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Acceptability and Satisfaction of Contraceptive Vaginal Rings in Clinical Studies: A Systematic Review and Narrative Synthesis.

ABSTRACT: Introduction: Acceptability of and satisfaction with contraceptive methods are paramount for uptake and continuation. In the current context of multipurpose prevention of pregnancy and sexually transmitted diseases/HIV development, it is critical to have a better understanding of acceptability of and satisfaction with the contraceptive vaginal ring (CVR) including sexual satisfaction. The objective of this study was to review the evidence about acceptability of CVRs and general and sexual satisfaction of users. Methods: We searched PubMed, CINAHL, and Web of Science (until December 31, 2020) and selected original studies documenting actual use of hormonal CVR and explicitly addressing any of the 3 outcomes. Results: Of a total of 1,129 records screened, 46 studies were included. Most studies (n = 43, 93%) were prospective, conducted in high-income settings (n = 35), and reported on NuvaRing^® use (n = 31). Overall, 27 (59%) studies included a comparison group, 38 (82%) studies used exclusively quantitative questionnaires, with qualitative only (n = 4, 9%), or mixed methods (n = 4, 9%) studies being less common. Ease of CVR insertion/removal/reinsertion was high in all the settings and improved with time of use, with qualitative studies supporting these findings. When mentioned, ring-related events were associated with discontinuation, and results on continuation of use were mixed. Among NuvaRing^® studies, general satisfaction (being satisfied or very satisfied) was between 80 and 90% and tended to mirror continuation. Sexual satisfaction was less commonly reported and results were mixed. Overall, limited information was provided on actual CVR experiences of women (and men) and cultural norms that may affect sexuality and CVR use. Conclusion: Positive aspects of acceptability of and satisfaction with CVRs were reported, but ring-related events and factors, which may affect long-term CVR use, deserve further study. More information is needed on actual experiences of women using CVRs, relationship aspects, male partner opinions, and contextual norms to better understand the acceptability of and satisfaction with CVRs.

SUBMITTER: Delvaux T

PROVIDER: S-EPMC8712726 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The vaginal ring (VR) is a female-initiated drug-delivery platform used for different indications, including HIV pre-exposure prophylaxis (PrEP). We conducted a systematic review of VR acceptability, values and preferences among women in low- and middle-income countries (LMIC) to inform further investment and/or guidance on VR use for HIV prevention. Following PRISMA guidelines, we used structured methods to search, screen, and extract data from randomized controlled trials (RCTs) and observational studies reporting quantitative outcomes of acceptability of the VR for any indication published 1/1970-2/2019 (PROSPERO: CRD42019122220). Of 1,110 records identified, 68 met inclusion criteria. Studies included women 15-50+ years from 25 LMIC for indications including HIV prevention, contraception, abnormal bleeding, and menopause. Overall VR acceptability was high (71-98% across RCTs; 62-100% across observational studies), with 80-100% continuation rates in RCTs and favorable ease of insertion (greater than 85%) and removal 89-99%). Users reported concerns about the VR getting lost in the body (8-43%), although actual expulsions and adverse events were generally infrequent. Most women disclosed use to partners, with some worrying about partner anger/violence. The VR was not felt during intercourse by 70-92% of users and 48-97% of partners. Acceptability improved over time both within studies (as women gained VR experience and worries diminished), and over chronological time (as the device was popularized). Women expressed preferences for accessible, long-acting, partner-approved methods that prevent both HIV and pregnancy, can be used without partner knowledge, and have no impact on sex and few side effects. This review was limited by a lack of standardization of acceptability measures and study heterogeneity. This systematic review suggests that most LMIC women users have a positive view of the VR that increases with familiarity of use; and, that many would consider the VR an acceptable future delivery device for HIV prevention or other indications.

Project description:BackgroundContraceptives are used to prevent unwanted pregnancies and treat certain gynecologic conditions, but many women report non-use or inconsistent use because of method dissatisfaction. The sexual acceptability of contraception-how birth control methods affect users' sexual well-being-is likely an important component of contraceptive satisfaction but has yet to be systematically examined.ObjectiveThis study aimed to assess contraceptive satisfaction among new-start contraceptive users and examine whether sexual acceptability measures predict contraceptive satisfaction at 3 months while controlling for more commonly measured contraceptive side effects.Study designThis analysis used data derived from the baseline, 1-month, and 3-month surveys of the HER Salt Lake Contraceptive Initiative, a prospective cohort study of new contraceptive clients. From March 2016 to March 2017, enrolled participants received their desired contraceptive method at no cost and could switch or discontinue at any time (up to 3 years). This analysis included individuals who continued their new contraceptive method for at least 1 month and completed all relevant survey measures. We used ordered logistic regression modeling to predict contraceptive satisfaction at 3 months. Primary predictor variables included changes in sexual functioning (6-item Female Sexual Function Index), sexual satisfaction (New Sexual Satisfaction Scale), and perceived impact of the contraceptive method on sex life at 1 month. Covariates included vaginal bleeding changes, physical side effects, and mood-related side effects.ResultsOur analytical sample included 1879 individuals. At 3 months, 52.1% of participants were "completely satisfied" with their contraceptive method, 30.7% were "somewhat satisfied," 4.2% were "neither satisfied nor dissatisfied," 6.9% were "somewhat dissatisfied," and 6.2% were "completely dissatisfied." Compared with patients who said their contraceptive method made their sex life "a lot" worse at 1 month, patients whose method improved their sex life "a lot" had a 7.7 times increased odds of greater satisfaction at 3 months (95% confidence interval, 4.02-14.60; P<.0001) and patients whose method improved their sex life a "little" had a 5.88 times increased odds of greater satisfaction (confidence interval, 3.12-11.11; P<.001). To a much lesser degree, experiencing less or no bleeding was significantly associated with increased satisfaction, whereas worsening of physical side effects was linked to decreased satisfaction. The only other factors significantly associated with satisfaction were changes in bleeding and physical side effects.ConclusionOur findings suggest that patients' sexual experiences of their contraceptive methods are important correlates of satisfaction. Clinicians may wish to underscore that sexual experiences of birth control methods matter and encourage patients to find a contraceptive method that works for them sexually.

Project description:BackgroundResearch is ongoing to develop multipurpose vaginal rings to be used continuously for contraception and to prevent Human Immunodeficiency Virus (HIV) infection. Contraceptive vaginal rings (CVRs) are available in a number of countries and are most of the time used intermittently i.e. three weeks out of a 4-week cycle. Efficacy trials with a dapivirine-containing vaginal ring for HIV prevention are ongoing and plans to develop multi-purpose vaginal rings for prevention of both HIV and pregnancy have been elaborated. In contrast with the CVRs, multi-purpose vaginal rings will have to be used continuously. Women who continuously use a CVR will no longer have menses. Furthermore, some safety aspects of CVR use have never been studied in-depth in the past, such as the impact of the vaginal ring on the vaginal microbiota, biofilm formation and induction of inflammation. We studied acceptability and these novel aspects of safety in Rwandan women. Although significant progress has been made over the past decade, Rwanda still has a high unmet need for contraception (with 47% unplanned births) and a generalized HIV epidemic, and CVRs are not yet available.MethodsWe will conduct an open label, single centre, randomized controlled trial. A total of 120 HIV-negative women will be randomized to intermittent CVR use (to allow menstruation) or continuous CVR use. Women will be followed for a maximum of 14 weeks. In parallel, we will conduct a qualitative study using in-depth interview and focus group discussion methodology.DiscussionIn addition to evaluating the safety and acceptability of intermittent and continuous CVR use in Rwandan women, we hope that our findings will inform the development of future multipurpose vaginal rings, will prepare Rwandan study populations for future clinical trials of multipurpose vaginal rings, and will pave the way for introduction of CVRs on African markets.Trial registrationClinicaltrials.gov NCT01796613 . Registered 14 February 2013.

Project description:ObjectivesA systematic narrative literature review was undertaken to assess the acceptability of childhood screening interventions to identify factors to consider when planning or modifying childhood screening programs to maximize participation and uptake.Study designThis is a systematic narrative literature review.MethodsElectronic databases were searched (MEDLINE, EMBASE, PsycINFO via Ovid, CINAHL, and Cochrane Library) to identify primary research studies that assessed screening acceptability. Studies were categorized using an existing theoretical framework of acceptability consisting of seven constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. A protocol was developed and registered with PROSPERO (registration no. CRD42018099763) RESULTS: The search identified 4529 studies, and 46 studies met the inclusion criteria. Most studies involved neonatal screening. Programs identified included newborn blood spot screening (n = 22), neonatal hearing screening (n = 13), Duchenne muscular dystrophy screening (n = 4), cystic fibrosis screening (n = 3), screening for congenital heart defects (n = 2), and others (n = 2). Most studies assessed more than one construct of acceptability. The most common constructs identified were affective attitude (how a parent feels about the program) and intervention coherence (parental understanding of the program, and/or the potential consequences of a confirmed diagnosis).ConclusionsThe main acceptability component identified related to parental knowledge and understanding of the screening process, the testing procedure(s), and consent. The emotional impact of childhood screening mostly explored maternal anxiety. Further studies are needed to examine the acceptability of childhood screening across the wider family unit. When planning new (or refining existing) childhood screening programs, it is important to assess acceptability before implementation. This should include assessment of important issues such as information needs, timing of information, and when and where the screening should occur.

Project description: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.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.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.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.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.

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Acceptability and Satisfaction of Contraceptive Vaginal Rings in Clinical Studies: A Systematic Review and Narrative Synthesis.

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