Microbicide Trials Network

MTN Publications

(List is sorted by most recent publications.  Updated August 18, 2017)

 

van der Straten A, Shapley-Quinn M, Reddy K, Cheng H, Etima J, Woeber K, Musara P, Palanee-Phillips T, Baeten JM, Montgomery ET, and on behalf of the MTN-020/ASPIRE Study Team. Favoring “Peace of Mind”: A Qualitative Study of African Women's HIV Prevention Product Formulation Preferences from the MTN-020/ASPIRE Trial. AIDS Patient Care and STDs 2017 July ; 31(7): 305-314

 

Carballo-Diéguez A, Balán IC, Brown W 3rd, Giguere R, Dolezal C, Leu CS, Marzinke MA, Hendrix CW, Piper JM, Richardson BA, Grossman C, Johnson S, Gomez K, Horn S, Kunjara Na Ayudhya RP, Patterson K, Jacobson C, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla C, Lama J, McGowan I, Cranston RD. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One 2017 Jul 27;12(7):e0181607. PMCID: PMC5531503

 

Husnik MJ, Brown ER, Marzinke M, Livant E, Palanee-Phillips T, Hendrix C, Kiweewa FM, Nair G, Soto-Torres LE, Schwartz K, Hillier SL, Baeten JM; MTN-020 ASPIRE Study Team. Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial. J Acquir Immune Defic Syndr 2017; Jul 24 [Epub ahead of print]

 

Cosentino LA, Danby CS, Rabe LK, Macio I, Meyn LA, Wiesenfeld HC, Hillier SL. Use of Nucleic Acid Amplification Testing for the Diagnosis of Extragenital Sexually Transmitted Infections: NAAT Detection of STIs in Rectal and Pharyngeal Swabs. J Clin Microbiol 2017 Jul 5. pii: JCM.00616-17  [Epub ahead of print]

 

DeMarco AL, Rabe LK, Austin MN, Stoner KA, Avolia HA, Meyn LA, Hillier SL. Survival of vaginal microorganisms in three commercially available transport systems. Anaerobe. 2017 Jun;45:44-49. PMCID: PMC5466887

 

Livant E, Heaps A, Kelly C, Maharaj R, Samsunder N, Nhlangulela L, Karugaba P, Panchia R, Marrazzo J, Chirenje ZM, Parikh UM; VOICE Study Team. The fourth generation AlereTM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples. J Clin Virol 2017 Jun 29;94:15-21 [Epub ahead of print]

 

Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, Siva S, Jeenarain N, Nair G, Selepe P, Kabwigu S, Palanee-Phillips T, Panchia R, Mhlanga F, Levy L, Livant E, Patterson K, Elharrar V, Balkus J. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One 2017 Jun 28;12(6):e0178594.

 

Akello CA, Bunge KE, Nakabiito C, Mirembe BG, Fowler MG, Mishra A, Marrazzo J, Chirenje ZM, Celum C, Balkus JE. Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial. J Womens Health (Larchmt) 2017 Jun;26(6):670-676.

 

Montgomery ET, Noguchi LM, Dai JY, Pan J, Biggio J, Hendrix C, Isaacs K, Watts DH, Schwartz JL, Piper J, Beigi R. Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States. AIDS Behav 2017 May 26 [Epub ahead of print]

 

Balkus JE, Palanee-Phillips T, Reddy K, Siva S, Harkoo I, Nakabiito C, Kintu K, Nair G, Chappell C, Kiweewa FM, Kabwigu S, Naidoo L, Jeenarain N, Marzinke M, Soto-Torres L, Brown ER, Baeten JM. Dapivirine vaginal ring use does not diminish the effectiveness of hormonal contraception. J Acquir Immune Defic Syndr 2017 May 23 [Epub ahead of print]

 

Montgomery ET, van der Straten A, Chitukuta M, Reddy K, Woeber K, Atujuna M, Bekker LG, Etima J, Nakyanzi T, Mayo AJ, Katz A, Laborde N, Grossman CI, Soto-Torres L, Palanee-Phillips T, Baeten JM; MTN-020/ASPIRE Study. Acceptability and use of a dapivirine vaginal ring in a phase III trial. AIDS 2017 May 15;31(8):1159-1167.

 

Kasaro MP, Husnik MJ, Chi BH, Reid C, Magure T, Makanani B, Tembo T, Ramjee G, Maslankowski L, Rabe L, Brad Guffey M. Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study. Int J STD AIDS 2017 Apr;28(5):467-475. PMCID: PMC5145791

 

Richardson-Harman N, Parody R, Anton P, McGowan I, Doncel G, Thurman AR, Herrera C, Kordy K, Fox J, Tanner K, Swartz G, Dezzutti CS. Analytical Advances in the Ex Vivo Challenge Efficacy Assay. AIDS Res Hum Retroviruses 2017 Apr;33(4):395-403. PMCID: PMC5372762

 

Koss CA, Bacchetti P, Hillier SL, Livant E, Horng H, Mgodi N, Mirembe BG, Gomez Feliciano K, Horn S, Liu AY, Glidden DV, Grant RM, Benet LZ, Louie A, van der Straten A, Chirenje ZM, Marrazzo JM, Gandhi M. Differences in Cumulative Exposure and Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as Determined via Hair Concentrations. AIDS Res Hum Retroviruses 2017; Mar 2 [Epub ahead of print]

 

Cranston RD, Lama JR, Richardson BA, Carballo-Diéguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel. Clin Infect Dis 2017 Mar 1;64(5):614-620.

 

Chirenje ZM, Gundacker HM, Richardson B, Rabe L, Gaffoor Z, Nair GL, Mirembe BG, Piper JM, Hillier S, Marrazzo J. Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Transm Dis 2017 Mar;44(3):135-140.

 

DeMarco AL, Rabe LK, Austin MN, Stoner KA, Avolia HA, Meyn LA, Hillier SL. Survival of vaginal microorganisms in three commercially available transport systems. Anaerobe 2017 Feb 24. pii: S1075-9964  [Epub ahead of print]

 

Montgomery ET, Mensch B, Musara P, Hartmann M, Woeber K, Etima J, van der Straten A. Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty. AIDS Behav 2017 Feb;21(2):481-491. PMCID: PMC5290166

 

Musara P, Montgomery ET, Mgodi NM, Woeber K, Akello CA, Hartmann M, Cheng H, Levy L, Katz A, Grossman CI, Chirenje ZM, van der Straten A, Mensch B; Microbicide Trials Network-003D Study Team. How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe. AIDS Behav 2017 Jan 21 [Epub ahead of print]

 

Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM,  et al. Use of a vaginal Ring containing dapivirine for HIV-1 prevention in women. N Engl J Med 2016;375(22):2121-32. PMCID:PMC4993693.

 

Stadler J, Scorgie F, van der Straten A, Saethre E. Adherence and The Lie in a HIV Prevention Clinical Trial. Med Anthropol 2016 Nov-Dec;35(6):503-516. PMCID: PMC4977196.

 

Duby Z, Hartmann M, Mahaka I, Munaiwa O, Nabukeera J, Vilakazi N, Mthembu F, Colvin CJ, Mensch B, van der Straten A. Lost in Translation: Language, Terminology, and Understanding of Penile-Anal Intercourse in an HIV Prevention Trial in South Africa, Uganda, and Zimbabwe. J Sex Res 2016 Nov-Dec;53(9):1096-1106. PMCID: PMC4961617.

 

Mensch BS, Brown ER, Liu K, Marrazzo J, Chirenje ZM, Gomez K, Piper J, Patterson K, van der Straten A. Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Non-use Increase at the Termination Visit? AIDS Behav 2016 Nov;20(11):2654-2661.

 

van der Straten A, Panther L, Laborde N, Hoesley CJ, Cheng H, Husnik MJ, Horn S, Nel A, Soto-Torres L, Chen BA. Adherence and acceptability of a multidrug vaginal ring for HIV prevention in a phase I study in the United States. AIDS Behav 2016 Nov;20(11):2644-2653. PMCID:PMC4970965

 

Moodley J, Naidoo S, Moodley J, Ramjee G. Sharing of Investigational Drug Among Participants in the Voice Trial. AIDS Behav 2016 Nov;20(11):2709-2714. PMCID: PMC5071120.

 

Polis CB, Phillips SJ, Hillier SL, Achilles SL. Levonorgestrel in contraceptives and multipurpose prevention technologies: does this progestin increase HIV risk or interact with antiretrovirals? AIDS 2016 Nov 13;30(17):2571-2576. PMCID:PMC5083202

 

Beigi RH, Noguchi LM, Montgomery E, Biggio J, Hendrix CW, Marzinke MA, Dai JY, Pan J, Kunjara Na Ayudhya R, Schwartz JL, Isaacs K, Piper JM, Watts DH. A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy. J Int AIDS Soc 2016 Sep 21;19(1):20990. PMCID: PMC5034095.

 

Scott Y, Dezzutti CS. Non-Antiretroviral Microbicides for HIV Prevention. AIDS Rev 2016 Jul-Sep;18(3):145-150. PMCID: PMC5053894

 

Riddler SA, Husnik M, Gorbach PM, Levy L, Parikh U, Livant E, Pather A, Makanani B, Muhlanga F, Kasaro M, Martinson F, Elharrar V, Balkus JE; MTN-015 Protocol Team for the Microbicide Trials Network. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015. HIV Clin Trials 2016 Sep;17(5):204-11. PMCID: PMC5002236.

 

Noguchi LM, Montgomery ET, Biggio JR, Hendrix CW, Bogen DL, Hillier SL, Dai JY, Piper JM, Marzinke MA, Dezzutti CS, et al. Detectable tenofovir levels in breastfeeding infants of mothers exposed to topical tenofovir. Antimicrob Agents Chemother 2016 Aug 22;60(9):5616-9.

 

Beigi RH, Noguchi L, Brown G, Piper J, Watts DH. Performing Drug Safety Research During Pregnancy and Lactation: Biomedical HIV Prevention Research as a Template. J Womens Health (Larchmt) 2016 Jul;25(7):761-6. PMCID:PMC4939378

 

Minnis AM, van der Straten A, Salee P, Hendrix CW. Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions. AIDS Behav 2016 Jul;20(7):1541-8.

 

Balkus JE, Brown E, Palanee T, Nair G, Gafoor Z, Zhang J, Richardson BA, Chirenje ZM, Marrazzo JM, Baeten JM. An Empiric HIV Risk Scoring Tool to Predict HIV-1 Acquisition in African Women. J Acquir Immune Defic Syndr 2016 Jul 1;72(3):333-43. PMCID: PMC4911322

 

Dezzutti CS, Richardson-Harman N, Rohan LC, Marzinke MA, Hoesley CJ, Panther L, Johnson S, Nuttall JP, Nel A, Chen BA; Microbicide Trials Network, MTN-013IPM 026 Protocol Team. Pharmacodynamic correlations using fresh and cryopreserved tissue following use of vaginal rings containing dapivirine and/or maraviroc in a randomized, placebo controlled trial. Medicine (Baltimore) 2016 Jul;95(28):e4174.

 

Hartmann M, Montgomery E, Stadler J, Laborde N, Magazi B, Mathebula F, van der Straten A. Negotiating the use of female-initiated HIV prevention methods in a context of gender-based violence: the narrative of rape. Cult Health Sex 2016 Jun;18(6):611-24. PMCID:PMC4845669

 

Luecke EH, Cheng H, Woeber K, Nakyanzi T, Mudekunye-Mahaka IC, van der Straten A; MTN-003D Study Team. Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study. J Int AIDS Soc 2016 May 30;19(1):20875.

 

Duby Z, Hartmann M, Montgomery ET, Colvin CJ, Mensch B, van der Straten A. Condoms, Lubricants and Rectal Cleansing: Practices Associated with Heterosexual Penile-Anal Intercourse Amongst Participants in an HIV Prevention Trial in South Africa, Uganda and Zimbabwe. AIDS Behav 2016 Apr;20(4):754-62. PMCID:PMC4698090

 

Mirembe BG, Kelly, Clifton W, Mgodi N, Greenspan S, Dai JY, Mayo A, Piper, J, Akello CA, Kiweewa FM, Magure T, Nakabiito C, Marazzo JM, Chirenje MZ, Riddler SA, MTN-003B Protocol team. Bone mineral density changes among young, healthy african women receiving oral tenofovir for HIV pre-exposure prophylaxis. J Acquir Immune Defic Syndr 2016 Mar 1;71(3):287-94. PMCID: PMC4755358

 

van der Straten A, Brown ER, Marrazzo JM, Chirenje MZ, Liu K, Gomez K, Marzinke MA, Piper JM, Hendrix CW, MTN-003 VOICE Protocol Team for the Microbicide Trials Network. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc  2016 Feb 4;19(1):20642.

 

Danby CS, Cosentino LA, Rabe LK, Priest CL, Damare KC, Macio IS, Meyn LA, Wiesenfeld HC, Hillier SL. Patterns of extragenital Chlamydia and Gonorrhea in women and men who have sex with men reporting a history of receptive anal intercourse. Sex Transm Dis 2016;43(2):105-9.

 

Herold BC, Chen BA, Salata RA, Marzinke MA, Kelly CW, Dezzutti CS, McGowan I, Galaska B, Levy L, Piper JM,  et al. Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel. Clin Infect Dis 2016 Feb 1;62(3):375-82. PMCID: PMC4706638

 

Dai JY, Hendrix CW, Richardson BA, Kelly C, Marzinke M, Chirenje ZM, Marrazzo JM, Brown ER. Pharmacological Measures of Adherence and Risk of HIV Acquisition in the VOICE Study.  J Infect Dis 2016 Feb 1;213(3):335-342.  PMCID:PMC4704663

 

Balkus JE, Brown ER, Hillier SL, Coletti A, Ramjee G, Mgodi N, Makanani B, Reid C, Martinson F, Soto-Torres L, Abdool Karim SS, Chirenje ZM. Oral and injectable contraceptive use and HIV acquisition risk among women in 4 African countries: a secondary analysis of data from a microbicide trial. Contraception 2016 Jan;93(1):25-31. PMCID:PMC4688130

 

Duby Z,  Hartmann M,  Montgomery ET, Colvin CJ, Mensch B,  van der Straten A. Sexual scripting of heterosexual penile-anal intercourse amongst participants in an HIV prevention trial in South Africa, Uganda and Zimbabwe. Cult Health Sex  2016 Jan;18(1):30-44. PMCID:PMC4659730

 

Parikh UM, Mellors JW. Should we fear resistance from tenofovir/emtricitabine preexposure prophylaxis? Curr Opin HIV AIDS 2016 Jan;11(1):49-55.

 

Dezzutti CS. Animal and human mucosal tissue models to study HIV biomedical interventions: can we predict success?  J Int AIDS Soc 2015 Nov 2;18(1):20301. PMCID: PMC4631705

 

Chen BA, Panther L, Marzinke MA, Hendrix CW, Hoesley CJ, van der Straten A, Husnik MJ, Soto-Torres L, Nel A, Johnson S, Richardson-Harman N, Rabe LK, Dezzutti CS. Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial. J Acquir Immune Defic Syndr 2015 Nov 1;70(3):242-9. PMCID: PMC460758

 

Dezzutti CS, Yandura S, Wang L, Moncla B, Teeple EA, Devlin B, Nuttall J, Brown ER, Rohan LC. Pharmacodynamic Activity of Dapivirine and Maraviroc Single Entity and Combination Topical Gels for HIV-1 Prevention. Pharm Res 2015 Nov;32(11):3768-81. PMCID:PMC4600024

 

Scott YM, Park SY, Dezzutti CS. Broadly Neutralizing Anti-HIV Antibodies Prevent HIV Infection of Mucosal Tissue Ex Vivo.  Antimicrob Agents Chemother 2015 Nov 23;60(2):904-12.  PMCID: PMC4750682

 

Mensch BS, Gorbach PM, Kelly C, Kiepiela P, Gomez K, Ramjee G, Ganesh S, Morar N, Soto-Torres L, Parikh UM. Characteristics Associated with HIV Drug Resistance Among Women Screening for an HIV Prevention Trial in KwaZulu-Natal, South Africa. AIDS Behav 2015 Nov;19(11):2076-86. PMCID: PMC4600421

 

Janocko L, Althouse AD1, Brand RM, Cranston RD, McGowan I. The Molecular Characterization of Intestinal Explant HIV Infection Using Polymerase Chain Reaction-Based Techniques. AIDS Res Hum Retroviruses 2015 Oct;31(10):981-91. PMCID: PMC4576939.

 

Murphy K, Richardson BA, Dezzutti CS, Marrazzo J, Hillier SL, Hendrix CW, Herold BC. Levels of Genital Tract Defensins and Cytokines Differ between HIV-Uninfected US and African Women. Am J Reprod Immunol 2015 Oct;74(4):313-22. PMCID:PMC4573314

 

Balkus JE, Nair G, Montgomery ET, Mishra A, Palanee-Phillips T, Ramjee G, Panchia R, Selepe P, Richardson BA, Chirenje ZM, et al. Age-Disparate Partnerships and Risk of HIV-1 Acquisition among South African Women Participating in the VOICE Trial. J Acquir Immune Defic Syndr 2015 Oct; 70(2): 212-17. PMCID: PMC4573287

 

Pellett Madan R, Dezzutti CS, Rabe L, Hillier SL, Marrazzo J, McGowan I, Richardson BA, Herold BC. Soluble Immune Mediators and Vaginal Bacteria Impact Innate Genital Mucosal Antimicrobial Activity in Young Women. Am J Reprod Immunol 2015 Oct;74(4):323-32. PMCID:PMC4573238

 

van der Straten A, Montgomery ET, Musara P, Etima J, Naidoo S, Laborde N, Hartmann M, Levy L, Bennie T, Cheng H, et al.   Disclosure of pharmacokinetic drug results to understand non-adherence: results from the VOICE-D study. AIDS 2015; 29(16):2161–2171. PMCID:PMC4638164

 

Noguchi LM, Richardson BA, Balkus JE, Marrazzo JM. Interpretation, communication, and mechanisms of associations between injectable contraception and HIV risk - Authors' reply. Lancet HIV 2015 Sep;2(9):e366-7.

 

Lade JM, To EE, Hendrix CW, Bumpus NN. Discovery of Genetic Variants of the Kinases That Activate Tenofovir in a Compartment-specific Manner. EBioMedicine 2015; 2: 1145-1152. PMCID: PMC4588390

 

Noguchi LM, Richardson BA, Baeten JM, Hillier SL, Balkus JE, Chirenje ZM, Bunge K, Ramjee G, Nair G, Palanee-Phillips T, et al. Risk of HIV-1 acquisition among women who use different types of injectable progestin contraception in South Africa: a prospective cohort study. Lancet HIV 2015 Jul 1;2(7):e279-e287. PMCID:PMC4491329

 

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.

 

Palanee-Phillips T, Schwartz K, Brown ER, Govender V, Mgodi N, et al.  Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.  PLoS ONE 2015; 10(6): e0128857. PMCID: PMC4489588

 

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

 

Mgodi NM, Kelly C, Gati B, Greenspan S, Dai JY, Bragg V, Livant E, Piper JM, Nakabiito C, Magure T, et al. Factors associated with bone mineral density in healthy African women. Arch  Osteoporos 2015 Dec;10(1):206. PMCID: PMC4564062

 

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

 

Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van der Straten A, Noguchi L, et al. 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, et al. Mucosal effects of tenofovir 1% gel. eLife  2015 Feb 3;4. PMCID: PMC4391502

 

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

 

Richardson-Harman N, Hendrix CW, Bumpus NN, Mauck C, Cranston RD, Yang K, Elliott J, Tanner K, McGowan I, Kashuba A, et al. 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;9(10):e111507. PMCID:PMC4211741

 

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

 

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;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, et al. 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

 

Seaton KE, Ballweber L, Lan A, Donathan M, Hughes S, Vojtech L, Moody MA, Liao HX, Haynes BF, Galloway CG, et al. 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;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;9(7):e102585. PMCID:PMC4099179

 

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, 17(Suppl 2):19146. PMCID: PMC4163995

 

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

 

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;11(5):553-9. PMCID:PMC4156886

 

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

 

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;17(3 Suppl 2):19159. PMCID:PMC4163996

 

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;14:88. PMCID:PMC4115485

 

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

 

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.

 

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;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

 

Richardson BA, Kelly C, Ramjee G, Fleming T, Makanani B, Roberts S, Musara P, Mkandawire N, Moench T, Coletti A, et al. 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

 

Gorbach PM, Mensch BS, Husnik M, Coly A, Masse B, Makanani B, Nkhoma C, Chinula L, Tembo T, Mierzwa S, et al. 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

 

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

 

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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

 

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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

 

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

 

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;15(2):17376. PMCID:PMC3494172

 

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

 

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

 

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

 

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

 

Giguere R, Carballo-Dieguez A, Ventuneac A, Mabragana M, Dolezal C, Chen BA, Kahn JA, Zimet GD, McGowan I. Variations in microbicide gel acceptability among young women in the USA and Puerto Rico. Cult Health Sex 2012;14(2):151-66. PMCID:PMC3265079

 

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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

 

Dezzutti CS, Brown ER, Moncla B, Russo J, Cost M, Wang L, Uranker K, Kunjara Na Ayudhya RP, Pryke K, Pickett J, Leblanc MA, Rohan LC. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One 2012;7(11):e48328. PMCID:PMC3492332

 

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

 

Moncla BJ, Pryke K, Rohan LC, Yang H. Testing of viscous anti-HIV microbicides using Lactobacillus. J Microbiol Methods 2012 Feb;88(2):292-6. PMCID:PMC3271802

 

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Abdool Karim SS, Richardson BA, Ramjee G, Hoffman IF, Chirenje ZM, Taha T, Kapina M, Maslankowski L, Coletti A, Profy A, Moench TR, Piwowar-Manning E, Masse B, Hillier SL, Soto-Torres L. Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women. AIDS 2011 Apr 24;25(7):957-66. PMCID:PMC3083640

 

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White R, Chileshe M, Dawson L, Donnell D, Hillier S, Morar N, Noguchi L, Dixon D. Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa. Clin Trials 2011 Feb;8(1):103-11. PMCID:PMC3478774

 

McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, Husnik M, Livant E, Price C, Jacobson C. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS 2011 May 15;25(8):1057-64. PMCID:PMC3103767

 

Boily MC, Masse BR, Dimitrov D. Oral antiretroviral pre-exposure prophylaxis reduces the risk of HIV acquisition among men who have sex with men. Evid Based Med 2011 Oct;16(5):146-7. PMCID:PMC3480078

 

Piehler B, Nelson EK, Eckels J, Ramsay S, Lum K, Wood B, Greene KM, Gao H, Seaman MS, Montefiori DC, Igra M. LabKey Server NAb: a tool for analyzing, visualizing and sharing results from neutralizing antibody assays. BMC Immunol 2011;12:33. PMCID:PMC3115917

 

Moncla BJ, Pryke K, Rohan LC, Graebing PW. Degradation of naturally occurring and engineered antimicrobial peptides by proteases. Adv Biosci Biotechnol 2011 Dec;2(6):404-8. PMCID:PMC3354962

 

Dezzutti CS, Hendrix CW, Marrazzo JM, Pan Z, Wang L, Louissaint N, Kalyoussef S, Torres NM, Hladik F, Parikh U, Mellors J, Hillier SL, Herold BC. Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators. PLoS One 2011;6(8):e23136. PMCID:PMC3155537

 

Nelson EK, Piehler B, Eckels J, Rauch A, Bellew M, Hussey P, Ramsay S, Nathe C, Lum K, Krouse K, Stearns D, Connolly B, Skillman T, Igra M. LabKey Server: an open source platform for scientific data integration, analysis and collaboration. BMC Bioinformatics 2011;12:71. PMCID:PMC3062597

 

Rosas SR, Kagan JM, Schouten JT, Slack PA, Trochim WM. Evaluating research and impact: a bibliometric analysis of research by the NIH/NIAID HIV/AIDS clinical trials networks. PLoS One 2011;6(3):e17428. PMCID:PMC3048860

 

Abbas UL, Hood G, Wetzel AW, Mellors JW. Factors influencing the emergence and spread of HIV drug resistance arising from rollout of antiretroviral pre-exposure prophylaxis (PrEP). PLoS One 2011;6(4):e18165. PMCID:PMC3078109

 

Boily MC, Dimitrov D, Abdool Karim SS, Masse B. The future role of rectal and vaginal microbicides to prevent HIV infection in heterosexual populations: implications for product development and prevention. Sex Transm Infect 2011 Dec;87(7):646-53. PMCID:PMC3332062

 

Dimitrov DT, Boily MC, Baggaley RF, Masse B. Modeling the gender-specific impact of vaginal microbicides on HIV transmission. J Theor Biol 2011 Nov 7;288:9-20. PMCID:PMC3184649

 

Marrazzo JM, Cates W. Interventions to prevent sexually transmitted infections, including HIV infection. Clin Infect Dis 2011 Dec;53 Suppl 3:S64-S78. PMCID:PMC3213401

 

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Rohan LC, Moncla BJ, Kunjara Na Ayudhya RP, Cost M, Huang Y, Gai F, Billitto N, Lynam JD, Pryke K, Graebing P, Hopkins N, Rooney JF, Friend D, Dezzutti CS. In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide. PLoS One 2010;5(2):e9310. PMCID:PMC2824823

 

Piwowar-Manning EM, Tustin NB, Sikateyo P, Kamwendo D, Chipungu C, Maharaj R, Mushanyu J, Richardson BA, Hillier S, Brooks JJ. Validation of rapid HIV antibody tests in 5 African countries. J Int Assoc Physicians AIDS Care (Chic ) 2010 May;9(3):170-2. PMCID:PMC2989535

 

Chirenje ZM, Marrazzo J, Parikh UM. Antiretroviral-based HIV prevention strategies for women. Expert Rev Anti Infect Ther 2010 Oct;8(10):1177-86. PMCID: PMC4381115

 

Moncla BJ, Pryke KM. Oleate lipase activity in Gardnerella vaginalis and reconsideration of existing biotype schemes. BMC Microbiol 2009;9:78. PMCID:PMC2680412

 

Austin MN, Rabe LK, Hillier SL. Limitations of the dye-based method for determining vaginal applicator use in microbicide trials. Sex Transm Dis 2009 Jun;36(6):368-71. PMCID:PMC2760219

 

Boily MC, Baggaley RF, Masse B. The role of heterosexual anal intercourse for HIV transmission in developing countries: are we ready to draw conclusions? Sex Transm Infect 2009 Oct;85(6):408-10. PMCID:PMC3395196

 

Masse BR, Boily MC, Desai K. Using mathematical modeling to bridge phase 3 microbicide trials with public health decision making. J Acquir Immune Defic Syndr 2009 Apr 1;50(4):434-5.

 

Masse BR, Boily MC, Dimitrov D, Desai K. Efficacy dilution in randomized placebo-controlled vaginal microbicide trials. Emerg Themes Epidemiol 2009;6:5. PMCID:PMC2768687

 

Boily MC, Baggaley RF, Wang L, Masse B, White RG, Hayes RJ, Alary M. Heterosexual risk of HIV-1 infection per sexual act: systematic review and meta-analysis of observational studies. Lancet Infect Dis 2009 Feb;9(2):118-29.

 

Hendrix CW, Cao YJ, Fuchs EJ. Topical microbicides to prevent HIV: clinical drug development challenges. Annu Rev Pharmacol Toxicol 2009;49:349-75

 

Schreiber CA, Sammel M, Hillier SL, Barnhart KT. A little bit pregnant: modeling how the accurate detection of pregnancy can improve HIV prevention trials. Am J Epidemiol 2009 Feb 15;169(4):515-21. PMCID:PMC2732971

 

Woodsong C, Alleman P. Sexual pleasure, gender power and microbicide acceptability in Zimbabwe and Malawi. AIDS Educ Prev 2008 Apr;20(2):171-87.

 

Stoner KA, Rabe LK, Austin MN, Meyn LA, Hillier SL. Quantitative survival of aerobic and anaerobic microorganisms in Port-A-Cul and Copan transport systems. J Clin Microbiol 2008 Aug;46(8):2739-44. PMCID:PMC2519491

 

Boily MC, Abu-Raddad L, Desai K, Masse B, Self S, Anderson R. Measuring the public-health impact of candidate HIV vaccines as part of the licensing process. Lancet Infect Dis 2008 Mar;8(3):200-7.

 

Boily MC, Desai K, Masse B, Gumel A. Incremental role of male circumcision on a generalised HIV epidemic through its protective effect against other sexually transmitted infections: from efficacy to effectiveness to population-level impact. Sex Transm Infect 2008 Oct;84 Suppl 2:ii28-ii34. PMCID:PMC3423078

 

Fichorova RN, Richardson-Harman N, Alfano M, Belec L, Carbonneil C, Chen S, Cosentino L, Curtis K, Dezzutti CS, Donoval B, et al. Biological and technical variables affecting immunoassay recovery of cytokines from human serum and simulated vaginal fluid: a multicenter study. Anal Chem 2008 Jun 15;80(12):4741-51. PMCID:PMC2646866

 

Hladik F, Dezzutti CS. Can a topical microbicide prevent rectal HIV transmission? PLoS Med 2008 Aug 5;5(8):e167. PMCID:PMC2494564

 

Rohan LC, Hillier SL, Dezzutti CS. Preventing the sexual transmission of HIV-1 with topical microbicides: another piece of the equation. J Infect Dis 2007 Nov 1;196(9):1285-7 (comment)

 

MacQueen KM, Namey E, Chilongozi DA, Mtweve SP, Mlingo M, Morar N, Reid C, Ristow A, Sahay S. Community perspectives on care options for HIV prevention trial participants. AIDS Care 2007 Apr;19(4):554-60.

 

Abbas UL, Anderson RM, Mellors JW. Potential impact of antiretroviral chemoprophylaxis on HIV-1 transmission in resource-limited settings. PLoS One 2007;2(9):e875. PMCID:PMC1975470