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.

Trial registration: ClinicalTrials.gov NCT00584038.

Fig. 1. Total number of women recruited and followed at 3, 6, and 12 months by intervention group

DC=Discontinued; mo=month; S=Standard clinic practice; C=Clinic-based intervention; C+P= Clinic-based intervention with phone reinforcement.

Fig. 2. Participants with correct oral contraceptive use by intervention

Based on initial number of participants in each intervention group S=Standard clinic practice (n=388); C=Clinic-based intervention (n=383); C+P=Clinic-based intervention with phone reinforcement (n=384).