Abstract
Objectives
Develop and test a theoretical acceptability model for the Nestorone®/ethinyl estradiol
contraceptive vaginal ring (CVR); explore whether domains of use within the model
predict satisfaction, method adherence and CVR continuation.
Study Design
Four domains of use were considered relative to outcome markers of acceptability,
that is, method satisfaction, adherence and continuation. A questionnaire to evaluate
subjects' experiences relative to the domains, their satisfaction (Likert scale) and
adherence to instructions for use was developed and administered to 1036 women enrolled
in a 13-cycle Phase 3 trial. Method continuation was documented from the trial database.
Stepwise logistic regression (LR) analysis was conducted and odds ratios (ORs) calculated
to assess associations of satisfaction with questions from the four domains. Fisher's
Exact Test was used to determine the association of satisfaction with outcome measures.
Results
A final acceptability model was developed based on the following determinants of CVR
satisfaction: ease of use, side effects, expulsions/feeling the CVR and sexual activity
including physical effects during intercourse. Satisfaction was high (89%) and related
to higher method adherence [OR, 2.6 (1.3, 5.2)] and continuation [OR, 5.5 (3.5, 8.4)].
According to the LR analysis, attributes of CVR use representing items from the four
domains — finding it easy to remove, not complaining of side effects, not feeling
the CVR while wearing it and experiencing no change or an increase in sexual pleasure
and/or frequency — were associated with higher odds of satisfaction.
Conclusion
Hypothesized domains of CVR use were related to satisfaction, which was associated
with adherence and continuation. Results provide a scientific basis for introduction
and future research.
Implications Statement
Acceptability research is important when introducing a new method of contraception
and determining whether it can be a successful option in meeting the reproductive
health needs of women and men. This study was designed to test a conceptual model
of acceptability and identify factors associated with successful use of a new contraceptive
delivery modality. Original research was conducted for this publication.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to ContraceptionAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Contraceptive vaginal rings releasing Nestorone and ethinyl estradiol: a 1-year dose-finding trial.Contraception. 2005; 71: 122-129
- Current status of contraceptive vaginal rings.Contraception. 2013; 87: 264-272
- Acceptability of the contraceptive vaginal ring by rural and urban populations in two Latin American countries.Contraception. 1981; 24: 393-414
- Contraceptives technologies: responding to women's needs.Guttmacher Institute, NewYork2011
- In search of breakthroughs: renewing support for contraceptive research and development.in: Guttmacher Policy Review Winter. 16 (1). 2013
- Meeting the unmet need for family planning; now is the time.Lancet. 2013; 381: 1696-1699
- User's perception of the contraceptive vaginal ring: a field study in Brazil and the Dominican Republic.Stud Fam Plan. 1983; 14: 284-290
- The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability.Contraception. 2003; 67: 187-194
- New frontiers in contraceptive research: a blueprint for action.Institute of Medicine, National Academy of Sciences, 2004: 10
- Progesterone vaginal ring: introducing a contraceptive to meet the needs of breastfeeding women.Contraception. 2013; 88: 591-598
- Women’s perceptions and experience with the progesterone vaginal ring for contraception during breastfeeding.Reprod Health Matters. 1997; : 49-57
- Westhoff C acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive.Contraception. 2006; 73: 488-492
- Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial.Obstet Gynecol. 2008; 111: 267-277
- Vaginal ring contraception.Contraception. 2011; 83: 107-115
- The acceptability of a combined oestrogen/progestogen contraceptive vaginal ring.Contraception. 1995; 51: 39-44
- Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol.Hum Reprod. 2001; 16: 463-475
- Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 micrograms of ethinyl estradiol and 3 mg of drospirenone.Contraception. 2006; 74: 451-457
- A comparison between the vaginal ring and oral contraceptives.Obstet Gynecol. 2004; 104: 555-563
- Contraceptive vaginal ring.Clin Obstet Gynecol. 2007; 50: 878-885
- Review of the vaginal contraceptive ring (NuvaRing).J Fam Plann Reprod Health Care. 2008; 34: 247-250
- Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives.Contraception. 2006; 74: 220-223
- Cycle control, tolerability, efficacy and acceptability of the vaginal contraceptive ring, NuvaRing: results of clinical experience in Germany.Eur J Contracept Reprod Health Care. 2008; 13: 31-38
- Efficacy, cycle control, and user acceptability of a novel combined contraceptive vaginal ring.Obstet Gynecol. 2002; 100: 585-593
- Contraceptive methods women have ever used: United States, 1982–2010.in: National Health Statistics Report. 2013 ([62])
- Consistency in the reporting of sexual behavior by adolescent girls in Kenya: a comparison of interviewing methods.Sex Transm Infect. 2004; 80: ii43-ii48
- Psychometric theory.McGraw Hill, Inc., USA1978
- Applied logistic regression.Wiley, New York2000
- Vaginal ring adherence in sub-Saharan Africa: expulsion, removal, and perfect use.AIDS Behav. 2012; 16: 1787-1798
- Vaginal rings for menopausal symptom relief.Drugs Aging. 2004; 21: 757-766
- State of the art intravaginal ring technology for topical prophylaxis of HIV infection.AIDS Rev. 2012; 14: 62-77
Article info
Publication history
Published online: June 02, 2014
Accepted:
May 27,
2014
Received in revised form:
May 7,
2014
Received:
December 26,
2013
Footnotes
☆Funding Sources: National Institute of Health/NICHD 3RO1HD047764-02S2; USAID GPO-A-00-04-00019.
☆☆Clinical Trial Registration Number: NCT00263341.
Identification
Copyright
© 2014 Published by Elsevier Inc.
