MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.
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
Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003).
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
Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.
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
Use of a vaginal Ring containing dapivirine for HIV-1 prevention in women.
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.
Lost in Translation: Language, Terminology, and Understanding of Penile-Anal Intercourse in an HIV Prevention Trial in South Africa, Uganda, and Zimbabwe.
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.
Adherence and The Lie in a HIV Prevention Clinical Trial.
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.
Levonorgestrel in contraceptives and multipurpose prevention technologies: does this progestin increase HIV risk or interact with antiretrovirals?
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
Adherence and acceptability of a multidrug vaginal ring for HIV prevention in a phase I study in the United States.
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
Sharing of Investigational Drug Among Participants in the Voice Trial.
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.
Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Non-use Increase at the Termination Visit?
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
A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy.
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.
Non-Antiretroviral Microbicides for HIV Prevention
Scott Y, Dezzutti CS. Non-Antiretroviral Microbicides for HIV Prevention AIDS Rev 2016 Jul-Sep;18(3):145-150. PMCID: PMC5053894
Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.
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.
Detectable tenofovir levels in breastfeeding infants of mothers exposed to topical tenofovir.
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
Pharmacodynamic correlations using fresh and cryopreserved tissue following use of vaginal rings containing dapivirine and/or maraviroc in a randomized, placebo controlled trial.
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
Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions.
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
An Empiric HIV Risk Scoring Tool to Predict HIV-1 Acquisition in African Women.
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
Performing Drug Safety Research During Pregnancy and Lactation: Biomedical HIV Prevention Research as a Template.
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
Negotiating the use of female-initiated HIV prevention methods in a context of gender-based violence: the narrative of rape.
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
Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study.
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
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.
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
Bone mineral density changes among young, healthy african women receiving oral tenofovir for HIV pre-exposure prophylaxis.
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
Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.
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
Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel.
Herold BC, Chen BA, Salata RA, Marzinke MA, Kelly CW, Dezzutti CS, McGowan I, Galaska B, Levy L, Piper JM, Hillier S, Hendrix CW. Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel. Clin Infect Dis 2016 Feb 1;62(3):375-82. PMCID: PMC4706638
Pharmacological Measures of Adherence and Risk of HIV Acquisition in the VOICE Study.
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
Patterns of extragenital Chlamydia and Gonorrhea in women and men who have sex with men reporting a history of receptive anal intercourse.
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 Feb;43(2):105-9. PMCID: PMC4955797
Sexual scripting of heterosexual penile-anal intercourse amongst participants in an HIV prevention trial in South Africa, Uganda and Zimbabwe.
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
Oral and injectable contraceptive use and HIV acquisition risk among women in 4 African countries: a secondary analysis of data from a microbicide trial.
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
Should we fear resistance from tenofovir/emtricitabine preexposure prophylaxis?
Parikh UM, Mellors JW. Should we fear resistance from tenofovir/emtricitabine preexposure prophylaxis? Curr Opin HIV AIDS 2016 Jan;11(1):49-55. PMCID: PMC4970748
Factors associated with bone mineral density in healthy African women.
Mgodi NM, Kelly C, Gati B, Greenspan S, Dai JY, Bragg V, Livant E, Piper JM, Nakabiito C, Magure T, Marrazzo JM, Chirenje ZM, Riddler SA; MTN-003B Protocol Team. Factors associated with bone mineral density in healthy African women. Arch Osteoporos 2015 Dec;10(1):206. PMCID: PMC4564062
Broadly Neutralizing Anti-HIV Antibodies Prevent HIV Infection of Mucosal Tissue Ex Vivo.
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
Animal and human mucosal tissue models to study HIV biomedical interventions: can we predict success?
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
Pharmacodynamic Activity of Dapivirine and Maraviroc Single Entity and Combination Topical Gels for HIV-1 Prevention.
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
Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial.
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: PMC4607587
Characteristics Associated with HIV Drug Resistance Among Women Screening for an HIV Prevention Trial in KwaZulu-Natal, South Africa.
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
Disclosure of pharmacokinetic drug results to understand non-adherence: results from the VOICE-D study.
van der Straten A, Montgomery ET, Musara P, Etima J, Naidoo S, Laborde N, Hartmann M, Levy L, Bennie T, Cheng H, Piper J, Grossman CI, Marrazzo J, Mensch B; Microbicide Trials Network-003D Study Team. Disclosure of pharmacokinetic drug results to understand non-adherence: results from the VOICE-D study. AIDS 2015 Oct 23; 29(16):2161–2171. PMCID:PMC4638164
Soluble Immune Mediators and Vaginal Bacteria Impact Innate Genital Mucosal Antimicrobial Activity in Young Women.
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
Age-Disparate Partnerships and Risk of HIV-1 Acquisition Among South African Women Participating in the VOICE Trial.
Balkus JE, Nair G, Montgomery ET, Mishra A, Palanee-Phillips T, Ramjee G, Panchia R, Selepe P, Richardson BA, Chirenje ZM, Marrazzo JM. 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 1;70(2):212-7. PMCID: PMC4573287
Levels of Genital Tract Defensins and Cytokines Differ between HIV-Uninfected US and African Women.
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
The Molecular Characterization of Intestinal Explant HIV Infection Using Polymerase Chain Reaction-Based Techniques.
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.
Interpretation, communication, and mechanisms of associations between injectable contraception and HIV risk - Authors' reply.
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.
Discovery of Genetic Variants of the Kinases That Activate Tenofovir in a Compartment-specific Manner.
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 Jul 9;2(9):1145-52. PMCID: PMC4588390
Risk of HIV-1 acquisition among women who use different types of injectable progestin contraception in South Africa: a prospective cohort study.
Noguchi LM, Richardson BA, Baeten JM, Hillier SL, Balkus JE, Chirenje ZM, Bunge K, Ramjee G, Nair G, Palanee-Phillips T, Selepe P, van der Straten A, Parikh UM, Gomez K, Piper JM, Watts DH, Marrazzo JM. 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
Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.
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
Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women.
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
Male Partner Influence on Women's HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the Importance of "Understanding".
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
Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial.
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
Tenofovir-Based Preexposure Prophylaxis for HIV Infection among African Women.
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
Mucosal effects of tenofovir 1% gel.
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
Preventing HIV in Women - Still Trying to Find Their VOICE
Saag MS. Preventing HIV in Women - Still Trying to Find Their VOICE N Engl J Med 2015 Feb 5;372(6):564-6.