Vaginal Ring Research Articles

In vitro drug release, mechanical performance and stability testing of a custom silicone elastomer vaginal ring releasing dapivirine and levonorgestrel

We have previously reported a multipurpose silicone elastomer vaginal ring providing sustained release of dapivirine (an antiretroviral) and levonorgestrel (a progestin) for HIV prevention and hormonal contraception. During initial development, issues arose due to reaction between the ethynyl group in the levonorgestrel molecule and the hydride-functionalised polydimethylsiloxane components in the silicone elastomer formulation. This unwanted reaction occurred both during and to a lesser extent after ring manufacture, impacting the curing process, the mechanical properties of the ring, and the in vitro release of levonorgestrel. Recently, we reported custom silicone elastomer grades that minimise this reaction. In this follow-on study, we describe the manufacture, in vitro drug release, mechanical, and pharmaceutical stability testing of ring formulations prepared from a custom silicone elastomer and containing 200 mg dapivirine and 80, 160, 240 or 320 mg levonorgestrel. The rings showed mechanical properties similar to marketed ring products, sustained in vitro release of both drugs over 30 days in quantities deemed clinically relevant, offered acceptable assay values, and provided good product stability over 15 weeks at 40 °C and 75% relative humidity.

An intersectional analysis of contraceptive types chosen among sexual minority women: A nationally representative study

ObjectiveThe purpose of this study is to use an intersectional approach in which race, insurance, care setting, and disclosure of sexual orientation to a provider are used to assess patterns of contraceptive use in sexual minority women. Study designThis study analyzes cross-sectional data from the 2011–2019 National Survey of Family Growth (NSFG). Sexual orientation of 21,075 respondents’ data was used to investigate contraceptive use in sexual minority women, specifically lesbian and bisexual women, as compared to heterosexual women, controlling for variables such as race, age, and socioeconomic factors. ResultsBlack and Hispanic lesbian women (adjusted odds ratio [aOR] = 0.39 confidence interval [CI] 0.20–0.76 and aOR = 0.44 CI 0.23–0.82, respectively) and Hispanic and Other Race bisexual women use hormonal contraceptive methods less than their White lesbian and bisexual peers (aOR = 0.45 CI 0.29–0.69 and aOR = 0.43 CI 0.20–0.94). Care setting was not correlated with long-acting reversible contraceptive methods (LARC; such as intra-uterine device, hormonal implants) or prescription-based hormonal methods (such as oral contraceptive pills, injectables, vaginal rings, and patches) in lesbian women (aOR = 2.92 CI 0.60–14.2 and aOR = 1.43 CI 0.47–4.38, respectively) or bisexual women (aOR = 0.90 CI 0.48–1.58 and aOR = 0.83 CI 0.37–1.86), but it was for straight women (aOR = 1.28 CI 1.03–1.59 and aOR = 0.68 CI 0.53–0.86). Similarly, insurance status did not correlate with contraceptive patterns in sexual minority women. Importantly, adjusting for nationally representative data did not impact the results; in other words, the odds ratios after adjusting yielded the same results as before adjustment. ConclusionsInsurance and care setting are important determinants of straight women's contraceptive use patterns with fewer effects seen among sexual minority women. These findings support previous work and indicate that known advantages of insurance coverage or use of public clinics may not positively impact sexual minority women as much as they do straight women. Provider awareness of sexual identity and sexual orientation is important for adequate contraceptive care. ImplicationsWhile prior research has presented findings on sexual minority women contraceptive use, to our knowledge there are limited studies that address the social and demographic implications for contraceptive use in this population.

Ring-ing in the Future: Participant and Male Partner Perspectives Regarding Future Use of the Dapivirine Vaginal Ring for HIV Prevention.

Women account for a disproportionate percentage of new HIV infections in sub-Saharan Africa indicating a need for female-initiated HIV prevention options congruent with their lifestyles. The dapivirine vaginal ring for HIV prevention is one such option. We explored the interest of women, who used this ring during the Microbicide Trials Network's ASPIRE and HOPE studies, in using the ring post-licensure and what they perceived as important considerations for future use. We also explored perspectives of HOPE participants' male partners on their involvement in their partners' future ring use. Women appeared keen to use the ring in the future and expressed desires for easy access, support for both ongoing and new users and intense community engagement. In parallel, male partners indicated high levels of interest in supporting their partners' ring use and being involved in ring use decision making. These data offer important insights for ring rollout planning and engagement activities.

Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda

ObjectivesParticipation in HIV prevention trials could trigger risk compensation among participants. We evaluated potential risk compensation following use of a vaginal ring microbicide by women in a phase III trial...

Rectovaginal Fistula Due to an Erosive Pessary: A Case Report

Background: Pelvic organ prolapse (POP) occurs when pelvic organs protrude through the vagina due to displacement from their normal anatomic position, as a result of a weakening of the pelvic muscles. Pessaries have long been used to treat POP, but they may result in rectovaginal fistulas as a rare complication. The Case: We report a rare case of a rectovaginal fistula following vaginal ring pessary use in an 82-year-old G7P7 woman. She had a past medical history of bipolar disorder, and initially presented for nursing care and psychiatric support. A trained psychologist evaluated her, and found no psychological morbidity. A two-day history of a fall, diffuse abdominal pain, and chronic urinary incontinence were rather identified. Gynecological pelvic examination revealed a rectovaginal fistula and impacted stools in the vagina. Conclusion: The use of ring pessaries, though a conservative management option for POP, may lead to a rectovaginal fistula, a rare but severe complication.

Preferences for HIV Preexposure Prophylaxis Products Among Black Women in the U.S.

In a nationwide sample of Black women in the U.S., we assessed preferences for HIV preexposure prophylaxis (PrEP) products, including long-acting injectable (LAI) PrEP and once-daily oral PrEP. Among 315 respondents, 32.1% were aware of PrEP and 40.6% were interested in using it; interest increased to 62.2% if PrEP were provided for free. Oral PrEP was the preferred option (51.1%), followed by LAI PrEP (25.7%), vaginal gel (16.5%), and vaginal ring (6.7%). When examining oral and LAI PrEP alone, most (62.7%) preferred oral PrEP. LAI PrEP was more likely to be preferred among respondents with concerns about healthcare costs or PrEP-related stigma, and among those who reported inconsistent condom use and multiple sexual partners. Although most Black women preferred oral PrEP, LAI PrEP may be appealing to a subset with social and structural barriers to PrEP use, such as cost and stigma, and those at increased risk of HIV infection.

Colombian adolescents fail in knowledge regarding HIV and other sexually transmitted infections

Abstract Introduction/objective: Sexually transmitted infections (STIs) -HIV included- are a major problem in Latin America, mainly in Colombia. In 2021, 17647 cases were reported, which compared to the previous year showed an increase of 29.7%. The main aim of this study was to assess the knowledge regarding HIV and other STIs among the adolescent population in Colombia. Method: A total of 2012 Colombian adolescents between 12-19 years of age participated in this study. The HIV and Other Sexually Transmitted Infections Knowledge Scale (KSI), a self-report measure, was administered. The results showed moderate to low general knowledge (M = 9.90, SD = 4.64) regarding HIV and other STIs. Adolescents did not know if a tongue-kiss led to an HIV infection (75%), or whether both the vaginal ring and the IUD were effective methods for preventing HIV/AIDS (82%). Results: Results showed better scores in knowledge regarding HIV transmission (84%), HIV testing (66%), and condom use to prevent HIV infection (71%). Conclusions: Significant differences were observed in HIV/STIs knowledge between both sexes, but the effect magnitudes were small. Thus, these differences were neglected. This study contributes to understanding the state of knowledge and strengthening prevention strategies of professionals linked to the field of quality of life, education, and sexual healthcare in Colombia.

HIV prevention: better choice for better coverage.

IntroductionAntiretroviral‐based pre‐exposure prophylaxis (PrEP) is today an established, effective and safe method of HIV prevention used in multiple countries worldwide by a broad range of populations at risk of HIV infection. Biomedical innovations are critical in supporting the primary prevention of HIV; however, their potential can only be maximized if end‐user challenges are recognized, described and used to develop next‐generation models.DiscussionFirst‐generation PrEP, a daily oral pill, is highly efficacious, discreet and affords users the ability to commence and conclude treatment rapidly. However, consistent daily adherence and persistence is challenging, especially among younger populations, due in part to side effects, the risk of stock‐outs and a lack of pill storage options. Second‐generation PrEP, longer acting agents that require less frequent dosing, could overcome such challenges. Agents that have shown efficacy in clinical trials include a monthly vaginal ring and PrEP injectables to be administered every 8 weeks, while products in development include 6 monthly injectables, oral therapy that uses monthly rather than daily pills, implants and the potential for long‐acting passive immunization.ConclusionsSecond‐generation PrEP agents will have the potential to offer improved adherence and less frequent reminders once they have undergone further development and the delivery systems that will best support them have been established. In order to pursue global UNAIDS targets of reducing new HIV infections to fewer than 500,000 annually by 2025, and to ensure that all people have access to prevention options that meet their specific prevention needs, both early and next‐generation PrEP options are needed.

Husbands’ concerns and experiences with the progesterone vaginal ring in three sub-Saharan African countries: a mixed methods study

The introduction of progesterone vaginal ring (PVR) in sub-Saharan Africa calls for insights on the product’s role in promoting women’s autonomy regarding their reproductive decision-making and behaviour. Such insights could inform the positioning of the method within family planning programmes in the region. In this paper, we explore husbands’ experiences with PVR as perceived by their wives and as reported by husbands of a subset of women users in Kenya, Nigeria, and Senegal. We discuss how such experiences might influence women’s rights and autonomy regarding their reproductive decisions and contraceptive behaviour. We use a mixed-methods approach drawing on data from quantitative interviews with 174 women and qualitative in-depth interviews with 10 husbands of a subset of the women in the three countries. The findings show that husbands appreciated PVR’s attributes relating to user-control (women could insert and remove the method themselves), ease of use, and non-interference with sex and flow of breast milk. Wives’ perceptions of their husbands’ experiences regarding PVR’s non-interference with sex were consistent with the husbands’ own reports. In addition, health care providers played important roles in supporting sustainable use of the method through giving information, counselling, and assisting women who experienced ring slippage to manage those challenges. The findings suggest that self-managed health technologies such as PVR could expand women’s choices and control over their reproductive decisions. The findings further suggest that sustainable use of such products could require linkages with appropriate health systems structures to address challenges with use if and when they arise.

Dapivirine Vaginal Ring for HIV Prevention in Women in South Africa

Young women remain disproportionately affected by the HIV epidemic in South Africa. Clinical trials have shown that the dapivirine vaginal ring (DVR) is safe and effective at reducing HIV infection in women. In March 2022, the South African Health Products Regulatory Authority approved the use of the DVR in women aged 18 years and older who are unable or unwilling to use oral pre-exposure prophylaxis, as an additional choice for preventing HIV in women at substantial risk. Modelling studies have suggested that the DVR could have a substantial impact if prioritized for women at substantial risk of HIV or women aged 22–29 years. The licensing of the DVR in South Africa is a milestone event that brings the first long-acting and woman-controlled HIV prevention method another step closer to reaching the people who need it. As South Africa prepares its introduction, it is critical to examine the unmet need for HIV prevention and to review the clinical trial data that led to the DVR's approval.

Evidence for use of a healthy relationships assessment tool in the CHARISMA pilot study.

IntroductionThe CHARISMA intervention, nested within the MTN-025/HOPE vaginal ring trial in Johannesburg, South Africa, seeks to facilitate women’s use of HIV prevention products by promoting partner dialogue and mitigating intimate partner violence (IPV). We developed “HEART”, a lay counselor-administered relationship assessment tool, for the CHARISMA pilot. The five-scale tool assesses participants’ endorsement of Traditional Values (TV), her HIV Prevention Readiness (HPR) and levels of partner support (PS), abuse and control (PAC), and resistance to HIV prevention (PR), guiding decisions about which of three counselling modules to offer (partner communication/A; ring disclosure/B; and IPV prevention/C).MethodsWe correlated baseline scores on HEART subscales with a) independent measures of relationship stability, disclosure and IPV to assess construct validity, and b) with specific modules offered to determine how HEART was used in the pilot. We examined changes in HEART scores at three and six months. Finally, we ran separate growth models for each subscale to examine changes in scores, accounting for partnership changes and counseling module(s) received.ResultsBaseline HEART scores correlated as predicted among subscales and with other measures. Reliabilities for four subscales were 0.75 or higher. Women who disclosed study participation and ring use scored higher on PS and lower on PR. Women experiencing IPV scored lower on PS, and higher on PAC and PR. During the pilot, 82% of women received one and 17% received two or more modules; over half received the IPV module. Women with higher PAC and PR scores were more likely to receive the IPV than the communication or disclosure modules. Over time, the TV, PAC and PR scores decreased, and PS score increased. Receiving the IPV module was associated with a decreased PAC score.ConclusionsThese data offer preliminary evidence for HEART construct and predictive validity and support its further evaluation to guide implementation and monitor the impact of the CHARISMA intervention in a randomized controlled evaluation.

The use of serum segesterone acetate levels to assess adherence of trial participants with a contraceptive vaginal ring

ObjectivesTo determine the incidence of out-of-range segesterone acetate (NES) concentrations in participants of a pharmacokinetic/pharmacodynamic trial of a continuous use contraceptive vaginal ring (CVR) releasing NES and estradiol (E2). We hypothesized that out-of-range concentrations reflect nonadherent ring use and predict ovulation risk. Study DesignWe conducted a secondary analysis of data from a prospective, multi-centered, randomized, Phase IIa dose-finding trial for a CVR releasing NES and E2. Our primary outcome was the risk of ovulation associated with out-of-range NES events. We calculated the 5th and 95th percentile NES concentrations of subjects at steady state to determine high and low cutoffs. We used a Fisher's exact test to determine group differences, and calculated the relative risk of ovulation for each group. ResultsWe analyzed available serum NES data from cycles 2 (n = 172), 3 (n = 156) and 7 (n = 115) to determine the 5th and 95th percentile of all NES concentrations (64, 296 pg/mL). In the 443 cycles of observation, no ovulations occurred in participants with NES concentrations within the expected range. In contrast, we found ovulatory elevations of progesterone in 21 cycles with out-of-range values. Of these, 15 (71%) cycles had evidence of one or more nonadherent low and 6 (29%) one or more unexpected peak. The relative risk of ovulation increased with evidence of multiple non-adherent levels. ConclusionsWe found out-of-range NES concentrations, suggestive of improper use of a CVR associated with an increased risk of ovulation, with a direct relationship between the number of out-of-range events and the relative risk. ImplicationsThe results of this study support the use of out-of-range serum NES values as a marker of adherence in contraceptive clinical trials of continuous vaginal rings, and suggest that nonadherence occurs even in early phase clinical trials with close monitoring.

Investigating the Contribution of Drug-Metabolizing Enzymes in Drug-Drug Interactions of Dapivirine and Miconazole.

Dapivirine (DPV) is a potent NNRTI used to prevent the sexual transmission of HIV. In a phase 1 trial (IPM 028), the concomitant use of a DPV vaginal ring and an antifungal miconazole (MIC) vaginal capsule was found to increase the systemic exposure to DPV in women, suggesting a potential for drug-drug interactions. This study’s objective was to investigate the mechanism of DPV-MIC interactions using drug-metabolizing enzymes (DMEs; CYPs and UGTs) that are locally expressed in the female reproductive tract (FRT). In vitro studies were performed to evaluate the metabolism of DPV and its inhibition and induction potential with DMEs. In addition, the impact of MIC on DPV metabolism and the inhibitory potential of DPV with DMEs were studied. Our findings suggest that DPV is a substrate of CYP1A1 and CYP3A4 enzymes and that MIC significantly decreased the DPV metabolism by inhibiting these two enzymes. DPV demonstrated potent inhibition of CYP1A1 and moderate/weak inhibition of the six CYP and eight UGT enzymes evaluated. MIC showed potent/moderate inhibition of seven CYP enzymes and weak/no inhibition of eight UGT enzymes. The combination of DPV and MIC showed potent inhibition of seven CYP enzymes (1A1, 1A2, 1B1, 2B6, 2C8, 2C19, and 3A4) and four UGT enzymes (1A3, 1A6, 1A9, and 2B7). DPV was not an inducer of CYP1A2, CYP2B6, and CYP3A4 enzymes in primary human hepatocytes. Therefore, the increased systemic concentrations of DPV observed in IPM 028 were likely due to the reduced metabolism of DPV because of CYP1A1 and CYP3A4 enzymes inhibition by MIC in the FRT.

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

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.

Impact of Dapivirine and Placebo Vaginal Rings on the Microbiota of Adolescent, Lactating, and Postmenopausal Females.

A 25-mg dapivirine vaginal ring has been demonstrated to reduce risk of human immunodeficiency virus (HIV) acquisition in nonpregnant adult women. In this secondary analysis of studies conducted in US adolescent, lactating, and postmenopausal females, vaginal microbiota was assessed prior to and after ring use, and between dapivirine and placebo ring users. Vaginal fluid swabs were collected before and after product use for the evaluation of microbiota using Nugent criteria, quantitative culture, and quantitative polymerase chain reaction. Vaginal ring use did not impact bacterial vaginosis prevalence among the 3 populations and was associated with minimal shifts in microbiota. Adolescents in both arms demonstrated an increased prevalence of Lactobacillus crispatus and a decrease in quantity of Megasphaera lornae. Postmenopausal active and placebo ring users demonstrated an increased prevalence of lactobacilli and non-albicans yeast, while dapivirine ring users demonstrated an increased prevalence of Candida albicans and increased quantity of group B Streptococcus and non-albicans yeasts. Prevotella species were increased in lactating women, whereas Prevotella timonensis increased in prevalence and concentration among adolescent and postmenopausal females and Prevotella bivia increased in prevalence among adolescent dapivirine ring users. Dapivirine vaginal ring use was associated with minimal changes in the vaginal microbiota that are likely not clinically significant.

Pregnant and breastfeeding women's prospective acceptability of two biomedical HIV prevention approaches in Sub Saharan Africa: A multisite qualitative analysis using the Theoretical Framework of Acceptability.

HIV infection during pregnancy and breastfeeding has implications for maternal health. Between May- November 2018, we explored prospective acceptability of two novel HIV Pre-exposure Prophylaxis (PrEP) products, oral pills and vaginal rings, through focus group discussions with 65 pregnant and breastfeeding women in Malawi, South Africa, Uganda, Zimbabwe. Qualitative analysis was completed, guided by the Theoretical Framework of Acceptability (TFA). First, a deductive thematic analysis was applied to relevant coded data, into the seven TFA constructs (Affective Attitude; Burden; Ethicality, Intervention Coherence; Opportunity Costs; Perceived Effectiveness; Self-efficacy). Next, an iterative analysis was completed to generate themes within each of the TFA constructs. Women's positive attitudes towards daily oral PrEP highlighted the familiarity of taking pills, understanding the purpose of taking pills, and the perception that it is an effective method to protect mothers and babies from HIV during pregnancy and breastfeeding. Women emphasized the ease of using the ring given its monthly duration that lowers burden on the user, its discreetness and invisibility once in place. The TFA analysis highlighted how acceptability of both methods could be enhanced by focusing on perceptions of the end users (i.e. the women) and not just the products themselves. This approach provided insights into how to refine the intervention materials and plans for implementation.

Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.

Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study

BackgroundLow adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use.MethodsAll sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Residual dapivirine remaining in the last ring returned by each participant was used to estimate drug released from the ring, which was then adjusted for time participants had the ring to calculate probable use categorized into three levels (low/intermittent/high). Product use was connected to PEA attendance using participant identification numbers. We used multivariate Poisson regression with robust standard errors to explore differences in ring use between PEA attendance groups and reviewed qualitative reports for illustrative quotes highlighting participant experiences with PEAs.Results2312 of 2629 study participants attended at least one of 389 PEAs conducted across sites. Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p < 0.05). When controlling for these variables, participants who attended at least one event were more likely to return a last ring showing at least some use (RR = 1.40) than those who never attended an event. There was a stronger correlation between a last returned ring showing use and participant attendance at multiple events (RR = 1.52).ConclusionsOur analysis supports the growing body of work illustrating the importance of meaningfully engaging research participants to achieve study success and aligns with other analyses of adherence support efforts during ASPIRE. While causation between PEA attendance and product use cannot be established, residual drug levels in returned rings strongly correlated with participant attendance at PEAs, and the benefits of incorporating PEAs should be considered when designing future studies of investigational products.

Accessibility of Pharmacist-Prescribed Contraceptives in Utah.

To assess pharmacy participation in and accessibility of pharmacist-prescribed contraception after legislation effective in the state of Utah in 2019. A secret-shopper telephone survey was used to assess participation in pharmacist-prescribed contraception. Geospatial analysis was used to map the distribution of participating pharmacies by population characteristics. Of all operating Class A retail pharmacies in Utah, 127 (27%) were providing pharmacist-prescribed contraception 1 year after implementation of the Utah standing order. Oral contraceptive pills were widely accessible (100%); however, other allowed methods were not (vaginal ring 14%; contraceptive patch 2%). Consultation fees and medication costs varied widely. Participating pharmacies were mainly concentrated in population centers. Assuming access to a personal vehicle, urban areas with a high percentage of Hispanic people (Utah's largest minority race or ethnicity group) have access to a participating pharmacy within a 20-minute driving distance. However, access in rural areas with a high percentage Hispanic or other minority were limited. We identified 235 (40%) census tracts with a high proportion of Utah's residents living below the poverty line or of minority race or ethnicity who also had low access to pharmacist-prescribed contraception. Although the pharmacy-based model is intended to increase access to contraception, practical availability 1 year after the authorization of pharmacist-prescribed contraception in Utah suggests that this service does not adequately serve rural areas, particularly rural areas with a high proportion of minorities and those living below the federal poverty line.

Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial.

As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential.