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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
Montgomery ET, Stadler J, Naidoo S, Katz A, Laborde N, Garcia M, Reddy K, Mansoor L, Etima J, Zimba C, Chitukuta M, Soto-Torres L. Reasons for non-adherence to the dapivirine vaginal ring: results of the MTN-032/ AHA study. AIDS 2018; May 11 [Epub ahead of print]
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.
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
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 2017; Sep 27. PMCID: PMC5871553 [Epub ahead of print]
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
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
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
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. PMCID: PMC5564054 [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. 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.
Noguchi LM, Montgomery ET, Biggio JR, Hendrix CW, Bogen DL, Hillier SL, Dai JY, Piper JM, Marzinke MA, Dezzutti CS, Isaacs SK, Schwartz JL, Watts DH, Beigi RH. Detectable tenofovir levels in breastfeeding infants of mothers exposed to topical tenofovir. Antimicrob Agents Chemother 2016 Aug 22;60(9):5616-9. PMCID: PMC4997886
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. PMCID: PMC4956805
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. PMCID: PMC4957649
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
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. 2016 Jul;25(7):761-6. PMCID:PMC4939378
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. PMCID: PMC4887458
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. PMCID: PMC4744323