africa and Zimbabwe by the National Institutes of Health-funded Microbicide Trials Network (MTN). The vast majority (97 percent) of the study's 247 participants, who were between the ages of 16 and 21 when they enrolled, used the vaginal ring and daily oral PrEP some or all of the time. Fewer than three percent of participants used neither of the products, according to laboratory tests for adherence.

These and other results from the study's first two periods, during which participants were asked to use each of the products for six months, are being reported at IAS 2021 - the 11th IAS Conference on HIV Science - taking place virtually from 18-21 July, and were featured in an official IAS press conference today.

Both approaches received high marks from the study's participants: during the six months they were asked to use the monthly dapivirine ring, 88 percent said they liked it, and during the period when they were assigned to use oral PrEP, 64 percent said they liked the daily pill-taking regimen.

The research team attributes the study's findings of high product adherence and acceptability to the ongoing support measures, tailored for this population, and nonjudgmental counseling approach provided as part of the study.

"In many ways, these results exceeded even our own expectations, yet at the same time, it's not surprising to find that these young women have the capacity and desire to protect themselves against HIV. They simply need to feel empowered and have the agency to make choices based on what they feel is right for them," said Gonasagrie (Lulu) Nair, MBChB, MPH, REACH protocol chair and senior lecturer, Centre for Medical Ethics and Law, Faculty of Medicine, at Stellenbosch University in South Africa.

Globally, more than half of all people living with HIV are women, and in sub-Saharan Africa, women account for more than 60 percent of adults with HIV. Rates of infection are especially high among adolescent girls and young women. According to UNAIDS, in 2020, one in four new infections in sub-Saharan Africa were in young women ages 15-24, despite making up only 10 percent of the population.

REACH, also known as MTN-034, was designed to fill important gaps in information about the safety and acceptability of the dapivirine ring and Truvada (a tablet containing a combination of the ARV drugs tenofovir disoproxil fumarate and emtricitabine) as oral PrEP in girls younger than 18. Of the 247 participants in REACH, 86 (35 percent) were age 16 or 17 at the time of enrollment. The study is also collecting important data that will supplement existing safety and acceptability data among young women ages 18-21.

Indeed, interim results also found both Truvada as oral PrEP and the dapivirine ring were well tolerated with no safety concerns. As REACH is still an ongoing study, the safety of these products continues to be monitored by the research team.

Information about the safety of the ring among adolescent girls is especially important. The ring, which was developed by the nonprofit International Partnership for Microbicides (IPM), would be the first biomedical prevention method designed specifically for women, and the first long-acting method. However, because the product's Phase III trials were conducted among cisgender women ages 18-45, additional data would be needed to support the ring's use in women younger than 18. Pending its final results, data from REACH, as well as from the MTN-023/IPM 030 study among adolescent girls ages 15 to 17 in the United States, will be submitted to regulators so that they may consider approving the ring for adolescent girls.

REACH also seeks to understand what adolescent girls and young women need to help them to use the dapivirine ring and oral PrEP as consistently as possible, and their preferences for either or both. After having experienced using both of the products, each for six months, participants then choose which one they want to use for the remaining six months of the study, or to choose neither. Moreover, participants are free to change their minds. The choice phase of REACH is still ongoing, with approximately 50 participants still in the study.

As researchers are reporting at IAS 2021, adherence to both products was high during the first two periods of the study. Adherence to oral PrEP was based on levels of drug in blood samples taken at each monthly visit. For the ring, researchers looked at the amount of residual drug left in rings participants returned after a month of use. The ring contains 25mg of the ARV dapivirine, about 4 mg of which is released into the vagina when used continuously for 28 days.

Using these measures, researchers determined that during the six months participants were assigned to use oral PrEP, 39.9 percent of the participants had drug levels that suggested they used oral PrEP at least some of the time, meaning they took the tablets between one and three times a week; and 58.6 percent were classified as high users, whose drug levels suggested they took the tablets at least four times a week, which among men who have sex with men has been associated with 100 percent protection. The threshold for protection in cisgender women has yet to be determined. For the ring, drug levels in returned rings suggested that 45.4 percent used it at least some of the time, and that 50.2 percent used the ring for the full month. Full compliance to oral PrEP, whereby blood levels indicate taking at least six pills per week, was evident for 22 percent of the participants.

"It's important to note that our aim is not to make direct comparisons between oral PrEP and the ring, which wouldn't be feasible anyway because the methods for measuring adherence are not the same. Rather, the study aims to compare participants' adherence to the ring and oral PrEP in this study with what had been observed among young women in other trials of these products, as a way to understand whether these are feasible options for young women and whether they are willing to use either or both," explained Dr. Nair. "The answer, as these results make clear, is yes."

In the two Phase III trials of the ring, younger women used the ring least regularly, and as a group, had the lowest rates of risk reduction. In ASPIRE, for example, the ring was not shown to be effective among women ages 18-21, with levels of drug in returned rings also indicating low adherence to use. Likewise, daily pill taking was more challenging for younger women in the Phase III trials of oral PrEP (VOICE and FEM-PrEP). Moreover, results of the HPTN 082 open-label study among adolescent girls and young women in South Africa and Zimbabwe, found that 85 percent of the participants used oral PrEP with some regularity at the beginning of the study, but when clinic visits changed from monthly to every three months, there was a steep decline. Three months into the study, fewer than 25 percent were using oral PrEP, and by month 12, it was only nine percent.

"What strikes me most about REACH is that not only are we seeing high adherence, but persistence appears to be high as well. Clearly, the ongoing support and individual attention paid to participants seems to make a difference," noted Connie Celum, M.D., M.P.H., professor of global health and medicine and director of the International Clinical Research Center at the University of Washington in Seattle, who is a REACH protocol co-chair and led the HPTN 082 study. "To see this kind of high adherence - it's pretty remarkable, especially during this time of COVID-19."

As part of REACH, study participants receive extensive support and counseling focused on helping them to use their assigned (or chosen) product as best they can. Every monthly visit includes a meeting with a counselor, and participants can also choose from a menu of additional forms of support, including daily text messages or weekly check-ins by phone; having a "Peer Buddy"; and adherence support groups. At some sessions, participants receive their individual adherence test results as a way to help facilitate discussion about adherence and how it relates to HIV risk reduction. Results are presented in terms of what they may mean for level of protection they are receiving and given without judgement.

"We've tried to empower these young women by letting them take control of their own health and behaviors and to make their own decisions. If participants don't want to or cannot use either the ring or oral PrEP, we simply want to understand the reasons why, while also seeing what kind of support may help. And if they change their mind, that's okay as well, because as their circumstances change, so will their needs and preferences for HIV prevention," added Kenneth Ngure, Ph.D., MPH, chair of the department of community health at Jomo Kenyatta University of Agriculture & Technology in Nairobi, Kenya, and REACH protocol co-chair.

REACH began in February 2019 and is expected to be completed by October 2021, with final results, including outcomes from the choice period, anticipated in early-to-mid 2022.

While the study was originally designed to enroll 300 participants, 100 of whom would be 16- and 17-years old, in March 2020, in the face of the emerging COVID-19 pandemic, MTN and study leadership decided to close the study to further enrollment so that fullest attention could be paid to ensuring the safety of its current participants as well as clinic staff. By this time, REACH had already enrolled 247 participants, including 86 who were under the age of 18, such that the study would still be able to provide sufficient data about the safety of the dapivirine vaginal ring and oral PrEP in adolescent girls and young women, and to do so in less time as well.

Just four months later, in July 2020, the ring received a positive opinion from the European Medicines Agency (EMA) for its use among women ages 18 and older in developing countries, and soon after, was added to the World Health Organization's (WHO) list of pre-qualified medicines. IPM is now seeking approval of the ring in eastern and southern Africa, including in countries where REACH is being conducted. Just yesterday, the ring received its first approval, which came from the Medicines Control Authority of Zimbabwe. IPM is also seeking regulatory approval from the US Food and Drug Administration.

In anticipation of the ring's potential approval, WHO's updated guidelines for HIV prevention, published in March 2021, recommend the ring as an additional HIV prevention choice for women at substantial risk of HIV, while also acknowledging that study's like REACH will help to better understand ways to support consistent and persistent use of both PrEP and the ring in adolescent girls and young women.

The clinical research sites (CRSs) where REACH is being conducted are Makerere University-Johns Hopkins University CRS in Kampala, Uganda; the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre Spilhaus CRS, Harare; and in South Africa, the Wits Reproductive Health and HIV Institute in Johannesburg and the Emavundleni CRS of the Desmond Tutu HIV Foundation in Cape Town.

###

MTN and the REACH study are supported by U.S. National Institutes of Health grants UM1AI068633, UM1AI068615 and UM1AI106707.

The study products for REACH were provided by the International Partnership for Microbicides (IPM) and Gilead Sciences.

More information about REACH is at mtnstopshiv.org/reach-study and http://www.mtnstopshiv.org/news/studies/mtn034,.

To learn more about the monthly dapivirine ring, visit https://www.ipmglobal.org/

Trends in Diversity and Representativeness of Health Care Workers in the United States, 2000 to 2019

Research Letter 

Health Policy

July 15, 2021

Dan P. Ly, MD, PhD, MPP^1,2; Anupam B. Jena, MD, PhD^3,4,5

Author Affiliations Article Information

JAMA Netw Open. 2021;4(7):e2117086. doi:10.1001/jamanetworkopen.2021.17086

Introduction

Despite evidence that greater diversity among health care workers may allow them to better care for patients with diverse cultural, social, economic, and clinical needs,^1-3 data are limited on trends in diversity and representativeness of US health care workers by occupation. Using US Census data from 2000 to 2019, we examined national trends in representativeness in select health care occupations by race/ethnicity and sex.

Methods

In this cross-sectional study, we used 2 data sources: (1) the Decennial Census long form, a nationally representative, US Census–administered survey, from 2000, and (2) the American Community Survey, a nationally representative Census-administered survey, from 2001 to 2019. Response rates for both exceeded 90%.^4,5 This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. The University of California Los Angeles institutional review board determined that the study was not human subjects research and therefore exempt from review and the requirement for informed consent.

Occupation, race, (White, Black, American Indian or Alaska Native, Chinese, Japanese, other Asian or Pacific Islander, other race, 2 major races, or ≥3 major races) and ethnicity (not Hispanic, Mexican, Puerto Rican, Cuban, and other Hispanic origin) were self-reported. Participants who selected Chinese, Japanese, or other Asian or Pacific Islander were included into the category Asian. Participants who selected Mexican, Puerto Rican, Cuban, and other were included in the Hispanic category. Participants who selected other race, 2 major races, or 3 or more major races were excluded, leaving 4 groups: non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, and Hispanic. We estimated the composition of select health care occupations (Table 1) by race/ethnicity and sex in 2000 to 2004 and 2015 to 2019. For each occupation, we calculated the change in percentage in each race/ethnicity and sex subgroup between these 2 periods using linear regression. In addition, in each occupation, we assessed the population representativeness of each race/ethnicity and sex subgroup by calculating the ratio of the percentage of a specific subgroup in an occupation (eg, Black male physicians) to the percentage of the US population in that subgroup (eg, Black men).⁶ We used Census-provided sampling weights to make nationally representative estimates. P values were from 2-sided tests, and results were deemed statistically significant at P < .05. Analyses were conducted in Stata version 16.1 (StataCorp).

Results

Our study included 1 648 924 individuals (1 303 496 [79.1%] women; 345 428 [20.9%] men) across 6 health care occupations (Table 1). The percentage of White men in relatively more remunerative occupations (ie, physicians and surgeons, pharmacists, and dentists) decreased between 2000 to 2004 and 2015 to 2019. For example, the percentage of physicians and surgeons who were White men decreased from 54.1% (95% CI, 53.3% to 54.9%) to 43.8% (95% CI, 43.3% to 44.3%) (difference, −10.3 [95% CI, −11.2 to −9.3] percentage points), while the percentage of dentists who were White men decreased 15.6 (95% CI, 13.5 to 17.6) percentage points. Little to no change was observed in the percentage of men from underrepresented minorities in these occupations. For example, no change was observed in the percentage of physicians and surgeons who were Hispanic men (difference, 0.2 [95% CI, −0.2 to 0.6] percentage points) or in the percentage of pharmacists who were Black men (difference, −0.06 [95% CI, −0.8 to 0.6] percentage points). Statistically significant increases were observed in the percentage of both Black and Hispanic women in these 3 occupations. For example, the percentage of pharmacists who were Black women increased 1.3 (95% CI, 0.6 to 2.0) percentage points, and the percentage of dentists who were Hispanic women increased 1.0 (95% CI, 0.4 to 1.7) percentage points. Increases for White and Asian women in these occupations were larger than for Black and Hispanic women.

Significant increases were observed among most minority race/ethnicity and sex subgroups in less remunerative occupations (ie, nurses, therapists, and health care aides). In an analysis of population representativeness in 2015 to 2019, Black and Hispanic men and women remained considerably underrepresented relative to the US population in more remunerative occupations (Table 2).

Discussion

In a nationally representative sample, little to no increase in Black or Hispanic men was observed among physicians and surgeons, pharmacists, and dentists between 2000 and 2019. While there were increases in Black and Hispanic women in these occupations, increases among White and Asian women were larger. Altogether, increases in representation of these 4 subgroups of women were accompanied by large declines in the proportion of White men. Other health care occupations, such as nurses, therapists, and health care aides, had increases across most minority subgroups during the examined period. These results quantify the current representativeness of the US health care workforce and changes in its composition during the past 2 decades. Study limitations include the use of self-reported survey data.

Back to top

Article Information

Accepted for Publication: May 12, 2021.

Published: July 15, 2021. doi:10.1001/jamanetworkopen.2021.17086

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Ly DP et al. JAMA Network Open.

Corresponding Author: Anupam B. Jena, MD, PhD, Department of Health Care Policy, Harvard Medical School, 180 Longwood Ave, Boston, MA 02115 (jena@hcp.med.harvard.edu).

Author Contributions: Dr Ly had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Both authors.

Acquisition, analysis, or interpretation of data: Both authors.

Drafting of the manuscript: Both authors.

Critical revision of the manuscript for important intellectual content: Both authors.

Statistical analysis: Both authors.

Supervision: Jena.

Conflict of Interest Disclosures: Dr Jena reported receiving consulting fees from Pfizer; Bioverativ; Bristol Myers Squibb; Merck, Sharp, and Dohme; Janssen Pharmaceuticals; Edwards Life Sciences; Novartis; Amgen; Eli Lilly and Co; Vertex Pharmaceuticals; AstraZeneca; Celgene; Tesaro; Sanofi Aventis; Precision Health Economics; and Analysis Group outside the submitted work. No other disclosures were reported.

Disclaimer: The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the US Department of Veterans Affairs or the US government.

References

1.

Alsan  M, Garrick  O, Graziani  G.  Does diversity matter for health? experimental evidence from Oakland.   Am Econ Rev 2019; 109: 4071-4111. doi:10.1257/aer.20181446Google ScholarCrossref

2.

Mertz  EA, Wides  CD, Kottek  AM, Calvo  JM, Gates  PE.  Underrepresented minority dentists: quantifying their numbers and characterizing the communities they serve.   Health Aff (Millwood). 2016;35(12):2190-2199. doi:10.1377/hlthaff.2016.1122PubMedGoogle ScholarCrossref

3.

Institute of Medicine. In the nation’s compelling interest: ensuring diversity in the health-care workforce. Accessed May 4, 2021. https://www.nap.edu/catalog/10885/in-the-nations-compelling-interest-ensuring-diversity-in-the-health

4.

Griffin  DH, Love  SP, Obenski  SM. Can the American Community Survey replace the Census long form? Accessed May 4, 2021. http://www.asasrms.org/Proceedings/y2003/Files/JSM2003-000596.pdf

5.

IPUMS USA. Select samples. Accessed May 4, 2021. https://usa.ipums.org/usa-action/samples

6.

Lett  LA, Murdock  HM, Orji  WU, Aysola  J, Sebro  R.  Trends in racial/ethnic representation among US medical students.   JAMA Netw Open. 2019;2(9):e1910490. doi:10.1001/jamanetworkopen.2019.10490
ArticlePubMedGoogle Scholar

Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines

 July 15, 2021

Manuel E. Jimenez, MD, MS^1,2; Zorimar Rivera-Núñez, PhD, MS³; Benjamin F. Crabtree, PhD²; et alDiane Hill, PhD⁴; Maria B. Pellerano, MA, MBA, MPH²; Donita Devance, MCRP⁵; Myneka Macenat, MPH²; Daniel Lima, MSW¹; Emmanuel Martinez Alcaraz, MD²; Jeanne M. Ferrante, MD²; Emily S. Barrett, PhD³; Martin J. Blaser, MD^6,7; Reynold A. Panettieri Jr, MD⁸; Shawna V. Hudson, PhD²

Author Affiliations Article Information

JAMA Netw Open. 2021;4(7):e2117074. doi:10.1001/jamanetworkopen.2021.17074

Key Points

Question  What are the experiences of Black and Latinx communities during the COVID-19 pandemic, and how are these experiences associated with their perspectives on COVID-19 mitigation behaviors, testing, and vaccines?

Findings  This community-engaged qualitative study found that fear, illness, and loss experienced during the pandemic motivated information seeking and mitigation behaviors; vaccine skepticism was high, as was demand for clearer information. Among Black participants, racism and medical experimentation were associated with distrust.

Meaning  These findings suggest that perspectives on COVID-19 mitigation behaviors, testing, and vaccines among Black and Latinx communities are informed by devastating experiences, and transparent information from public officials is needed to eliminate vaccine skepticism.

Abstract

Importance  Black and Latinx communities have been disproportionately affected by the COVID-19 pandemic, yet little work has sought to understand their perspectives.

Objective  To explore the experiences of Black and Latinx communities during the pandemic to better understand their perspectives on COVID-19 mitigation behaviors (eg, mask wearing), testing, and vaccines.

Design, Setting, and Participants  In this community-engaged qualitative study conducted with 18 community-based organizations and 4 health care organizations between November 19, 2020, and February 5, 2021, in New Jersey counties severely affected by the pandemic, group and individual interviews were used to purposively sample 111 Black and Latinx individuals. A total of 13 group interviews were organized by race/ethnicity and language: 4 English-speaking groups with Black participants (n = 34), 3 Spanish-speaking groups with Latinx participants (n = 24), and 4 English-speaking groups with Black and Latinx participants (n = 36). To understand the views of health care workers from these communities, 2 additional groups (n = 9) were convened and supplemented with individual interviews.

Main Outcomes and Measures  Description of Black and Latinx participants’ experiences during the COVID-19 pandemic and their perspectives on mitigation behaviors, testing, and vaccines.

Results  The study included 111 participants (87 women [78.4%]; median age, 43 years [range, 18-93 years]). Participants described the devastating effects of the pandemic on themselves, loved ones, and their community. Their experiences were marked by fear, illness, loss, and separation. These experiences motivated intense information seeking, mitigation behaviors, and testing. Nevertheless, vaccine skepticism was high across all groups. Participants did not trust the vaccine development process and wanted clearer information. Black participants expressed that they did not want to be subjects of experiments.

Conclusions and Relevance  The remaining unknowns about new vaccines need to be acknowledged and described for Black and Latinx communities to make informed decisions. Ultimately, scientists and public officials need to work transparently to address unanswered questions and work collaboratively with trusted community leaders and health professionals to foster partnered approaches, rather than focusing on marketing campaigns, to eliminate vaccine skepticism.

Introduction

As of May 2021, the US has the highest number of cases and deaths in the world. Within the US, the pandemic is disproportionately affecting Black and Latinx groups.^1,2 For example, age-adjusted mortality rates for Black and Latinx Americans far exceed those for White Americans.³ Multiple factors are associated with this inequality, including comorbid conditions that increase susceptibility and disease severity.^4,5 Disparities in COVID-19 outcomes are also a function of structural and institutional racism.⁶ Factors such as residential segregation, wealth inequality, and mass incarceration impact the ability of members from different racial/ethnic and socioeconomic groups to avoid infection and seek care.^7-11 These factors are the legacy of slavery, Jim Crow laws (state and local laws enacted in the late 19th and early 20th centuries that enforced racial segregation in the southern United States), and discriminatory public health interventions that together are associated with a pervasive sense of distrust of public health authorities.^12,13

Black and Latinx groups have been the target of multiple discriminatory health interventions.¹⁴ Experiences including experimentation during slavery, the Tuskegee Syphilis Study, and the contraception trials in Puerto Rican women, predispose Black and Latinx communities to skepticism about public health interventions.^12,15 Today, this history provides critical context for the strategies needed to fight the COVID-19 pandemic, including Centers for Disease Control and Prevention–recommended mitigation behaviors (eg, mask wearing, handwashing, and physical distancing), testing, and vaccines.¹⁶ In recent surveys, Black, Latinx, and low-income respondents were much less likely to report trust in public health officials in association with COVID-19, compared with White respondents.¹⁷ Black and Latinx adults are also more likely to “wait and see” before receiving the COVID-19 vaccination.¹⁸

Surveys, news reports, and anecdotes have brought attention to the inequities experienced by Black and Latinx communities during the COVID-19 pandemic.^17,19 To date, little work has delved deeply into the experiences of these communities to better understand their perspectives on COVID-19 mitigation behaviors, testing, and vaccines. Such information is critical to develop appropriate public health messages and strategies. Therefore, this study explores the experiences of Black and Latinx adults during the pandemic to understand how these experiences are associated with their perspectives on COVID-19 public health strategies.

Methods

We conducted online group and individual interviews as part of NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education Study–Testing Overlooked Occupations),^20,21 funded by the National Institutes of Health Rapid Acceleration of Diagnostics–Underserved Populations (RADx-UP) Initiative.²² The RADx-UP Initiative seeks to better understand disparities among underserved populations, including access to testing. We purposively sampled Black and Latinx individuals from New Jersey counties (ie, Essex, Middlesex, Passaic, and Union) with high rates of COVID-19 infections and deaths during the initial surge in 2020, high levels of poverty, and large concentrations of Black and Latinx populations. Adults older than 18 years of age who identified as Black or Latinx with English or Spanish as their primary language were eligible. We partnered with 18 community-based organizations and 4 health care organizations in these counties. Through biweekly online meetings, representatives helped with development of the research protocol, recruitment, and debriefing sessions to help interpret findings.²³ This study was approved by the Rutgers Biomedical Health Sciences institutional review board and follows the Standards for Reporting Qualitative Research (SRQR) reporting guideline.²⁴ All participants provided verbal consent prior to participation.

Data Collection

We organized 13 group interviews and 8 individual interviews between November 19, 2020, and February 5, 2021, using a secure Zoom platform. Group interviews had a primary and secondary facilitator (M.E.J., D.H., D.L., and/or S.V.H.) with 2 study team members (Z.R.-N., M.B.P., M.M., and/or E.M.A.) for notetaking and technical assistance. Facilitators followed the interview guide, which we developed through literature review, the team’s experience, and partner feedback (eMethods in the Supplement). We adapted and added questions to explore emerging themes. Group interviews were organized by race/ethnicity and language: 4 English-speaking groups with Black participants, 3 Spanish-speaking groups with Latinx participants, and 4 English-speaking groups that included Black and Latinx participants (Figure). We also conducted 2 group interviews with Black and Latinx participants who worked in health care settings as ancillary or support staff, given their unique perspective as health care workers and community members. We supplemented health care worker group interviews with 8 individual interviews to accommodate their schedules. Group interviews lasted approximately 90 minutes, and individual interviews lasted 20 to 30 minutes. All interviews were recorded and transcribed. We used ATLAS.ti 8 software (ATLAS.ti) to facilitate data management.

Data Analysis

We used an “editing” approach to analyze the data.²⁵ Transcripts were first read openly to gain an initial sense of the group conversation. On a second reading, meaningful segments of text were highlighted, then cut, pasted, and rearranged to create 4- to 5-page summaries organized around emerging themes. We then analyzed the summaries together of groups with only Black participants to identify themes that were common to those groups; subsequently, we identified themes in summaries of groups with only Latinx participants in the same manner. Looking across both sets, we then identified the themes common to both groups. At that point, we analyzed the groups with Black and Latinx participants to confirm or disconfirm the existing findings and found that we had achieved data saturation—no new themes emerged from this analysis. Finally, we analyzed health care worker data, using the same process, which yielded similar findings; therefore, we include health care worker perspectives under our key themes.

Results

We recruited 200 individuals, 64 of whom were not eligible and 25 did not attend, for a final sample of 111 individuals (87 women [78.4%]; 68 Black participants [61.3%] and 43 Latinx participants [38.7%]; median age, 43 years [range, 18-93 years]). The Table summarizes sample demographic characteristics, and the eTable in the Supplement summarizes demographic characteristics by group. We identified 2 key themes from the data: (1) the devastating effects of the pandemic motivated intense information seeking and mitigation behaviors and testing and (2) even within that context, vaccine skepticism was high (Box).

READ ON

Black and Latinx Community Perspectives on COVID-19 Mitigation Behaviors, Testing, and Vaccines | Vaccination | JAMA Network Open | JAMA Network

 

Black, Latinx people confident in COVID-19 safety precautions but skeptical about vaccines

A Rutgers study finds vaccine campaigns in Black and Latinx communities depend on transparent information and building on trusted relationships

RUTGERS UNIVERSITY

Research News

Black and Latinx people intensely sought information on COVID-19 and engaged in public health measures such as mask-wearing and testing due to devastating experiences during the pandemic but are still skeptical about vaccines, according to a Rutgers study.

The findings, which appear in JAMA Network Open, offer insight into what motivates people in Black and Latinx communities - which have been disproportionately affected by the pandemic - to embrace COVID-19 safety precautions but to hesitate about vaccines. The findings may also help to develop appropriate public health messages and strategies.

Researchers interviewed 111 Black and Latinx people from New Jersey low-income counties with high rates of COVID-19 infections and deaths during the initial surge in 2020. They also interviewed health care workers in these communities to understand their views.

"Fear, illness and loss experienced during the pandemic motivated them to intensely seek information and take safety precautions like wearing a mask, social distancing and washing hands to protect themselves and loved ones," said co-author Manuel Jimenez, an assistant professor of pediatrics, family medicine and community health at Rutgers Robert Wood Johnson Medical School. "However, participants did not trust the vaccine development process and wanted clearer information."

The study found that:

• Latinx participants, in particular, reported difficulty finding testing sites, transportation issues and language barriers. This was more pronounced for undocumented people who were told to pay for testing if they are ineligible for unemployment benefits and other assistance programs.
• Some participants did not feel safe inside or outside their homes, and described uncertainty about who among them had the virus. Crowded living conditions resulted in contact with neighbors and housemates who had COVID-19.
• Participants questioned how a vaccine for a new virus could be developed so rapidly when other diseases have been around for decades without successful vaccines. They also expressed concerns that the vaccine development process, including that clinical trials had been "rushed," and worried about the short- and long-term side effects.
• They questioned whether vaccines would work against variants and wanted clear and transparent information on vaccine effectiveness. Many wanted to see how others would respond to vaccination first.
• Black participants mentioned distrust of health care systems and government, citing experience of racism, discriminatory interventions and medical experimentation.

"We need to reduce logistical barriers and improve access to testing within underserved communities, regardless of documentation status," said co-principal investigator Shawna Hudson, professor and research division chief in the Department of Family Medicine and Community Health at Rutgers Robert Wood Johnson Medical School. "Health care providers should offer convenient testing options, accessible sites within walking distance, translated information and transparency about free testing to address these barriers."

Logistical barriers to testing must be addressed and vaccine skepticism needs to be taken seriously, the report concluded, the researchers said.

"The remaining unknowns about new vaccines need to be acknowledged and described for these communities to make informed decisions," Jimenez said. "Scientists and public officials need to work collaboratively with trusted community leaders and health professionals to provide transparent information, including remaining unknowns, so that these communities can make informed decisions rather than focusing on marketing campaigns to eliminate vaccine hesitancy."

###

The study was conducted as part of NJ HEROES TOO (New Jersey Healthcare Essential Worker OutReach and Education Study - Testing Overlooked Occupations) in collaboration with 18 community-based organizations and four health care organizations, funded by the NIH Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) Initiative.

Other Rutgers authors include Zorimar Rivera-Núñez, Benjamin F. Crabtree, Diane Hill, Maria B. Pellerano, Donita Devance, Myneka Macenat, Daniel Lima, Emmanuel Martinez Alcaraz, Jeanne M. Ferrante, Emily S. Barrett, Martin J. Blaser and Reynold A. Panettieri Jr.

 

Body mass index as a risk factor for diabetes varies throughout the world

A new study provides the first empirical evidence for tailoring BMI thresholds for diabetes screening in low- and middle-income countries.

MASSACHUSETTS GENERAL HOSPITAL

Research News

BOSTON - The unprecedented increase in overweight and obesity in low- and middle-income countries (LMICs) has led to an alarming rise in diabetes in these regions. Of the estimated 463 million people with diabetes worldwide, 79% live in LMICs.

Until now, however, there were scant empirical data to guide clinicians and health systems in determining which individuals should be screened for diabetes based on body mass index (BMI). "There are guidelines from the World Health Organization that recommend screening individuals age 40 and older with a BMI of 25 kg/m2 and above for diabetes," says Jennifer Manne-Goehler, MD, ScD, faculty member at the Medical Practice Evaluation Center at Massachusetts General Hospital (MGH). "But it's long been suspected that these BMI and age thresholds may not be optimal for diabetes screening in all regions of the world. Our goal was to estimate the relationship between BMI and diabetes risk across many low- and middle-income countries to help resource-strapped health systems devise the most effective screening programs for their populations," says Manne-Goehler, senior author of a new study published in The Lancet.

Manne-Goehler and investigators from 57 countries spent five years compiling and leveraging existing datasets of more than 680,000 people in LMICs that included every individual's weight, height and a diabetes biomarker--either a blood glucose measurement or hemoglobin A1c.

The study, the first of its kind, found substantial regional differences in the association between BMI and diabetes risk. Across all LMICs, people with a BMI of 23 kg/m2 or greater had an increased risk of diabetes. There was, however, variability in the optimal BMI to choose for diabetes screening among regions and genders, ranging from 23.8 kg/m2 among men in East/Southeast Asia to 28.3 kg/m2 among women in the Middle East, North Africa, Latin America and the Caribbean. The investigators also found differences in the risk of diabetes across BMI categories in several regions. For example, men and women in sub-Saharan Africa and East/Southeast Asia had more than a 100% increase in the risk of diabetes between being overweight and obese. These findings, in part, reinforced a growing literature from Asian and South Asian countries that recommends using lower BMI thresholds to better characterize metabolic risk in these populations.

And while diabetes increased in middle age and beyond, the proportion of individuals with diabetes rose steeply across all regions in the 35-to-44 age group, and among men 25 to 34 years old in sub-Saharan Africa. "Diagnosing diabetes in younger adults can prevent long-term complications of the disease," says Manne-Goehler.

"Although the data aren't prescriptive, our hope is that policymakers in LMICs will find this evidence useful as they try to decide how they will spend limited resources to optimize diabetes screening for their particular populations," she adds.

The research also demonstrates the power of collaborations among countries to create important evidence to inform public health guidelines. "It's difficult to draw meaningful high-level global conclusions when individual countries are examining diabetes risk in only one country's survey," says Manne-Goehler. The World Health Organization is creating a global strategy called the Global Diabetes Compact to scale up care for people with diabetes, for example. "We believe that our collaboration of many investigators across these 57 countries can help inform best diabetes screening practices throughout the world," she says.

"LMICs now have evidence-based specific answers to the 'Who? When? and How much?' regarding diabetes prevention and screening in relation with BMI," writes Siméon Pierre Choukem, MD, dean of the faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Cameroon, in a related commentary in The Lancet. "These results have major public health implications as the actual burden of diabetes in LMICs is probably underestimated because of the current screening guidelines, and it is unclear to what extent."

The global team of investigators are now studying how waist circumference might increase the accuracy of diabetes risk assessment when used with BMI, and they are also examining the relationship between behavioral factors--alcohol, smoking, physical activity and diet--and risk of diabetes across these 57 countries. In the future, the researchers also hope to create collaborations that include surveys from high-income countries to facilitate direct comparisons across a wider spectrum of global health settings. "Health systems in every country in the world have to make the best use of their resources to improve the health of their populations," says Manne-Goehler.

###

Manne-Goehler is an attending physician in the Division of Infectious Diseases at Brigham and Women's Hospital. First author Felix Teufel is a medical student and research assistant at the Heidelberg Institute of Global Health, Heidelberg University Hospital, Germany. Second author Jacqueline Seiglie, MD, MSc, is an endocrinologist and global health fellow at MGH and an instructor in Medicine at Harvard Medical School (HMS). The other MGH co-authors are James Meigs, MD, MPH, co-director of the MGH Clinical Research Program's Clinical Effectiveness Research Group and professor of Medicine at HMS, and Deborah Wexler, MD, MSc, associate clinical chief of the MGH Diabetes Unit, clinical director of the MGH Diabetes Center and associate professor of Medicine at HMS.

About the Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In August 2020, Mass General was named #6 in the U.S. News & World Report list of "America's Best Hospitals."