A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms

Abstract

Background

The study was conducted to examine the effectiveness of two different interventions on oral contraception (OC) adherence and condom use.

Study Design

A total of 1,155 women 16–24 years of age requesting OC were randomized to receive either face-to-face behavioral counseling and education at their baseline clinic visit (C group; n= 383) or this same intervention followed by monthly phone calls for 6 months (C+P group; n= 384) or standard care (S group; n= 388). Phone interviews at 3, 6 and 12 months after the initial visit as well as a medical record review assessed OC continuation, condom use and several other secondary and clinically meaningful outcomes such as pregnancy and sexually transmitted infection (STI) rates and correct use of pills.

Results

The interventions did not have a significant effect on OC continuation after 3 (C+P: 58%; C: 50%; S: 55%), 6 (39%; 32%; 37%) or 12 months (20%; 18%; 20%) (p>.05). Condom use at last sexual intercourse did not differ by intervention methods (p>.05). Moreover, no effect was observed on pregnancy [S=48 (12.4%), C = 63 (16.5%), C+P=52 (13.5%); p=.22] and STI [S=18 (4.6%), C=12 (3.1%), C+P=13 (3.4%); p=.50] rates, and mean number of correctly used pill packs (p=.06). However, those randomized to C+P were more likely than C and S patients to identify a cue and report that the cue worked as a reminder to take their OC on time based on 3 and 6 months follow-up information (p<.01 for all relationships).

Conclusions

Neither intervention in this study improved OC adherence among young women.

Introduction

Many young women experience difficulty using oral contraception (OC) consistently or correctly. Moreover, among young users, almost half discontinue its use within 6 months of obtaining a prescription [1], [2]. These young women are at high risk of an unintended pregnancy because they often fail to use another contraceptive method after discontinuing their birth control pills. In one study of women, 33% of those 13–19 years of age and 18% of 20–22-year olds reported that they did not use any contraception for at least 1 month after stopping their birth control pills, even though they did not wish to become pregnant [3].

Further compounding the problem is that among those who continue to use OC for at least 6 months, a large proportion fail to take it correctly. In one nationwide study of 943 women (mean age 25 years), 47% of OC users missed ≥ 1 pill per cycle and 22% missed ≥ 2. Increased odds of missing ≥ 2 pills was associated with lacking an established pill-taking routine, not reading or understanding the informational material accompanying the pill package, or experiencing side effects [4]. Difficulty with adherence is even more pronounced among high school and college age women. In one study, only 52% of university students who were prescribed OC took all their active birth control pills during the first 3 months [5]. A prior study on 211 teens seen at our institution reported that nearly 60% of OC users missed one or more pills within the last 3 months and 10% missed at least three pills in the last cycle [1].

From these data, it is apparent that interventions must be developed to improve the consistency and correctness of OC use among young women. Suggestions on how to address this problem were made in 2003 by an interdisciplinary group of researchers and service providers, following a National Institutes of Health-funded meeting on this topic [6]. They noted that the current system used by most clinics of providing oral contraception at a single brief visit is not effective as providers can spend only a few minutes on education [7], which is not sufficient to meet the needs of younger women. This problem is compounded by the fact that the next follow-up visit does not occur until several months later. To address this, they suggested adding health educators to clinic staff or phone call interactions between visits [6]. Others have suggested that providers give OC users a toll-free number they could call if they missed pills, experienced breakthrough bleeding, or were confused about when to start a new package [8].

An examination of the literature, however, demonstrates that few studies have actually evaluated the effectiveness of additional educational or behavioral counseling on contraceptive adherence. Furthermore, most of those that have been published are limited in their usefulness because they did not measure clinically meaningful outcomes, such as unintended pregnancy rates [9], [10], [11]. A recent Cochrane review based on randomized controlled trials (RCTs) also emphasized the need for a high quality RCT as the RCTs included in the review had several limitations [12]. The purpose of the present study was to fill this gap in knowledge by testing two comprehensive educational and behavioral interventions designed to increase contraceptive adherence among young low income women. Furthermore, the efficacy of these interventions in increasing dual method use (joint use of a condom for protection from STIs and a highly effective contraceptive method) and decreasing rates of STI and unintended pregnancy was assessed.