Abstract:IntroductionThe effectiveness of HIV pre-exposure prophylaxis (PrEP) requires consistent and correct product use, thus a deeper understanding of women's stated product formulation preferences, and the correlates of those preferences, can help guide future research. VOICE-D (MTN-003D), a qualitative ancillary study conducted after the VOICE trial, retrospectively explored participants’ tablet and gel use, as well as their preferences for other potential PrEP product formulations.MethodsWe conducted an analysis … Show more
“…Similar results were reported among adolescent users of the contraceptive NuvaRing in the United States . Other studies in Africa have likewise identified that familiarity with a delivery method is correlated to preference . Product developers and researchers should therefore be mindful that introduction of a novel method may face initial resistance, but these opinions may be amenable to change through provision of information, support and practice in use of the method through introductory use periods.…”
Section: Discussionsupporting
confidence: 68%
“…The findings of both studies highlight the importance of conducting multisite research to assess the generalizability of findings across settings. Furthermore, the fact that there were country differences, and that the distribution of products chosen and ranked number one was fairly evenly distributed support the findings of other research studies and the call for continued research and development of a range of options for women, a priority that has been threatened by funding cuts, fears of expensive registration trials, and false assumptions about what methods women will use . The contraceptive field can offer important parallels: as the method mix for modern contraception has increased in Sub‐Saharan Africa, so has the overall proportion of users .…”
Introduction
Adherence to
HIV
prevention methods is a challenge, particularly for young women in Sub‐Saharan Africa. End‐user research during product development can inform modifiable factors to increase future uptake and adherence.
Methods
Preferences for four vaginally inserted placebo
HIV
prevention methods were assessed among Zimbabwean and South African young women using a crossover clinical design. For each of months 1 to 4, participants were asked to use a pre‐coitally inserted film, insert (vaginal tablet) and gel once/week for a month, and a monthly ring in a randomly assigned sequence. Participants subsequently chose one preferred product to use as directed for the final study month. Women ranked the four products from most preferred to least preferred at enrolment and after trying all products.
Results
A total of 200 women aged 18 to 30 (mean 23) were enrolled; 178 (89%) completed follow‐up. At baseline, 41% of participants selected the gel as their most preferred product and 61% selected the ring as least preferred. During the crossover period, most (82% to 85%) self‐reported using each product at least once a week, although only half the time with sex. Objective biomarker data confirmed adequate use of all products. After trying each product, rankings changed with the film, ring, insert and gel being selected by 29%, 28%, 26% and 16% respectively. Choice varied significantly by country (
p
<
0.001): More Zimbabweans chose the film (45%), and more South Africans chose the insert (34%). Among women choosing the ring, 88% reported using it every time with sex. By contrast, self‐reported adherence was lower for “on‐demand” (coitally associated) products, with 40% to 55% using them every time during sex (
p
<
0.001).
Conclusions
Preferences for these four dosage forms varied before and after use, and both within and across countries – there was no clear favourite – indicating the need for a range of options for end‐users The ring's popularity increased the most with use, was the second most preferred delivery system, and per self‐report, provided more coverage during sex. These end‐user perspectives provide important information to product developers and funding agencies.
“…Similar results were reported among adolescent users of the contraceptive NuvaRing in the United States . Other studies in Africa have likewise identified that familiarity with a delivery method is correlated to preference . Product developers and researchers should therefore be mindful that introduction of a novel method may face initial resistance, but these opinions may be amenable to change through provision of information, support and practice in use of the method through introductory use periods.…”
Section: Discussionsupporting
confidence: 68%
“…The findings of both studies highlight the importance of conducting multisite research to assess the generalizability of findings across settings. Furthermore, the fact that there were country differences, and that the distribution of products chosen and ranked number one was fairly evenly distributed support the findings of other research studies and the call for continued research and development of a range of options for women, a priority that has been threatened by funding cuts, fears of expensive registration trials, and false assumptions about what methods women will use . The contraceptive field can offer important parallels: as the method mix for modern contraception has increased in Sub‐Saharan Africa, so has the overall proportion of users .…”
Introduction
Adherence to
HIV
prevention methods is a challenge, particularly for young women in Sub‐Saharan Africa. End‐user research during product development can inform modifiable factors to increase future uptake and adherence.
Methods
Preferences for four vaginally inserted placebo
HIV
prevention methods were assessed among Zimbabwean and South African young women using a crossover clinical design. For each of months 1 to 4, participants were asked to use a pre‐coitally inserted film, insert (vaginal tablet) and gel once/week for a month, and a monthly ring in a randomly assigned sequence. Participants subsequently chose one preferred product to use as directed for the final study month. Women ranked the four products from most preferred to least preferred at enrolment and after trying all products.
Results
A total of 200 women aged 18 to 30 (mean 23) were enrolled; 178 (89%) completed follow‐up. At baseline, 41% of participants selected the gel as their most preferred product and 61% selected the ring as least preferred. During the crossover period, most (82% to 85%) self‐reported using each product at least once a week, although only half the time with sex. Objective biomarker data confirmed adequate use of all products. After trying each product, rankings changed with the film, ring, insert and gel being selected by 29%, 28%, 26% and 16% respectively. Choice varied significantly by country (
p
<
0.001): More Zimbabweans chose the film (45%), and more South Africans chose the insert (34%). Among women choosing the ring, 88% reported using it every time with sex. By contrast, self‐reported adherence was lower for “on‐demand” (coitally associated) products, with 40% to 55% using them every time during sex (
p
<
0.001).
Conclusions
Preferences for these four dosage forms varied before and after use, and both within and across countries – there was no clear favourite – indicating the need for a range of options for end‐users The ring's popularity increased the most with use, was the second most preferred delivery system, and per self‐report, provided more coverage during sex. These end‐user perspectives provide important information to product developers and funding agencies.
“…Acceptability research conducted since VOICE and FEM‐PrEP indicate that women desire low burden prevention strategies that are compatible with their lifestyles and provide peace of mind . Indeed, a daily pill regimen can be both logistically and emotionally burdensome (as it may remind women about HIV or IPV) .…”
Section: Discussionmentioning
confidence: 99%
“…Indeed, a daily pill regimen can be both logistically and emotionally burdensome (as it may remind women about HIV or IPV) . When offered HIV prevention alternatives through discrete choice experiments which assess hypothetical preferences and trade‐offs between them, women prefer longer‐acting and more adherence “forgiving” products, supporting the development of a range of PrEP delivery modalities – ring, injectable, implantable – from which young women can choose . In parallel with development of formulations with less frequent dosing, it is important to learn about delivery and use of oral PrEP, a vanguard product.…”
Introduction
Adolescent girls and young women (AGYW) in Africa have high HIV incidence despite scale‐up of HIV testing and HIV treatment. Placebo‐controlled trials of tenofovir‐based pre‐exposure prophylaxi (PrEP) in diverse populations demonstrated that PrEP works with close to 100% effectiveness if taken with high, but not perfect, adherence. Divergent efficacy estimates among African AGYW led to demonstration and implementation projects to better understand motivations for HIV prevention, uptake, adherence and persistence to PrEP. To inform PrEP programmes, the design and initial findings from PrEP demonstration projects for AGYW are reviewed.
Discussion
Early lessons from PrEP implementation projects among young African women include: (1) awareness and demand creation with positive messaging about the benefits of PrEP are critical to motivate AGYW to consider this novel prevention technology and to foster awareness among peers, partners, parents and guardians to support AGYW's effective PrEP use; (2) PrEP initiation is high in projects that are integrating PrEP into youth‐friendly clinics, family planning clinics and mobile clinics; (3) young African women at risk are initiating PrEP, based on behavioural characteristics, history of intimate partner violence, depression and 30% prevalence of chlamydia and/or gonorrhoea; (4) provision of youth‐friendly PrEP delivery programmes that integrate reproductive health services, including contraception and the diagnosis and treatment of sexually transmitted infections, increase health impact; (5) messages that emphasize the necessity for high adherence while at potential risk of HIV exposure and support strategies that addresses AGYW's adherence challenges are essential; and, (6) a substantial proportion of AGYW do not persist with PrEP, and strategies are needed to help AGYW assess their ongoing need, motivation and challenges with persisting with PrEP.
Conclusions
PrEP is feasible to implement in integrated reproductive health service delivery models to reach African AGYW. While PrEP demonstration projects indicate that women with behavioural risks and high rates of sexually transmitted diseases are initiating PrEP; effective strategies to support AGYW's adherence and persistence with PrEP are needed. Lessons learned from oral PrEP delivery, a novel first generation HIV prevention product, are relevant to longer‐acting and less adherence‐dependent strategies which are currently in clinical trials.
“…Yet, findings from our research published in an earlier paper showed that amongst a range of eight modes of delivery for biomedical HIV prevention products (cervical barrier, implants, injectables, oral tablets, vaginal gel, vaginal film, vaginal ring, and vaginal suppository), gels did not rank highly in product preference ratings (Luecke et al, 2016). Women perceived gels to create uncomfortable sensations of being wet and leaky.…”
Preferences and practices related to the vaginal condition have implications for the use of vaginal HIV prevention products. We used qualitative methods to explore narratives relating to the vaginal state amongst women in South Africa, Uganda and Zimbabwe who had previously participated in a biomedical HIV prevention trial. We investigated women’s behaviours related to optimising the vaginal state, experiences and perceptions of the gel’s effect on the vaginal state and on penile-vaginal intercourse, women’s narratives on male partner perceptions, and how preferences relating to the vaginal state may have interfered with gel use.
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