Elizabeth E Tolley

FHI 360, Durham, North Carolina, United States

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Publications (47)139.57 Total impact

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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
  • 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: 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
    This article is viewable in ResearchGate's enriched format
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    ABSTRACT: 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.
    Journal of the International AIDS Society 09/2014; 17(3 Suppl 2):19158. DOI:10.7448/IAS.17.3.19158 · 4.21 Impact Factor
    This article is viewable in ResearchGate's enriched format
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    ABSTRACT: 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.
    Journal of the International AIDS Society 09/2014; 17(3 Suppl 2):19151. DOI:10.7448/IAS.17.3.19151 · 4.21 Impact Factor
    This article is viewable in ResearchGate's enriched format
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    ABSTRACT: 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.
    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
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    ABSTRACT: Under-representation of female adolescents in HIV clinical trials may inhibit their access to future prevention technologies. Domestic violence, broadly defined as violence perpetrated by intimate partners and/or family members, may affect trial participation. This study describes violence in the lives of adolescents and young women in Tanzania, explores use of the Women's Experience with Battering (WEB) Scale to measure battering, and examines the associations between battering and socio-demographic and HIV risk factors. Community formative research (CFR) and a mock clinical trial (MCT) were conducted to examine the challenges of recruiting younger (15-17) versus older (18-21) participants into HIV prevention trials. The CFR included qualitative interviews with 23 participants and there were 135 MCT participants. The WEB was administered in both the CFR and MCT. Nineteen CFR participants experienced physical and/or sexual violence and 17 % scored positive for battering. All married participants reported partner-related domestic violence, and half scored positive for battering. Many believed beatings were normal. None of the single participants scored positive on battering, but one-third reported abuse by relatives. Among MCT participants, 15 % scored positive for battering; most perpetrators were relatives. Younger participants were more likely to report battering. Adolescents experienced high rates of domestic violence and the WEB captured battering from both partners and relatives. The level of familial violence was unexpected and has implications for parental roles in study recruitment. Addressing adolescent abuse in HIV prevention trials and in the general population should be a public health priority.
    Maternal and Child Health Journal 04/2014; 19(1). DOI:10.1007/s10995-014-1492-1 · 2.24 Impact Factor
  • Elizabeth E Tolley, Kathleen M Morrow, Derek H Owen
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    ABSTRACT: Multipurpose Prevention Technologies (MPTs) are new tools aimed at reducing or preventing multiple and overlapping sexual and reproductive health risks faced by women and couples around the globe. While MPTs could prove more acceptable and easier to adhere to than single-purpose prevention products, continuing high rates of HIV and unintended pregnancy remind us that these new products will need to be efficacious, acceptable and effectively used to achieve a public health impact. In this paper, we describe how a range of research methods can be applied during the pre-clinical phase of product development to inform decisions related to formulation and vehicle or product delivery mechanisms, and consider how choices in product-related characteristics may influence future demand for, delivery and use of future products. We draw on examples from the development of new single-purpose HIV and contraceptive products and then extend our discussion to the development of MPTs, including vaginal rings and injections. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.
    Antiviral research 10/2013; DOI:10.1016/j.antiviral.2013.09.029 · 3.61 Impact Factor