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 APerry B, Collyar D, Powers III JH, Farley JJ, Calvert SB, Santiago J, Donnelly HK, Swezey TDombeck 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 CBWeinfurt KPParticipants’ perspectives on safety monitoring in clinical trialsClin 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 trialContraception. 2012; 85(3):263-9.

Flynn KE, Reese JB, Jeffery DD, Abernethy AP, Lin L, Shelby RA, Porter LS, Dombeck CBWeinfurt KPPatient experiences with communication about sex during and after treatment for cancerPsycho-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 studyJ 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 TEvidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infectionsSex 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, MalawiContemp 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 trialsJ 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 misconceptionTheor 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 AfricaAIDS 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 TrialsAIDS 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-PrEPJAIDS. 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 prophylaxisJAIDS. 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 trialJAIDS. 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 pillsJAIDS. 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 TrialPLoS 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 AfricaAIDS 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 MalawiGlobal 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 contraceptiveGlob 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 ProvidersContraception. 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 studyAfr 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 SenegalContraception. 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 SenegalContraception. 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 practicesMed 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 methodsAIDS 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 Behav. 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 MissionClin Trials. 2018; 15(S1):13-18.

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

Guest G, Namey E, McKenna KHow 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 KEvaluating bang for the buck: A cost-effectiveness comparison between individual interviews and focus groups.  Am 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 AUse of mobile devices to measure outcomes in clinical research, 2010-2016: A systematic literature reviewDigit 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 settingsGlob 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 journalingSoc 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 exampleCambridge 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 stentsPLoS ONE. 2008; 3(5):e2128.

Simon C, Hegedus S. Exploring websites on cancer clinical trials: an empirical reviewContemp 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 questionSoc Sci Med. 2005; 61(12):2577-87.


Anderson E and Corneli A100 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 Med2016; 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 DKDombeck 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 WittgensteinAJOB 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 considerBiopreserv 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 modelsGenet 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 consentClin 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 trialsJ 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 settingPerspect Biol Med. 2005; 48(1 Suppl):S123-S138.

Weinfurt, KP. Discursive versus information-processing perspectives on a bioethical problem: the case of “unrealistic” patient expectationTheor 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 oncologyJ Clin Oncol. 2004; 22(13): 2708-17.