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BACKGROUND: Young women, especially adolescents, often lack access to modern contraception. Reasons vary by geography and regional politics and culture. The projected 2015 birth rate in 'developing' regions was 56 per 1000 compared with 17 per 1000 for 'developed' regions. OBJECTIVES: To identify school‐based interventions that improved contraceptive use among adolescents SEARCH METHODS: Until 6 June 2016, we searched for eligible trials in PubMed, CENTRAL, ERIC, Web of Science, POPLINE, ClinicalTrials.gov and ICTRP. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that assigned individuals or clusters. The majority of participants must have been 19 years old or younger. The educational strategy must have occurred primarily in a middle school or high school. The intervention had to emphasize one or more effective methods of contraception. Our primary outcomes were pregnancy and contraceptive use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into RevMan; a second author verified accuracy. We examined studies for methodological quality. For unadjusted dichotomous outcomes, we calculated the Mantel‐Haenszel odds ratio (OR) with 95% confidence interval (CI). For cluster randomized trials, we used adjusted measures, e.g. OR, risk ratio, or difference in proportions. For continuous outcomes, we used the adjusted mean difference (MD) or other measures from the models. We did not conduct meta‐analysis due to varied interventions and outcome measures. MAIN RESULTS: The 11 trials included 10 cluster RCTs and an individually randomized trial. The cluster RCTs had sample sizes from 816 to 10,954; the median number of clusters was 24. Most trials were conducted in the USA and UK; one was from Mexico and one from South Africa. We focus here on the trials with moderate quality evidence and an intervention effect. Three addressed preventing pregnancy and HIV/STI through interactive sessions. One trial provided a ...

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.

IntroductionCurrent 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.MethodsBased 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.ResultsWe 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.ConclusionsIf 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.

After two decades of microbicide clinical trials it remains uncertain if vaginally‐ delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre‐licensure implementation trials, Phase IV post‐marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large‐scale microbicide efficacy trials completed to‐date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post‐marketing research, and microbicide introduction and delivery programs.

IntroductionPoor adherence to product use has been observed in recent trials of antiretroviral (ARV)‐based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV‐based vaginal ring products enter the clinical trial stage.MethodsTo identify technologies that have potential future application for vaginal ring adherence measurement, a comprehensive literature search was conducted that covered a number of biomedical and public health databases, including PubMed, Embase, POPLINE and the Web of Science. Published patents and patent applications were also searched. Technical experts were also consulted to gather more information and help evaluate identified technologies. Approaches were evaluated as to feasibility of development and clinical trial implementation, cost and technical strength.ResultsNumerous approaches were identified through our landscape analysis and classified as either point measures or cumulative measures of vaginal ring adherence. Point measurements are those that give a measure of adherence at a particular point in time. Cumulative measures attempt to measure ring adherence over a period of time.DiscussionApproaches that require modifications to an existing ring product are at a significant disadvantage, as this will likely introduce additional regulatory barriers to the development process and increase manufacturing costs. From the point of view of clinical trial implementation, desirable attributes would be high acceptance by trial participants, and little or no additional time or training requirements on the part of participants or clinic staff. We have identified four promising approaches as being high priority for further development based on the following measurements: intracellular drug levels, drug levels in hair, the accumulation of a vaginal analyte that diffuses into the ring, and the depletion of an intrinsic ring constituent.ConclusionsWhile some approaches show significant promise over others, it is recommended that a strategy of using complementary biometric and behavioural approaches be adopted to best understand participants' adherence to ARV‐based ring products in clinical trials.

IntroductionStakeholders 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.MethodsIn 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.ResultsAll 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.ConclusionsThe 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.

IntroductionDespite 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.MethodsWe 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.ResultsIn 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.ConclusionsAdolescent 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.

IntroductionProduct 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.DiscussionThe 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.ConclusionsBetter 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.

AbstractIntroductionHigh HIV incidence and low adherence to daily oral PrEP among women underscore the need for more acceptable and easier to use HIV prevention products. Global demand for injectable contraception suggests that new, long‐acting, injectable formulations could meet this need. We examine acceptability of a long‐acting injectable PrEP among HIV‐uninfected women in Zimbabwe, South Africa and two United States phase 2 trial sites.MethodsQuantitative surveys were administered at the first, fourth and sixth injection visits. Focus group discussions (FGD) were conducted after the sixth injection visit. We compared the acceptability of injectable product attributes, prevention preferences and future interest in injectable PrEP by site and arm and ran longitudinal ordinal logistic regression models to identify determinants of future interest in injectable PrEP.ResultsBetween April 2015 and February 2017, the trial enrolled 136 (100 African, 36 US) women with a median age of 31 years. Most participants (>75%) rated injectable attributes as very acceptable. While few reported rash or other side effects, 56% to 67% reported injection pain, with nonsignificant differences over time and between arms. During FGDs, participants described initial fear of the injectable and variable experiences with pain. Most US and African participants preferred injectable PrEP to daily oral pills (56% to 96% vs. 4% to 25%). Future interest in using injectable PrEP was associated with acceptability of product attributes and was higher in African than US sites. In FGDs, participants described multiple reasons for trial participation, including a combination of monetary, health‐related and altruistic motivations. While associated with future interest in use in univariate models, neither altruistic nor personal motivations remained significant in the multivariate model.ConclusionsThis study found that long‐acting injectable PrEP is acceptable among African and US women experiencing product use. Acceptability of product attributes better predicted future interest in injectable use than experience of pain. This is reassuring as a single‐dose regimen of a different product has advanced to phase 3 trials. Finally, the study suggests that future demand for an injectable PrEP by women may be greater in African than US settings, where the risk of HIV is highest.