MTN Publications

Palanee-Phillips T, Schwartz K, Brown ER, Govender V, Mgodi N, Kiweewa FM, Nair G, Mhlanga F, Siva S, Bekker LG, Jeenarain N, Gaffoor Z, Martinson F, Makanani B, Naidoo S, Pather A, Phillip J, Husnik MJ, van der Straten A, Soto-Torres L, Baeten J. Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention. PLoS One 2015 Jun 10;10(6):e0128857. PMCID: PMC4489588

Burns RN, Hendrix CW, Chaturvedula A. Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women. J Clin Pharmacol 2015 Jun;55(6):629-38. PMCID: PMC5008110

Montgomery ET, van der Straten A, Stadler J, Hartmann M, Magazi B, Mathebula F, Laborde N, Soto-Torres L. Male Partner Influence on Women's HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the Importance of "Understanding". AIDS Behav 2015 May;19(5):784-93. PMCID: PMC4416996

van der Straten A, Mayo A, Brown ER, Amico KR, Cheng H, Laborde N, Marrazzo J, Torjesen K. Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial. AIDS Behav 2015 May;19(5):770-83. PMCID:PMC4416998

Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van der Straten A, Noguchi L, Hendrix CW, Dai JY, Ganesh S, Mkhize B, Taljaard M, Parikh UM, Piper J, Mâsse B, Grossman C, Rooney J, Schwartz JL, Watts H, Marzinke MA, Hillier SL, McGowan IM, Chirenje ZM; VOICE Study Team. Tenofovir-Based Preexposure Prophylaxis for HIV Infection among African Women. N Engl J Med 2015 Feb 5;372(6):509-18. PMCID: PMC4341965

Hladik F, Burgener A, Ballweber L, Gottardo R, Vojtech L, Fourati S, Dai JY, Cameron MJ, Strobl J, Hughes SM, Hoesley C, Andrew P, Johnson S, Piper J, Friend DR, Ball TB, Cranston RD, Mayer KH, McElrath MJ, McGowan I. Mucosal effects of tenofovir 1% gel. eLife 2015 Feb 3;4. PMCID: PMC4391502

Saag MS. Preventing HIV in Women - Still Trying to Find Their VOICE N Engl J Med 2015 Feb 5;372(6):564-6.

Penrose KJ, Richardson BA, Besson G, Dezzutti CS, Herold BC, Abdool Karim SS, Mellors JW, Parikh UM. Y Chromosome and HIV DNA Detection in Vaginal Swabs as Biomarkers of Semen and HIV Exposure in Women. Sex Transm Dis 2014 Nov;41(11):674-9. PMCID: PMC4346249

Yang KH, Hendrix C, Bumpus N, Elliott J, Tanner K, Mauck C, Cranston R, McGowan I, Richardson-Harman N, Anton PA, Kashuba AD. A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate. PLoS One 2014 Oct 28;9(10):e106196. PMCID:PMC4211672

Richardson-Harman N, Hendrix CW, Bumpus NN, Mauck C, Cranston RD, Yang K, Elliott J, Tanner K, McGowan I, Kashuba A, Anton PA. Correlation between Compartmental Tenofovir Concentrations and an Ex Vivo Rectal Biopsy Model of Tissue Infectibility in the RMP-02/MTN-006 Phase 1 Study. PLoS One 2014 Oct 28;9(10):e111507. PMCID:PMC4211741

Rosas SR, Schouten JT, Dixon D, Varghese S, Cope MT, Marci J, Kagan JM. Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials. Clin Trials 2014 Oct;11(5):553-9. PMCID:PMC4156886

van der Straten A, Stadler J, Luecke E, Laborde N, Hartmann M, Montgomery ET, on behalf of the VOICE-C Study Team. Perspectives on use of oral and vaginal antiretrovirals for HIV prevention: the VOICE-C qualitative study in Johannesburg, South Africa. J Int AIDS Soc 2014 Sep 8, 17(Suppl 2):19146. PMCID: PMC4163995

Lanham M, Wilcher R, Montgomery ET, Pool R, Schuler S, Lenzi R, Friedland B. Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction. J Int AIDS Soc 2014 Sep 8;17(3 Suppl 2):19159. PMCID:PMC4163996

Parsons TL, Emory JF, Seserko LA, Aung WS, Marzinke MA. Dual quantification of dapivirine and maraviroc in cervicovaginal secretions from ophthalmic tear strips and polyester-based swabs via liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. J Pharm Biomed Anal 2014 Sep;98:407-416. PMCID: PMC4143664

Guffey MB, Richardson B, Husnik M, Makanani B, Chilongozi D, Yu E, Ramjee G, Mgodi N, Gomez K, Hillier SL, Karim SA, HIV Prevention Trials Network (HPTN) 035 Study Team. HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women. Sex Transm Infect 2014 Aug;90(5):363-9. PMC4278566

Magazi B, Stadler J, Delany-Moretlwe S, Montgomery E, Mathebula F, Hartmann M, van der Straten A. Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa. BMC Womens Health 2014 Jul 28;14:88. PMCID:PMC4115485

Seaton KE, Ballweber L, Lan A, Donathan M, Hughes S, Vojtech L, Moody MA, Liao HX, Haynes BF, Galloway CG, Richardson BA, Karim SA, Dezzutti CS, McElrath MJ, Tomaras GD, Hladik F. HIV-1 specific IgA detected in vaginal secretions of HIV uninfected women participating in a microbicide trial in Southern Africa are primarily directed toward gp120 and gp140 specificities. PLoS One 2014 Jul 23;9(7):e101863. PMCID:PMC4108330

Dezzutti CS, Russo J, Wang L, Abebe KZ, Li J, Friend DR, McGowan IM, Rohan LC. Development of HIV-1 rectal-specific microbicides and colonic tissue evaluation. PLoS One 2014 Jul 15;9(7):e102585. PMCID:PMC4099179

Gorbach PM, Kelly CW, Borgerding JA, Ramjee G, Tembo T, Kumwenda N, Musara P, Roberts S, Maslankowski L. Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035). AIDS Behav 2014 May;18(5):855-61. PMCID:PMC3988261

Gorbach PM, Mensch BS, Husnik M, Coly A, Mâsse B, Makanani B, Nkhoma C, Chinula L, Tembo T, Mierzwa S, Reynolds K, Hurst S, Coletti A, Forsyth A. Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial. AIDS Behav 2013 Feb;17(2):790-800. PMCID:PMC3550005

Emory JF, Seserko LA, Marzinke MA. Development and bioanalytical validation of a liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for the quantification of the CCR5 antagonist maraviroc in human plasma. Clin Chim Acta 2014 Apr 20;431:198-205. PMCID: PMC4029414

Parikh UM, Kiepiela P, Ganesh S, Gomez K, Horn S, Eskay K, Kelly C, Mensch B, Gorbach P, Soto-Torres L, Ramjee G, Mellors JW. Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009). PLoS One 2013 Apr 9;8(4):e59787. PMCID:PMC3621859

van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, Schwartz K, Laborde N, Soto-Torres L. Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS One 2014 Feb 21;9(2):e89118. PMCID:PMC3931679

Cranston RD, Hoesley C, Carballo-Dieguez A, Hendrix CW, Husnik M, Levy L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). AIDS Res Hum Retroviruses 2014 Feb;30(2):184-9. PMCID:PMC3910451

Chaturvedula A, Fossler MJ, Hendrix CW. Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies. J Clin Pharmacol 2014 Feb;54 (2):150-160. PMCID: PMC5001555

Balkus JE, Richardson BA, Rabe LK, Taha TE, Mgodi N, Kasaro MP, Ramjee G, Hoffman IF, Abdool Karim SS. Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women. Sex Transm Dis 2014 Feb;41(2):123-8. PMCID:PMC4128240

van der Straten A, Cheng H, Mensch B, Friedland B, Katzen L, Littlefield S, Buckley N, Espinoza L, Keller MJ, Herold BC, Einstein M. Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials. Sex Transm Dis 2013 Dec;40(12):950-6. PMCID:PMC4130378

Leu CS, Mabragana M, Giguere R, Dolezal C, Carballo-Dieguez A, McGowan I. Use of a novel technology to track adherence to product use in a microbicide trial of short duration (MTN-007). AIDS Behav 2013 Nov;17(9):3101-7. PMCID: PMC4157755

Mabragana M, Carballo-Dieguez A, Giguere R. Young women's experience with using videoconferencing for the assessment of sexual behavior and microbicide use. Telemed J E Health 2013 Nov;19(11):866-71. PMCID:PMC3810614

Seserko LA, Emory JF, Hendrix CW, Marzinke MA. The development and validation of an UHPLC-MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma. Bioanalysis 2013 Nov;5(22):2771-83. PMCID:PMC4104354

Dimitrov D, Boily MC, Marrazzo J, Beigi R, Brown ER. Population-level benefits from providing effective HIV prevention means to pregnant women in high prevalence settings. PLoS One 2013 Sep 16;8(9):e73770. PMCID:PMC3774771

Giguere R, Zimet GD, Kahn JA, Dolezal C, Leu CS, Mabragana M, McGowan I, Carballo-Dieguez A. The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico. World J AIDS 2013 Sep;3(3). PMCID:PMC3855411

Rosas SR, Schouten JT, Cope MT, Kagan JM. Modeling the dissemination and uptake of clinical trials results. Res Eval 2013 Sep;22(3):179-86. PMCID:PMC3745267

Amico KR, Mansoor LE, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav 2013 Jul;17(6):2143-55. PMCID:PMC3672509

Richardson BA, Kelly C, Ramjee G, Fleming T, Makanani B, Roberts S, Musara P, Mkandawire N, Moench T, Coletti A, Soto-Torres L, Karim SA; HPTN 035 Study Team. Appropriateness of hydroxyethylcellulose gel as a placebo control in vaginal microbicide trials: a comparison of the two control arms of HPTN 035. J Acquir Immune Defic Syndr 2013 May 1;63(1):120-5. PMCID:PMC3625489

Etter P, Landovitz R, Sibeko S, Sobieszczyk ME, Riddler SA, Karg C, Tsibris A, Schouten J. Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies. AIDS 2013 Apr 24;27(7):1119-28. PMCID: PMC4286368

van der Straten A, Montgomery E, Pillay D, Cheng H, Naidoo A, Cele Z, Naidoo K, Hartmann M, Piper J, Nair G. Feasibility, performance, and acceptability of the Wisebag for potential monitoring of daily gel applicator use in Durban, South Africa. AIDS Behav 2013 Feb;17(2):640-8. PMCID:PMC3562379

Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, Nakabiito C, Hoesley C, Justman J, Soto-Torres L, Patterson K, Gomez K, Hendrix CW. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav 2013 Feb;17(2):737-47. PMCID:PMC3562423

Dai JY, Gilbert PB, Hughes JP, Brown ER. Estimating the efficacy of preexposure prophylaxis for HIV prevention among participants with a threshold level of drug concentration. Am J Epidemiol 2013 Feb 1;177(3):256-63. PMCID:PMC3577049

McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, Carballo-Dieguez A, Ayudhya RK, Piper J, Hladik F, Mayer K. A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007). PLoS One 2013;8(4):e60147. PMCID:PMC3616022

Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One 2013;8(1):e55013. PMCID:PMC3559346

Dezzutti CS, Richardson BA, Marrazzo JM, Tugetman J, Ramjee G, Taha T, Chirenje ZM, Abdool Karim SS, Hillier SL, Herold BC. Mucosal Escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial. J Infect Dis 2012 Dec 15;206(12):1931-5. PMCID:PMC3502373

Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, Cumberland WG, Ju C, Carballo-Diéguez A, Mauck C, McGowan I. RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate. AIDS Res Hum Retroviruses 2012 Nov;28(11):1412-21. PMCID:PMC3484811

Carballo-Dieguez A, Giguere R, Dolezal C, Chen BA, Kahn J, Zimet G, Mabragana M, Leu CS, McGowan I. "Tell Juliana": acceptability of the candidate microbicide VivaGel(R) and two placebo gels among ethnically diverse, sexually active young women participating in a phase 1 microbicide study. AIDS Behav 2012 Oct;16(7):1761-74. PMCID:PMC3272128

Dezzutti CS, Rohan LC, Wang L, Uranker K, Shetler C, Cost M, Lynam JD, Friend D. Reformulated tenofovir gel for use as a dual compartment microbicide. J Antimicrob Chemother 2012 Sep;67(9):2139-42. PMCID:PMC3417689

Chirenje ZM, Masse BR, Maslankowski LA, Ramjee G, Coletti AS, Tembo TN, Magure TM, Soto-Torres L, Kelly C, Hillier S, Karim A. Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel. J Int AIDS Soc 2012 Aug 27;15(2):17376. PMCID:PMC3494172

Dimitrov D, Boily MC, Masse BR, Brown ER. Impact of Pill Sharing on Drug Resistance Due to a Wide-Scale Oral Prep Intervention in Generalized Epidemics. J AIDS Clin Res 2012 Jul 8;Suppl 5(4). PMCID:PMC3870903

Cosentino LA, Campbell T, Jett A, Macio I, Zamborsky T, Cranston RD, Hillier SL. Use of nucleic acid amplification testing for diagnosis of anorectal sexually transmitted infections. J Clin Microbiol 2012 Jun;50(6):2005-8. PMCID:PMC3372150

Woodsong C, Alleman P, Musara P, Chandipwisa A, Chirenje M, Martinson F, Hoffman I. Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe. AIDS Behav 2012 Apr;16(3):785-90. PMCID:PMC3658446

Dai JY, Gilbert PB, Masse BR. Partially hidden Markov model for time-varying principal stratification in HIV prevention trials. J Am Stat Assoc 2012 Mar 1;107(497):52-65. PMCID:PMC3649016