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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception

David Hubacher, Hannah Spector, Charles Monteith, Pai-Lien Chen, Catherine Hart
Contraception 2015, 91 (3): 185-92
25500324

OBJECTIVES: Most published contraceptive continuation rates have scientific limitations and cannot be compared; this is particularly true for dissimilar contraceptives. This study uses a new approach to determine if high continuation rates of long-acting reversible contraception (LARC) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC.

STUDY DESIGN: We are conducting a partially randomized patient preference trial (PRPPT) to compare continuation rates of short-acting reversible contraception (SARC) and LARC. Only women seeking SARC were invited to participate. Participants chose to be in the preference cohort (self-selected method use) or opted to be randomized to SARC or LARC; only those in the randomized cohort received free product. We compared participant characteristics, reasons for not trying LARC previously and the contraceptive choices that were made.

RESULTS: We enrolled 917 eligible women; 57% chose to be in the preference cohort and 43% opted for the randomized trial. The preference and randomized cohorts were similar on most factors. However, the randomized cohort was more likely than the preference cohort to be uninsured (48% versus 36%, respectively) and to cite cost as a reason for not trying LARC previously (50% versus 10%) (p<.01 for both comparisons). In the preference cohort, fear of pain/injury/side effects/health risks were the predominant reasons (cited by over 25%) for not trying LARC previously (p<.01 in comparison to randomized cohort).

CONCLUSIONS: Enrollment was successful and the process created different cohorts to compare contraceptive continuation rates and unintended pregnancy in this ongoing trial. The choices participants made were associated with numerous factors; lack of insurance was associated with participation in the randomized trial.

IMPLICATIONS: This PRPPT will provide new estimates of contraceptive continuation rates, such that any benefits of LARC will be more easily attributable to the technology and not the user. Combined with measuring level of satisfaction with LARC, the results will help project the potential role and benefits of expanding voluntary use of LARC.

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