Exploring public perceptions of vaccine-derived poliovirus and a novel oral polio vaccine in the Democratic Republic of the Congo, Kenya, and Nigeria.

BACKGROUND: The Global Polio Eradication Initiative introduced novel oral polio vaccine Type 2 (nOPV2) to address circulating vaccine-derived poliovirus Type 2 (cVDPV2). Although nOPV2 is a more genetically stable vaccine, it may not have the immediate trust of communities and health workers due to its novelty, potential side effects, and introduction under an Emergency Use Listing (EUL). We explored how nOPV2 introduction might be perceived by stakeholders and identified communications barriers related to nOPV2 hesitancy. METHODS: This work was conducted in the Democratic Republic of the Congo, Kenya, and Nigeria between January and March 2020. We used a rapid qualitative approach to conduct focus group discussions and in-depth interviews with four stakeholder groups: caregivers of children under 5, polio frontline workers, healthcare practitioners, and social/health influencers. Data are presented according to awareness, attitudes/beliefs, and concerns about cVDPV2 and nOPV2. RESULTS: Stakeholders were largely unaware of cVDPV2. The causes of recent polio outbreaks were characterized as poor sanitation, under-immunization/in-migration, or poor vaccine management procedures. Caregivers were aware of and concerned by repeated vaccination campaigns. All stakeholder groups anticipated initial hesitancy, fear, and suspicion from caregivers due to nOPV2 introduction, with primary concerns linked to vaccine testing, safety, effectiveness, side effects, and support from authorities. Stakeholders thought the term "genetic modification" could be controversial but that introduction under an EUL would be acceptable given the emergency nature of cVDPV2 outbreaks. Stakeholders called for adequate and timely information to counter concerns. CONCLUSIONS: Despite initial concerns, stakeholders felt nOPV2 would ultimately be accepted by caregivers. However, public health officials have a small window for "getting things right" when introducing nOPV2. Strategic communication interventions addressing key concerns and targeted communications with stakeholder groups, especially frontline workers, could improve community acceptance of nOPV2.

How does qualitative data collection modality affect disclosure of sensitive information and participant experience? Findings from a quasi-experimental study.

Focus groups (FGs) and individual interviews (IDIs) can be conducted in-person or in several different online contexts. We conducted a quasi-experimental study and assessed sharing of sensitive or dissenting information and participant comfort in FGs and IDIs across four modalities: (1) in-person, (2) online video-based, (3) online chat-based (synchronous), and (4) online email/message board-based (asynchronous). Participants were systematically assigned to one of the four modalities and randomized to one of 24 FGs or 48 IDIs (N = 171). The study topic was medical risk during pregnancy. All participants also completed a survey on their perceptions of the data collection process. We found no significant difference in the frequency of disclosure of sensitive information by modality. Text-based FGs (chat and message board) were more likely to contain dissenting opinions than visually-based FGs (in-person and video). Participants also reported feeling less rapport and personal comfort in sharing information in the FG video modality than other modalities. These findings provide initial data that can guide researchers in choosing among data collection modalities to maximize participant engagement and comfort.

The financial lives of female sex workers in Addis Ababa, Ethiopia: Implications for economic strengthening interventions for HIV prevention.

Understanding the financial context of the lives of female sex workers (FSWs) is essential to address structural drivers of HIV risk. We used a financial diary methodology to record daily financial transactions over six weeks from a stratified purposive sample (n = 34) of FSWs in Addis Ababa, Ethiopia. FSWs also provided information on their experience with gender-based violence and condom use. FSWs generated 90.1% of total cash from sex work, with a median weekly income of USD 60.53. They engaged mostly in protected vaginal sex, earning approximately USD 4.57 per act. Food, housing, and clothing represented the largest areas of expenditure. Around 17% of expenses were recorded as costs of sex work (e.g., alcohol). Median weekly expenditures accounted for 62% of median weekly income. Nearly all participants reported depositing money into savings at least once over six weeks, while 71% reported a loan transaction during the six-week period, most as borrowers. Findings suggest that financial literacy and formalized savings activities, with life skills and empowerment training, have potential to build FSW's economic resilience, mitigating a structural driver of sex work and HIV risk.

A simple method to assess and report thematic saturation in qualitative research.

Data saturation is the most commonly employed concept for estimating sample sizes in qualitative research. Over the past 20 years, scholars using both empirical research and mathematical/statistical models have made significant contributions to the question: How many qualitative interviews are enough? This body of work has advanced the evidence base for sample size estimation in qualitative inquiry during the design phase of a study, prior to data collection, but it does not provide qualitative researchers with a simple and reliable way to determine the adequacy of sample sizes during and/or after data collection. Using the principle of saturation as a foundation, we describe and validate a simple-to-apply method for assessing and reporting on saturation in the context of inductive thematic analyses. Following a review of the empirical research on data saturation and sample size estimation in qualitative research, we propose an alternative way to evaluate saturation that overcomes the shortcomings and challenges associated with existing methods identified in our review. Our approach includes three primary elements in its calculation and assessment: Base Size, Run Length, and New Information Threshold. We additionally propose a more flexible approach to reporting saturation. To validate our method, we use a bootstrapping technique on three existing thematically coded qualitative datasets generated from in-depth interviews. Results from this analysis indicate the method we propose to assess and report on saturation is feasible and congruent with findings from earlier studies.

Beyond the Individual: Social and Cultural Influences on the Health-Seeking Behaviors of African American Men.

Morbidity and mortality rates are alarmingly high among African American men and are influenced by the health-seeking behaviors of this population. This study examined data from 40 focus groups with African American men in Durham, North Carolina, to better understand social and cultural influences on health-seeking behaviors. Data were analyzed using inductive thematic analysis. Three broad types of social/cultural influence on motivation to seek health care services were identified: family, culture and upbringing, and peers. Study findings confirm the importance of social relationships in influencing African American men's health-seeking behaviors and offer characterization of the nature of influence across different types of relationships, according to the direct support or indirect messages they provide. Future programs can draw on these data to inform efforts to include family and peers as well as utilize existing cultural gender norms to the advantage of health promotion for African American men.

Beyond the Page: A Process Review of Using Ethnodrama to Disseminate Research Findings.

Public health researchers are charged with communicating study findings to appropriate audiences. Dissemination activities typically target the academic research community. However, as participatory research grows, researchers are increasingly exploring innovative dissemination techniques to reach broader audiences, particularly research participants and their communities. One technique is ethnodrama/ethnotheatre, a written or live performance based on study findings. Though used effectively in social change programs, dramas are seldom used to distribute research findings exclusively. Therefore, little information is available about planning and implementing an ethnodrama for this purpose. We present a case study describing the process of planning and implementing an ethnodrama in the context of the Durham Focus Group Study, which explored men's health-seeking behaviors and experiences with health and healthcare services in Durham, North Carolina. Here, we highlight lessons learned throughout the production of the ethnodrama, and how we addressed challenges associated with transforming research data into educational entertainment. Additionally, we provide discussion of audience feedback, which indicated that our ethnodrama evoked an urgency to change health behaviors among lay persons (67%) and delivery of health services among those identifying as providers (84%), pointing to the success of the performance in both entertaining and educating the audience.

Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

Advancing HIV research with pregnant women: navigating challenges and opportunities.

OBJECTIVE: Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. METHODS: We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. RESULTS: Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. CONCLUSION: Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

When and why women might suspend PrEP use according to perceived seasons of risk: implications for PrEP-specific risk-reduction counselling.

Oral pre-exposure prophylaxis (PrEP) using the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (Truvada) has been shown to dramatically reduce the risk of HIV acquisition for women at higher risk of infection if taken daily. Understanding when and why women would intentionally stop using an efficacious oral PrEP drug within the context of their 'normal' daily lives is essential for delivering effective PrEP risk-reduction counselling. As part of a larger study, we conducted 60 qualitative interviews with women at higher risk of HIV in Bondo, Kenya, and Pretoria, South Africa. Participants charted their sexual contacts over the previous six months, indicated whether they would have taken PrEP if available and discussed whether and why they would have suspended PrEP use. Nearly all participants said they would have used PrEP in the previous six months; half indicated they would have suspended PrEP use at some point. Participants' reasons for an extended break from PrEP were related to partnership dynamics (e.g., perceived low risk of a stable partner) and phases of life (e.g., trying to conceive). Life events (e.g., holidays and travel) could prompt shorter breaks in PrEP use. These circumstances may or may not correspond to actual contexts of lower risk, highlighting the importance of tailored PrEP risk-reduction counselling.

Motivations for Reducing Other HIV Risk-Reduction Practices if Taking Pre-Exposure Prophylaxis: Findings from a Qualitative Study Among Women in Kenya and South Africa.

Findings from a survey conducted among women at high risk for HIV in Bondo, Kenya, and Pretoria, South Africa, demonstrated that a substantial proportion would be inclined to reduce their use of other HIV risk-reduction practices if they were taking pre-exposure prophylaxis (PrEP). To explore the motivations for their anticipated behavior change, we conducted qualitative interviews with 60 women whose survey responses suggested they would be more likely to reduce condom use or have sex with a new partner if they were taking PrEP compared to if they were not taking PrEP. Three interrelated themes were identified: (1) "PrEP protects"--PrEP was perceived as an effective HIV prevention method that replaced the need for condoms; (2) condoms were a source of conflict in relationships, and PrEP would provide an opportunity to resolve or avoid this conflict; and (3) having sex without a condom or having sex with a new partner was necessary for receiving material goods and financial assistance--PrEP would provide reassurance in these situations. Many believed that PrEP alone would be a sufficient HIV risk-reduction strategy. These findings suggest that participants' HIV risk-reduction intentions, if they were to use PrEP, were based predominately on their understanding of the high efficacy of PrEP and their experiences with the limitations of condoms. Enhanced counseling is needed to promote informed decision making and to ensure overall sexual health for women using PrEP for HIV prevention, particularly with respect to the prevention of pregnancy and other sexually transmitted infections when PrEP is used alone.

Preparing for the Rollout of Pre-Exposure Prophylaxis (PrEP): A Vignette Survey to Identify Intended Sexual Behaviors among Women in Kenya and South Africa if Using PrEP.

INTRODUCTION: Several clinical trials have demonstrated the efficacy of pre-exposure prophylaxis (PrEP) in reducing HIV risk. One concern with introducing PrEP is whether users will engage in riskier sexual behaviors. METHODS: We assessed the effect that PrEP may have on sexual risk behaviors by administering a survey to 799 women in Bondo, Kenya, and Pretoria, South Africa. Participants were asked about their sexual behavior intentions twice--once as if they were taking PrEP and once as if they were not taking PrEP--within four risk situations (vignettes). They responded using a 5-point ordinal scale. We used a series of linear mixed effects models with an unstructured residual covariance matrix to estimate the between- and within-subject differences in the mean likelihood of engaging in risky sexual behavior across the PrEP and non-PrEP contexts. We also calculated the total percentage of participants who reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP, by vignette. RESULTS: We found statistically significant differences in the mean likelihood of engaging in risky sexual behavior with the between-subject comparison (-0.17, p < 0.01) and with the within-subject comparison (-0.31, p < 0.001). Depending on the vignette, 27% to 40% of participants reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP. CONCLUSIONS: Our findings indicate that modest increases in risky sexual behavior could occur with PrEP. Although responses from the majority of participants suggest they would not be more likely to engage in risky sexual behavior if they took PrEP, a substantial proportion might. Programs rolling out PrEP should be prepared to assist similar women in making informed choices about reducing their risk of HIV and about their sexual health beyond HIV prevention.

Factors influencing the retention of midwives in the public sector in Afghanistan: a qualitative assessment of midwives in eight provinces.

OBJECTIVE: to examine factors that affect retention of public sector midwives throughout their career in Afghanistan. DESIGN: qualitative assessment using semi-structured in-depth interviews (IDIs) and focus group discussions (FGDs). SETTING: health clinics in eight provinces in Afghanistan, midwifery education schools in three provinces, and stakeholder organisations in Kabul. PARTICIPANTS: purposively sampled midwifery profession stakeholders in Kabul (n=14 IDIs); purposively selected community midwifery students in Kabul (n=3 FGDs), Parwan (n=1 FGD) and Wardak (n=1 FGD) provinces (six participants per FGD); public sector midwives, health facility managers, and community health workers from randomly selected clinics in eight provinces (n=48 IDIs); midwives who had left the public sector midwifery service (n=5 IDIs). MEASUREMENTS AND FINDINGS: several factors affect a midwife throughout her career in the public sector, including her selection as a trainee, the training itself, deployment to her pre-assigned post, and working in clinics. Overall, appropriate selection is the key to ensuring deployment and retention later on in a midwife's career. Other factors that affect retention of midwives include civil security concerns in rural areas, support of family and community, salary levels, professional development opportunities and workplace support, and inefficient human resources planning in the public sector. KEY CONCLUSIONS: Factors affecting midwife retention are linked to problems within the community midwifery education (CME) programme and those reflecting the wider Afghan context. Civil insecurity and traditional attitudes towards women were major factors identified that negatively affect midwifery retention. IMPLICATIONS FOR PRACTICE: Factors such as civil insecurity and traditional attitudes towards women require a multisectoral response and innovative strategies to reduce their impact. However, factors inherent to midwife career development also impact retention and may be more readily modified.

Institutional review boards' use and understanding of certificates of confidentiality.

Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants' privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public's health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders' views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions' use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or 'unsure'. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an 'extra layer' of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants' confidentiality, and the need for further empirical investigation of Certificates' effect on researchers and research participants.

Recommendations for ethical approaches to genotype-driven research recruitment.

Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation. However, it also presents significant ethical challenges that, to date, have received only minimal consideration. We convened a multi-disciplinary workshop to discuss key issues relevant to the conduct and oversight of genotype-driven recruitment and to translate those considerations into practical policy recommendations. Workshop participants were invited from around the US, and included genomic researchers and study coordinators, research participants, clinicians, bioethics scholars, experts in human research protections, and government representatives. Discussion was directed by experienced facilitators and informed by empirical data collected in a national survey of IRB chairs and in-depth interviews with research participants in studies where genotype-driven recontact occurred. A high degree of consensus was attained on the resulting seven recommendations, which cover informed consent disclosures and choices, the process for how and by whom participants are recontacted, the disclosure of individual genetic research results, and the importance of tailoring approaches based on specific contextual factors. These recommendations are intended to represent a balanced approach-protecting research participants, yet avoiding overly restrictive policies that hinder advancement on important scientific questions.

Research participants' perspectives on genotype-driven research recruitment.

Genotype-driven recruitment is a potentially powerful approach for studying human genetic variation but presents ethical challenges. We conducted in-depth interviews with research participants in six studies where such recruitment occurred. Nearly all responded favorably to the acceptability of recontact for research recruitment, and genotype-driven recruitment was viewed as a positive sign of scientific advancement. Reactions to questions about the disclosure of individual genetic research results varied. Common themes included explaining the purpose of recontact, informing decisions about further participation, reciprocity, "information is valuable," and the possibility of benefit, as well as concerns about undue distress and misunderstanding. Our findings suggest contact about additional research may be least concerning if it involves a known element (e.g., trusted researchers). Also, for genotype-driven recruitment, it may be appropriate to set a lower bar for disclosure of individual results than the clinical utility threshold recommended more generally.

Epilepsy patient-participants and genetic research results as "answers".

Better understanding of how research participants with a known condition ascribe meaning to individual genetic results is important to help researchers and institutional review boards evaluate the potential benefits and harms of disclosing results in the context of genotype-driven research recruitment. Based on 29 in-depth interviews with epilepsy patients participating in a genetic study, we found that this population of research subjects anticipated that genetic research results would provide answers to a range of questions about the research process and their condition. Their multi-layered interpretations underscore the need for clear communication about the nature and limitations of results if individual or aggregate genetic results are returned in the process of recruitment for additional research.

Parent perspectives on pediatric genetic research and implications for genotype-driven research recruitment.

As genetic research is increasingly conducted in children, it is important to understand how parents make decisions about enrolling their children and what they think about receiving their children's genetic research results. We conducted semi-structured phone interviews with 23 parents of children enrolled in genetic studies of autism or diabetes. Qualitative thematic analysis focused on two important components of genetic research and genotype-driven recruitment: participation in genetic research and return of results. Our findings suggest that parents' preferences and perspectives may be specific to their child's disease and the needs of the family as a whole. Assessing the expectations of target research populations will be beneficial for developing best practices for pediatric genetic research, return of results, and genotype-driven recruitment.

The meaning of "control" for childbearing women in the US.

Childbearing women, healthcare providers, and commentators on birth broadly identify control as an important issue during childbirth; however, control is rarely defined in literature on the topic. Here we seek to deconstruct the term control as used by childbearing women to better understand the issues and concepts underpinning it. Based on qualitative interviews with 101 parous women in the United States, we analyze meanings of control within the context of birth narratives. We find these meanings correspond to five distinct domains: self-determination, respect, personal security, attachment, and knowledge. We also find ambivalence about this term and concept, in that half our sample recognizes "you cannot control birth". Together, these findings call into question the usefulness of the term for measuring quality or improving maternity care and highlight other concepts which may be more fruitfully explored.