An open‐label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose)

Gill, Katherine; Happel, Anna-Ursula; Pidwell, Tanya; Mendelsohn, Andrea S.; Duyver, Menna; Lf, Johnson; Meyer, Landon; Slack, Catherine; Strode, Ann; Mendel, Eve; Fynn, Lauren; Wallace, Melissa; Spiegel, Hans; Jaspan, Heather B.; Passmore, Jo‐Ann S.; Hosek, Sybil; Smit, Dionne; Rinehart, Alex; Bekker, Linda‐Gail

doi:10.1002/jia2.25626

Cited by 30 publications

(51 citation statements)

References 21 publications

(21 reference statements)

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“…Of the 180 screened for the parent study, 130 adolescent females (median age 17 years; interquartile range (IQR) [16][17][18] were enrolled into a randomized study with crossover ( Fig. 1) 25 . Of these, 45 were randomized to NuvaRing® (hereon referred to as CCVR), 45 to Net-En, and 40 to COC (Table 1 and Fig.…”

Section: Resultsmentioning

confidence: 99%

“…Study cohort. Adolescents were recruited through a parent study, UChoose, an open-label, randomized crossover study designed to evaluate the feasibility of different HC options among adolescents 25 . The parent study was approved by the Division of AIDS and the University of Cape Town (UCT) Health Science Research Ethics Committee and was conducted in full compliance with South African Good Clinical Practice (SA-GCP), ICH76 GCP guidelines, and ICMJE guidelines, and registered in the public registry database of ClinicalTrials.gov (NCT02404038).…”

Section: Methodsmentioning

confidence: 99%

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Unexpected dependence of the anomalous Hall angle on the Hall conductivity in amorphous transition metal thin films

Karel

Bouma

Fuchs

et al. 2020

Phys. Rev. Materials

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Young women in sub-Saharan Africa are disproportionally affected by HIV infection and unintended pregnancies. However, hormonal contraceptive (HC) use may influence HIV risk through changes in genital tract microbiota and inflammatory cytokines. To investigate this, 130 HIV negative adolescent females aged 15-19 years were enrolled into a substudy of UChoose, an open-label randomized crossover study (NCT02404038), comparing acceptability and contraceptive product preference as a proxy for HIV prevention delivery methods. Participants were randomized to injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) or etonorgesterol/ethinyl estradiol combined contraceptive vaginal ring (CCVR) for 16 weeks, then crossed over to another HC for 16 weeks. Cervicovaginal samples were collected at baseline, crossover and exit for characterization of the microbiota and measurement of cytokine levels; primary endpoints were cervical T cell activation, vaginal microbial diversity and cytokine concentrations. Adolescents randomized to COCs had lower vaginal microbial diversity and relative abundance of HIV risk-associated taxa compared to Net-En or CCVR. Cervicovaginal inflammatory cytokine concentrations were significantly higher in adolescents randomized to CCVR compared to COC and Net-En. This suggests that COC use may induce an optimal vaginal ecosystem by decreasing bacterial diversity and inflammatory taxa, while CCVR use is associated with genital inflammation.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Unexpected dependence of the anomalous Hall angle on the Hall conductivity in amorphous transition metal thin films

Karel

Bouma

Fuchs

et al. 2020

Phys. Rev. Materials

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“…Twelve-month continuation rates were at 54% for CVR users compared to 86% among long-acting reversible contraception (IUD and implant), 57% for DMPA, 55% for COC, and 49% for patch users in a study conducted in the US. A recent study conducted among adolescents in South Africa showed that more NuvaRing ® users (24/116; 20.7%) significantly requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074) (18).…”

Section: Nuvaring ®mentioning

confidence: 99%

“…These seven dimensions were included in a validated 21item questionnaire by Novak et al (54) and subsequently used in other studies (20,(30)(31)(32)36,37,47). The ORTHO-BC-SAT satisfaction questionnaire related to the use of hormonal contraception in general and including eight dimensions similar to Novack et al questionnaire was used in one CVR study (18). Over 80% of NuvaRing ® users in all studies using the seven/eight dimensions showed that CVR instructions and packaging were clear, and that the ring was easy to insert and remove (Table 3).…”

Section: Nuvaring ®mentioning

confidence: 99%

“…In South Africa, significantly more injection users (96.3%) thought this delivery mode was convenient to use compared to NuvaRing ® (83.1%; p = 0.0409) or COC (76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill (18). Willingness to recommend NuvaRing ® to others ranged from 60% to over 90% in the studies documenting satisfaction.…”

Section: Nuvaring ®mentioning

confidence: 99%

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Acceptability and satisfaction of contraceptive vaginal rings in clinical studies: a systematic review and narrative synthesis

Delvaux

Jespers

Beňová

et al. 2021

Preprint

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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 CVRs acceptability, and users general and sexual satisfaction. Methods We searched PubMed, CINAHL and Web of Science (until December 31th, 2020) and selected original studies documenting actual use of hormonal CVR and explicitly addressing any of the three outcomes. Main Results Of a total of 1129 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%) 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 setting and improved with time of use, with qualitative studies supporting these findings. When reported, results on continuation of use were mixed and ring-related events were associated with discontinuation. 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 continuation rates and ring-related events 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.

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HIV prevention: better choice for better coverage

2022

Self Cite

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Introduction: Antiretroviral-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. Discussion: First-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. Conclusions: Second-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 nextgeneration PrEP options are needed.

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An open‐label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose)

Cited by 30 publications

References 21 publications

Unexpected dependence of the anomalous Hall angle on the Hall conductivity in amorphous transition metal thin films

Unexpected dependence of the anomalous Hall angle on the Hall conductivity in amorphous transition metal thin films

Acceptability and satisfaction of contraceptive vaginal rings in clinical studies: a systematic review and narrative synthesis

HIV prevention: better choice for better coverage

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