Elizabeth E Tolley

National AIDS Research Institute - Pune, Poona, Mahārāshtra, India

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Publications (26)60.46 Total impact

  • 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; · 3.61 Impact Factor
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    ABSTRACT: To identify reasons for non-use of modern family planning in Rwanda, to examine specific barriers to contraception, and to explore psychosocial factors influencing modern contraceptive use. In total, 637 in-union, parous, and non-pregnant women aged 21-49years participated in a cross-sectional community-based survey in 5 districts. In-depth interviews (IDIs) were conducted with 54 women and 27 male partners. Multivariate logistic regression examined correlates of current non-use. IDI transcripts were analyzed independently and compared thematically with survey findings. Overall, 50% of survey respondents were using a modern method. Fertility- and partner-related variables were key correlates of non-use. The most commonly reported reasons for non-use were related to perceived fecundity. Men were mostly supportive of contraceptive use and had an important role in a woman's decision to use contraception. Women's IDIs revealed misperceptions about fertility leading to gaps in contraceptive coverage, particularly postpartum. Those IDIs also highlighted how provider practices, including screening for pregnancy through direct observation of menses, may hamper contraceptive use. Programmatic recommendations include increasing information efforts aimed at men; developing effective messages about postpartum risk of pregnancy and training providers on postpartum contraceptive eligibility and needs; and reinforcing use of alternative pregnancy-screening methods.
    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 08/2013; · 1.41 Impact Factor
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    ABSTRACT: Abstract The availability of female-initiated HIV prevention options does not necessarily lead to their uptake. We investigated if married men were willing to support open or covert use of microbicides by their spouses in Pune, India. Data was collected using an interview-administered questionnaire from 151 consenting married men with a mean age of 34 years. Logistic regression analysis was used to examine the relationships between sociodemographic and behavioural factors. One hundred and thirty-seven men (71.5%) were educated and 146 men (96.7%) were employed. Men aged <34 years were eight times (p=0.024) and those in a harmonious relationship were seven times (p=0.008) more willing to use microbicides compared with men aged ≥34 years and men in less harmonious relationships, respectively. Men practicing high-risk sexual behaviour were twice (p=0.049) and men with a history of using contraceptives were three times (p=0.05) more likely to support the covert use of microbicides compared with those reporting no or low-risk sexual behaviour and those who had never used contraceptives, respectively. This suggests that sociodemographic and behavioural factors relating to men as well as women should be considered when developing and marketing microbicides.
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    ABSTRACT: The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples' ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction.
    · 3.49 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The availability of female-initiated HIV prevention options does not necessarily lead to their uptake. We investigated if married men were willing to support open or covert use of microbicides by their spouses in Pune, India. Data was collected using an interview-administered questionnaire from 151 consenting married men with a mean age of 34 years. Logistic regression analysis was used to examine the relationships between sociodemographic and behavioural factors. One hundred and thirty-seven men (71.5%) were educated and 146 men (96.7%) were employed. Men aged <34 years were eight times (p=0.024) and those in a harmonious relationship were seven times (p=0.008) more willing to use microbicides compared with men aged ≥34 years and men in less harmonious relationships, respectively. Men practicing high-risk sexual behaviour were twice (p=0.049) and men with a history of using contraceptives were three times (p=0.05) more likely to support the covert use of microbicides compared with those reporting no or low-risk sexual behaviour and those who had never used contraceptives, respectively. This suggests that sociodemographic and behavioural factors relating to men as well as women should be considered when developing and marketing microbicides.
    International Health 09/2012; 4(3):200-3. · 1.01 Impact Factor
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    ABSTRACT: This study reports on the acceptability of 1% tenofovir microbicide gel among participants randomised to the coitally-associated use (n = 50) or daily use (n = 50) arms of a Phase II clinical trial in Pune, India. In a 6-month follow-up study, information on behavioural domains was collected on a 6-point Likert scale and gel acceptability was measured on a 5-point Likert scale. Random intercept logistic modelling was performed to examine the simultaneous effects of study arm, follow-up time, sociodemographic factors and behavioural domains on gel acceptability. The mean age of female participants was 32.7 years. Women in both study arms had similar sociodemographic profiles. Women liked features such as easy use of the gel and its protective effect against HIV. Messiness was the most disliked feature. Gel acceptability increased during subsequent follow-up visits in both arms, especially in the coitally-associated use arm. Non-acceptability of the gel was almost two and a half times higher in daily users (adjusted odds ratio 2.55, 95% CI 1.18-5.51; p = 0.017). Acceptability differed significantly between the two study arms at 2 months (68% vs 40%; p = 0.006) and 6 months (64% vs 46%; p = 0.07). Acceptability was significantly lower in those participants who reported 'messiness' as the most disliked feature (odds ratio 2.42, 95% CI 1.02-5.72; p = 0.045). In conclusion, microbicides were more acceptable in coitally-associated users than in daily users. Leakage was a problem that requires attention. Positioning of the product in a setting such as India where the majority of decision-making is done by men would need extensive and systematic education of men.
    International Health 03/2012; 4(1):63-9. · 1.01 Impact Factor
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    ABSTRACT: Researchers have raised concerns that microbicide use during clinical trials would displace condom use. We sought to understand whether condom use changed for participants in a microbicide clinical trial in Pune, India, to understand whether condom shifts were a legitimate concern. We hypothesize that women participating in a microbicide clinical trial in Pune, India, were more likely, on average, to report condom use at follow-up. We further hypothesize that men, whose female partners participated in a microbicide clinical trial were more likely, on average, to report condom use at follow-up. The outcome measure for reported condom use was a dichotomous variable to indicate whether or not the participant had used a male or female condom with a sexual partner since 2 months before enrollment or since the last survey, depending on the visit. Data are from semi-structured interviews at baseline, 2 months, 4 months, and 6 months with HPTN 059 clinical trial participants (100 women and 57 male partners). We used generalized estimating equations with a logit link function, exchangeable correlation, and a binomial family to model condom use. The odds of condom use for clinical trial women increased from baseline to 6 months by a factor of 3.7 (95% CI: 1.84-7.63) and the change in odds of condom use for clinical trial men from baseline to 6 months increased by a factor of 2.58 (95% CI: 1.37-4.85). We found concerns about microbicide use displacing condom use were not merited in this study population. The percent of participants reporting condom use declined from 4 to 6 months, suggesting that increases in condom use may only be during active study participation. Information about clinical trial factors that enabled these men and women to enact this important HIV prevention behavior is needed to develop interventions.
    AIDS Care 11/2011; 24(5):539-43. · 1.60 Impact Factor
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    ABSTRACT: Research suggests that the HIV/AIDS epidemic has spread to monogamous women in India. Gender inequalities prevent women from asserting control over the circumstances that increase their vulnerability to infection. Men control most of the sexual decision-making. The present study explores views on use of microbicides by men and circumstances in which they might find microbicide use with their wives acceptable. Progressive in-depth interviews were conducted among 15 consenting men from Pune, India. Men felt that women with identifiable HIV risk, such as being a sex worker, having an HIV infected husbands or being educated; were more likely to use microbicides. Most high-risk men would permit or force their wives to use microbicides and had a higher intention to use microbicides compared with low-risk men probably due to perceived susceptibility. The majority of men with previous experience of microbicide use mentioned that privacy was important for gel use. Most low-risk men believed that they would be angry with covert gel use by their wives. They felt that covert use was impossible since their wives were under their control and they would notice the gel due to a change in their sexual experience. Low-risk men also opined that husband's permission was not required if he was HIV-infected or having extra-marital sex. Some men stressed the need for exercising sexual control while women inserted gel before sex. Men's risk-perception, knowledge about their safety concerns, as well as their behavior may affect acceptability of gel use, hence men's involvement and cooperation is imperative for microbicide gel use by women in India.
    · 1.60 Impact Factor
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    [Show abstract] [Hide abstract]
    ABSTRACT: The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples' ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction.
    AIDS and Behavior 08/2011; 16(7):1808-15. · 3.49 Impact Factor
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    ABSTRACT: In the last decade, three randomized controlled trials in Kenya, South Africa, and Uganda have shown that medical male circumcision (MMC) reduces the sexual transmission of HIV from women to men. Objectives of this assessment were to measure acceptability of adult MMC and circumcision of children to inform policies regarding whether and how to promote MMC as an HIV prevention strategy. This mixed-method study, conducted across four Ugandan districts, included a two-stage household survey of 833 adult males and 842 adult females, focus group discussions, and a health provider survey. Respondents' acceptability of MMC was positive and substantial after being informed about the results of recent randomized trials. In uncircumcised men, between 40% and 62% across the districts would consider getting circumcised. Across the four districts between 60% and 86% of fathers and 49% and 95% of mothers were supportive of MMC for sons. Widespread support exists among men and women in this study for promoting MMC as part of Uganda's current 'ABC + ' HIV prevention strategy.
    AIDS Care 07/2011; 23(12):1578-85. · 1.60 Impact Factor
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    ABSTRACT: Research suggests that the HIV/AIDS epidemic has spread to monogamous women in India. Gender inequalities prevent women from asserting control over the circumstances that increase their vulnerability to infection. Men control most of the sexual decision-making. The present study explores views on use of microbicides by men and circumstances in which they might find microbicide use with their wives acceptable. Progressive in-depth interviews were conducted among 15 consenting men from Pune, India. Men felt that women with identifiable HIV risk, such as being a sex worker, having an HIV infected husbands or being educated; were more likely to use microbicides. Most high-risk men would permit or force their wives to use microbicides and had a higher intention to use microbicides compared with low-risk men probably due to perceived susceptibility. The majority of men with previous experience of microbicide use mentioned that privacy was important for gel use. Most low-risk men believed that they would be angry with covert gel use by their wives. They felt that covert use was impossible since their wives were under their control and they would notice the gel due to a change in their sexual experience. Low-risk men also opined that husband's permission was not required if he was HIV-infected or having extra-marital sex. Some men stressed the need for exercising sexual control while women inserted gel before sex. Men's risk-perception, knowledge about their safety concerns, as well as their behavior may affect acceptability of gel use, hence men's involvement and cooperation is imperative for microbicide gel use by women in India.
    AIDS Care 06/2011; 23(10):1344-9. · 1.60 Impact Factor
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    ABSTRACT: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base. Review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. We searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, EMBASE, ClinicalTrials.gov, and ICTRP). We also wrote to researchers to find other trials. Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups and preventing sexually transmitted infections or HIV. Interventions addressed the use of one or more contraceptive methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice, initiating or changing contraceptive use, contraceptive regimen adherence, and contraception continuation. The primary author evaluated abstracts for eligibility. Two authors extracted data from included studies. We calculated the odds ratio for dichotomous outcomes. No meta-analysis was conducted due to intervention differences. Fourteen RCTs met our inclusion criteria. In 2 of 10 trials with pregnancy or birth data, a theory-based group showed better results. Four of 10 trials with contraceptive use data (other than condoms) showed better outcomes in an experimental group. For condom use, a theory-based group had favorable results in three of eight trials. Social Cognitive Theory was the main theoretical basis for five trials, of which three showed positive results. Two based on other social cognition models had favorable results, as did two of four focused on motivational interviewing. Thirteen trials provided multiple sessions or contacts. Of seven effective interventions, five targeted adolescents, including four with group sessions. Three effective trials had individual sessions. Seven trials were rated as having high or moderate quality; three of those had favorable results. Family planning researchers and practitioners could adapt the effective interventions. Reproductive health needs high-quality research on behavior change, especially for clinical and low-resource settings. More thorough use of single theories would help, as would better reporting on research design and intervention implementation.
    Cochrane database of systematic reviews (Online) 01/2011; · 5.70 Impact Factor
  • Margaret E. Bentley, Elizabeth E. Tolley, Willo Pequegnat
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    ABSTRACT: While culture is both complex and multifaceted, it is important to examine health behaviors and outcomes within a particular sociocultural setting. Culture can best be described through in-depth, ethnographic research or through qualitative methods. Qualitative inquiry is both a means and an end in conducting research. You can use it to learn about the meaning of knowledge, attitudes, and behavior in order to design a prevention program or as a primary aim to describe a group of people and the context in which they exhibit behaviors. This chapter is intended to provide a diverse group of researchers with some “basics” related to the process of qualitative research, including an overview of types of qualitative research and methods, the importance of identifying a theoretical framework, and systematic research design, which should guide the choice of methods. A detailed discussion of qualitative data management and analysis is provided, as this is often the least understood part of qualitative research and the section of a grant proposal that is least developed and described. The chapter provides a starting point for understanding how qualitative methods can be used in health research and in preparing a grant proposal that incorporates qualitative research.
    11/2010: pages 153-172;
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    ABSTRACT: Previous research in India indicates that there is little communication within marriage about sex. Lack of communication about safe sexual behaviours may increase couples' vulnerability to HIV. This study explores couple level sexual communication and socio-cultural norms that influence couples' communication about sex and its implications for HIV prevention. Data derive from in-depth interviews at two points in time with 10 couples. Secondary qualitative analyses of the interviews were conducted using inductive and deductive coding techniques. Half of the couples described improved communication about sex and HIV and AIDS after participation in the clinical trial and/or acceptability study, as well as increased sexual activity, improved relationships by alleviating doubts about their partner's fidelity and forgiving their partners. The findings show that creating safe spaces for couples where they can ask frank questions about HIV and AIDS, sex and sexuality potentially can improve couples' communication about sex and reduce their risk for HIV infection.
    Culture Health & Sexuality 11/2010; 12(8):899-912. · 1.55 Impact Factor
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    ABSTRACT: HIV prevention trials typically randomize thousands of participants to active or control intervention arms, with regular (e.g. monthly) clinic visits over one or more years of follow-up. Because HIV infection rates are often lower than 3 per 100 person-years even in high prevalence settings, tens of thousands of clinic visits may take place before the number of infections required to achieve adequate study power has been observed. In addition to clinical outcomes, the multitude of study visits provides an opportunity to assess adherence and related participant behaviors in great detail. These data may be used to refine counseling messages, gain insight into patterns of behavior, and perform supporting analyses in an attempt to obtain more precise estimates of treatment efficacy. Exploratory analyses were performed to assess how our understanding of participant behaviors and their relationships to biological outcomes in two recent prevention trials might have been impacted had the frequency of routine behavioral data collection been reduced from monthly to just months 1, 3, 6, 9, and 12. Results were comparably informative in the reduced case, suggesting that unnecessarily extensive amounts of routine behavioral data may be collected in these trials.
    AIDS and Behavior 10/2010; 15(2):389-95. · 3.49 Impact Factor
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    ABSTRACT: Vaginal microbicides currently under development are substances that may prevent the transmission of HIV. Qualitative, in-depth post-trial interview data from a Phase III clinical trial of 6% Cellulose Sulfate microbicide gel in two sites in Africa (Uganda and Benin) and two in India (Chennai and Bagalkot) were examined in order to better understand factors that influence microbicide acceptability and adherence in a clinical trial setting. Women found the gel relatively easy to use with partners with whom there were no expectations of fidelity, in situations where they had access to private space and at times when they were expecting to engage in sexual intercourse. Adherence to gel seemed significantly more difficult with primary partners due to decreased perceptions of risk, inconvenience or fear of partner disapproval. Findings suggest that women in a variety of settings may find a microbicide gel to be highly acceptable for its lubricant qualities and protective benefits but that adherence and consistent use may depend greatly on contextual and partner-related factors. These findings have important implications for future trial designs, predicting determinants of microbicide use and acceptability and marketing and educational efforts should a safe and efficacious microbicide be found.
    Culture Health & Sexuality 10/2010; 12(7):739-54. · 1.55 Impact Factor
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    ABSTRACT: Adherence optimization and measurement have emerged as critically challenging issues for clinical trials of topical microbicides. Although microbicide trials have routinely collected adherence data, their utilization in trial design, implementation, and interpretation has been inconsistent. Drawing on data-driven presentations from several focused meetings, this paper synthesizes lessons from past microbicide trials and provides recommendations for future trials of microbicide and other HIV prevention technologies. First, it describes four purposes for adherence data collection, with particular attention to intention-to-treat versus adherence-adjusted analyses for determining effectiveness. Second, the microbicide field's experiences with adherence measures and data collection modes are discussed, including the strengths and weaknesses of various options and approaches for improving measurement. Then, several approaches to optimizing trial participants' adherence are presented. The paper concludes with a set of recommendations for immediate use or further research.
    AIDS and Behavior 11/2009; 14(5):1124-36. · 3.49 Impact Factor
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    ABSTRACT: Theories and models help explain how behavior change occurs. We systematically reviewed randomized controlled trials that examined theory-based interventions for improving contraceptive use. We searched electronic databases for eligible trials. Primary outcomes included pregnancy and contraceptive use. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. Of 14 included trials, 10 showed positive results for a theory-based group: 2 of 10 studies with pregnancy or birth data, 4 of 9 addressing contraceptive use (for contraception) and 5 of 9 with condom use (to prevent HIV/sexually transmitted infections). An experimental group had favorable results for six of seven trials based on Social Cognitive Theory, two based on other social cognition models and two using motivational interviewing. Most interventions focused on adolescents and involved multiple sessions. Effects were not consistent across outcomes and comparisons. The field could benefit from thorough use of single theories and better reporting on intervention implementation.
    Contraception 07/2009; 79(6):411-7. · 3.09 Impact Factor
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    ABSTRACT: We evaluated female adolescents' comprehension of a prototype over-the-counter package label for an emergency contraceptive pill product. Volunteers aged 12-17 years who could read English were recruited at malls and clinics in six United States metropolitan areas. After completing a literacy assessment, subjects examined the prototype package and answered 20 questions that assessed understanding of six key concepts related to appropriate use of the product. The analysis population included 335 subjects, 54 to 59 of each year of age between 12 and 17 years. When asked what the product is used for, 264 respondents (79%) specifically indicated contraception. The six key concepts were each understood by 83-96% of subjects. In all 24 population subgroups examined, each key concept was understood by at least 72% of subjects. Female adolescents aged 17 years and younger understand the prototype package label well enough to enable safe and effective use without assistance from a clinician.
    Contraception 04/2009; 79(3):199-205. · 3.09 Impact Factor
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    ABSTRACT: Recently revised statistics show the number of individuals living with HIV at over 33 million worldwide, with 68% being in sub-Saharan Africa. Current HIV prevention methods, such as condom use, monogamy and abstinence, are not always feasible. The need for improved HIV preventative technologies remains urgent. Of these, microbicides represent a promising female-initiated preventative method. Microbicides are designed to be applied vaginally to prevent HIV and STI acquisition. Research is also being undertaken to assess the safety of the product during rectal application.The biannual Microbicides conference took place in New Delhi, India from 24-27 February 2008. The conference was open to delegates from the scientific and medical fields, as well as communities and advocates. In addition to microbicide research and development, the conference afforded the opportunity for the discussion of key issues such as ethics, acceptability, access, and community involvement.In this conference report we provide brief summaries of recent advancements made and challenges experienced in microbicide research and development, including updates on basic and clinical science, social and behavioural science, and community mobilisation and advocacy activities pertaining to clinical trials.
    AIDS Research and Therapy 09/2008; 5:19. · 2.54 Impact Factor

Publication Stats

297 Citations
60.46 Total Impact Points

Institutions

  • 2011
    • National AIDS Research Institute - Pune
      • Department of Social and Behavioural Science
      Poona, Mahārāshtra, India
  • 2006
    • U.S. Army Research Institute for the Behavioral and Social Sciences
      Fort Belvoir, Virginia, United States