Elizabeth E Tolley

FHI 360, Durham, North Carolina, United States

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Publications (50)146.02 Total impact

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    ABSTRACT: This case study describes the experience of developing communication messages and materials to position microbicide gel—a product still in clinical trials—for HIV prevention in Kenya. A robust development process included stakeholder and audience consultations, a national message development workshop, two rounds of pretesting, and an evaluation study to evaluate the impact of the materials on intentions and attitudes related to microbicide use. Awareness-raising and in-depth educational materials for both potential microbicide users and health care providers were developed. The project team tested two different ways of positioning microbicides—one focused primarily on the HIV prevention benefits of the product and the other focused on other benefits, such as increased sexual pleasure and intimacy. This experience presented a number of unique social marketing and communication challenges related to the inherent characteristics of microbicides, the fact that they are not yet licensed for use, and the potential for inadvertently stigmatizing the product and encouraging condom migration. The project confirmed that marketing microbicides to women in a wide variety of sexual contexts—and gaining support of male partners—will be critical for avoiding stigmatization of the product. It also confirmed that the positioning of the product can impact interest in using microbicides and that in-depth counseling of users will be critical for ensuring correct use.
    Social Marketing Quarterly 04/2015; 21(2):100-114. DOI:10.1177/1524500415583058
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    ABSTRACT: More than 40 million women use injectable contraceptives to prevent pregnancy, and most current or previous injectable users report being satisfied with the method. However, while women may find injectables acceptable, they may not always find them accessible due to stock-outs and difficulties with returning to the clinic for reinjections. FHI 360 is spearheading efforts to develop a longer-acting injectable (LAI) contraceptive that could provide at least 6 months of protection against pregnancy. This article addresses systems-level considerations for the introduction of a new LAI. We conducted qualitative case studies in Kenya and Rwanda-two countries that have high levels of injectable use but with different service delivery contexts. Between June and September 2012, we conducted in-depth interviews with 27 service providers and 19 policy makers and program implementers focusing on 4 themes: systems-level barriers and facilitators to delivering LAI services; process for introducing an LAI; LAI distribution approaches; and potential LAI characteristics. We also obtained electronic feedback from 28 international family planning opinion leaders. Respondents indicated strong interest in an LAI and thought it would appeal to existing injectable users as well as new family planning clients, both for spacing and for limiting births. Providers appreciated the potential for a lighter workload due to fewer follow-up visits, but they were concerned that fewer visits would also decrease their ability to help women manage side effects. The providers also appreciated the 1-month grace period for follow-up LAI injections; some seemed unaware of the latest international guidance that had increased the grace period from 2 weeks to 4 weeks for the currently available 3-month injectable. The majority of policy makers and program implementers were supportive of letting community health workers provide the method, but many nurses and midwives in Kenya had reservations about the approach. At the policy level, respondents indicated that obtaining regulatory approvals before introducing the new method could be costly and time-consuming. Manufacturing and procurement decisions could also affect cost and availability. Successful introduction of a potential longer-acting injectable may be enhanced by considering broader systemic issues, including managing cost to the health system and users, expanding access through community-based distribution, and training providers on the latest service delivery guidelines. © McKenna et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly cited. To view a copy of the license, visit http://creativecommons.org/licenses/by/3.0/. When linking to this article, please use the following permanent link: http://dx.doi.org/10.9745/GHSP-D-14-00106.
    Global Health: Science and Practice 12/2014; 2(4):459-71. DOI:10.9745/GHSP-D-14-00106
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    ABSTRACT: Background: Contraceptive discontinuation is common for the current injectable, despite its popularity, and FHI 360 is spearheading efforts to develop a longer acting injectable (LAI) to address some of the causes of discontinuation. Contraceptive discontinuation can be affected by policy decisions, logistical problems, and other systems-level issues. Thus, the impact of a new LAI will rely not only on its acceptability by users, but its fit within current healthcare systems. Methods: We conducted qualitative case studies in Kenya and Rwanda. In-depth interviews were conducted with 27 service providers and 19 policymakers and program implementers focused on systems-level barriers and facilitators to contraceptive delivery services, for both medroxyprogesterone acetate and for a potential LAI. We also surveyed 28 international contraception leaders. Results: The regulatory process for drug registration was seen as cumbersome by policymakers; similarly, they saw manufacturing and procurement processes as potentially costly and time-consuming with limited funding available to cover the cost of a new product. Providers saw an LAI filling a need by providing a longer-term method that would appeal to women wanting to limit and space births. Respondents emphasized a well-planned introduction as essential in securing access and ensuring uptake of an LAI. Conclusions: An LAI could be integrated into existing contraceptive commodity policy-making, program planning, and distribution activities. However, to better ensure access to such a product, systems-level considerations and opportunities should be examined. Early involvement of all policy and healthcare cadres and communities will be important for introducing an affordable and accessible product.
    142nd APHA Annual Meeting and Exposition 2014; 11/2014
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    ABSTRACT: In developing-country settings, pregnancy intentions are often assessed using a series of questions from the Demographic and Health Surveys, yet research conducted in several countries yields conflicting results regarding these questions' ability to predict pregnancy. Conducted in Malawi and South Africa, this study identified individual, partner and societal factors that influence desire for pregnancy, and women's ability to achieve their intentions. Data come from interviews and focus-group discussions conducted prior to the FEM-PrEP HIV-prevention trial with women from communities at high risk of HIV infection. Cultural norms regarding contraceptive use and childbearing influenced both women's desire for pregnancy and ability to achieve those goals. Partner's expectations for pregnancy, financial concerns, family composition and contraceptive experiences were additional influences. Actively planning for pregnancy was not a salient concept to the majority of participants. Results support the call for a multidimensional measure of pregnancy intention that reflects the variety of factors that influence intentions, highlight the fluid nature of many women's reproductive health decision making and challenge the notion that all fertility decisions are the result of conscious action. Additional work on how women's plans for pregnancy are achieved would be programmatically more useful than current measures of intention.
    Culture Health & Sexuality 10/2014; 17(3):1-16. DOI:10.1080/13691058.2014.968806 · 1.55 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A105. DOI:10.1089/aid.2014.5196.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A164. DOI:10.1089/aid.2014.5342.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A104. DOI:10.1089/aid.2014.5194.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A96-7. DOI:10.1089/aid.2014.5178.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A275-6. DOI:10.1089/aid.2014.5621.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A136. DOI:10.1089/aid.2014.5272.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A171-2. DOI:10.1089/aid.2014.5361.abstract · 2.46 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A164. DOI:10.1089/aid.2014.5341.abstract · 2.46 Impact Factor
  • M Brady, E Tolley
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    ABSTRACT: Multipurpose prevention technologies provide a compelling response to the multiple and reinforcing sexual and reproductive health risks faced by women globally. To ensure that this potential is realised, product-specific characteristics and their social-behavioural correlates must be considered early in the product development process. This paper provides an overview of the key user-related social and behavioural dimensions of three broad categories of multipurpose prevention technologies: 1) sustained release vaginal rings, 2) pericoital vaginal products, and 3) co-formulated or co-administered injectables. The authors build upon the broad parameters of Target Product Profiles for such products, aligning them with user perspective considerations.
    BJOG An International Journal of Obstetrics & Gynaecology 10/2014; 121 Suppl 5:70-8. DOI:10.1111/1471-0528.12844 · 3.86 Impact Factor
  • AIDS Research and Human Retroviruses 10/2014; 30 Suppl 1:A104-5. DOI:10.1089/aid.2014.5195.abstract · 2.46 Impact Factor
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    ABSTRACT: Introduction Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. Discussion The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support – sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures – creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence – real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research along these three pathways will result in a comprehensive approach to product adherence within clinical trials. Conclusions Better measurement of adherence will not, by itself, ensure that future effectiveness trials will be able to address the most basic question: if the product is used per instructions, will it prevent HIV transmission? The challenges to adherence measurement must be addressed as one component of a more integrated system that has as its central focus adherence as a behaviour emerging from the social context of the user.
    Journal of the International AIDS Society 09/2014; 17(3 Suppl 2):19158. DOI:10.7448/IAS.17.3.19158 · 4.21 Impact Factor
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    ABSTRACT: Introduction Stakeholders continue to discuss the appropriateness of antiretroviral-based pre-exposure prophylaxis (PrEP) for HIV prevention among sub-Saharan African and other women. In particular, women need formulations they can adhere to given that effectiveness has been found to correlate with adherence. Evidence from family planning shows that contraceptive use, continuation and adherence may be increased by expanding choices. To explore the potential role of choice in women's use of HIV prevention methods, we conducted a secondary analysis of research with female sex workers (FSWs) and men and women in serodiscordant couples (SDCs) in Kenya, and adolescent and young women in South Africa. Our objective here is to present their interest in and preferences for PrEP formulations – pills, gel and injectable. Methods In this qualitative study, in Kenya we conducted three focus groups with FSWs, and three with SDCs. In South Africa, we conducted two focus groups with adolescent girls, and two with young women. All focus groups were audio-recorded, transcribed and translated into English as needed. We structurally and thematically coded transcripts using a codebook and QSR NVivo 9.0; generated code reports; and conducted inductive thematic analysis to identify major trends and themes. Results All groups expressed strong interest in PrEP products. In Kenya, FSWs said the products might help them earn more money, because they would feel safer accepting more clients or having sex without condoms for a higher price. SDCs said the products might replace condoms and reanimate couples’ sex lives. Most sex workers and SDCs preferred an injectable because it would last longer, required little intervention and was private. In South Africa, adolescent girls believed it would be possible to obtain the products more privately than condoms. Young women were excited about PrEP but concerned about interactions with alcohol and drug use, which often precede sex. Adolescents did not prefer a particular formulation but noted benefits and limitations of each; young women's preferences also varied. Conclusions The circumstances and preferences of sub-Saharan African women are likely to vary within and across groups and to change over time, highlighting the importance of choice in HIV prevention methods.
    Journal of the International AIDS Society 09/2014; 17(Suppl 2). DOI:10.7448/IAS.17.3.19157 · 4.21 Impact Factor
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    ABSTRACT: Introduction Current HIV prevention options are unrealistic for most women; however, HIV prevention research has made important strides, including on-going development of antiretroviral-based vaginal microbicide gels. Nevertheless, social-behavioural research suggests that women's ability to access and use new HIV prevention technologies will be strongly influenced by a range of socio-cultural, gender and structural factors which should be addressed by communications and marketing strategies, so that these products can be positioned in ways that women can use them. Methods Based on an extensive literature review and in-country policy consultation, consisting of approximately 43 stakeholders, we describe barriers and facilitators to HIV prevention, including potential microbicide use, for four priority audiences of Kenyan women (female sex workers [FSWs], women in stable and discordant relationships, and sexually active single young women). We then describe how messages that position microbicides might be tailored for each audience of women. Results We reviewed 103 peer-reviewed articles and reports. In Kenya, structural factors and gender inequality greatly influence HIV prevention for women. HIV risk perception and the ability to consistently use condoms and other prevention products often vary by partner type. Women in stable relationships find condom use challenging because they connote a lack of trust. However, women in other contexts are often able to negotiate condom use, though they may face challenges with consistent use. These women include FSWs who regularly use condoms with their casual clients, young women in the initial stages of a sexual relationship and discordant couples. Thus, we consider two approaches to framing messages aimed at increasing general awareness of microbicides – messages that focus strictly on HIV prevention and ones that focus on other benefits of microbicides such as increased pleasure, intimacy or sexual empowerment, in addition to HIV prevention. Conclusions If carefully tailored, microbicide communication materials may facilitate product use by women who do not currently use any HIV prevention method. Conversely, message tailoring for women with high-risk perception will help ensure that microbicides are used as additional protection, together with condoms.
    Journal of the International AIDS Society 09/2014; 17(3 Suppl 2):19151. DOI:10.7448/IAS.17.3.19151 · 4.21 Impact Factor
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    ABSTRACT: Introduction Despite the disproportionate impact of HIV on women, and adolescents in particular, those below age 18 years are underrepresented in HIV prevention trials due to ethical, safety and logistical concerns. This study examined and compared the sexual risk contexts of adolescent women aged 15–17 to young adult women aged 18–21 to determine whether adolescents exhibited similar risk profiles and the implications for their inclusion in future trials. Methods We conducted a two-phase, mixed-method study to assess the opportunities and challenges of recruiting and retaining adolescents (aged 15–17) versus young women (18–21) in Tanzania. Phase I, community formative research (CFR), used serial in-depth interviews with 11 adolescent and 12 young adult women from a range of sexual risk contexts in preparation for a mock clinical trial (MCT). For Phase II, 135 HIV-negative, non-pregnant adolescents and young women were enrolled into a six-month MCT to assess and compare differences in sexual and reproductive health (SRH) outcomes, including risky sexual behaviour, incident pregnancy, sexually transmitted infections (STIs), reproductive tract infections (RTIs) and HIV. Results In both research phases, adolescents appeared to be at similar, if not higher, risk than their young adult counterparts. Adolescents reported earlier sexual debut, and similar numbers of lifetime partners, pregnancy and STI/RTI rates, yet had lower perceived risk. Married women in the CFR appeared at particular risk but were less represented in the MCT. In addition, adolescents were less likely than their older counterparts to have accessed HIV testing, obtained gynaecological exams or used protective technologies. Conclusions Adolescent women under 18 are at risk of multiple negative SRH outcomes and they underuse preventive services. Their access to new technologies such as vaginal microbicides or pre-exposure prophylaxis (PrEP) may similarly be compromised unless greater effort is made to include them in clinical trial research.
    Journal of the International AIDS Society 09/2014; 17(3 Suppl 2):19149. DOI:10.7448/IAS.17.3.19149 · 4.21 Impact Factor
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    ABSTRACT: To estimate whether continuous combined oral contraceptive pill (OCP) use leads to higher continuation and lower pregnancy rates over 12 months than cyclic use in a developing country setting. We enrolled healthy women aged 18 to 30 years, in Santo Domingo, Dominican Republic. We randomly assigned women to cyclic or continuous use of OCPs. Participants made quarterly clinic visits for 12 months. During follow-up, we reviewed OCP adherence and continuation, side effects, and bleeding, and we tested for pregnancy. We enrolled 358 women (mean age, 22.7 years) and 335 (93.6%) completed the study. In intent-to-treat analyses, 77.6% of the continuous use group and 71.7% of the cyclic group continued OCPs at 12 months (P=.21). The main reason for OCP discontinuation in both groups was running out of OCPs or forgetting. Across all visits, 26.1% of women in the continuous use group and 22.3% of women in the cyclic group ever reported missing three or more OCPs in the past month (P=.43). In multivariable analyses, regimen was not associated with discontinuation, but both previous birth and perceived ease of use of OCPs decreased risk of discontinuation, whereas desire for reduced menstruation increased risk of discontinuation. Although more women reported amenorrhea or infrequent bleeding in the continuous use group, more women in the cyclic group found their bleeding patterns acceptable. Bleeding was not associated with discontinuation in multivariable analyses. Pregnancy rates at 12 months were similar (16.2% continuous and 17.4% cyclic). Continuous and cyclic OCP regimens were associated with similar 12-month continuation and pregnancy rates. Few factors predicted OCP discontinuation or pregnancy. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00570440. LEVEL OF EVIDENCE:: I.
    Obstetrics and Gynecology 05/2014; 123(5):1012-1022. DOI:10.1097/AOG.0000000000000235 · 4.37 Impact Factor
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    ABSTRACT: Between 1995 and 2005, injectable use doubled worldwide. However, discontinuation rates remain high, partly because of side effects but also because of missed appointments for reinjection. A longer-acting injectable (LAI) may improve compliance by reducing the required number of reinjection visits, thereby reducing unintentional discontinuation. This study examined acceptability of LAI characteristics comprising the target product profile (TPP).
    Global Health: Science and Practice 05/2014; 2(2):182-194. DOI:10.9745/GHSP-D-13-00147