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(List is sorted by most recent publications.  Updated May 17, 2018)

 

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

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.

 

Reasons for non-adherence to the dapivirine vaginal ring: results of the MTN-032/ AHA study

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]

 

Challenges and Solutions Implementing an SMS Text Message-based Survey CASI and Adherence Reminders in an International Biomedical HIV PrEP Study (MTN 017)

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

 

Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017

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.

 

How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe

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

 

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

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.

 

Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States

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

 

Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial

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

 

Performance of a validated risk score to predict HIV-1 acquisition among African women participating in a trial of the dapivirine vaginal ring

Balkus JE, Brown ER, Palanee-Phillips T, Kiweewa FM, 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

 

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

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; 19 (1): 8-14.

 

Achieving the optimal vaginal state: the use of vaginal products and study gels in Uganda, Zimbabwe and South Africa

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.

 

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.

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.

 

Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial

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.

 

Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception

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

 

The fourth generation AlereTM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples

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.

 

Use of Nucleic Acid Amplification Testing for Diagnosis of Extragenital Sexually Transmitted Infections

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.

 

Prevalent Herpes Simplex Virus-2 Increases the Risk of Incident Bacterial Vaginosis in Women from South Africa

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 [Epub ahead of print]

 

Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial?

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 2017; Aug 24[Epub ahead of print]

 

Favoring “Peace of Mind”: A Qualitative Study of African Women's HIV Prevention Product Formulation Preferences from the MTN-020/ASPIRE Trial

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

 

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

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

 

Survival of vaginal microorganisms in three commercially available transport systems

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

 

HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial

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.

 

Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial

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.

 

Acceptability and use of a dapivirine vaginal ring in a phase III trial

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.

 

Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study

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

 

Analytical Advances in the Ex Vivo Challenge Efficacy Assay

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

 

Differences in Cumulative Exposure and Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as Determined via Hair Concentrations

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]

 

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.

 

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.

 

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,  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.

 

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.

 

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.

 

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.

 

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.

 

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

 

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, et al. Detectable tenofovir levels in breastfeeding infants of mothers exposed to topical tenofovir. Antimicrob Agents Chemother 2016 Aug 22;60(9):5616-9.

 

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. J Womens Health (Larchmt) 2016 Jul;25(7):761-6. PMCID:PMC4939378

 

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.

 

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

 

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.

 

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.

 

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.

 

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;43(2):105-9.

 

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,  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

 

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

 

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

 

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

 

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.

 

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

 

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: PMC460758

 

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

 

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

 

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

 

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.

 

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

 

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, 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

 

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

 

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, 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

 

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; 2: 1145-1152. 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, 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

 

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.

 

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, 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

 

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

 

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, et al. Factors associated with bone mineral density in healthy African women. Arch Osteoporos 2015;10(1):206. PMCID: PMC4564062

 

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

 

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, 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

 

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, et al. Mucosal effects of tenofovir 1% gel. eLife  2015 Feb 3;4. PMCID: PMC4391502

 

Y Chromosome and HIV DNA Detection in Vaginal Swabs as Biomarkers of Semen and HIV Exposure in Women

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

 

Correlation between Compartmental Tenofovir Concentrations and an Ex Vivo Rectal Biopsy Model of Tissue Infectibility in the RMP-02/MTN-006 Phase 1 Study

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

 

A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate

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

 

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

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

 

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

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

 

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

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

 

Development of HIV-1 rectal-specific microbicides and colonic tissue evaluation

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

 

Perspectives on use of oral and vaginal antiretrovirals for HIV prevention: the VOICE-C qualitative study in Johannesburg, South Africa

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

 

Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035)

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

 

Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials

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

 

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

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

 

Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction

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

 

Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa

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

 

Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women

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

 

Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies

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.

 

Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa

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

 

A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010)

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

 

Appropriateness of hydroxyethylcellulose gel as a placebo control in vaginal microbicide trials: a comparison of the two control arms of HPTN 035

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

 

Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial

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

 

MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments

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

 

Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, Nakabiito C, Hoesley C, Justman J, Soto-Torres L, et al. 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

 

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials

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

 

Feasibility, performance, and acceptability of the Wisebag for potential monitoring of daily gel applicator use in Durban, South Africa

van der Straten A, Montgomery E, Pillay D, Cheng H, Naidoo A, Cele Z, et al. 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

 

The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico

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

 

Young women's experience with using videoconferencing for the assessment of sexual behavior and microbicide use

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

 

Use of a novel technology to track adherence to product use in a microbicide trial of short duration (MTN-007)

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

 

A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007)

McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, et al. 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

 

Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009)

Parikh UM, Kiepiela P, Ganesh S, Gomez K, Horn S, Eskay K, et al. Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009). PLoS One 2013;8(4):e59787. PMCID:PMC3621859

 

The development and validation of an UHPLC-MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma

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

 

Population-level benefits from providing effective HIV prevention means to pregnant women in high prevalence settings

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;8(9):e73770. PMCID:PMC3774771

 

Modeling the dissemination and uptake of clinical trials results

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

 

Recommendations for the follow-up of study participants with breakthrough HIV infections during HIV/AIDS biomedical prevention studies

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

 

Estimating the efficacy of preexposure prophylaxis for HIV prevention among participants with a threshold level of drug concentration

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

 

Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials

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

 

Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel

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

 

Mucosal Escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial

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

 

Partially hidden Markov model for time-varying principal stratification in HIV prevention trials

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

 

Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe

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

 

"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

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

 

Variations in microbicide gel acceptability among young women in the USA and Puerto Rico

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

 

RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate

Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, et al. 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

 

Use of nucleic acid amplification testing for diagnosis of anorectal sexually transmitted infections

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

 

Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity

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

 

Reformulated tenofovir gel for use as a dual compartment microbicide

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

 

Testing of viscous anti-HIV microbicides using Lactobacillus

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

 

Impact of Pill Sharing on Drug Resistance Due to a Wide-Scale Oral Prep Intervention in Generalized Epidemics

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

 

Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women

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

 

Good intentions: risk factors for unintended pregnancies in the US cohort of a microbicide trial

Schreiber CA, Whittington S, Cen L, Maslankowski L. Good intentions: risk factors for unintended pregnancies in the US cohort of a microbicide trial. Contraception 2011 Jan;83(1):74-81

 

Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy

Beigi R, Noguchi L, Parsons T, Macio I, Kunjara Na Ayudhya RP, Chen J, Hendrix CW, Masse B, Valentine M, Piper J, Watts DH. Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy. J Infect Dis 2011 Nov 15;204(10):1527-31. PMCID:PMC3192189

 

Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa

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

 

Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004)

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

 

Oral antiretroviral pre-exposure prophylaxis reduces the risk of HIV acquisition among men who have sex with men

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

 

LabKey Server NAb: a tool for analyzing, visualizing and sharing results from neutralizing antibody assays

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

 

Degradation of naturally occurring and engineered antimicrobial peptides by proteases

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

 

Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators

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

 

LabKey Server: an open source platform for scientific data integration, analysis and collaboration

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

 

Evaluating research and impact: a bibliometric analysis of research by the NIH/NIAID HIV/AIDS clinical trials networks

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