Skip to main content

Amy Lynn Corneli

Professor in Population Health Sciences
Population Health Sciences

Selected Publications


Patient and Physician Perspectives of Systemic Lupus Erythematosus Flare: A Qualitative Study.

Journal Article J Rheumatol · May 1, 2024 OBJECTIVE: Systemic lupus erythematosus (SLE) flares are associated with increased damage and decreased health-related quality of life. We hypothesized that there is discordance between physicians' and patients' views of SLE flare. In this study, we aimed ... Full text Link to item Cite

How men influence young women taking PrEP: perspectives from young women, male partners, and male peers in Siaya county, Western Kenya.

Conference BMC Womens Health · April 3, 2024 BACKGROUND: Daily oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention option for those who are most vulnerable to HIV infection, especially young women (YW). Objection by or lack of support from male sexual partners has been shown to impact ... Full text Link to item Cite

Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study.

Journal Article Harm Reduct J · March 26, 2024 BACKGROUND: People who inject drugs (PWID) are at high risk for opioid overdose and infectious diseases including HIV. We piloted PARTNER UP, a telemedicine-based program to provide PWID with medication for opioid use disorder (MOUD) with buprenorphine/nal ... Full text Link to item Cite

The Type 1 & 2 systemic lupus erythematosus model: Perspectives of people living with systemic lupus erythematosus.

Journal Article Lupus · March 2024 OBJECTIVE: In the new Type 1 & 2 model for systemic lupus erythematosus (SLE), Type 1 SLE represents classic inflammatory manifestations, such as arthritis, while Type 2 SLE encompasses symptoms such as pain and fatigue where the relationship to inflammati ... Full text Link to item Cite

Identifying Implementation Strategies to Enhance HIV Pre-Exposure Prophylaxis Uptake Among Black Cisgender Women in New Orleans, Louisiana.

Journal Article AIDS Patient Care STDS · March 2024 There is an unmet need for HIV prevention among Black cisgender women. From January to November 2020, we conducted formative research to develop locally informed implementation strategies to enhance pre-exposure prophylaxis (PrEP) uptake among Black cisgen ... Full text Link to item Cite

Sexually Transmitted Infection Prevention Perspectives in Black Men Who Have Sex With Men Taking Preexposure Prophylaxis in New Orleans.

Journal Article Sex Transm Dis · February 1, 2024 INTRODUCTION: Profound sexual health disparities exist for Black men who have sex with men (MSM) in the US South, including a high prevalence of sexually transmitted infections (STIs). Sexually transmitted infection prevention strategies beyond condoms are ... Full text Link to item Cite

A qualitative study of facilitators of medication adherence in systemic lupus erythematosus: Perspectives from rheumatology providers/staff and patients.

Journal Article Lupus · February 2024 OBJECTIVE: Systemic lupus erythematosus (SLE) disproportionately affects patients from racial and ethnic minority groups. Medication adherence is lower among these patient populations, and nonadherence is associated with worse health outcomes. We aimed to ... Full text Open Access Link to item Cite

Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.

Journal Article Pilot Feasibility Stud · January 17, 2024 BACKGROUND: The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. METHODS: Using a randomized, cross-over study design, we conducted a qualitative descri ... Full text Link to item Cite

Impact of a Multi-Institutional Initiative to Engage Students and Early-Stage Scholars From Underrepresented Racial and Ethnic Minority Groups in HIV Research: The Centers for AIDS Research Diversity, Equity, and Inclusion Pathway Initiative.

Journal Article J Acquir Immune Defic Syndr · October 1, 2023 BACKGROUND: The Centers for AIDS Research Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI) aims to establish programs to develop pathways for successful careers in HIV science among scholars from underrepresented racial and ethnic populations. ... Full text Link to item Cite

Evidence2Practice (E2P): Leveraging Implementation Science to Promote Careers in HIV Research Among Students From Historically Black Colleges and Universities.

Journal Article J Acquir Immune Defic Syndr · October 1, 2023 BACKGROUND: The HIV research workforce is not representative of populations most affected by the epidemic. Innovative educational programs are needed to motivate diverse student populations to pursue careers in HIV research. METHODS: The Duke University Ce ... Full text Open Access Link to item Cite

Centers for AIDS Research (CFAR) Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI): Developing Career Pathways for Early-Stage Scholars From Racial and Ethnic Groups Underrepresented in HIV Science and Medicine.

Journal Article J Acquir Immune Defic Syndr · October 1, 2023 BACKGROUND: There is an urgent need to increase diversity among scientific investigators in the HIV research field to be more reflective of communities highly affected by the HIV epidemic. Thus, it is critical to promote the inclusion and advancement of ea ... Full text Link to item Cite

Patients' Experiences With the Removal of a Ureteral Stent: Insights From In-depth Interviews With Participants in the USDRN STENTS Qualitative Cohort Study.

Journal Article Urology · August 2023 OBJECTIVE: To describe the experiences of patients undergoing stent removal in the USDRN Study to Enhance Understanding of Stent-Associated Symptoms (STENTS), a prospective, observational cohort study of patients with short-term ureteral stent placement po ... Full text Link to item Cite

A Multi-Study Synthesis of Facilitators and Barriers to SARS-CoV-2 Testing Enrollment in School Settings.

Journal Article Pediatrics · July 1, 2023 OBJECTIVES: Understanding the motivators and barriers to testing enrollment from different stakeholder perspectives is essential to increasing participation in school-based testing programs, particularly among underserved populations. This multistudy analy ... Full text Link to item Cite

The Patient Voice: Stent Experiences After Ureteroscopy-Insights from In-Depth Interviews with Participants in the USDRN STENTS Nested Qualitative Cohort Study.

Journal Article J Endourol · June 2023 Purpose: Ureteral stents are commonly used after ureteroscopy and cause significant discomfort, yet qualitative perspectives on patients' stent experiences remain unknown. We describe psychological, functional, and interpersonal effects of post-ureteroscop ... Full text Link to item Cite

Multilevel Factors Influencing Interruptions in PrEP Use Among Young Women in Siaya County, Kenya.

Journal Article AIDS Educ Prev · April 2023 Young women in sub-Saharan Africa continue to be disproportionately at risk for HIV. Oral pre-exposure prophylaxis (PrEP) can reduce women's HIV risk when taken daily throughout their "seasons of risk". We used photovoice to describe community views on fac ... Full text Link to item Cite

A survey of South Carolina pharmacists' readiness to prescribe human immunodeficiency virus pre-exposure prophylaxis.

Journal Article J Am Coll Clin Pharm · April 2023 INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is largely underutilized in the Southern United States. Given their community presence, pharmacists are well positioned to provide PrEP within rural, Southern regions. However, pharmacists' readiness to pre ... Full text Link to item Cite

Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data.

Journal Article Arthritis Care Res (Hoboken) · March 2023 OBJECTIVE: Despite high rates of medication nonadherence among patients with systemic lupus erythematosus (SLE), effective interventions to improve adherence in SLE are limited. We aimed to assess the feasibility of a pilot intervention and explore its eff ... Full text Open Access Link to item Cite

Investigating gender-based differential item functioning on the Kansas City Cardiomyopathy Questionnaire (KCCQ) using qualitative content analysis.

Journal Article Qual Life Res · March 2023 PURPOSE: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KC ... Full text Link to item Cite

Patient and Physician Perspectives of Systemic Lupus Erythematosus Flare: A Qualitative Study.

Journal Article J Rheumatol · May 1, 2024 OBJECTIVE: Systemic lupus erythematosus (SLE) flares are associated with increased damage and decreased health-related quality of life. We hypothesized that there is discordance between physicians' and patients' views of SLE flare. In this study, we aimed ... Full text Link to item Cite

How men influence young women taking PrEP: perspectives from young women, male partners, and male peers in Siaya county, Western Kenya.

Conference BMC Womens Health · April 3, 2024 BACKGROUND: Daily oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention option for those who are most vulnerable to HIV infection, especially young women (YW). Objection by or lack of support from male sexual partners has been shown to impact ... Full text Link to item Cite

Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study.

Journal Article Harm Reduct J · March 26, 2024 BACKGROUND: People who inject drugs (PWID) are at high risk for opioid overdose and infectious diseases including HIV. We piloted PARTNER UP, a telemedicine-based program to provide PWID with medication for opioid use disorder (MOUD) with buprenorphine/nal ... Full text Link to item Cite

The Type 1 & 2 systemic lupus erythematosus model: Perspectives of people living with systemic lupus erythematosus.

Journal Article Lupus · March 2024 OBJECTIVE: In the new Type 1 & 2 model for systemic lupus erythematosus (SLE), Type 1 SLE represents classic inflammatory manifestations, such as arthritis, while Type 2 SLE encompasses symptoms such as pain and fatigue where the relationship to inflammati ... Full text Link to item Cite

Identifying Implementation Strategies to Enhance HIV Pre-Exposure Prophylaxis Uptake Among Black Cisgender Women in New Orleans, Louisiana.

Journal Article AIDS Patient Care STDS · March 2024 There is an unmet need for HIV prevention among Black cisgender women. From January to November 2020, we conducted formative research to develop locally informed implementation strategies to enhance pre-exposure prophylaxis (PrEP) uptake among Black cisgen ... Full text Link to item Cite

Sexually Transmitted Infection Prevention Perspectives in Black Men Who Have Sex With Men Taking Preexposure Prophylaxis in New Orleans.

Journal Article Sex Transm Dis · February 1, 2024 INTRODUCTION: Profound sexual health disparities exist for Black men who have sex with men (MSM) in the US South, including a high prevalence of sexually transmitted infections (STIs). Sexually transmitted infection prevention strategies beyond condoms are ... Full text Link to item Cite

A qualitative study of facilitators of medication adherence in systemic lupus erythematosus: Perspectives from rheumatology providers/staff and patients.

Journal Article Lupus · February 2024 OBJECTIVE: Systemic lupus erythematosus (SLE) disproportionately affects patients from racial and ethnic minority groups. Medication adherence is lower among these patient populations, and nonadherence is associated with worse health outcomes. We aimed to ... Full text Open Access Link to item Cite

Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.

Journal Article Pilot Feasibility Stud · January 17, 2024 BACKGROUND: The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. METHODS: Using a randomized, cross-over study design, we conducted a qualitative descri ... Full text Link to item Cite

Impact of a Multi-Institutional Initiative to Engage Students and Early-Stage Scholars From Underrepresented Racial and Ethnic Minority Groups in HIV Research: The Centers for AIDS Research Diversity, Equity, and Inclusion Pathway Initiative.

Journal Article J Acquir Immune Defic Syndr · October 1, 2023 BACKGROUND: The Centers for AIDS Research Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI) aims to establish programs to develop pathways for successful careers in HIV science among scholars from underrepresented racial and ethnic populations. ... Full text Link to item Cite

Evidence2Practice (E2P): Leveraging Implementation Science to Promote Careers in HIV Research Among Students From Historically Black Colleges and Universities.

Journal Article J Acquir Immune Defic Syndr · October 1, 2023 BACKGROUND: The HIV research workforce is not representative of populations most affected by the epidemic. Innovative educational programs are needed to motivate diverse student populations to pursue careers in HIV research. METHODS: The Duke University Ce ... Full text Open Access Link to item Cite

Centers for AIDS Research (CFAR) Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI): Developing Career Pathways for Early-Stage Scholars From Racial and Ethnic Groups Underrepresented in HIV Science and Medicine.

Journal Article J Acquir Immune Defic Syndr · October 1, 2023 BACKGROUND: There is an urgent need to increase diversity among scientific investigators in the HIV research field to be more reflective of communities highly affected by the HIV epidemic. Thus, it is critical to promote the inclusion and advancement of ea ... Full text Link to item Cite

Patients' Experiences With the Removal of a Ureteral Stent: Insights From In-depth Interviews With Participants in the USDRN STENTS Qualitative Cohort Study.

Journal Article Urology · August 2023 OBJECTIVE: To describe the experiences of patients undergoing stent removal in the USDRN Study to Enhance Understanding of Stent-Associated Symptoms (STENTS), a prospective, observational cohort study of patients with short-term ureteral stent placement po ... Full text Link to item Cite

A Multi-Study Synthesis of Facilitators and Barriers to SARS-CoV-2 Testing Enrollment in School Settings.

Journal Article Pediatrics · July 1, 2023 OBJECTIVES: Understanding the motivators and barriers to testing enrollment from different stakeholder perspectives is essential to increasing participation in school-based testing programs, particularly among underserved populations. This multistudy analy ... Full text Link to item Cite

The Patient Voice: Stent Experiences After Ureteroscopy-Insights from In-Depth Interviews with Participants in the USDRN STENTS Nested Qualitative Cohort Study.

Journal Article J Endourol · June 2023 Purpose: Ureteral stents are commonly used after ureteroscopy and cause significant discomfort, yet qualitative perspectives on patients' stent experiences remain unknown. We describe psychological, functional, and interpersonal effects of post-ureteroscop ... Full text Link to item Cite

Multilevel Factors Influencing Interruptions in PrEP Use Among Young Women in Siaya County, Kenya.

Journal Article AIDS Educ Prev · April 2023 Young women in sub-Saharan Africa continue to be disproportionately at risk for HIV. Oral pre-exposure prophylaxis (PrEP) can reduce women's HIV risk when taken daily throughout their "seasons of risk". We used photovoice to describe community views on fac ... Full text Link to item Cite

A survey of South Carolina pharmacists' readiness to prescribe human immunodeficiency virus pre-exposure prophylaxis.

Journal Article J Am Coll Clin Pharm · April 2023 INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is largely underutilized in the Southern United States. Given their community presence, pharmacists are well positioned to provide PrEP within rural, Southern regions. However, pharmacists' readiness to pre ... Full text Link to item Cite

Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data.

Journal Article Arthritis Care Res (Hoboken) · March 2023 OBJECTIVE: Despite high rates of medication nonadherence among patients with systemic lupus erythematosus (SLE), effective interventions to improve adherence in SLE are limited. We aimed to assess the feasibility of a pilot intervention and explore its eff ... Full text Open Access Link to item Cite

Investigating gender-based differential item functioning on the Kansas City Cardiomyopathy Questionnaire (KCCQ) using qualitative content analysis.

Journal Article Qual Life Res · March 2023 PURPOSE: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KC ... Full text Link to item Cite

Caregivers of Black and Latino/a/x Students and School Personnel Perspectives on School-Based SARS-CoV-2 Testing: Implications for Testing and Test-to-Stay Programs in K-12 Schools.

Journal Article J Sch Health · March 2023 BACKGROUND: "Test-to-stay" (TTS) is an effective approach for keeping students in school post-exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To prepare for school-based SARS-CoV-2 testing, we implemented formative research to gat ... Full text Link to item Cite

Enhancing Diversity and Inclusion in Clinical Trials.

Journal Article Clin Pharmacol Ther · March 2023 Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of t ... Full text Link to item Cite

Development of an mHealth App to Support the Prevention of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Engaged in Pre-exposure Prophylaxis Care in New Orleans, Louisiana: Qualitative User-Centered Design Study.

Journal Article JMIR Form Res · February 27, 2023 BACKGROUND: Sexual health disparities exist for Black men who have sex with men (BMSM) in New Orleans, Louisiana. Rates of sexually transmitted infections (STIs) are high for both BMSM and those taking HIV pre-exposure prophylaxis (PrEP). OBJECTIVE: In thi ... Full text Link to item Cite

Patient perspectives on considerations, tradeoffs, and experiences with multiple myeloma treatment selection: a qualitative descriptive study.

Journal Article BMC Cancer · January 19, 2023 BACKGROUND: Advances in multiple myeloma treatment and a proliferation of treatment options have resulted in improved survival rates and periods of symptom-free remission for many multiple myeloma patients. As a result, health-related quality of life (HRQo ... Full text Link to item Cite

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints.

Journal Article Digit Biomark · 2023 INTRODUCTION: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. METHOD ... Full text Link to item Cite

Stakeholder Reflections on Implementing the National Institutes of Health's Policy on Single Institutional Review Boards.

Journal Article Ethics Hum Res · 2023 The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-depth interviews wit ... Full text Link to item Cite

Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation.

Journal Article Harm Reduct J · December 3, 2022 BACKGROUND: People who inject drugs (PWID) are at risk for HIV and opioid overdose. We piloted PARTNER UP, a telemedicine-based program to provide PWID with access to both oral pre-exposure prophylaxis (PrEP) for HIV prevention and medication for opioid us ... Full text Link to item Cite

EngagINg the COmmunity to Reduce Preterm birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3): intervention development and future pilot study design.

Journal Article J Matern Fetal Neonatal Med · December 2022 OBJECTIVE: Non-Hispanic Black birthing individuals are at increased risk of preterm birth compared to other racial and ethnic groups. In our clinical setting, we offer a tailored package of recommendations to reduce the risk of preterm birth known as an in ... Full text Link to item Cite

Initial Content Validation and Roadmap for a New Patient-Reported Outcome Measure of Pain Intensity.

Journal Article J Pain · November 2022 Measures of pain intensity (eg, numeric rating scales [NRS]) are widely used in clinical research and practice. While these measures have evidence for validity and reliability, poor standardization of instructions, and response options limits precision of ... Full text Link to item Cite

Stakeholders' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2).

Journal Article Contemp Clin Trials Commun · October 2022 BACKGROUND: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, ... Full text Link to item Cite

Episodic Use of Pre-Exposure Prophylaxis Among Young Cisgender Women in Siaya County, Kenya.

Journal Article AIDS Patient Care STDS · October 2022 The concept "seasons of risk" promotes use of pre-exposure prophylaxis (PrEP) only during periods of HIV risk. PrEP guidelines are aligned on daily use in women having vaginal sex during a risk period, and daily use for 28 days after the last potential exp ... Full text Link to item Cite

Barriers to Taking Medications for Systemic Lupus Erythematosus: A Qualitative Study of Racial Minority Patients, Lupus Providers, and Clinic Staff.

Journal Article Arthritis Care Res (Hoboken) · September 2022 OBJECTIVE: Underrepresented racial and ethnic minorities are disproportionately affected by systemic lupus erythematosus (SLE). Racial and ethnic minorities also have more severe SLE manifestations that require use of immunosuppressive medications, and oft ... Full text Open Access Link to item Cite

Intermittent and Persistent Type 2 lupus: patient perspectives on two distinct patterns of Type 2 SLE symptoms.

Journal Article Lupus Sci Med · August 2022 OBJECTIVE: We have developed a new conceptual model to characterise the signs and symptoms of SLE: the Type 1 and 2 SLE Model. Within the original model, Type 1 SLE consists of inflammatory manifestations like arthritis, nephritis and rashes; Type 2 SLE in ... Full text Link to item Cite

Identification of Determinants and Implementation Strategies to Increase PrEP Uptake Among Black Same Gender-Loving Men in Mecklenburg County, North Carolina: The PrEP-MECK Study.

Journal Article J Acquir Immune Defic Syndr · July 1, 2022 BACKGROUND: Pre-exposure prophylaxis (PrEP) use is low among Black same gender-loving men (BSGLM) in Mecklenburg County, NC, an Ending the HIV Epidemic priority jurisdiction. We created PrEP-MECK-an investigator partnership among a community-based organiza ... Full text Link to item Cite

Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.

Journal Article Health Expect · June 2022 INTRODUCTION: Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as ... Full text Link to item Cite

"An Extra Variable to Consider"-Vaccine-Induced Seropositivity and Adolescent HIV Vaccine Clinical Trials.

Journal Article J Pediatric Infect Dis Soc · May 30, 2022 Our study explores the understanding of vaccine-induced seropositivity (VISP) and its potential impact on US adolescents' and caregivers' willingness to participate in adolescent HIV vaccine clinical trials. Findings from in-depth interviews suggest that a ... Full text Link to item Cite

Perspectives of HIV specialists and cardiologists on the specialty referral process for people living with HIV: a qualitative descriptive study.

Journal Article BMC Health Serv Res · May 9, 2022 BACKGROUND: Cardiology care may be beneficial for risk factor management in people living with HIV (PLWH), yet limited information is available about the referral process from the perspectives of HIV specialists and cardiologists. METHODS: We conducted 28 ... Full text Link to item Cite

Seminary Students and Physical Health: Beliefs, Behaviors, and Barriers.

Journal Article J Relig Health · April 2022 As an occupational group, clergy exhibit numerous physical health problems. Given the physical health problems faced by clergy, understanding where physical health falls within the priorities of seminary students, the ways students conceptualize physical h ... Full text Link to item Cite

HIV Prevention During the COVID-19 Pandemic: Sexual Activity and PrEP Use Among Black Same-Gender-Loving Men and Black Cisgender Women.

Journal Article AIDS Educ Prev · April 2022 Black populations in the U.S. South are disproportionally affected by HIV and COVID-19 due to longstanding inequalities. We conducted 20 in-depth interviews-12 with Black same-gender-loving men and 8 with Black cisgender women-to explore the impact of the ... Full text Link to item Cite

Masking Adherence in K-12 Schools and SARS-CoV-2 Secondary Transmission.

Journal Article Pediatrics · February 1, 2022 OBJECTIVES: Masking is an essential coronavirus 2019 mitigation tool assisting in the safe return of kindergarten through 12th grade children and staff to in-person instruction; however, masking adherence, compliance evaluation methods, and potential conse ... Full text Link to item Cite

A Qualitative Study Documenting Black Birthing Individuals' Perspectives on the Disproportionate Rate of Preterm Birth in the Black Community.

Journal Article Womens Health Rep (New Rochelle) · 2022 BACKGROUND: Compared with all other racial and ethnic groups, the rate of preterm birth (PTB) is 50% higher among non-Hispanic Blacks (NHB). There are limited published data focused on the etiology of the racial disparity in PTB from the perspective of Bla ... Full text Link to item Cite

IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk.

Journal Article Health Equity · 2022 INTRODUCTION: Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic bl ... Full text Open Access Link to item Cite

Racial Differences in Patient-provider Communication, Patient Self-efficacy, and Their Associations With Systemic Lupus Erythematosus-related Damage: A Cross-sectional Survey.

Journal Article J Rheumatol · July 2021 OBJECTIVE: Despite significant racial disparities in systemic lupus erythematosus (SLE) outcomes, few studies have examined how disparities may be perpetuated in clinical encounters. We aimed to explore associations between areas of clinical encounters - p ... Full text Open Access Link to item Cite

Stakeholders' recommendations for revising Good Clinical Practice.

Journal Article Contemp Clin Trials Commun · June 2021 The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is revising ICH E6 Good Clinical Practice (GCP). The Clinical Trials Transformation Initiative (CTTI) initiated a project to identify and provide ... Full text Link to item Cite

Pediatric Trials Network: Stakeholder views on thanking families and providing study findings on pragmatic pediatric clinical research.

Journal Article Contemp Clin Trials Commun · June 2021 We conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric studies ... Full text Link to item Cite

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.

Journal Article Ethics Hum Res · May 2021 The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human ... Full text Link to item Cite

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development.

Journal Article Ther Innov Regul Sci · March 2021 INTRODUCTION: Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is curr ... Full text Link to item Cite

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study.

Journal Article JMIR Mhealth Uhealth · February 12, 2021 BACKGROUND: The successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mob ... Full text Link to item Cite

Couple communication and contraception use in urban Senegal.

Journal Article SAGE Open Med · 2021 OBJECTIVES: Couple communication about family planning has been shown to increase uptake of contraception. However, couple communication is often measured based solely on one partner's report of communication. This research investigates the influence of co ... Full text Link to item Cite

Cohorts as collections of bodies and communities of persons: insights from the SEARCH010/RV254 research cohort.

Journal Article International health · November 2020 Longitudinal research cohorts are uniquely suited to answer research questions about morbidity and mortality. Cohorts may be comprised of individuals identified by specific conditions or other shared traits. We argue that research cohorts are more than sim ... Full text Cite

Pregnancy vs. paycheck: a qualitative study of patient's experience with employment during pregnancy at high risk for preterm birth.

Journal Article BMC Pregnancy Childbirth · September 25, 2020 BACKGROUND: Pregnant women with a history of preterm birth are at risk for recurrence, often requiring frequent prenatal visits for close monitoring and/or preventive therapies. Employment demands can limit uptake and adherence to recommended monitoring an ... Full text Link to item Cite

Parallel but connected: Nuances of conducting behavioral and social science research alongside ethically challenging HIV remission trials.

Journal Article Contemp Clin Trials Commun · September 2020 Collaborations between clinical investigators and behavioral and social science researchers (BSSR) produce many benefits, but also may generate challenges and complexities. Ongoing relationships between teams may affect the research carried out by the BSSR ... Full text Link to item Cite

More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.

Journal Article Contemp Clin Trials Commun · September 2020 BACKGROUND: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist about whether the current structure and delivery of GCP training sufficiently prepares cli ... Full text Link to item Cite

Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.

Journal Article Ther Innov Regul Sci · July 2020 BACKGROUND: Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentraliz ... Full text Link to item Cite

Racial Disparities in Medication Adherence between African American and Caucasian Patients With Systemic Lupus Erythematosus and Their Associated Factors.

Journal Article ACR Open Rheumatol · July 2020 OBJECTIVE: Medication nonadherence is more common in African Americans compared with Caucasians. We examined the racial adherence gaps among patients with systemic lupus erythematosus (SLE) and explored factors associated with nonadherence. METHODS: Cross- ... Full text Open Access Link to item Cite

Understanding of Perceived Infectiousness and Its Influence on Sexual Behavior Among Individuals With Acute HIV Infection in Lilongwe, Malawi (HPTN 062).

Journal Article AIDS Educ Prev · June 2020 We implemented HPTN 062, an acceptability and feasibility study of a motivational-interviewing (MI) intervention to reduce HIV transmission among individuals with acute HIV infection (AHI) in Lilongwe, Malawi. Participants were randomly assigned to receive ... Full text Link to item Cite

Consensus on Language for Advance Informed Consent in Health Care-Associated Pneumonia Clinical Trials Using a Delphi Process.

Journal Article JAMA Netw Open · May 1, 2020 IMPORTANCE: Information to be included in advance informed consent forms for health care-associated pneumonia treatment trials remains to be determined. OBJECTIVE: To identify and determine how to describe information to be included in an advance informed ... Full text Link to item Cite

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials.

Journal Article Contemp Clin Trials Commun · March 2020 BACKGROUND/AIMS: Numerous reasons have been identified for why U.S.-based principal investigators choose to not continue participating in FDA-regulated trials. However, unexplored are reasons why a substantial number of principal investigators, facing the ... Full text Link to item Cite

Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative.

Journal Article Contemp Clin Trials Commun · December 2019 The Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project was prompted by the need to understand the reasons for high rates of turnover among investigators who lead US Food and Administration-regulated clinical t ... Full text Link to item Cite

Patient preferences for using mobile technologies in clinical trials.

Journal Article Contemp Clin Trials Commun · September 2019 The use of mobile technologies to collect participant data in clinical trials offers a number of scientific and logistical advantages. However, little is known about potential research participant preferences about how to incorporate mobile technologies in ... Full text Link to item Cite

How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches.

Journal Article AIDS Behav · August 2019 In the field of biomedical HIV prevention, researchers have meaningfully incorporated behavioral and social sciences research (BSSR) into numerous clinical trials, though the timing and degree of integration have been highly variable. The literature offers ... Full text Link to item Cite

Improving Uptake and Adherence to 17-Hydroxyprogesterone Caproate in Non-Hispanic Black Women: A Mixed Methods Study of Potential Interventions from the Patient Perspective.

Journal Article Biores Open Access · 2019 Women with a history of a preterm birth (PTB) are at high risk for recurrence. Weekly 17-hydroxyprogestrone caproate (17-P) injections can reduce the risk of recurrence in women with prior spontaneous PTB. PTB occurs disproportionately in non-Hispanic blac ... Full text Link to item Cite

Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia.

Journal Article JAMA Netw Open · December 7, 2018 IMPORTANCE: Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However ... Full text Link to item Cite

Adaptation and delivery of a motivational interviewing-based counseling program for persons acutely infected with HIV in Malawi: Implementation and lessons learned.

Journal Article Patient Educ Couns · June 2018 OBJECTIVE: Individuals diagnosed with acute HIV infection (AHI) are highly infectious and require immediate HIV prevention efforts to minimize their likelihood of transmitting HIV to others. We sought to explore the relevance of Motivational Interviewing ( ... Full text Link to item Cite

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

Journal Article Contemp Clin Trials Commun · March 2018 Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recrui ... Full text Link to item Cite

Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

Journal Article Contemp Clin Trials Commun · March 2018 An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators complet ... Full text Link to item Cite

Perceptions of Equipoise, Risk-Benefit Ratios, and "Otherwise Healthy Volunteers" in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry.

Journal Article Journal of empirical research on human research ethics : JERHRE · February 2018 Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the co ... Full text Cite

The Clinical Trials Transformation Initiative: Methodology supporting the mission.

Journal Article Clin Trials · February 2018 The mission of the Clinical Trials Transformation Initiative, a public-private partnership co-founded by the U.S. Food and Drug Administration and Duke University, is to develop and drive adoption of practices that will increase the quality and efficiency ... Full text Link to item Cite

Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review.

Journal Article Digit Biomark · 2018 BACKGROUND: The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to ... Full text Link to item Cite

Research on HIV cure: Mapping the ethics landscape.

Journal Article PLoS Med · December 2017 In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure. ... Full text Link to item Cite

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial.

Journal Article Contemp Clin Trials Commun · June 2017 Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA) Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principa ... Full text Link to item Cite

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

Journal Article J Empir Res Hum Res Ethics · February 2017 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 clini ... Full text Link to item Cite

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

Journal Article Cult Health Sex · September 2016 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 w ... Full text Link to item Cite

Contraceptive service delivery in Kenya: A qualitative study to identify barriers and preferences among female sex workers and health care providers.

Journal Article Contraception · July 2016 OBJECTIVE: Female sex workers (FSWs) need access to contraceptive services, yet programs often focus on HIV prevention and less on the broader sexual and reproductive health needs of FSWs. We aimed to identify barriers to accessing contraceptive services a ... Full text Link to item Cite

Participants' Explanations for Nonadherence in the FEM-PrEP Clinical Trial.

Journal Article J Acquir Immune Defic Syndr · April 1, 2016 BACKGROUND: FEM-PrEP-a clinical trial of daily, oral emtricitabine/tenofovir disoproxil fumarate for HIV prevention among women in sub-Saharan Africa-did not show a reduction in HIV acquisition because of low adherence to the study pill. We conducted a fol ... Full text Link to item Cite

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.

Journal Article AIDS Patient Care STDS · September 2015 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-ex ... Full text Link to item Cite

Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials.

Journal Article AIDS Behav · May 2015 Oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has been evaluated as pre-exposure prophylaxis (PrEP). We describe the accuracy of self-reported adherence to FTC/TDF and pill counts when compared to drug concentrations in the FEM-PrEP trial. Usi ... Full text Link to item Cite

The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.

Journal Article J Acquir Immune Defic Syndr · April 15, 2015 BACKGROUND: FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good ... Full text Link to item Cite

HPTN 062: A Pilot Randomized Controlled Trial Exploring the Effect of a Motivational-Interviewing Intervention on Sexual Behavior among Individuals with Acute HIV Infection in Lilongwe, Malawi.

Journal Article PLoS One · 2015 OBJECTIVE: We pilot tested a Motivational Interviewing (MI) -based counseling intervention for individuals with Acute HIV Infection (AHI) to reduce risky sexual behavior in Lilongwe, Malawi. METHODS: Twenty-eight individuals diagnosed with AHI were randomi ... Full text Link to item Cite

Perceptions of voluntary medical male circumcision among circumcising and non-circumcising communities in Malawi.

Journal Article Glob Public Health · 2015 Three randomised controlled trials in Africa indicated that voluntary medical male circumcision (VMMC) is an effective method to reduce a man's risk of becoming infected through sex with an HIV-positive female partner. The success of recent public health i ... Full text Link to item Cite

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.

Journal Article PLoS One · 2015 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 P ... Full text Link to item Cite

Facilitators of adherence to the study pill in the FEM-PrEP clinical trial.

Journal Article PLoS One · 2015 INTRODUCTION: FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up stud ... Full text Link to item Cite

Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial

Journal Article Open Access Journal of Clinical Trials · December 19, 2014 We implemented an empirically informed, geographically based recruitment approach for FEM-PrEP, a human immunodeficiency virus (HIV) prevention clinical trial of daily oral emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) for HIV prevention. Dur ... Full text Cite

Perception of HIV risk and adherence to a daily, investigational pill for HIV prevention in FEM-PrEP.

Journal Article J Acquir Immune Defic Syndr · December 15, 2014 BACKGROUND: FEM-PrEP was unable to demonstrate the effectiveness of oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis for HIV prevention because of low adherence. We hypothesized that one reason for the poor adherence w ... Full text Link to item Cite

HPTN 062: a feasibility and acceptability pilot intervention to reduce HIV transmission risk behaviors among individuals with acute and early HIV infection in Lilongwe, Malawi.

Journal Article AIDS Behav · September 2014 Acute HIV infection (AHI) is a relatively brief period of time when individuals are highly infectious and the opportunity to intervene to prevent forward transmission is extremely limited. HPTN 062 partnered with CHAVI 001 to evaluate the feasibility and a ... Full text Link to item Cite

FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis.

Journal Article J Acquir Immune Defic Syndr · July 1, 2014 BACKGROUND: Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate (TDF), with or without emtricitabine (FTC), as pre-exposure prophylaxis (PrEP) for reducing the risk of HIV acquisition. Adherence to t ... Full text Link to item Cite

Widow cleansing and inheritance among the Luo in Kenya: the need for additional women-centred HIV prevention options.

Journal Article J Int AIDS Soc · 2014 INTRODUCTION: The customs of widow cleansing and widow inheritance are practiced in several communities throughout sub-Saharan Africa. In the Nyanza Province of Kenya, according to tradition, Luo widows are expected to engage in sexual intercourse with a " ... Full text Link to item Cite

A descriptive analysis of perceptions of HIV risk and worry about acquiring HIV among FEM-PrEP participants who seroconverted in Bondo, Kenya, and Pretoria, South Africa.

Journal Article J Int AIDS Soc · 2014 INTRODUCTION: Risk perception is a core construct in many behaviour change theories in public health. Individuals who believe they are at risk of acquiring an illness may be more likely to engage in behaviours to reduce that risk; those who do not feel at ... Full text Link to item Cite

The sexual risk context among the FEM-PrEP study population in Bondo, Kenya and Pretoria, South Africa.

Journal Article PLoS One · 2014 BACKGROUND: Incidence rates in the FEM-PrEP and VOICE trials demonstrate that women from diverse sub-Saharan African communities continue to be at substantial HIV risk. OBJECTIVE: To describe and compare the sexual risk context of the study population from ... Full text Link to item Cite

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials.

Journal Article AIDS Behav · July 2013 Adherence is a critical component of the success of antiretroviral-based pre-exposure prophylaxis (PrEP) in averting new HIV-infections. Ensuring drug availability at the time of potential HIV exposure relies on self-directed product use. A deeper understa ... Full text Link to item Cite

Preexposure prophylaxis for HIV infection among African women.

Journal Article N Engl J Med · August 2, 2012 BACKGROUND: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. METHODS: In this randomized, double-blind, placebo-controlled trial, we ass ... Full text Link to item Cite

No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial.

Journal Article Contraception · March 2012 BACKGROUND: Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials. STUDY DESIGN: Qualitative research was conducted in Madagascar, South Africa, a ... Full text Link to item Cite

Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods.

Journal Article AIDS Behav · February 2012 Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilong ... Full text Link to item Cite

Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: A focus on local stakeholder involvement

Journal Article Open Access Journal of Clinical Trials · January 1, 2012 Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and the AIDS Vaccine Advocacy Coalition developed good participatory p ... Full text Cite

Are there adverse consequences of quizzing during informed consent for HIV research?

Journal Article J Med Ethics · November 2011 INTRODUCTION: While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational H ... Full text Link to item Cite

Continued high risk sexual behavior following diagnosis with acute HIV infection in South Africa and Malawi: implications for prevention.

Journal Article AIDS Behav · August 2011 Understanding sexual behavior following diagnosis of acute HIV infection (AHI) is key to developing prevention programs targeting individuals diagnosed with AHI. We conducted separate qualitative and quantitative interviews with individuals newly diagnosed ... Full text Link to item Cite

The role of disclosure in relation to assent to participate in HIV-related research among HIV-infected youth: a formative study.

Journal Article J Int AIDS Soc · August 27, 2009 BACKGROUND: The objective of this study was to develop a culturally appropriate approach for obtaining assent from children aged eight to 17 years to participate in paediatric HIV-related operational research in Kinshasa, Democratic Republic of Congo (DRC) ... Full text Link to item Cite

The process of HIV status disclosure to HIV-positive youth in Kinshasa, Democratic Republic of the Congo.

Journal Article AIDS Care · August 2008 As access to HIV/AIDS treatment increases in sub-Saharan Africa, greater attention is being paid to HIV-infected youth. Little is known about how HIV-positive youth are informed of their HIV infection. As part of a larger formative study informing a treatm ... Full text Link to item Cite

Patient and provider perspectives on implementation models of HIV counseling and testing for patients with TB.

Journal Article Int J Tuberc Lung Dis · March 1, 2008 SETTING: TB clinics in Kinshasa, Democratic Republic of Congo. OBJECTIVES: To identify an acceptable approach to human immunodeficiency virus (HIV) counseling and testing (CT) for patients with tuberculosis (TB) from health care worker (HCWs) and patient p ... Link to item Cite

Patient and provider perspectives on implementation models of HIV counseling and testing for patients with TB.

Journal Article Int J Tuberc Lung Dis · March 2008 SETTING: TB clinics in Kinshasa, Democratic Republic of Congo. OBJECTIVES: To identify an acceptable approach to human immunodeficiency virus (HIV) counseling and testing (CT) for patients with tuberculosis (TB) from health care worker (HCWs) and patient p ... Link to item Cite

Focusing HIV prevention on those most likely to transmit the virus.

Journal Article AIDS Educ Prev · August 2007 Despite some success in reducing HIV incidence, the global epidemic continues to grow. For every person with AIDS in developing countries placed on treatment in 2005, many others were newly infected. We need more effective prevention programs that focus in ... Full text Link to item Cite

Applying research ethics guidelines: the view from a sub-saharan research ethics committee.

Journal Article J Empir Res Hum Res Ethics · June 2007 CONSIDERABLE VARIATION HAS BEEN demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of i ... Full text Link to item Cite

Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.

Journal Article Contemp Clin Trials · January 2007 OBJECTIVE: To learn the attitudes and concerns of the local community on participating in research, infant feeding practices, and maternal nutrition in order to inform the design of a clinical trial in Lilongwe, Malawi on the safety and efficacy of antiret ... Full text Link to item Cite

Using formative research to develop a context-specific approach to informed consent for clinical trials.

Journal Article J Empir Res Hum Res Ethics · December 2006 PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the conse ... Full text Link to item Cite

Differences between international recommendations on breastfeeding in the presence of HIV and the attitudes and counselling messages of health workers in Lilongwe, Malawi.

Journal Article Int Breastfeed J · March 9, 2006 BACKGROUND: To prevent postnatal transmission of HIV in settings where safe alternatives to breastfeeding are unavailable, the World Health Organization (WHO) recommends exclusive breastfeeding followed by early, rapid cessation of breastfeeding. Only limi ... Full text Link to item Cite

Perceptions of the role of maternal nutrition in HIV-positive breast-feeding women in Malawi.

Journal Article J Nutr · April 2005 A neglected issue in the literature on maternal nutrition and HIV is how HIV-positive women perceive their own bodies, health, and well-being, particularly in light of their infection, and whether these perceptions influence their infant feeding practices ... Full text Link to item Cite

Hantavirus pulmonary syndrome--United States: updated recommendations for risk reduction. Centers for Disease Control and Prevention.

Journal Article MMWR Recomm Rep · July 26, 2002 This report provides updated recommendations for prevention and control of hantavirus infections associated with rodents in the United States. It supersedes the previous report (CDC. Hantavirus infection--southwestern United States: interim recommendations ... Link to item Cite

Experimental evaluation of rodent exclusion methods to reduce hantavirus transmission to residents in a Native American community in New Mexico.

Journal Article Vector Borne Zoonotic Dis · 2002 We conducted a pilot study to evaluate the efficacy of rodent proofing continuously occupied homes as a method for lowering the risk for hantavirus pulmonary syndrome (HPS) among residents of a Native American community in northwestern New Mexico. Rodent p ... Full text Link to item Cite

Hantavirus pulmonary syndrome in the Americas: the early years.

Journal Article Semin Respir Crit Care Med · 2000 The initial recognition of hantavirus pulmonary syndrome (HPS) as a new disease associated with a cluster of acute respiratory deaths among American Indians in the southwestern United States in 1993 bears little resemblance to the current understanding of ... Full text Link to item Cite