Illustrative Publications

Listed below is a sample of studies with which The BASE Lab faculty and staff have been involved:

Formative and Stakeholder Preferences Research

Corneli A, Perry B, Collyar D, Powers III JH, Farley JJ, Calvert SB, Santiago J, Donnelly HK, Swezey T, Dombeck CB, De Anda C, Fowler VG, Holland TL. Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia. JAMA Network Open. 2018; 1(8):e185816.

Flynn KE, Kramer JM, Dombeck CB, Weinfurt KPParticipants’ perspectives on safety monitoring in clinical trials.  Clin Trials. 2013; 10(4):552-9.

Corneli A, Wong C, Eley NT, Mueller MP, Rabenja NL, Manzini N, Swezey T, Damme KV, Smit J, Behets F.  No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial. Contraception. 2012; 85(3):263-9.

Flynn KE, Reese JB, Jeffery DD, Abernethy AP, Lin L, Shelby RA, Porter LS, Dombeck CB, Weinfurt KP. Patient experiences with communication about sex during and after treatment for cancer. Psycho-oncology. 2012; 21(6):594-601.

Corneli A, Vaz L, Dulyx J, Omba S, Rennie S, Behets F. The role of disclosure in relation to assent to participate in HIV-related research among HIV-infected youth: a formative study. J Int AIDS Soc. 2009; 12(1):17.

Behets F, Van Damme K, Norris Turner A, Rabenja NL, Ravelomanana N, Raharinivo MSM, Zeller K, Rennie S, Swezey T. Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections. Sex Transm Dis. 2008; 35(3):238-42.

Corneli A, Piwoz E, Bentley ME, Moses A, Nkhoma JR, Tohill BC, Adair L, Mtimuni B, Ahmed Y, Duerr A, Kazembe P, van der Horst C; UNC Project BAN Study Team. Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi. Contemp Clin Trials. 2007; 28(1):59-67.

Corneli AL, Bentley ME, Sorenson JR, Henderson GE, van der Horst C, Moses A, Nkhoma J, Tenthani L, Ahmed Y, Heilig CM, Jamieson DJ. Using formative research to develop a context-specific approach to informed consent for clinical trials. J Empir Res Hum Res Ethics. 2006; 1(4):45-60.

Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ. Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth. 2003; 24(4):329-44. 


Qualitative/Mixed-Methods Research Embedded within Clinical Trials

MacQueen KM, Dlamini S, Perry B, Okumu E, Sortijas S, Singh C, Pillay D, Majors A, Jerome S, Watson S, Karim SA, Karim QA, Mansoor LE. Social Context of Adherence in an Open-Label 1 % Tenofovir Gel Trial: Gender Dynamics and Disclosure in KwaZulu-Natal, South Africa. AIDS Behav. 2016; 20:2682–91.

Agot K, Taylor D, Corneli A, Wang M, Ambia J, Kashuba A, Parker C, Lemons A, Malahleha M, Lombaard J, Damme L.  Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials. AIDS Behav. 2015; 19(5):743-5.

Corneli A, Wang M, Agot K, Ahmed K, Lombaard J, Van Damme L. Perception of HIV risk and adherence to a daily, investigational product for HIV prevention in FEM-PrEP. JAIDS. 2014; 67(5): 555-563.

Corneli A, Deese J, Wang M, Taylor D, Ahmed K, Agot K, Lombaard J, Manongi R, Kapiga S, Kashuba A, Van Damme L, for the FEM-PrEP Study Group. FEM-PrEP: Adherence patterns and factors associated with adherence to a daily, oral study product for pre-exposure prophylaxis. JAIDS. 2014; 66(3):324-331.


Qualitative/Mixed-Methods Studies to Explain Clinical Trial Findings

Corneli A, Perry B, McKenna K, Agot K, Ahmed K, Taylor J, Malamatsho F, Odhiambo J, Skhosana J, Van Damme L. Participants’ explanations for non-adherence in the FEM-PrEP clinical trial. JAIDS. 2016; 71(4):452-61.

Corneli A, McKenna K, Perry B, Ahmed K, Agot K, Malamatsho F, Skhosana J, Odhiambo J, Van Damme L. The science of being a study participant: FEM-PrEP participants’ explanations for over-reporting adherence to the study pills and on the whereabouts of unused pills. JAIDS. 2015; 68(5):578-84.

Corneli A, Perry B, Agot K, Ahmed K, Malamatsho F, Skhosana J, Odhiambo J, Damme L. Facilitators of Adherence to the Study Pill in the FEM-PrEP Clinical Trial. PLoS One. 2015; 10(4):e0125458.


Qualitative/Mixed Methods Research in Implementation Science

Corneli A, Namey E, Ahmed K, Agot K, Skhosana J, Odhiambo J, Guest G.  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. AIDS Patient Care STDs, . 2015; 29(9):503-9

Rennie S, Perry B, Corneli A, Chilungo A, Umar E. Perceptions of voluntary medical male circumcision among circumcising and non-circumcising communities in Malawi.  Global Public Health, . 2015; 2015; 10:679-91.

McKenna K, Arcara J, Rademacher K, Mackenzie C, Ngabo F, Munyambanza E, Wesson J, Tolley E.  Policy and programmatic considerations for introduction of a longer-acting injectable contraceptive. Glob Health Sci Pract. 2014; 2(4): 459-71.


Qualitative/Mixed Methods Research in Health Systems Research

Corneli A, Lemons A, Otieno-Masaba R, Ndiritu J, Packer C, Lamarre-Vincent J, Dulli L. Contraceptive Service Delivery in Kenya:  A Qualitative Study to Identify Barriers and Preferences among Female Sex Workers and Health Care Providers. Contraception. 2016; 94(1):34-9.

Mack N, Wong C, McKenna K, Lemons A, Odhiambo J, Agot K. Human Resource Challenges to integrating pre-exposure prophylaxis (PrEP) into the public health system in Kenya: A qualitative study. Afr J Reprod Health. 2015; 19(1):54-62.

Burke HM, Mueller MP, Perry B, Packer C, Bufumbo L, Mbengue D, Mall I, Daff BM, Mbonye AK. Observational study of the acceptability of Sayana® Press among intramuscular DMPA users in Uganda and Senegal. Contraception. 2014; 89(5):361-7.

Burke HM, Mueller MP, Packer C, Perry B, Bufumbo L, Mbengue D, Daff BM, Mbonye AK. Provider acceptability of Sayana® Press: Results from community health workers and clinic-based providers in Uganda and Senegal. Contraception. 2014; 89(5):368-73.


Qualitative/Mixed Methods Evaluation Research

Weinfurt K, Bollinger JM, Brelsford KM, Bresciani M, Lampron Z, Lin L, Topazian RJ, Sugarman J. Comparison of approaches for notification and authorization in pragmatic clinical research evaluating commonly used medical practices. Med Care. 2017; 55:970-8.

Corneli A, Pettifor A, Kamanga G, Golin C, McKenna K, Ou S, Hamela G, Massa C, Martinson F, Tharaldson J, Hilgenberg D, Yu X, Chege W, Hoffman I and the HPTN 062 study team. HPTN 062:  A feasibility and acceptability pilot intervention to reduce HIV transmission risk behaviors among individuals with acute and early HIV infection in Lilongwe, MalawiAIDS Behav. 2014; 19(9):1785-1800.

Corneli A, Sorenson J, Bentley ME, Henderson GE, Bowling JM, Nkhoma J, Moses A, Zulu C, Chilima J, Ahmed Y, Heilig CM, Jamieson DJ, van der Horst C. Improving participant understanding of informed consent in a HIV-prevention clinical trial: a comparison of methods. AIDS Behav. 2012; 16(2):412-21.


Methodological Research

Corneli A, Meagher K, Henderson G, Peay H, Rennie S. How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches. AIDS and Behavior. 2018; doi: 10.1007/s10461-018-2358-0. [Epub ahead of print]

Corneli A, Hallinan Z, Hamre G, Perry B, Goldsack JC, Calvert SB, Forrest A. The Clinical Trials Transformation Initiative: Methodology Supporting the Mission. Clin Trials. 2018; 15(S1):13-18.

Guest G, Namey E, Taylor J, Eley N, McKenna K. Comparing focus groups and individual interviews: Findings from a randomized study. Int J Soc Res Methodol. 2017; 1364-5579.

Guest G, Namey E, McKenna K. How many focus groups are enough? Building an evidence base for non-probability sample sizesField Methods. 2017, 29(1): 3-22.

Guest G, Namey E, McKenna K. Evaluating bang for the buck: A cost-effectiveness comparison between individual interviews and focus groupsAm J Eval. 2016; 37(3): 425-40.


Commentaries and Review Articles

Perry B, Herrington W, Goldsack JC, Grandinetti CA, Vasisht, KP, Landray MJ, Bataille L, DiCicco RA, Bradley C, Narayan A, Papadopoulos EJ, Sheth N, Skodacek K, Stem K, Strong TV, Walton MK, Corneli A. Use of mobile devices to measure outcomes in clinical research, 2010-2016: A systematic literature review. Digit Biomark. 2018; 2:11-30.

Shattuck D, Perry B, Packer C, Quee DC. A review of 10 years of vasectomy programming and research in low-resource settings. Glob Health Sci Pract. 2016; 4(4):647–60.

Mosavel M, Ahmed R, Daniels D, Simon C. Community researchers conducting health disparities research: ethical and other insights from fieldwork journaling. Soc Sci Med. 2011; 73 (1):145-152.

Weinfurt KP, Hall MA, King NM, Friedman JY, Schulman KA, Sugarman J. Disclosure of financial relationships to participants in clinical researchN Engl J Med.  2009; 361(9):916-21.

Simon C, Mosavel M. Key conceptual issues in the forging of ‘culturally competent’ community health initiatives: a South African example. Cambridge Quarterly of Healthcare Ethics. 2008; 17(2):195-205.

Weinfurt KP, Seils DM, Tzeng JP, Lin L, Schulman KA, Califf RM. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. PLoS ONE. 2008; 3(5):e2128.

Simon C, Hegedus S. Exploring websites on cancer clinical trials: an empirical review. Contemp Clin Trials. 2005; 26(5): 530-3.

Mosavel M, Simon C, van Stade D, Buchbinder M. Community-based participatory research (CBPR) in South Africa: engaging multiple constituents to shape the research question. Soc Sci Med. 2005; 61(12):2577-87.


Ethics

Anderson E and Corneli A. 100 Questions (and Answers) About Human Research Ethics. Thousand Oaks, CA: Sage Publications, 2018.

Beskow L, Hammack C, Brelsford K, McKenna K. Thought leader perspectives on risks in precision medicine research. In: G Cohen, H Lynch, E Vayena (Eds), Big Data, Health Law, and Bioethics. Cambridge, UK: Cambridge University Press. 2018.

Corneli A, Namey E, Mueller M, Tharaldson J, Sortijas S, Grey T, Sugarman J. Evidence-based strategies for shortening informed consent forms in clinical research. J Empir Res Hum Res Ethics. 2017; 12(1):14-25.

Corneli A, Sugarman J. Reducing Consent Form Length:  Stakeholder Support, Evidence-Based Strategies, and Regulatory Requirements. IRB: Ethics and Human Research. 2017: 39 (2).

Beskow LM, Lin L, Dombeck CB, Gao E, Weinfurt KP.  Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention. Genet Med. 2017; 19(5):505-12.

Simon C, Klein DW, Schartz HA. Interactive multimedia consent for biobanking: a randomized trial. Genet Med. 2016; 18(1):57-64 .  

Simon C, Klein D, Schartz H. Digitizing Consent: The Food and Drug Administration’s Draft Guidance on Electronic Informed Consent. IRB: Ethics & Human Research. 2016; 38(5).

Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, Bang S, Perlmutter J, Khin-Maung-Gyi FA, Weinfurt KP. Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013; 8(1):e54999. 

Weinfurt KP.  Understanding what participants in empirical bioethical studies mean: Historical cautions from William James and Ludwig Wittgenstein.  AJOB Prim Res. 2013; 4(3):49-54.

L'Heureux J, Murray JC, Newbury E, Shinkunas L, Simon C. Public perspectives on biospecimen procurement: what biorepositories should consider. Biopreserv Biobank. 2013; 11(3):137-43.

Corneli A, Sorenson J, Bentley ME, Henderson GE, Bowling JM, Nkhoma J, Moses A, Zulu C, Chilima J, Ahmed Y, Heilig CM, Jamieson DJ, van der Horst C. Improving participant understanding of informed consent in a HIV-prevention clinical trial: a comparison of methods. AIDS Behav. 2012; 16(2):412-21.

Simon C, L'Heureux J, Murray JC, Winokur P, Weiner G, Newbury E, Shinkunas L, Zimmerman B. Active choice, but not too active: public perspectives on biobank consent models. Genet Med. 2011; 13(9):821-31.

Simon C, Williams JK, Shinkunas L, Brandt D, Daack-Hirsch S, Driessnack M. Informed consent and genomic incidental findings: IRB chair perspectives J Empir Res Hum Res Ethics. 2011; 6(4):53-67.

Weinfurt KP. Varieties of uncertainty and the validity of informed consent. Clin Trials. 2008; 5(6):624-5.

Simon C, Zyzanski SJ, Durand E, Jimenez X, Kodish ED. Interpreter accuracy and informed consent among Spanish-speaking families with cancer. J Health Commun. 2006; 11(5):509-22.

Corneli AL, Bentley ME, Sorenson JR, Henderson GE, van der Horst C, Moses A, Nkhoma J, Tenthani L, Ahmed Y, Heilig CM, Jamieson DJ. Using formative research to develop a context-specific approach to informed consent for clinical trials. J Empir Res Hum Res Ethics. 2006; 1(4):45-60.

Simon C, Kodish ED. "Step into my zapatos, Doc': understanding and reducing communication disparities in the multicultural informed consent setting. Perspect Biol Med. 2005; 48(1 Suppl):S123-S138.

Weinfurt, KP.  Discursive versus information-processing perspectives on a bioethical problem: the case of “unrealistic” patient expectation. Theor Psychol, 2004; 14(2):191-203.

Simon C, Siminoff LA, Kodish ED, Burant C. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol. 2004; 22(13): 2708-17.