Skip to main content
Top
Published in: Current HIV/AIDS Reports 1/2013

01-03-2013 | The Science of Prevention (S Kalichman, Section Editor)

Methodological Lessons from Clinical Trials and the Future of Microbicide Research

Authors: Ariane van der Straten, Elizabeth T. Montgomery, Miriam Hartmann, Alexandra Minnis

Published in: Current HIV/AIDS Reports | Issue 1/2013

Login to get access

Abstract

Interpretation of microbicide trial results has been compromised by challenges to accurate measurement of product adherence and sexual risk behaviors. This article provides an evaluation of the methods used to measure adherence and other sensitive behaviors relevant to assessment of product safety and effectiveness in recently completed trials of vaginal and rectal microbicides. We review the strengths and limitations of existing and novel behavioral measurement strategies and provide recommendations for future trial design with the goal of facilitating the development and identification of safe and effective microbicides for HIV prevention.
Footnotes
1
Microbicide Trials Network statements on decision to discontinue use of oral Tenofovir tablets and Tenofovir gel in VOICE, a major HIV prevention study in women. http://​www.​mtnstopshiv.​org/​node/​3909: Microbicide Trials Network; 2011. Note that the oral Truvada and placebo arms continued and were completed on schedule in August 2012 (http://​www.​mtnstopshiv.​org/​studies/​70).
 
Literature
1.
go back to reference Verma NA, Lee AC, Herold BC, et al. Topical prophylaxis for HIV prevention in women: becoming a reality. Curr HIV/AIDS Rep. 2011;8:104–13.PubMedCrossRef Verma NA, Lee AC, Herold BC, et al. Topical prophylaxis for HIV prevention in women: becoming a reality. Curr HIV/AIDS Rep. 2011;8:104–13.PubMedCrossRef
2.
go back to reference •• Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74. This paper presents the results of CAPRISA 004, the only trial demonstrating effectiveness of a microbicide gel to date. •• Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74. This paper presents the results of CAPRISA 004, the only trial demonstrating effectiveness of a microbicide gel to date.
3.
go back to reference van der Straten A, Van Damme L, Haberer JE, et al. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012;26:F13–9.PubMedCrossRef van der Straten A, Van Damme L, Haberer JE, et al. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012;26:F13–9.PubMedCrossRef
4.
go back to reference Weiss HA, Wasserheit JN, Barnabas RV, et al. Persisting with prevention: the importance of adherence for HIV prevention. Emerg Themes Epidemiol. 2008;5:1–7.CrossRef Weiss HA, Wasserheit JN, Barnabas RV, et al. Persisting with prevention: the importance of adherence for HIV prevention. Emerg Themes Epidemiol. 2008;5:1–7.CrossRef
5.
go back to reference Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399–410.PubMedCrossRef Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399–410.PubMedCrossRef
6.
go back to reference Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587–99.PubMedCrossRef Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587–99.PubMedCrossRef
7.
go back to reference • Karim SSA, Kashuba ADM, Werner L, et al. Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women. Lancet. 2011;378:279–81. This study showed the relationship between drug level in vaginal fluids and protection from HIV acquisition in the CAPRISA 004 trial.PubMedCrossRef • Karim SSA, Kashuba ADM, Werner L, et al. Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women. Lancet. 2011;378:279–81. This study showed the relationship between drug level in vaginal fluids and protection from HIV acquisition in the CAPRISA 004 trial.PubMedCrossRef
8.
go back to reference Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411–22.PubMedCrossRef Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411–22.PubMedCrossRef
9.
go back to reference Institute of Medicine. Design considerations: adherence. In: Lagakos SW, Gable A, editors. Methodological challenges in biomedical HIV prevention trials. Washington, DC: Natl Academy Press; 2008. p. 119–47. Institute of Medicine. Design considerations: adherence. In: Lagakos SW, Gable A, editors. Methodological challenges in biomedical HIV prevention trials. Washington, DC: Natl Academy Press; 2008. p. 119–47.
10.
go back to reference • Amico K. Adherence to preexposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. Curr Opin HIV AIDS. 2012;7:542–48. This review focuses on recent Oral PrEP trials and the behavioral aspects of PrEP adherence. It proposes a behavioral agenda for both oral PrEP research and practice. • Amico K. Adherence to preexposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. Curr Opin HIV AIDS. 2012;7:542–48. This review focuses on recent Oral PrEP trials and the behavioral aspects of PrEP adherence. It proposes a behavioral agenda for both oral PrEP research and practice.
11.
go back to reference McGowan I, Taylor DJ. Heterosexual anal intercourse has the potential to cause a significant loss of power in vaginal microbicide effectiveness studies. Sex Transm Dis. 2010;37:361–4.PubMed McGowan I, Taylor DJ. Heterosexual anal intercourse has the potential to cause a significant loss of power in vaginal microbicide effectiveness studies. Sex Transm Dis. 2010;37:361–4.PubMed
12.
go back to reference Masse BR, Boily MC, Dimitrov D, et al. Efficacy dilution in randomized placebo-controlled vaginal microbicide trials. Emerg Themes Epidemiol. 2009;6(5). Masse BR, Boily MC, Dimitrov D, et al. Efficacy dilution in randomized placebo-controlled vaginal microbicide trials. Emerg Themes Epidemiol. 2009;6(5).
13.
go back to reference • Muchomba FM, Gearing RE, Simoni JM, et al. State of science of adherence in pre-exposure prophylaxis and microbicide trials. J Acquir Immune Defic Syndr. 2012; doi:10.1097/QAI.0b013e31826f9962. This is a review of adherence in all published oral PrEP and microbicide trials to date. • Muchomba FM, Gearing RE, Simoni JM, et al. State of science of adherence in pre-exposure prophylaxis and microbicide trials. J Acquir Immune Defic Syndr. 2012; doi:10.​1097/​QAI.​0b013e31826f9962​. This is a review of adherence in all published oral PrEP and microbicide trials to date.
14.
go back to reference Greene E, Batona G, Hallad J, et al. Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India. Cult Health Sex. 2010;12:739–54.PubMedCrossRef Greene E, Batona G, Hallad J, et al. Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India. Cult Health Sex. 2010;12:739–54.PubMedCrossRef
15.
go back to reference Van Damme L, Govinden R, Mirembe FM, et al. Lack of Effectiveness of Cellulose Sulfate Gel for the Prevention of Vaginal HIV Transmission. N Engl J Med. 2008;359:463–72.PubMedCrossRef Van Damme L, Govinden R, Mirembe FM, et al. Lack of Effectiveness of Cellulose Sulfate Gel for the Prevention of Vaginal HIV Transmission. N Engl J Med. 2008;359:463–72.PubMedCrossRef
16.
go back to reference McCormack S, Ramjee G, Kamali A, et al. PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial. Lancet. 2010;376:1329–37.PubMedCrossRef McCormack S, Ramjee G, Kamali A, et al. PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial. Lancet. 2010;376:1329–37.PubMedCrossRef
17.
go back to reference Abdool Karim SS, Richardson BA, Ramjee G, et al. Safety and effectiveness of BufferGel and 0.5 % PRO2000 gel for the prevention of HIV infection in women. AIDS. 2011;25:957–66.PubMedCrossRef Abdool Karim SS, Richardson BA, Ramjee G, et al. Safety and effectiveness of BufferGel and 0.5 % PRO2000 gel for the prevention of HIV infection in women. AIDS. 2011;25:957–66.PubMedCrossRef
18.
go back to reference • Pool R, Montgomery CM, Morar NS, et al. A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme. PloS One. 2010;5:e11600. This paper contributes to the triangulation methodology of various adherence measures. • Pool R, Montgomery CM, Morar NS, et al. A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme. PloS One. 2010;5:e11600. This paper contributes to the triangulation methodology of various adherence measures.
19.
go back to reference Pool R, Montgomery CM, Morar NS, et al. Assessing the accuracy of adherence and sexual behaviour data in the MDP301 vaginal microbicides trial using a mixed methods and triangulation model. PLoS One. 2010;5:e11632.PubMedCrossRef Pool R, Montgomery CM, Morar NS, et al. Assessing the accuracy of adherence and sexual behaviour data in the MDP301 vaginal microbicides trial using a mixed methods and triangulation model. PLoS One. 2010;5:e11632.PubMedCrossRef
20.
go back to reference Tolley EE, Tsui S, Mehendale S, et al. Predicting product adherence in a topical microbicide safety trial in Pune, India. AIDS Behav. 2011;16:1808–15. Tolley EE, Tsui S, Mehendale S, et al. Predicting product adherence in a topical microbicide safety trial in Pune, India. AIDS Behav. 2011;16:1808–15.
21.
go back to reference Hillier S. Safety and acceptability of daily and coitally dependent use of 1 % tenofovir over 6 months of use. Proceedings of the International Microbicides Conference; New Dehli, India, Feb 24–27, 2008. Hillier S. Safety and acceptability of daily and coitally dependent use of 1 % tenofovir over 6 months of use. Proceedings of the International Microbicides Conference; New Dehli, India, Feb 24–27, 2008.
22.
go back to reference Anton PA, Cranston RD, Kashuba A, et al. RMP-02/MTN-006: a phase 1 rectal safety, acceptability, pharmacokinetic and pharmacodynamic study of tenofovir 1 % gel compared to oral tenofovir disoproxil fumerate. AIDS Res Hum Retroviruses. 2012 (not available - ahead of print). Anton PA, Cranston RD, Kashuba A, et al. RMP-02/MTN-006: a phase 1 rectal safety, acceptability, pharmacokinetic and pharmacodynamic study of tenofovir 1 % gel compared to oral tenofovir disoproxil fumerate. AIDS Res Hum Retroviruses. 2012 (not available - ahead of print).
23.
go back to reference McGowan I, Hoesley C, Andrew P, et al. MTN-007: a phase 1 randomized, double-blind, placebo-controlled, rectal safety and acceptability study of tenofovir 1 % gel. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Seattle, March 5–8, 2012. McGowan I, Hoesley C, Andrew P, et al. MTN-007: a phase 1 randomized, double-blind, placebo-controlled, rectal safety and acceptability study of tenofovir 1 % gel. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Seattle, March 5–8, 2012.
24.
go back to reference Anton PA, Saunders T, Elliott J, et al. First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 Gel with a novel index of ex vivo efficacy. PLoS One. 2011;6:e23243.PubMedCrossRef Anton PA, Saunders T, Elliott J, et al. First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 Gel with a novel index of ex vivo efficacy. PLoS One. 2011;6:e23243.PubMedCrossRef
25.
go back to reference • Cohen CR, Brown J, Moscicki A-B, et al. A phase I randomized placebo controlled trial of the safety of 3 % SPL7013 Gel (VivaGel) in healthy young women administered twice daily for 14 days. PLoS One. 2011;6:e16258. This phase I microbicide trial used multiple measures of adherence, including a dye stain assay (DSA). This is the only microbicide trial reported in the past 2 years to use a DSA. They also used biomarkers to assess sexual abstinence during the trial.PubMedCrossRef • Cohen CR, Brown J, Moscicki A-B, et al. A phase I randomized placebo controlled trial of the safety of 3 % SPL7013 Gel (VivaGel) in healthy young women administered twice daily for 14 days. PLoS One. 2011;6:e16258. This phase I microbicide trial used multiple measures of adherence, including a dye stain assay (DSA). This is the only microbicide trial reported in the past 2 years to use a DSA. They also used biomarkers to assess sexual abstinence during the trial.PubMedCrossRef
26.
go back to reference McGowan I, Gomez K, Bruder K, et al. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011;25:1057–64.PubMedCrossRef McGowan I, Gomez K, Bruder K, et al. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011;25:1057–64.PubMedCrossRef
27.
go back to reference • Minnis AM, Gandham S, Richardson BA, 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. 2012. doi:10.1007/s10461-012-0333-8. This phase II trial is the first to directly compare 2 formulations (oral and vaginal) of the same product (tenofovir); and among the first to use drug levels as a primary adherence outcome for oral dosing. They also conducted a direct comparison between biomarker-based and self-reported adherence. • Minnis AM, Gandham S, Richardson BA, 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. 2012. doi:10.​1007/​s10461-012-0333-8. This phase II trial is the first to directly compare 2 formulations (oral and vaginal) of the same product (tenofovir); and among the first to use drug levels as a primary adherence outcome for oral dosing. They also conducted a direct comparison between biomarker-based and self-reported adherence.
28.
go back to reference Hendrix C, Minnis A, Guddera V, et al. MTN-001: a phase 2 cross-over study of daily oral and vaginal TFV in healthy, sexually active women results in significantly different product acceptability and vaginal tissue drug concentrations. Conference on Retroviruses and Opportunistic Infections; February 28; Boston, MA. 2011. Hendrix C, Minnis A, Guddera V, et al. MTN-001: a phase 2 cross-over study of daily oral and vaginal TFV in healthy, sexually active women results in significantly different product acceptability and vaginal tissue drug concentrations. Conference on Retroviruses and Opportunistic Infections; February 28; Boston, MA. 2011.
29.
go back to reference Isaacs M, Albertse M, Hellström E, et al. Daily monitored adherence (DMA) in a microbicide safety trial - IPM 014B. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012. Isaacs M, Albertse M, Hellström E, et al. Daily monitored adherence (DMA) in a microbicide safety trial - IPM 014B. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012.
30.
go back to reference Montgomery E, van der Straten A, Woodsong C, et al. Daily use of two dapivirine vaginal gels in the United States: adherence and acceptability. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012. Montgomery E, van der Straten A, Woodsong C, et al. Daily use of two dapivirine vaginal gels in the United States: adherence and acceptability. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012.
31.
go back to reference Nel AM, Coplan P, Smythe SC, et al. Pharmacokinetic assessment of dapivirine vaginal microbicide gel in healthy, HIV-negative women. AIDS Res Hum Retrovir. 2010;26:1181–90.PubMedCrossRef Nel AM, Coplan P, Smythe SC, et al. Pharmacokinetic assessment of dapivirine vaginal microbicide gel in healthy, HIV-negative women. AIDS Res Hum Retrovir. 2010;26:1181–90.PubMedCrossRef
32.
go back to reference Nel AM, Smythe SC, Habibi S, et al. Pharmacokinetics of 2 dapivirine vaginal microbicide gels and their safety vs Hydroxyethyl cellulose-based universal placebo gel. J Acquir Immune Defic Syndr. 2010;55:161–9.PubMedCrossRef Nel AM, Smythe SC, Habibi S, et al. Pharmacokinetics of 2 dapivirine vaginal microbicide gels and their safety vs Hydroxyethyl cellulose-based universal placebo gel. J Acquir Immune Defic Syndr. 2010;55:161–9.PubMedCrossRef
33.
go back to reference Adudans MK, Gitome SW, Njoroge BN, et al. Daily monitored adherence (DMA): optimizing adherence in a vaginal microbicide study in Kisumu, Kenya. Proceedings of the International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention; Rome, Italy, July 17–20, 2011. Adudans MK, Gitome SW, Njoroge BN, et al. Daily monitored adherence (DMA): optimizing adherence in a vaginal microbicide study in Kisumu, Kenya. Proceedings of the International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention; Rome, Italy, July 17–20, 2011.
36.
go back to reference van der Straten A, Woodsong C, Montgomery E, et al. High adherence and acceptability of a monthly Dapivirine vaginal ring for HIV prevention in Africa. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012. van der Straten A, Woodsong C, Montgomery E, et al. High adherence and acceptability of a monthly Dapivirine vaginal ring for HIV prevention in Africa. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012.
37.
go back to reference Nel A, Kamupira M, Woodsong C, et al. Safety, acceptability and pharmacokinetic assessment (adherence) of monthly Dapivirine Vaginal Microbicide Rings (Ring-004) for HIV prevention. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Seattle, WA, March 5–8, 2012. Nel A, Kamupira M, Woodsong C, et al. Safety, acceptability and pharmacokinetic assessment (adherence) of monthly Dapivirine Vaginal Microbicide Rings (Ring-004) for HIV prevention. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Seattle, WA, March 5–8, 2012.
38.
go back to reference Nel A, Habibi S, Smythe S, et al. Pharmacokinetic and safety assessment of monthly anti-HIV dapivirine vaginal microbicide rings with multiple dosing. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Boston, MA, Feb 27–March 2, 2011. Nel A, Habibi S, Smythe S, et al. Pharmacokinetic and safety assessment of monthly anti-HIV dapivirine vaginal microbicide rings with multiple dosing. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Boston, MA, Feb 27–March 2, 2011.
39.
go back to reference Kiser PF, Johnson TJ, Clark JT. State of the art in intravaginal ring technology for topical prophylaxis of HIV infection. AIDS Rev. 2012;14:62–77.PubMed Kiser PF, Johnson TJ, Clark JT. State of the art in intravaginal ring technology for topical prophylaxis of HIV infection. AIDS Rev. 2012;14:62–77.PubMed
40.
go back to reference Montgomery ET, van der Straten A, Cheng H, et al. Vaginal ring adherence in sub-Saharan Africa: expulsion, removal, and perfect use. AIDS Behav. 2012;7:1787–98. Montgomery ET, van der Straten A, Cheng H, et al. Vaginal ring adherence in sub-Saharan Africa: expulsion, removal, and perfect use. AIDS Behav. 2012;7:1787–98.
41.
go back to reference Montgomery ET, Woodsong C, Musara P, et al. An acceptability and safety study of the Duet cervical barrier and gel delivery system in Zimbabwe. J Int AIDS Soc. 2010;13:30.PubMedCrossRef Montgomery ET, Woodsong C, Musara P, et al. An acceptability and safety study of the Duet cervical barrier and gel delivery system in Zimbabwe. J Int AIDS Soc. 2010;13:30.PubMedCrossRef
42.
go back to reference Woodsong C, Alleman P. Sexual pleasure, gender power and microbicide acceptability in Zimbabwe and Malawi. AIDS Educ Prev. 2008;20:171–87. Epub 2008/04/25.PubMedCrossRef Woodsong C, Alleman P. Sexual pleasure, gender power and microbicide acceptability in Zimbabwe and Malawi. AIDS Educ Prev. 2008;20:171–87. Epub 2008/04/25.PubMedCrossRef
43.
go back to reference Woodsong C, Alleman P, Musara P, et al. 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;16:785–90.PubMedCrossRef Woodsong C, Alleman P, Musara P, et al. 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;16:785–90.PubMedCrossRef
44.
go back to reference Nel AM, Mitchnick LB, Risha P, et al. Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women. J Womens Health (Larchmt). 2011;20:1207–14.CrossRef Nel AM, Mitchnick LB, Risha P, et al. Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women. J Womens Health (Larchmt). 2011;20:1207–14.CrossRef
45.
go back to reference Vrijens B, Urquhart J. Patient adherence to prescribed antimicrobial drug dosing regimens. J Antimicrob Chemother. 2005;55:616–27.PubMedCrossRef Vrijens B, Urquhart J. Patient adherence to prescribed antimicrobial drug dosing regimens. J Antimicrob Chemother. 2005;55:616–27.PubMedCrossRef
46.
go back to reference •• Blaschke TF, Osterberg L, Vrijens B, et al. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2012;52:275–301. This thorough review of the treatment adherence literature presents a new framework for adherence assessment and standardized definitions for the components of adherence.PubMedCrossRef •• Blaschke TF, Osterberg L, Vrijens B, et al. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2012;52:275–301. This thorough review of the treatment adherence literature presents a new framework for adherence assessment and standardized definitions for the components of adherence.PubMedCrossRef
48.
go back to reference Meyer J, Summers B, Lentsoane P, et al. Is a simple self-rating or visual analogue scale more accurate than prescription refill data, as an indicator of non-adherence in a resource-limited setting in South Africa. Proceedings of the International Conference on HIV Treatment and Prevention Adherence; Miami, FL, June 3–5, 2012. Meyer J, Summers B, Lentsoane P, et al. Is a simple self-rating or visual analogue scale more accurate than prescription refill data, as an indicator of non-adherence in a resource-limited setting in South Africa. Proceedings of the International Conference on HIV Treatment and Prevention Adherence; Miami, FL, June 3–5, 2012.
49.
go back to reference Lu M, Safren S, Skolnik P, et al. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008;12:86–94.PubMedCrossRef Lu M, Safren S, Skolnik P, et al. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008;12:86–94.PubMedCrossRef
50.
go back to reference Minnis AM, Steiner MJ, Gallo MF, et al. Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe. Am J Epidemiol. 2009;170:918–24.PubMedCrossRef Minnis AM, Steiner MJ, Gallo MF, et al. Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe. Am J Epidemiol. 2009;170:918–24.PubMedCrossRef
51.
go back to reference Ghanem KG, Melendez JH, McNeil-Solis C, et al. Condom use and vaginal Y-chromosome detection: the specificity of a potential biomarker. Sex Transm Dis. 2007;34:620–3.PubMed Ghanem KG, Melendez JH, McNeil-Solis C, et al. Condom use and vaginal Y-chromosome detection: the specificity of a potential biomarker. Sex Transm Dis. 2007;34:620–3.PubMed
52.
go back to reference Carballo-Dieguez A, Giguere R, Dolezal C, et al. "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. 2011;7:1761–74. Carballo-Dieguez A, Giguere R, Dolezal C, et al. "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. 2011;7:1761–74.
53.
go back to reference Katzen L, Abbott S, Friedland B, et al. An evaluation of two methods for daily reporting of adherence in a placebo gel trial in southern India. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012. Katzen L, Abbott S, Friedland B, et al. An evaluation of two methods for daily reporting of adherence in a placebo gel trial in southern India. Proceedings of the International Microbicides Conference; Sydney, Australia, April 15–18, 2012.
54.
go back to reference Curran K, Mugo N, Kurth A, et al. A pilot study of daily SMS surveys of sexual behavior and PrEP use among Kenyan HIV discordent couples. Proceedings of the International Conference on HIV Treatment and Prevention Adherence; Miami, FL, June 4, 2012. Curran K, Mugo N, Kurth A, et al. A pilot study of daily SMS surveys of sexual behavior and PrEP use among Kenyan HIV discordent couples. Proceedings of the International Conference on HIV Treatment and Prevention Adherence; Miami, FL, June 4, 2012.
55.
go back to reference Mutua G, Sanders E, Mugo P, et al. Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers. PLoS One. 2012;7:e33103.PubMedCrossRef Mutua G, Sanders E, Mugo P, et al. Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers. PLoS One. 2012;7:e33103.PubMedCrossRef
56.
go back to reference Horvath T, Azman H, Kennedy GE, et al. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev. 2012;3:1–37. Horvath T, Azman H, Kennedy GE, et al. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev. 2012;3:1–37.
57.
go back to reference Haberer J, Baeten J, Celum C, et al. Near perfect early adherence to antiretroviral PrEP againstHIV infection among HIV serodiscordant couples as determined by multiple measures: preliminary data from the partners PrEP study. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Boston, MA, Feb 27–Mar 2, 2011. Haberer J, Baeten J, Celum C, et al. Near perfect early adherence to antiretroviral PrEP againstHIV infection among HIV serodiscordant couples as determined by multiple measures: preliminary data from the partners PrEP study. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Boston, MA, Feb 27–Mar 2, 2011.
58.
go back to reference • Moench TR, O'Hanlon DE, Cone RA. Evaluation of microbicide gel adherence monitoring methods. Sex Transm Dis. 2012;39:335–40. This methodological study compared different applicator insertion tests. They developed a simple UV light based applicator test, which they combined with electronic monitoring (MEMS) to monitor quality of execution and applicator insertion. • Moench TR, O'Hanlon DE, Cone RA. Evaluation of microbicide gel adherence monitoring methods. Sex Transm Dis. 2012;39:335–40. This methodological study compared different applicator insertion tests. They developed a simple UV light based applicator test, which they combined with electronic monitoring (MEMS) to monitor quality of execution and applicator insertion.
59.
go back to reference van der Straten A, Montgomery E, Pillay D, et al. Feasibility, performance, and acceptability of the Wisebag for potential monitoring of daily gel applicator use in Durban, South Africa. AIDS Behav. (in press). van der Straten A, Montgomery E, Pillay D, et al. Feasibility, performance, and acceptability of the Wisebag for potential monitoring of daily gel applicator use in Durban, South Africa. AIDS Behav. (in press).
60.
go back to reference Gengiah T, Mansoor L, Naidoo A, et al. The “Wisebag”: an innovative strategy for enhancing measurement of microbicide gel use in clinical trials. Proceedings of the International Microbicides Conference; Pittsburgh, PA, May 22–25, 2010. Gengiah T, Mansoor L, Naidoo A, et al. The “Wisebag”: an innovative strategy for enhancing measurement of microbicide gel use in clinical trials. Proceedings of the International Microbicides Conference; Pittsburgh, PA, May 22–25, 2010.
63.
go back to reference Skoler-Karpoff S, Ramjee G, Ahmed K, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1977–87.PubMedCrossRef Skoler-Karpoff S, Ramjee G, Ahmed K, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1977–87.PubMedCrossRef
64.
go back to reference Katzen LL, Fernandez-Romero JA, Sarna A, et al. Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators. Sex Transm Dis. 2011;38:1050–5.PubMedCrossRef Katzen LL, Fernandez-Romero JA, Sarna A, et al. Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators. Sex Transm Dis. 2011;38:1050–5.PubMedCrossRef
65.
go back to reference Mauck CK, Schwartz JL. Dyeing to know: the use of vaginal applicator staining and other techniques to assess adherence to product use in microbicide trials. Sex Transm Dis. 2012;39:713–5.PubMedCrossRef Mauck CK, Schwartz JL. Dyeing to know: the use of vaginal applicator staining and other techniques to assess adherence to product use in microbicide trials. Sex Transm Dis. 2012;39:713–5.PubMedCrossRef
66.
go back to reference Morey TE, Wasdo S, Wishin J, et al. Feasibility of a breath test for monitoring adherence to vaginal administration of antiretroviral microbicide gels. J Clin Pharmacol. 2012. doi:10.1177/0091270011434157. Morey TE, Wasdo S, Wishin J, et al. Feasibility of a breath test for monitoring adherence to vaginal administration of antiretroviral microbicide gels. J Clin Pharmacol. 2012. doi:10.​1177/​0091270011434157​.
67.
go back to reference van der Straten A, Wasdo S, Rivett K, et al. A novel breath-based technology to assess concurrent use of vaginal gel and condom. Proceedings of the International AIDS Society Conference; Rome, Italy, July 17–20, 2011. van der Straten A, Wasdo S, Rivett K, et al. A novel breath-based technology to assess concurrent use of vaginal gel and condom. Proceedings of the International AIDS Society Conference; Rome, Italy, July 17–20, 2011.
68.
go back to reference Au-Yeung KY, Moon GD, Robertson TL, et al. Early clinical experience with networked system for promoting patient self-management. Am J Manag Care. 2011;17:e277–87.PubMed Au-Yeung KY, Moon GD, Robertson TL, et al. Early clinical experience with networked system for promoting patient self-management. Am J Manag Care. 2011;17:e277–87.PubMed
70.
go back to reference •• Anderson PL, Glidden DV, Liu A, et al. Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men. Sci Transl Med. 2012;4(151):151ra25. Epub 2012/09/14. This is the first published study to establish a quantitative relationship between active intracellular drug concentration in peripheral blood mononuclear cells and level of protection from HIV-1 acquisition, using data from the oral PrEP trial iPrEx and from a separate study, the STRAND trial, which used directly observed oral dosing. •• Anderson PL, Glidden DV, Liu A, et al. Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men. Sci Transl Med. 2012;4(151):151ra25. Epub 2012/09/14. This is the first published study to establish a quantitative relationship between active intracellular drug concentration in peripheral blood mononuclear cells and level of protection from HIV-1 acquisition, using data from the oral PrEP trial iPrEx and from a separate study, the STRAND trial, which used directly observed oral dosing.
71.
go back to reference Liu A. What we might learn about PrEP adherence from biomarkers: promise and limitations. Proceedings of the International Microbicide Conference; Sydney, Australia, April 15–18, 2012. Liu A. What we might learn about PrEP adherence from biomarkers: promise and limitations. Proceedings of the International Microbicide Conference; Sydney, Australia, April 15–18, 2012.
72.
go back to reference Schwartz JL, Rountree W, Kashuba ADM, et al. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1 % tenofovir gel. PLoS One. 2011;6:e25974.PubMedCrossRef Schwartz JL, Rountree W, Kashuba ADM, et al. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1 % tenofovir gel. PLoS One. 2011;6:e25974.PubMedCrossRef
73.
go back to reference Romano J, Variano B, Coplan P, et al. Safety and availability of dapivirine (TMC120) delivered from an intravaginal ring. AIDS Res Hum Retrovir. 2009;25:483–8.PubMedCrossRef Romano J, Variano B, Coplan P, et al. Safety and availability of dapivirine (TMC120) delivered from an intravaginal ring. AIDS Res Hum Retrovir. 2009;25:483–8.PubMedCrossRef
74.
go back to reference Singer R, Mawson P, Derby N, et al. An intravaginal ring that releases the NNRTI MIV-150 reduces SHIV transmission in macaques. Sci Transl Med. 2012;4:150ra23–ra23.CrossRef Singer R, Mawson P, Derby N, et al. An intravaginal ring that releases the NNRTI MIV-150 reduces SHIV transmission in macaques. Sci Transl Med. 2012;4:150ra23–ra23.CrossRef
75.
go back to reference Keller MJ, Madan RP, Torres NM, et al. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1 % tenofovir gel. PLoS One. 2011;6:e16475.PubMedCrossRef Keller MJ, Madan RP, Torres NM, et al. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1 % tenofovir gel. PLoS One. 2011;6:e16475.PubMedCrossRef
76.
go back to reference de Bruin M, Viechtbauer W. The meaning of adherence when behavioral risk patterns vary: obscured use and method-effectiveness in HIV-prevention trials. PLoS One. 2012;7:e44029.PubMedCrossRef de Bruin M, Viechtbauer W. The meaning of adherence when behavioral risk patterns vary: obscured use and method-effectiveness in HIV-prevention trials. PLoS One. 2012;7:e44029.PubMedCrossRef
77.
go back to reference Low N, Chersich MF, Schmidlin K, et al. Intravaginal practices, bacterial vaginosis, and HIV infection in women: individual participant data meta-analysis. PLoS Med. 2011;8:e1000416.PubMedCrossRef Low N, Chersich MF, Schmidlin K, et al. Intravaginal practices, bacterial vaginosis, and HIV infection in women: individual participant data meta-analysis. PLoS Med. 2011;8:e1000416.PubMedCrossRef
78.
go back to reference Martin Hilber A, Chersich M, van de Wijgert J, et al. Vaginal practices, microbicides and HIV:what do we need to know? Sex Transm Dis. 2007;83:505–8.CrossRef Martin Hilber A, Chersich M, van de Wijgert J, et al. Vaginal practices, microbicides and HIV:what do we need to know? Sex Transm Dis. 2007;83:505–8.CrossRef
79.
go back to reference Martin Hilber A, Kenter E, Redmond S, et al. Vaginal practices as women's agency in Sub-Saharan Africa: A synthesis of meaning and motivation through meta-ethnography. Soc Sci Med. 2012;74:1311–23.PubMedCrossRef Martin Hilber A, Kenter E, Redmond S, et al. Vaginal practices as women's agency in Sub-Saharan Africa: A synthesis of meaning and motivation through meta-ethnography. Soc Sci Med. 2012;74:1311–23.PubMedCrossRef
80.
go back to reference Gorbach PM, Mensch BS, Husnik M, et al. Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial. AIDS Behav. 2012. doi:10.1007/s10461-012-0302-2. Gorbach PM, Mensch BS, Husnik M, et al. Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial. AIDS Behav. 2012. doi:10.​1007/​s10461-012-0302-2.
81.
go back to reference • Mensch BS, Hewett PC, Abbott S, et al. Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: an interview mode experiment using a placebo gel. AIDS Behav. 2011;15:407–21. This methodological experiment compared ACASI to FTFI modes for self-reported behaviors, including gel use, and biological markers of product adherence and sexual exposure. • Mensch BS, Hewett PC, Abbott S, et al. Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: an interview mode experiment using a placebo gel. AIDS Behav. 2011;15:407–21. This methodological experiment compared ACASI to FTFI modes for self-reported behaviors, including gel use, and biological markers of product adherence and sexual exposure.
82.
go back to reference Mauck CK. Biomarkers for evaluating vaginal microbicides and contraceptives: discovery and early validation. Sex Transm Dis. 2009;36:S73–5.PubMedCrossRef Mauck CK. Biomarkers for evaluating vaginal microbicides and contraceptives: discovery and early validation. Sex Transm Dis. 2009;36:S73–5.PubMedCrossRef
83.
go back to reference Walsh T, Warner L, Macaluso M, et al. Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance. Contraception. 2012;86:55–61.PubMedCrossRef Walsh T, Warner L, Macaluso M, et al. Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance. Contraception. 2012;86:55–61.PubMedCrossRef
84.
go back to reference Old J, Schweers BA, Boonlayangoor PW, et al. Developmental validation of RSID™ semen: a lateral flow immunochromatographic strip test for the forensic detection of human semen*. J Forensic Sci. 2012;57:489–99. Old J, Schweers BA, Boonlayangoor PW, et al. Developmental validation of RSID™ semen: a lateral flow immunochromatographic strip test for the forensic detection of human semen*. J Forensic Sci. 2012;57:489–99.
85.
go back to reference Ware NC, Wyatt MA, Haberer JE, et al. What's love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for HIV-serodiscordant couples. J Acquir Immune Defic Syndr. 2012;59:463.PubMedCrossRef Ware NC, Wyatt MA, Haberer JE, et al. What's love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for HIV-serodiscordant couples. J Acquir Immune Defic Syndr. 2012;59:463.PubMedCrossRef
86.
go back to reference Nunn A, McCormack S, Crook AM, et al. Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention. Trials. 2009;10:99.PubMedCrossRef Nunn A, McCormack S, Crook AM, et al. Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention. Trials. 2009;10:99.PubMedCrossRef
87.
go back to reference Stirratt MJ, Gordon CM. Adherence to biomedical HIV prevention methods: considerations drawn from HIV treatment adherence research. Curr HIV/AIDS Rep. 2008;5:186–92.PubMedCrossRef Stirratt MJ, Gordon CM. Adherence to biomedical HIV prevention methods: considerations drawn from HIV treatment adherence research. Curr HIV/AIDS Rep. 2008;5:186–92.PubMedCrossRef
88.
go back to reference Auerbach JD, Coates TJ. HIV prevention research: accomplishments and challenges for the third decade of AIDS. Am J Public Health. 2000;90:1029.PubMedCrossRef Auerbach JD, Coates TJ. HIV prevention research: accomplishments and challenges for the third decade of AIDS. Am J Public Health. 2000;90:1029.PubMedCrossRef
89.
go back to reference Friedland B, Abbott S, Sarna A, et al. Does advance knowledge of biomarkers improve adherence or the reporting of sexual activity, gel and condom use among clinical trial participants? Results from a placebo gel trial in Andhra Pradesh, India. Proceedings of the HIV/AIDS Network Coordination (HANC) Behavioral Science Working Group Meeting; Miami, FL, June 6, 2012. Friedland B, Abbott S, Sarna A, et al. Does advance knowledge of biomarkers improve adherence or the reporting of sexual activity, gel and condom use among clinical trial participants? Results from a placebo gel trial in Andhra Pradesh, India. Proceedings of the HIV/AIDS Network Coordination (HANC) Behavioral Science Working Group Meeting; Miami, FL, June 6, 2012.
90.
go back to reference Thomsen SC, Gallo MF, Ombidi W, et al. Randomised controlled trial on whether advance knowledge of prostate-specific antigen testing improves participant reporting of unprotected sex. Sex Transm Infect. 2007;83:419–20.PubMedCrossRef Thomsen SC, Gallo MF, Ombidi W, et al. Randomised controlled trial on whether advance knowledge of prostate-specific antigen testing improves participant reporting of unprotected sex. Sex Transm Infect. 2007;83:419–20.PubMedCrossRef
91.
go back to reference Castillo-Mancilla J, Zheng J-H, Bushman L, et al. Pharmacology of tenofovir, tenofovir-DP, and emtricitabine in RBC and DBS. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Seattle, WA, March 5–8, 2012. Castillo-Mancilla J, Zheng J-H, Bushman L, et al. Pharmacology of tenofovir, tenofovir-DP, and emtricitabine in RBC and DBS. Proceedings of the Conference on Retroviruses and Opportunistic Infections; Seattle, WA, March 5–8, 2012.
92.
go back to reference DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42:200.PubMedCrossRef DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42:200.PubMedCrossRef
93.
go back to reference Nel A, Kamupira M, Hetro C, et al. Safety and pharmacokinetics trial of Dapivirine Matrix Vaginal Ring. International AIDS Conference; Vienna, Austria, July 18–23, 2010. Nel A, Kamupira M, Hetro C, et al. Safety and pharmacokinetics trial of Dapivirine Matrix Vaginal Ring. International AIDS Conference; Vienna, Austria, July 18–23, 2010.
94.
go back to reference Joglekar NS, Joshi SN, Deshpande SS, et al. Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India. Trans R Soc Trop Med Hyg. 2010;104:412–5.PubMedCrossRef Joglekar NS, Joshi SN, Deshpande SS, et al. Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India. Trans R Soc Trop Med Hyg. 2010;104:412–5.PubMedCrossRef
95.
go back to reference Joshi SN, Dutta S, Kumar BK, et al. Expanded safety study of Praneem polyherbal vaginal tablet among HIV-uninfected women in Pune, India: a phase II clinical trial report. Sex Transm Infect. 2008;84:343–7.PubMedCrossRef Joshi SN, Dutta S, Kumar BK, et al. Expanded safety study of Praneem polyherbal vaginal tablet among HIV-uninfected women in Pune, India: a phase II clinical trial report. Sex Transm Infect. 2008;84:343–7.PubMedCrossRef
96.
go back to reference Lees S, Cook C, Vallely A, et al. Comparison of sexual behavior data collected using a coital diary and a clinic-based interview during a microbicide pilot study in Mwanza, Tanzania. Sex Transm Dis. 2010;37:497–501.PubMed Lees S, Cook C, Vallely A, et al. Comparison of sexual behavior data collected using a coital diary and a clinic-based interview during a microbicide pilot study in Mwanza, Tanzania. Sex Transm Dis. 2010;37:497–501.PubMed
97.
go back to reference Hemmerling A, Harrison WG, Brown JM, et al. Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations. Sex Transm Dis. 2012;39:710–2.PubMedCrossRef Hemmerling A, Harrison WG, Brown JM, et al. Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations. Sex Transm Dis. 2012;39:710–2.PubMedCrossRef
98.
go back to reference Naditz A. Medication compliance—helping patients through technology: modern “smart” pillboxes keep memory-short patients on their medical regimen. Telemed J E Health. 2008;14:875–80.PubMedCrossRef Naditz A. Medication compliance—helping patients through technology: modern “smart” pillboxes keep memory-short patients on their medical regimen. Telemed J E Health. 2008;14:875–80.PubMedCrossRef
Metadata
Title
Methodological Lessons from Clinical Trials and the Future of Microbicide Research
Authors
Ariane van der Straten
Elizabeth T. Montgomery
Miriam Hartmann
Alexandra Minnis
Publication date
01-03-2013
Publisher
Current Science Inc.
Published in
Current HIV/AIDS Reports / Issue 1/2013
Print ISSN: 1548-3568
Electronic ISSN: 1548-3576
DOI
https://doi.org/10.1007/s11904-012-0141-9

Other articles of this Issue 1/2013

Current HIV/AIDS Reports 1/2013 Go to the issue

The Science of Prevention (S Kalichman, Section Editor)

State of Condom Use in HIV Prevention Science and Practice

HIV Pathogenesis and Treatment (A Landay, Section Editor)

Attacking the HIV Reservoir from the Immune and Viral Perspective

HIV Pathogenesis and Treatment (A Landay, Section Editor)

Pathogenesis of HIV and the Lung

HIV Pathogenesis and Treatment (A Landay, Section Editor)

Immunity and Hepatitis C: A Review

Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.