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Wynne J, Muwawu R, Mubiru MC, Kamira B, Kemigisha D, Nakyanzi T, Kabwigu S, Nakabiito C, Kiweewa Matovu F; VOICE Team. Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study. HIV Clin Trials 2018 Oct 27:1-7 [Epub ahead of print]
Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015; MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the MTN-020/ASPIRE Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis 2018 Oct 22 [Epub ahead of print]
Cranston RD, Carballo-Diéguez A, Gundacker H, Richardson BA, Giguere R, Dolezal C, Siegel A, KunjaraNaAyudhya RP, Gomez K, Piper JM, Lama JR, McGowan I; MTN-017 Protocol Team. Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women. Int J STD AIDS 2018; Oct 18 [Epub ahead of print]
Leu CS, Giguere R, Bauermeister JA, Dolezal C, Brown W 3rd, Balán IC, Richardson BA, Piper JM, Lama JR, Cranston RD, Carballo-Diéguez A. Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care. 2018 Oct 14:1-9 [Epub ahead of print]
Liu AY, Zhang J, Anderson PL, Wagner T, Pan Z, Peda M, Gomez K, Beamer M, Jacobson C, Strizki J, Dezzutti CS, Piper JM; MTN-028 Protocol Team for the Microbicide Trials Network. Phase 1 Pharmacokinetic Trial of 2 Intravaginal Rings Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048. Clin Infect Dis 2018 Oct 4 [Epub ahead of print]
Hoesley CJ, Chen BA, Anderson PL, Dezzutti CS, Strizki J, Sprinkle C, Heard F, Bauermeister J, Hall W, Jacobson C, Berthiaume J, Mayo A, Gundacker H, Richardson-Harman N, Piper J; Microbicide Trials Network 027 Study Team. Phase 1 Safety and Pharmacokinetics Study of MK-2048/Vicriviroc (MK-4176)/MK-2048A Intravaginal Rings. Clin Infect Dis 2018 Oct 4 [Epub ahead of print]
Chen BA, Zhang J, Gundacker HM, Hendrix CW, Hoesley CJ, Salata RA, Dezzutti CS, van der Straten A, Hall WB, Jacobson CE, Johnson S, McGowan I, Nel AM, Soto-Torres L, Marzinke MA; MTN-024/IPM 031 Protocol Team for the Microbicide Trials Network. Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women. Clin Infect Dis 2018 Oct 4 [Epub ahead of print]
Palanee-Phillips T, Roberts ST, Reddy K, Vaneshree Govender, Naidoo L, Siva S, Gafoor Z, Pather A, Matovu F, Hlahla K, Makanani B, Nair G, Schwartz K, Torjesen K, Brown E, Soto-Torres L, Baeten J, Montgomery ET; MTN-020/ASPIRE team. Impact of partner-related social harms on women's adherence to the dapivirine vaginal ring during a phase III trial. J Acquir Immune Defic Syndr 2018; Sep 18 [Epub ahead of print]
Mensch BS, Richardson BA, Husnik M, Brown ER, Kiweewa FM, Mayo AJ, Baeten JM, Palanee-Phillips T, van der Straten A; MTN-020/ASPIRE study team. Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE. AIDS Behav 2018; Sep 14 [Epub ahead of print]
Hughes SM, Ferre AL, Yandura SE, Shetler C, Baker CAR, Calienes F, Levy CN, Astronomo RD, Shu Z, Lentz GM, Fialkow M, Kirby AC, McElrath MJ, Sinclair E, Rohan LC, Anderson PL, Shacklett BL, Dezzutti CS, Gao D, Hladik F. Cryopreservation of human mucosal tissues. PLoS One 2018 Jul 30;13(7):e0200653. PMCID:PMC6066204
Montgomery ET, Stadler J, Naidoo S, Katz AW, Laborde N, Garcia M, Reddy K, Mansoor LE, Etima J, Zimba C, Chitukuta M, Soto-Torres L. Reasons for non-adherence to the dapivirine vaginal ring: Narrative explanations of objective drug-level results. AIDS 2018 July 17; 32(11):1517-1525. PMCID: 29957723
Abbai NS, Nyirenda M, Naidoo S, Ramjee G. Prevalent Herpes Simplex Virus-2 Increases the Risk of Incident Bacterial Vaginosis in Women from South Africa. AIDS Behav 2018 Jul;22(7):2172-2180. PMCID:PMC5871553
Justman JE, Nair G, Hendrix CW, Piper JM, Marzinke MA, Dai JY, Pan Z, Galaska B, Levy L, Schwartz JL ; Balar B, Kunjara Na Ayudhya RP, Mushamiri I, McGowan I, Dezzutti CS, for the MTN-014 Study Team. Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study with Directly Observed Dosing. J Acquir Immune Defic Syndr 2018 Jun 1;78(2):175-182. PMCID: PMC5963717
Brown W 3rd, Giguere R, Sheinfil A, Ibitoye M, Balan I, Ho T, Brown B, Quispe L, Sukwicha W, Lama JR, Carballo-Diéguez A, Cranston RD. Challenges and Solutions Implementing an SMS Text Message-based Survey CASI and Adherence Reminders in an International Biomedical HIV PrEP Study (MTN 017). J Biomed Inform 2018 Apr;80:78-86. PMCID: PMC5920551
Giguere R, Brown Iii W, Balán IC, Dolezal C, Ho T, Sheinfil A, Ibitoye M, Lama JR, McGowan I, Cranston RD, Carballo-Diéguez A. Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial? J Am Med Inform Assoc. 2018 Apr 1;25(4):393-400. PMCID: PMC5885798
Balán IC, Giguere R, Brown W 3rd, Carballo-Diéguez A, Horn S, Hendrix CW, Marzinke MA, Ayudhya RPKN, Patterson K, Piper JM, McGowan I, Lama JR, Cranston RD; MTN-017 Protocol Team. Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017. AIDS Behav 2018 Mar;22(3):986-995. PMCID: PMC5983888
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 2018 Mar;22(3):877-886. PMCID:PMC5587392
Laborde ND, Pleasants E, Reddy K, Atujuna M, Nakyanzi T, Chitukuta M, Naidoo S, Palanee-Phillips T, Baeten JM, Montgomery ET; MTN-020/ASPIRE Study Team. Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex. AIDS Behav 2018 Feb;22(2):437-446. PMCID: PMC5866044
Mhlanga FG, Noguchi L, Balkus JE, Kabwigu S, Scheckter R, Piper J, Watts H, O'Rourke C, Torjesen K, Brown ER, Hillier SL, Beigi R. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials 2018 Feb;19(1):8-14. PMCID: PMC5995113
Giguere R, Rael CT, Sheinfil A, Balán IC, Brown W 3rd, Ho T, Dolezal C, Leu CS, Liu A, Mayer KH, Lama JR, McGowan I, Carballo-Diéguez A, Cranston RD, MTN-017 Protocol Team. Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav 2018 Feb;22(2):388-401. PMCID:PMC5818328
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 2018 Feb;22(2):402-411. PMCID:PMC5702586
Balkus JE, Brown ER, Palanee-Phillips T, Matovu Kiweewa F, Mgodi N, Naidoo L, Mbilizi Y, Jeenarain N, Gaffoor Z, Siva S, Nair G, Pather A, Baeten JM. Performance of a Validated Risk Score to Predict HIV-1 Acquisition Among African Women Participating in a Trial of the Dapivirine Vaginal Ring. J Acquir Immune Defic Syndr 2018 Jan 1;77(1):e8-e10. PMCID:PMC5720924
Carballo-Diéguez A, Giguere R, Dolezal C, Leu CS, Balán IC, Brown W 3rd, Rael C, Richardson BA, Piper JM, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla CD, Lama JR, McGowan I, Cranston RD; MTN-017 Protocol Team. Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men. AIDS Behav 2017 Dec;21(12):3336-3345. PMCID: PMC5856109
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 Nov 1;76(3):330-337. PMCID: PMC5634926
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. Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception. J Acquir Immune Defic Syndr 2017 Oct 1;76(2):e47-e51. PMCID: PMC5597463
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 Sep;94:15-21. PMCID: PMC5790424
Cosentino LA, Danby CS, Rabe LK, Macio I, Meyn LA, Wiesenfeld HC, Hillier SL. Use of Nucleic Acid Amplification Testing for Diagnosis of Extragenital Sexually Transmitted Infections. J Clin Microbiol 2017 Sep;55(9):2801-2807. PMCID: PMC5648715
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 August 1; 33(8): 778-783. PMCID: PMC5564054
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
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 PMCID: PMC5512310
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. PMCID: PMC5489164
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. PMCID: PMC5512296
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
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. PMCID: PMC5557083
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
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
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. PMCID: PMC5850518
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. PMCID: PMC5535309
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
Duby Z, Mensch B, Hartmann M, Montgomery E, Mahaka I, Bekker L, van der Straten A. Achieving the optimal vaginal state: the use of vaginal products and study gels in Uganda, Zimbabwe and South Africa. Int Perspect Sex Reprod Health 2017;29(3):247-257.
Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM, Matovu Kiweewa F, Nair G, Mhlanga F, Siva S, Bekker LG, Jeenarain N, Gaffoor Z, Martinson F, Makanani B, Pather A, Naidoo L, Husnik M, Richardson BA, Parikh UM, Mellors JW, Marzinke MA, Hendrix CW, van der Straten A, Ramjee G, Chirenje ZM, Nakabiito C, Taha TE, Jones J, Mayo A, Scheckter R, Berthiaume J, Livant E, Jacobson C, Ndase P, White R, Patterson K, Germuga D, Galaska B, Bunge K, Singh D, Szydlo DW, Montgomery ET, Mensch BS, Torjesen K, Grossman CI, Chakhtoura N, Nel A, Rosenberg Z, McGowan I, Hillier S; MTN-020–ASPIRE Study Team. Use of a vaginal Ring containing dapivirine for HIV-1 prevention in women. N Engl J Med 2016 Dec 1;375(22):2121-32. PMCID:PMC4993693.
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.
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.
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
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.
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. PMCID: PMC5354168
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.