Publications by authors named "Ariane van der Straten"

144 Publications

Giving voice to the end-user: input on multipurpose prevention technologies from the perspectives of young women in Kenya and South Africa.

Sex Reprod Health Matters 2021 Dec;29(1):1927477

Senior Fellow, Women's Global Health Imperative, RTI International, Berkeley, CA, USA; Adjunct Professor, Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, CA, USA; Consultant, ASTRA Consulting, Kensington, CA, USA.

Unintended pregnancy and unmet need for modern contraception contribute substantially to reproductive health disparities globally. In sub-Saharan Africa they occur in contexts of disproportionately high rates of HIV infection. Multipurpose prevention technologies (MPTs) can address HIV and pregnancy prevention needs in a single "2-in-1" product; however, few studies have solicited end-user views to inform design of new MPTs. We conducted the Tablets, Ring, Injections as Options (TRIO) study with young women aged 18-30 in Kenya and South Africa ( = 277) to examine preferences and acceptability of future MPTs. In a randomised clinical cross-over study in which women used three placebo delivery forms, we complemented quantitative acceptability assessments with in-depth interviews and focus group discussions ( = 88 participants). We examined anticipated enablers and barriers to adoption and use of future MPTs and synthesised novel product design recommendations. Participants expressed high interest in MPTs. Anticipated side effects constituted a primary concern; however, many expected barriers were not dosage form-specific, but addressed contextual factors instead, such as fears regarding use of new biomedical technologies, misunderstandings and stigma regarding use, and navigating partner disclosure and engagement. Women preferred MPTs that offered discreetness and long-duration protection to minimise user-burden, did not interfere with their relationships, and conferred protection for unanticipated situations. End-user research to identify and pre-emptively address potential barriers while underscoring benefits to a new MPT product is vital. Attention to cultural contexts in implementation of new MPTs is important to communicating perceived benefits, achieving acceptability and maximising public health benefits.
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http://dx.doi.org/10.1080/26410397.2021.1927477DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259853PMC
December 2021

Effects of Polymer Blending on the Performance of a Subcutaneous Biodegradable Implant for HIV Pre-Exposure Prophylaxis (PrEP).

Int J Mol Sci 2021 Jun 18;22(12). Epub 2021 Jun 18.

Engineered Systems RTI International, Durham, NC 27709, USA.

Long-acting (LA) HIV pre-exposure prophylaxis (PrEP) can mitigate challenges of adhering to daily or on-demand regimens of antiretrovirals (ARVs). We are developing a subcutaneous implant comprising polycaprolactone (PCL) for sustained delivery of ARVs for PrEP. Here we use tenofovir alafenamide (TAF) as a model drug. Previously, we demonstrated that the release rates of drugs are controlled by the implant surface area and wall thickness, and the molecular weight (MW) of PCL. Here, we further advance the implant design and tailor the release rates of TAF and the mechanical integrity of the implant through unique polymer blend formulations. In vitro release of TAF from the implant exhibited zero-order release kinetics for ~120 days. TAF release rates were readily controlled via the MW of the polymer blend, with PCL formulations of higher MW releasing the drug faster than implants with lower MW PCL. Use of polymer MW to tune drug release rates is partly explained by PCL crystallinity, as higher PCL crystalline material is often associated with a slower release rate. Moreover, results showed the ability to tailor mechanical properties via PCL blends. Blending PCL offers an effective approach for tuning the ARV release rates, implant duration, and integrity, and ultimately the biodegradation profiles of the implant.
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http://dx.doi.org/10.3390/ijms22126529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8235439PMC
June 2021

Advances in long-acting injectables, implants, and vaginal rings for contraception and HIV prevention.

Adv Drug Deliv Rev 2021 Jun 27:113849. Epub 2021 Jun 27.

Center for AIDS Prevention Studies, Dept of Medicine, University of California San Francisco, San Francisco, CA, USA; ASTRA Consulting, Kensington, CA, USA.

Worldwide, women face compounding reproductive health risks, including human immunodeficiency virus (HIV), sexually-transmitted infections (STIs), and unintended pregnancy. Multipurpose prevention technologies (MPTs) offer combined protection against these overlapping risks in singular prevention products that offer potential for simplified use, lower burden, higher acceptability, and increased public health benefits. Over the past decade, substantial progress has been made in development of extended-release MPTs, which have further potential to grant sexual and reproductive health autonomy to women globally and to offer choice for women to accommodate varying needs during their reproductive lives. Here, we highlight the advances made in injectable, implant, and ring delivery forms, and the importance of incorporating end-user preferences early in the research and development of these products.
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http://dx.doi.org/10.1016/j.addr.2021.113849DOI Listing
June 2021

Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States.

J Int AIDS Soc 2021 Jun;24(6):e25747

Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Introduction: Vaginal rings are a promising approach to provide a woman-centred, long-acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV-1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. We evaluated safety, pharmacokinetics, adherence and acceptability of two three-month rings with different DPV dosages, compared with the monthly DPV ring.

Methods: From December 2017 to October 2018, MTN-036/IPM-047 enrolled 49 HIV-negative participant in Birmingham, Alabama and San Francisco, California into a phase 1, randomized trial comparing two extended duration (three-month) rings (100 or 200 mg DPV) to a monthly 25 mg DPV ring, each used over 13 weeks, with follow-up completed in January 2019. Safety was assessed by recording adverse events (AEs). DPV concentrations were quantified in plasma, cervicovaginal fluid (CVF) and cervical tissue, at nominal timepoints. Geometric mean ratios (GMRs) relative to the comparator ring were estimated from a regression model.

Results: There were no differences in the proportion of participants with grade ≥2 genitourinary AEs or grade ≥3 AEs in the extended duration versus monthly ring arms (p = 1.0). Plasma and CVF DPV concentrations were higher in the extended duration rings compared to the monthly ring. Plasma GMRs were 1.31 to 1.85 and 1.41 to 1.86 and CVF GMRs were 1.45 to 2.87 and 1.74 to 2.60 for the 100 and 200 mg ring respectively. Cervical tissue concentrations were consistently higher in the 200 mg ring (GMRs 2.36 to 3.97). The majority of participants (82%) were fully adherent (ring inserted at all times, with no product discontinuations/outages) with no differences between the monthly versus three-month rings. Most participants found the ring acceptable (median = 8 on 10-point Likert scale), with a greater proportion of participants reporting high acceptability (9 or 10) in the 25 mg arm (73%) compared with the 100 mg (25%) and 200 mg (44%) arms (p = 0.01 and p = 0.15 respectively).

Conclusions: The extended duration DPV rings were well-tolerated and achieved higher DPV concentrations compared with the monthly DPV ring. These findings support further evaluation of three-month DPV rings for HIV prevention.
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http://dx.doi.org/10.1002/jia2.25747DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196716PMC
June 2021

Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention.

AIDS Behav 2021 Jun 11. Epub 2021 Jun 11.

University of Washington, Seattle, USA.

Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts.
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http://dx.doi.org/10.1007/s10461-021-03231-xDOI Listing
June 2021

Impact of Women's Home Environment on Use of the Dapivirine Vaginal Ring for HIV Prevention in Sub-Saharan Africa.

AIDS Behav 2021 May 19. Epub 2021 May 19.

Women's Global Health Imperative, RTI International, Berkley, CA, USA.

The monthly dapivirine vaginal ring has proven efficacious in reducing HIV incidence in two Phase 3 clinical trials. When considering the potential future availability of the ring to the public, key questions remain about the feasibility of integrating the ring as an HIV prevention intervention into women's lives. We conducted qualitative mapping interviews (n = 66) among women enrolled in MTN-025/HOPE, an open-label trial conducted in Malawi, South Africa, Uganda and Zimbabwe, to examine how home environments influenced use of the dapivirine vaginal ring. Most women had secure places to store their rings including wardrobes, suitcases, and bags. The primary concerns for ring storage were potential tampering from children or rodents. Household overcrowding limited the privacy some women had which made removal and insertion of vaginal rings challenging. Despite these challenges, ring storage, insertion, and removal was feasible across social and living contexts.
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http://dx.doi.org/10.1007/s10461-021-03311-yDOI Listing
May 2021

The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence.

AIDS Behav 2021 May 3. Epub 2021 May 3.

Women's Global Health Imperative, RTI International, 2150 Shattuck avenue, Berkeley, CA, USA.

We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women's internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence.
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http://dx.doi.org/10.1007/s10461-021-03286-wDOI Listing
May 2021

Tenofovir Alafenamide for HIV Prevention: Review of the Proceedings from the Gates Foundation Long-Acting TAF Product Development Meeting.

AIDS Res Hum Retroviruses 2021 06;37(6):409-420

Intarcia Therapeutics, Inc., Heyward, California, USA.

The ability to successfully develop a safe and effective vaccine for the prevention of HIV infection has proven challenging. Consequently, alternative approaches to HIV infection prevention have been pursued, and there have been a number of successes with differing levels of efficacy. At present, only two oral preexposure prophylaxis (PrEP) products are available, Truvada and Descovy. Descovy is a newer product not yet indicated in individuals at risk of HIV-1 infection from receptive vaginal sex, because it still needs to be evaluated in this population. A topical dapivirine vaginal ring is currently under regulatory review, and a long-acting (LA) injectable cabotegravir product shows strong promise. Although demonstrably effective, daily oral PrEP presents adherence challenges for many users, particularly adolescent girls and young women, key target populations. This limitation has triggered development efforts in LA HIV prevention options. This article reviews efforts supported by the Bill & Melinda Gates Foundation, as well as similar work by other groups, to identify and develop optimal LA HIV prevention products. Specifically, this article is a summary review of a meeting convened by the foundation in early 2020 that focused on the development of LA products designed for extended delivery of tenofovir alafenamide (TAF) for HIV prevention. The review broadly serves as technical guidance for preclinical development of LA HIV prevention products. The meeting examined the technical feasibility of multiple delivery technologies, pharmacokinetics, and safety of subcutaneous (SC) delivery of TAF in animal models. Ultimately, the foundation concluded that there are technologies available for long-term delivery of TAF. However, because of potentially limited efficacy and possible toxicity issues with SC delivery, the foundation will not continue investing in the development of LA, SC delivery of TAF products for HIV prevention.
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http://dx.doi.org/10.1089/AID.2021.0028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8213003PMC
June 2021

"I felt like a TRIO champion": end-user perspectives on their role as co-designers of multi-purpose technologies.

Gates Open Res 2020 26;4:163. Epub 2020 Oct 26.

Women's Global Health Imperative, RTI International, Berkeley, California, USA.

The likelihood that research will be relevant to and accepted by end-users and their communities is enhanced when the perspectives of both the "researchers" and the "researched" are considered. The Tablets, Ring, Injections as Options (TRIO) Study, conducted with young women in Kenya and South Africa, assessed the acceptability and preferences of three placebo-only multi-purpose technology (MPT) forms for prevention of HIV and unintended pregnancy. The objective of this analysis was to assess whether, and if so how, the women participating in the TRIO Study perceived themselves as co-designers of the three MPT products. We conducted 55 in-depth interviews, 6 focus group discussions, and 5 dissemination workshops with TRIO Study participants. Woven throughout these activities were questions and opportunities for participants to reflect on their role in the study, and to what extent they identified with their role as a co-designer. Qualitative data from these activities were analyzed thematically. The analysis revealed four key themes about what resulted in the women's views as co-designers: altruism, respectful treatment, agency, and reciprocity. The women were aware of their role in determining what end-users would and would not prefer and were motivated by a desire to help themselves and others. They recognized their role as co-designers and cited being treated well by study staff, being given a chance to make choices during the study period, and being recognized as equal partners of the researchers as the main reasons. If prevention products are going to be successfully developed, end-users and researchers must work hand in hand. Engaging participants meaningfully as co-designers in product development research can be a powerful tool in the effort to ensure new prevention products brought to market are acceptable to the population of interest.
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http://dx.doi.org/10.12688/gatesopenres.13182.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8028846PMC
October 2020

Development of an international sexual and reproductive health survey instrument: results from a pilot WHO/HRP consultative Delphi process.

Sex Transm Infect 2021 Apr 12. Epub 2021 Apr 12.

UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO, Geneva, Switzerland.

Population health surveys are rarely comprehensive in addressing sexual health, and population-representative surveys often lack standardised measures for collecting comparable data across countries. We present a sexual health survey instrument and implementation considerations for population-level sexual health research. The brief, comprehensive sexual health survey and consensus statement was developed via a multi-step process (an open call, a hackathon, and a modified Delphi process). The survey items, domains, entire instruments, and implementation considerations to develop a sexual health survey were solicited via a global crowdsourcing open call. The open call received 175 contributions from 49 countries. Following review of submissions from the open call, 18 finalists and eight facilitators with expertise in sexual health research, especially in low- and middle-income countries (LMICs), were invited to a 3-day hackathon to harmonise a survey instrument. Consensus was achieved through an iterative, modified Delphi process that included three rounds of online surveys. The entire process resulted in a 19-item consensus statement and a brief sexual health survey instrument. This is the first global consensus on a sexual and reproductive health survey instrument that can be used to generate cross-national comparative data in both high-income and LMICs. The inclusive process identified priority domains for improvement and can inform the design of sexual and reproductive health programs and contextually relevant data for comparable research across countries.
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http://dx.doi.org/10.1136/sextrans-2020-054822DOI Listing
April 2021

Religious leaders' role in pregnant and breastfeeding women's decision making and willingness to use biomedical HIV prevention strategies: a multi-country analysis.

Cult Health Sex 2021 Apr 2:1-16. Epub 2021 Apr 2.

Women's Global Health Imperative (WGHI), RTI International, Berkeley, CA, USA.

Oral Pre-Exposure Prophylaxis (PrEP) is an established option, and the dapivirine vaginal ring is emerging as a promising strategy for HIV prevention option for women. Because of this, understanding the contextual and cultural factors that will support the increased uptake of these products is crucial. In sub-Saharan Africa, religious leaders may be important stakeholders to involve in product information, education and roll-out. We conducted a sub-analysis of data from 232 participants taking part in the MTN-041/MAMMA study to explore religious leaders' involvement in pregnant and breastfeeding women's health. Study participants viewed biomedicine and spirituality as interlinked and believed that women could seek health-related care from medical experts and turn to faith-based organisations for religious or spiritual needs. Religious leaders were invested in the health of their congregations, endorsed a variety of sexual health strategies, and were eager to learn more about emerging HIV prevention technologies. These data signal the role of religious leaders in supporting their communities, and the importance of involving religious leaders in efforts to roll out new HIV prevention products to facilitate uptake.
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http://dx.doi.org/10.1080/13691058.2021.1874054DOI Listing
April 2021

Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial.

AIDS Behav 2021 Aug 13;25(8):2430-2440. Epub 2021 Mar 13.

Women's Global Health Imperative, RTI International, Berkeley, CA, USA.

We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15-30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were 'very likely' to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not "very likely" to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure.Trial Registration ClinicalTrials.gov Identifier: NCT01617096.
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http://dx.doi.org/10.1007/s10461-021-03205-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8222015PMC
August 2021

Experiences of oral pre-exposure prophylaxis (PrEP) use disclosure among South African adolescent girls and young women and its perceived impact on adherence.

PLoS One 2021 5;16(3):e0248307. Epub 2021 Mar 5.

The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.

Introduction: There is limited understanding of how social dynamics impact pre-exposure prophylaxis (PrEP) adherence among adolescent girls and young women (AGYW) in generalized HIV-epidemic settings. We examined experiences of oral PrEP use disclosure to various social groups with the goal of identifying supportive relationships that can be leveraged to promote adherence.

Methods: We used qualitative methods to explore experiences disclosing PrEP use and the perceived impact of disclosure on adherence among 22 South African AGYW (16-25 years) taking daily oral PrEP. Serial in-depth-interviews (IDIs) were conducted 1-, 3-, and 12-months post-PrEP initiation. Respondents also self-reported their disclosures separately for various social groups and adherence was assessed using intracellular tenofovir-diphosphate levels.

Results: Qualitative respondents had a median age of 20.5 years and reported disclosing their PrEP use to friends (n = 36 total disclosures), partners, siblings, other family members (n = 24 disclosures each), and parents (n = 19 disclosures). IDI data revealed that parents and partners provided the most support to respondents and a lack of support from these groups was most often perceived as negatively affecting PrEP use. AGYW described difficulties explaining PrEP to their mothers, who believed PrEP was HIV treatment or would lead to HIV infection. Disclosure to household members was notably meaningful for AGYW (both positively and negatively). Respondents reported leveraging supportive relationships for pill reminders. For respondents who perceived a household member would be unsupportive, however, non-disclosure was less feasible and PrEP use was often stigmatized. To avoid stigma, several respondents hid or discontinued PrEP.

Conclusions: While supportive relationships may facilitate PrEP use, disclosure can also lead to stigma. Counselors should support AGYW in disclosing to key people in their social networks and provide AGYW with materials that lend credibility to explanations of PrEP. Community education is necessary to alleviate PrEP-related stigma and facilitate disclosure.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248307PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7935254PMC
March 2021

Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study.

Lancet HIV 2021 02;8(2):e87-e95

Magee-Womens Research Institute, Pittsburgh, PA, USA.

Background: Two phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.

Methods: We did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.

Findings: Between July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (>0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p<0·0001). HIV-1 incidence was 2·7 per 100 person-years (95% CI 1·9-3·8, 35 infections), compared with an expected incidence of 4·4 per 100 person-years (3·2-5·8) among a population matched on age, site, and presence of a sexually transmitted infection from the placebo group of ASPIRE. No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR.

Interpretation: High uptake and persistent use in this open-label extension study support the DVR as an HIV-1 prevention option for women. With an increasing number of HIV-1 prophylaxis choices on the horizon, these results suggest that the DVR will be an acceptable and practical option for women in Africa.

Funding: The Microbicide Trials Network and the National Institute of Allergy and Infectious Diseases, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health, all components of the US National Institutes of Health.
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http://dx.doi.org/10.1016/S2352-3018(20)30304-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038210PMC
February 2021

The PrEP Journey: Understanding How Internal Drivers and External Circumstances Impact The PrEP Trajectory of Adolescent Girls and Young Women in Cape Town, South Africa.

AIDS Behav 2021 Jul 1;25(7):2154-2165. Epub 2021 Feb 1.

Women's Global Health Imperative, RTI International, 2150 Shattuck Avenue, #800, Berkeley, CA, 94704, USA.

Despite high risk for HIV, South African adolescent girls and young women (AGYW) experience numerous challenges with adherence to PrEP. To better understand AGYW's motivations for PrEP and factors that impact PrEP adherence, we conducted serial in-depth interviews with 22 South African AGYW during a 12 month prospective study. Interviews explored motivations and initial experiences of PrEP use, patterns of adherence, social support, and reasons for stopping or persisting with PrEP. We also assessed drug levels as a biomarker of adherence; dried blood spots were collected at months 1, 2, 3, 6, and 12 to assess intracellular tenofovir diphosphate levels. An end-user journey analytical approach revealed themes related to behavioral and emotional aspects of use, including multilevel factors leading to divergent PrEP adherence trajectories. Our findings highlight how internal versus external motivations drive PrEP use, as well as how positive identity formation and challenges are handled, which are essential to understand AGYW in their PrEP journeys.
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http://dx.doi.org/10.1007/s10461-020-03145-0DOI Listing
July 2021

Trajectories of PrEP Adherence Among Young Women Aged 16 to 25 in Cape Town, South Africa.

AIDS Behav 2021 Jul 2;25(7):2046-2053. Epub 2021 Jan 2.

Women's Global Health Imperative, RTI International, 2150 Shattuck avenue, Berkeley, CA, 94104, USA.

Despite demonstrated efficacy for HIV prevention, substantial challenges remain for the successful rollout of oral pre-exposure prophylaxis (PrEP), especially among adolescent girls and young women (AGYW). We characterized trajectories of PrEP adherence among 200 AGYW in South Africa and analyzed data from 22 qualitative interviews and 3 focus group discussions for explanatory purposes. Two adherence trajectory groups were identified: 52% with high early adherence that declined after month three and 48% with low adherence throughout. Adherence in the "consistently low" group was related to social support and logistical concerns, while the decrease in the "high declining" group corresponded to a change in the frequency of study visits from monthly to quarterly. PrEP support should be differentiated for those who need more frequent visits and adherence support initially versus later in PrEP use. Visits every month, when needed, should be considered for AGYW who need sustained support later into use.
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http://dx.doi.org/10.1007/s10461-020-03134-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8169554PMC
July 2021

After their wives have delivered, a lot of men like going out: Perceptions of HIV transmission risk and support for HIV prevention methods during breastfeeding in sub-Saharan Africa.

Matern Child Nutr 2021 04 15;17(2):e13120. Epub 2020 Dec 15.

Women's Global Health Imperative (WGHI), RTI International, Berkeley, CA, USA.

Female-initiated HIV prevention methods, such as oral pre-exposure prophylaxis (PrEP) and the vaginal ring, may be important risk reduction strategies for breastfeeding women. Given their novelty, information about the sociocultural context and how it influences perceptions of and support for their use during breastfeeding is lacking. To address this gap, we conducted 23 focus group discussions separately with pregnant and breastfeeding women, male partners and grandmothers (N = 196) and 36 in-depth interviews with key informants in Malawi, South Africa, Uganda and Zimbabwe. We analysed the data using a framework analysis method. Overall, breastfeeding was the norm, and participants described the transference of health (e.g., nutrition) and disease (e.g., HIV) to children through breast milk. Participants considered the early breastfeeding period as one of high HIV transmission risk for women. They explained that male partners tend to seek outside sexual partners during this period because women need time to recover from delivery, women focus their attention on the child, and some men are disgusted by breast milk. Participants highlighted concerns about the drugs in oral PrEP transferring to the child through breast milk, but fewer worried about the effects of the vaginal ring because the drug is localized. Women, grandmothers and key informants were supportive of women using these HIV prevention methods during breastfeeding, while male partners had mixed opinions. These findings can be used to tailor messages for promoting the use of PrEP or the vaginal ring during breastfeeding in sub-Saharan Africa.
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http://dx.doi.org/10.1111/mcn.13120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988874PMC
April 2021

Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial.

J Int AIDS Soc 2020 11;23(11):e25636

The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.

Introduction: HIV incidence remains high among African adolescent girls and young women (AGYW), who would benefit from pre-exposure prophylaxis (PrEP). Strategies to increase PrEP adherence and persistence need to be evaluated in African AGY, including incentives conditional on high adherence.

Methods: The 3Ps for Prevention Study was a 12-month prospective cohort of 200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018. Participants received retrospective feedback about drug levels at Months 1, 2 and 3; half was randomized to receive a 200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots (≥500 fmol/punch at Month 1, ≥700 fmol/punch at Months 2 and 3). The primary analysis was intention-to-treat, comparing the proportion with high PrEP adherence (≥700 fmol/punch) at Month 3 by randomized group, based on 100% efficacy among men who have sex with men.

Results: Median age of the 200 women was 19 years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner. At Month 3, the mean TFV-DP level was 822 fmol/punch (SD 522) in the incentive group and 689 fmol/punch (SD 546) in the control group (p = 0.11). Forty-five (56%) of 85 women in the incentive group and 35 (41%) of 85 women in the control group had TFV-DP levels ≥700 fmol/punch (RR 1.35; 95% CI 0.98, 1.86; p = 0.067), which declined to 8% and 5% in the incentive and control groups at Month 12 (no significant difference by arm). 44% refilled PrEP without gaps, 14% had a gap of ≥3 weeks in coverage subsequently restarted PrEP and 54% accepted at the final dispensing visit at Month 9. No new HIV infections were observed after PrEP initiation.

Conclusions: Among South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group. Over half persisted with the 12-month PrEP programme although high adherence declined after Month 3. Strategies to support PrEP adherence and persistence and longer-acting PrEP formulations are needed.
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http://dx.doi.org/10.1002/jia2.25636DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695999PMC
November 2020

Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial.

J Int AIDS Soc 2020 11;23(11):e25634

Departments of Medicine, Epidemiology, and Global Health, University of Washington, Seattle, WA, USA.

Introduction: A vaginal ring containing 25 mg of the antiretroviral dapivirine has demonstrated efficacy in reducing women's risk of sexually acquiring HIV-1; however, imperfect ring use likely diluted efficacy estimates in clinical trials. The amount of dapivirine remaining in returned rings may reflect the extent of product use, permitting estimation of HIV protection in the context of consistent use.

Methods: We measured the amount of dapivirine in returned rings from a placebo-controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women. Phase I/II studies established that greater than 4 mg of dapivirine on average is released from the ring when used consistently over 28 days and ≤0.9 mg released suggested non-use. We assessed the relative risk reduction associated with levels of ring use using residual dapivirine in returned rings as a time-dependent covariate for HIV-1 infection in multivariable Cox models, including multiple exploratory analyses designed to estimate upper limits of efficacy given uncertainty in timing of HIV-1 acquisition. All models were adjusted for baseline covariates associated with HIV risk and adherence.

Results: Residual dapivirine levels indicating at least some use (>0.9 mg released over a month) were associated with a 48% relative reduction in HIV-1 acquisition risk (95% confidence interval (CI): 21% to 66%; p = 0.002) compared to the placebo. Exploratory analyses accounting for potential misclassification in timing of HIV-1 acquisition estimated 75% to 91% HIV-1 risk reduction with> 4 mg released when compared to placebo. Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.

Conclusions: Residual dapivirine levels, an objective measure of adherence, were correlated with HIV-1 protection in a secondary analysis of a randomized trial. Periods of ring use were associated with approximately 50% protection, with exploratory analyses suggesting higher protection with more consistent use. The dapivirine vaginal ring is the first method to fulfil the promise of a fully reversible, long-acting, woman-initiated approach for discreet HIV-1 prevention.
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http://dx.doi.org/10.1002/jia2.25634DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673220PMC
November 2020

Performance and Stability of Tenofovir Alafenamide Formulations within Subcutaneous Biodegradable Implants for HIV Pre-Exposure Prophylaxis (PrEP).

Pharmaceutics 2020 Nov 5;12(11). Epub 2020 Nov 5.

Women's Global Health Imperative, RTI International, 2150 Shattuck avenue, Berkeley, CA 94704, USA.

A critical need exists to develop diverse biomedical strategies for the widespread use of HIV Pre-Exposure Prophylaxis (HIV PrEP). This manuscript describes a subcutaneous reservoir-style implant for long-acting delivery of tenofovir alafenamide (TAF) for HIV PrEP. We detail key parameters of the TAF formulation that affect implant performance, including TAF ionization form, the selection of excipient and the exposure to aqueous conditions. Both in-vitro studies and shelf stability tests demonstrate enhanced performance for TAF freebase (TAF) in this long-acting implant platform, as TAF maintains higher chemical stability than the TAF hemifumarate salt (TAF). We also examined the hydrolytic degradation profiles of various formulations of TAF and identified inflection points for the onset of the accelerated drug hydrolysis within the implant using a two-line model. The compositions of unstable formulations are characterized by liquid chromatography-mass spectrometry (LC-MS) and are correlated to predominant products of the TAF hydrolytic pathways. The hydrolysis rate of TAF is affected by pH and water content in the implant microenvironment. We further demonstrate the ability to substantially delay the degradation of TAF by reducing the rates of drug release and thus lowering the water ingress rate. Using this approach, we achieved sustained release of TAF formulations over 240 days and maintained > 93% TAF purity under simulated physiological conditions. The opportunities for optimization of TAF formulations in this biodegradable implant supports further advancement of strategies to address long-acting HIV PrEP.
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http://dx.doi.org/10.3390/pharmaceutics12111057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694512PMC
November 2020

DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men.

AIDS Behav 2021 Apr 12;25(4):1001-1012. Epub 2020 Oct 12.

Bridge HIV, San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 100, San Francisco, CA, 94102, USA.

Young men who have sex with men (YMSM) are highly vulnerable to HIV. While pre-exposure prophylaxis (PrEP) has demonstrated effectiveness, adherence has been low among YMSM and difficult to measure accurately. In collaboration with a healthcare company, we configured an automated directly-observed therapy (aDOT) platform for monitoring and supporting PrEP use. Based on interest expressed in focus groups among 54 YMSM, we combined aDOT with an electronic sexual diary to provide feedback on level of protection during sex and to motivate app use. In an 8-week optimization pilot with 20 YMSM in San Francisco and Atlanta, the app was found to be highly acceptable, with median System Usability Scale scores in the "excellent" range (80/100). App use was high, with median PrEP adherence of 91% based on aDOT-confirmed dosing. Most (84%) participants reported the app helped with taking PrEP. These promising findings support further evaluation of DOT Diary in future effectiveness studies.
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http://dx.doi.org/10.1007/s10461-020-03054-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7979437PMC
April 2021

Counselors' acceptability of adherence counseling session recording, fidelity monitoring, and feedback in a multi-site HIV prevention study in four African countries.

AIDS Care 2020 Jan - Dec;32(sup1):19-28. Epub 2020 Oct 6.

HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.

Biomedical HIV prevention trials increasingly include evidence-based adherence counseling to encourage product use. To retain effectiveness, interventions must contain key components. Monitoring counseling fidelity ensures inclusion of components but is challenging in multinational contexts with different languages and scarce local supervision. The MTN-025/HOPE Study, a Phase 3b open-label trial to assess continued safety of and adherence to the dapivirine vaginal ring for HIV prevention, was the largest such trial to integrate fidelity monitoring using audio recordings of counseling sessions. We describe the monitoring process, along with counselor and participants' perceptions of it, which were collected via quantitative online survey (counselors only  = 42) and in-depth interviews with a subset of counselors ( = 22) and participants ( = 10). Sessions were conducted in five languages across 14 study sites in four countries. In total, 1238 sessions (23% of submitted sessions) were randomly selected and rated. Assessment of interrater reliability was essential to address drift in ratings. Counselors were apprehensive about being monitored, but appreciated clear guidance and found ratings very helpful (mean = 6.64 out of 7). Some participants perceived sessions as time-consuming; others found monitoring improved counseling quality. Fidelity monitoring of counseling sessions in mult-isite biomedical HIV studies is feasible and supportive for counselors.
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http://dx.doi.org/10.1080/09540121.2020.1823312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7642092PMC
December 2020

Evaluation of a behavior-centered design strategy for creating demand for oral PrEP among young women in Cape Town, South Africa.

Gates Open Res 2020 3;4:29. Epub 2020 Jul 3.

Department of Global Health, University of Washington, Seattle, USA.

Background: There is an urgent need to find effective interventions that reduce young South African women's vulnerability to HIV, and pre-exposure prophylaxis (PrEP) is highly effective when taken consistently. As national programs in Africa launch PrEP programs for young women, it is critical to understand how to effectively create awareness, stimulate interest, and increase uptake of PrEP.

Methods: Behavior-centered design (BCD) guided the development of a PrEP social marketing campaign for young women. Ethnographic observations, in-depth interviews, and focus-group discussions with young South African women informed the content and design of a 90-second PrEP demand creation video and two informational brochures. A short survey was administered to young women at their homes after watching a video to evaluate PrEP interest. Of 800 households with a 16-25-year-old female identified from a Cape Town township census, 320 women in these households viewed the video and completed a survey about the video and their interest in PrEP.

Results: In focus groups, young women from the township preferred local characters and messaging that was empowering, simple, and motivational. From the household survey of young women who viewed the video, most reported interest in learning more about PrEP (67.7% 'definitely interested' and 9.4% 'somewhat interested') and taking PrEP (56.4% 'definitely interested' and 12.5% 'somewhat interested'). Factors significantly associated with interest in taking PrEP were having a primary partner with whom they regularly have sex (80.0% vs. 65.2% without a primary partner; adjusted odds ratio (AOR)=3.1, 95% CI: 1.3, 7.0) and being in a sexual partnership for <6 months (86.8% vs. 68.5% for >12 months; AOR=3.0, 95% CI: 1.2, 7.3).

Conclusions: A positively framed PrEP demand creation video generated high interest in PrEP among young South African women, particularly among women with a primary partner and a shorter-term relationship. NCT03142256; registered on 5 May 2017.
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http://dx.doi.org/10.12688/gatesopenres.13103.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7196718PMC
July 2020

Preferences and Acceptability of Vaginal Delivery Forms for HIV Prevention Among Women, Male Partners and Key Informants in South Africa and Zimbabwe: Qualitative Findings.

AIDS Behav 2021 Jan;25(1):124-138

Women's Global Health Imperative, RTI International, San Francisco, CA, USA.

The attributes of an HIV microbicide may affect its acceptability, uptake and use. Quatro, a clinical study with a qualitative component, was conducted to elicit input from end-users and key informants (KIs) on four different placebo vaginal microbicide delivery forms; fast dissolving insert, ring, film and gel. In-depth interviews and focus group discussions were conducted with young women, their male partners and KIs, to explore acceptability and preferences of the four placebo products, with the intention of improving product attributes, adherence, and consequently, long term effectiveness. None of the four microbicide delivery forms stood well above others as the most preferred. Product attributes; long-action, ease of use, invisibility, female initiated and non-interference during sex were favourable in both countries. Despite preference for the long-action, on-demand products were the most liked by women. Qualitative data from the Quatro study provided rich feedback on specific attributes important to the acceptability of four HIV prevention product platforms currently in development, enabling more informed and guided product development efforts moving forward.
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http://dx.doi.org/10.1007/s10461-020-02949-4DOI Listing
January 2021

Influences on willingness to use vaginal or oral HIV PrEP during pregnancy and breastfeeding in Africa: the multisite MAMMA study.

J Int AIDS Soc 2020 06;23(6):e25536

University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.

Introduction: Women in sub-Saharan Africa spend a substantial portion of their reproductive lives pregnant and/or breastfeeding (P/BF), yet they have limited options to prevent HIV during these maternal stages. In preparation for phase 3b prevention trials in P/BF women, we explored attitudes about using a vaginal ring or oral pills for pre-exposure prophylaxis (PrEP), perceptions of HIV risk during P/BF and key influences on future PrEP use.

Methods: In 2018, we conducted 16 single-sex focus group discussions (FGDs) with community- and clinic-recruited HIV-uninfected women, currently or recently P/BF, aged 18 to 40, and men with (currently or recently) P/BF partners, aged 18+. Participants completed a behavioural questionnaire, viewed an educational video and handled prototype placebo products. FGDs were conducted in local languages and transcribed, coded and analysed, using a socio-ecological framework, for key influences on willingness to use products, HIV risk perceptions and opinions on product attributes.

Results: Of the 128 participants (65 women, 63 men) 75% lived with their partner and 84% had a child. Women reported the most important influencers when P/BF were partners, and all stated that health decisions when P/BF are typically made jointly (e.g. medication use; ante/postnatal and baby care). There was consensus that P/BF women are at high risk for HIV, primarily because of their partner's infidelities, and new prevention options were welcomed. Participants valued multiple options and stated that woman's personal preference would be key to product choice. Anticipated concerns about products included risk of miscarriage, impact on infant development, complications during delivery and adequate production or taste of breastmilk. Specific perceived disadvantages emerged for the ring (e.g. vaginal discomfort, difficulty inserting/removing) and for pills (e.g. nausea/vomiting) that may be exacerbated during pregnancy. Health care providers' (HCPs) knowledge and approval of product use during P/BF was needed to mitigate anticipated fears.

Conclusions: Participants perceived pregnancy and breastfeeding as high HIV risk periods and valued new prevention options. HIV protection of the mother-child dyad, safety of the baby, and ultimately, health of the family were paramount. Endorsement by HCPs and support from partners were key to future product acceptance. Participants recommended involving partners and HCPs in sensitization efforts for future trials.
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http://dx.doi.org/10.1002/jia2.25536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287313PMC
June 2020

Contraceptive implant uptake in Kenya versus South Africa: Lessons for new implantable technologies.

Contraception 2020 04 23;101(4):220-225. Epub 2020 Jan 23.

RTI International, Women's Global Health Imperative, San Francisco, CA, USA; Center for AIDS Prevention Studies, University of California - San Francisco, San Francisco, CA, USA. Electronic address:

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http://dx.doi.org/10.1016/j.contraception.2020.01.001DOI Listing
April 2020

Contraceptive implant uptake in Kenya versus South Africa: Lessons for new implantable technologies.

Contraception 2020 04 23;101(4):220-225. Epub 2020 Jan 23.

RTI International, Women's Global Health Imperative, San Francisco, CA, USA; Center for AIDS Prevention Studies, University of California - San Francisco, San Francisco, CA, USA. Electronic address:

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http://dx.doi.org/10.1016/j.contraception.2020.01.001DOI Listing
April 2020

Insights for Implementation Science From 2 Multiphased Studies With End-Users of Potential Multipurpose Prevention Technology and HIV Prevention Products.

J Acquir Immune Defic Syndr 2019 12;82 Suppl 3:S222-S229

Women's Global Health Imperative, RTI International, San Francisco, CA.

Background: Lower adherence to biomedical HIV prevention and challenges with persistence among young women underscore the need for methods to identify factors that will achieve higher adoption and use of effective prevention options and inform new approaches.

Setting: South Africa, Kenya, and Zimbabwe.

Methods: We synthesized findings from 2 multiphased studies (TRIO and Quatro) conducted with young women aged 18-30 years that included a crossover clinical study with placebo products, a discrete-choice experiment, and qualitative interviews with women, male partners, and health providers. TRIO evaluated 3 products (tablets, ring, and injections), and Quatro compared 4 vaginal products (ring, insert, film, and gel) for HIV prevention. Both were designed to assess product preferences, choice, and use.

Results: Increased experience with placebo products in the crossover study informed young women's product ratings and preferences. Over half changed their mind regarding their most preferred product after trying each one. The integrated qualitative component was vital to understanding what prompted these preference shifts. The discrete choice experiment provided insights on how features not available in placebos, like efficacy and contraception, influence choice and the tradeoffs women may be willing to make to gain a desired product feature.

Conclusion: The use of multiple research methods allowed for evaluation of varied dimensions of acceptability, preference, and choice in the context of diverse biomedical HIV prevention delivery forms. Findings elucidated the value of product choice with differences in preference within and across settings. Collectively, the 3 methodologies offered important insights about these products informative to enhanced product design development and future implementation.
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http://dx.doi.org/10.1097/QAI.0000000000002215DOI Listing
December 2019

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis.

PLoS One 2019 8;14(11):e0224898. Epub 2019 Nov 8.

RTI International, Center for Global Health, Durham, NC, United States of America.

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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224898PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6839883PMC
March 2020

Efficacy is Not Everything: Eliciting Women's Preferences for a Vaginal HIV Prevention Product Using a Discrete-Choice Experiment.

AIDS Behav 2020 May;24(5):1443-1451

Women's Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA.

As new female-initiated HIV prevention products enter development, it is crucial to incorporate women's preferences to ensure products will be desired, accepted, and used. A discrete-choice experiment was designed to assess the relative importance of six attributes to stated choice of a vaginally delivered HIV prevention product. Sexually active women in South Africa and Zimbabwe aged 18-30 were recruited from two samples: product-experienced women from a randomized trial of four vaginal placebo forms and product-naïve community members. In a tablet-administered survey, 395 women chose between two hypothetical products over eight choice sets. Efficacy was the most important, but there were identifiable preferences among other attributes. Women preferred a product that also prevented pregnancy and caused some wetness (p < 0.001). They disliked a daily-use product (p = 0.002) and insertion by finger (p = 0.002). Although efficacy drove preference, wetness, pregnancy prevention, and dosing regimen were influential to stated choice of a product, and women were willing to trade some level of efficacy to have other more desired attributes.
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http://dx.doi.org/10.1007/s10461-019-02715-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990865PMC
May 2020
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