Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness
Elizabeth G. Raymond,Pai Lien Chen,Bosny Pierre-Louis,Joanne Luoto,Kurt T. Barnhart,Lynn Bradley,Mitchell D. Creinin,Alfred N. Poindexter,Livia Wan,Mark G. Martens,Robert S. Schenken,Cate Nicholas,Richard E. Blackwell +12 more
TLDR
Characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy were explored, finding that failure to complete is a major problem in barrier method trials that seriously compromises the interpretation of results.Abstract:
Background: In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy. Methods: Trial participants were expected to use the assigned spermicide for contraception for 7 months or until pregnancy occurred. In bivariable and multivariable analyses, we assessed the associations between failure to complete the trial and 17 pre-specified baseline characteristics. In addition, among women who participated for at least 6 weeks, we evaluated the relationships between failure to complete, various features of their first 6 weeks of experience with the spermicide, and characteristics of the study centers and population. Results: Of the 1514 participants in this analysis, 635 (42%) failed to complete the study for reasons other than pregnancy. Women were significantly less likely to complete if they were younger or unmarried, had intercourse at least 8 times per month, or were enrolled at a university center or at a center that enrolled fewer than 4 participants per month. Noncompliance with study procedures in the first 6 weeks was also associated with subsequent early withdrawal, butread more
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Journal ArticleDOI
Contraceptive Efficacy of a Novel Spermicidal Microbicide Used With a Diaphragm : A Randomized Controlled Trial
Kurt T. Barnhart,Michael J. Rosenberg,H Trent MacKay,Diana L. Blithe,James Higgins,Terri L. Walsh,Livia Wan,Michael A. Thomas,Mitchell D. Creinin,Carolyn Westhoff,William D. Schlaff,David F. Archer,Charletta Ayers,Andrew M. Kaunitz,Sutapa Das,Thomas R. Moench +15 more
TL;DR: An acid buffering gel used with a diaphragm is a safe, acceptable contraceptive with efficacy comparable to that of a common commercial spermicide with diaphrate, and safety and acceptability were similar between the two groups.
Journal ArticleDOI
Participant recruitment and retention in rehabilitation research.
Kathleen R. Bell,Flora M. Hammond,Tessa Hart,Allison K. Bickett,Nancy R. Temkin,Sureyya Dikmen +5 more
TL;DR: Bell KR, Hammond F, Hart T, Bickett AK, Temkin NR, Dikmen S: Participant recruitment and retention in rehabilitation research.
Journal ArticleDOI
Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial.
Anne E. Burke,Kurt T. Barnhart,Jeffrey T. Jensen,Mitchell D. Creinin,Terri L. Walsh,Livia Wan,Carolyn Westhoff,Michael A. Thomas,David F. Archer,Hongsheng Wu,James H. Liu,William D. Schlaff,Bruce R. Carr,Diana L. Blithe +13 more
TL;DR: C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9 and may provide another marketable option for women seeking spermicidal contraception.
Reference EntryDOI
Spermicide used alone for contraception
David A. Grimes,Laureen M Lopez,Elizabeth G. Raymond,Vera Halpern,Kavita Nanda,Kenneth F. Schulz +5 more
TL;DR: In the largest trial to date, the gel containing the lowest dose of nonoxynol-9 was significantly less effective in preventing pregnancy than were gels with higher doses of the same agent; the latter threatens trial validity.
Journal ArticleDOI
Predictors of pregnancy in microbicide trials.
TL;DR: The data suggest that current use or acceptance of intrauterine contraception, implants, sterilization or injectables is the most effective approach to reduce pregnancy rates and might be a useful eligibility criterion in future HIV prevention trials.
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