Preferences for oral and injectable PrEP among qualitative sub-study participants in HPTN 084.

Background: HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women.

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.

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 ( = 171).

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 ( = 34) of FSWs in Addis Ababa, Ethiopia. FSWs also provided information on their experience with gender-based violence and condom use.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

IRB chairs' perspectives on 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, but also presents ethical challenges. To inform policy development on this issue, we conducted a survey of U.S.

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.

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.

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.

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.

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.

Fertility patients' views about frozen embryo disposition: results of a multi-institutional U.S. survey.

Objective: To describe fertility patients' preferences for disposition of cryopreserved embryos and determine factors important to these preferences.

Design: Cross-sectional survey conducted between June 2006 and July 2007.

Setting: Nine geographically diverse U.

Women's Autonomy and Informed Consent in Microbicides Clinical Trials.

ACHIEVING RESPECT FOR PERSONS is problematic in settings with concepts of autonomy that differ from Western values. For international research, women's autonomy to consent to participation is an increasingly contentious issue. We present data from ancillary studies conducted in preparation for a clinical trial testing the safety and efficacy of topical microbicides, used to prevent HIV infection.