The role of disclosure in relation to assent to participate in HIV-related research among HIV-infected youth: a formative study

<p>Abstract</p> <p>Background</p> <p>The objective of this study was to develop a culturally appropriate approach for obtaining assent from children aged eight to 17 years to participate in paediatric HIV-related operational research in Kinshasa, Democratic Republic of Congo (DRC). Included within this objective was to determine whether or not HIV disclosure should be included as part of the assent process prior to research participation, a component of research participation, or not incorporated in any aspect of the child's involvement in the research. Factors that influence parents' and caregivers' decisions to disclose HIV status to children in non-research contexts were also explored.</p> <p>Methods</p> <p>A qualitative formative study was conducted. Semi-structured interviews were conducted with 19 youth living with HIV, 36 parents and caregivers of youth living with HIV, and 17 health professionals who provide care and support to youth living with HIV and their families. Participants were purposefully selected from three HIV care, treatment and/or psychosocial support programmes in Kinshasa, DRC.</p> <p>Results</p> <p>Most youth interviewed believed minors participating in HIV-related research should be informed of their HIV-positive status. Parents and caregivers and health professionals had varied perspectives on if and when HIV status should be disclosed to minors during research participation. The age of the youth influenced parents and caregivers' responses, and disclosure to adolescents was more frequently supported than disclosure to children.</p> <p>Several parents and caregivers, as well as some health professionals, suggested that minors should never be told their HIV-positive status when participating in HIV-related research, regardless of their age. Within the context of treatment programmes, disclosure of HIV status to minors was supported by youth, parents and caregivers, and health professionals as a means to improve adherence to medication.</p> <p>Conclusion</p> <p>In settings where most minors are unaware of their HIV infection, researchers should consider excluding the term, "HIV", when explaining HIV-related research to minors, and omitting it from assent forms or informational sheets related to research participation. However, an individualized disclosure plan should be initiated with parents and caregivers at the time of enrolment in HIV-related research, particularly in research that involves treatment.</p

Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories) and the severity of 36 barriers (grouped in 6 topical categories) to implementing pediatric antibacterial drug trials. Analysis focused on the identification of key factors that facilitate the successful implementation of pediatric antibacterial drug trials and the key barriers to implementation. Almost all investigators identified two factors as very important facilitators: having site personnel for enrollment and having adequate funding. Other top factors were related to staffing. Among the barriers, factors related to parent concerns and consent were prominent, particularly obtaining parental consent when there was disagreement between parents, concerns about the number of blood draws, and concerns about the number of invasive procedures. Having overly narrow eligibility criteria was also identified as a major barrier. The survey findings suggest three areas in which to focus efforts to help facilitate ongoing drug development: (1) improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial, (2) broadening inclusion criteria to allow more participants to enroll, and (3) ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks. The pediatric antibacterial drug trials enterprise is likely to benefit from focused efforts by all stakeholders to remove barriers and enhance facilitation

Perceptions of voluntary medical male circumcision among circumcising and non-circumcising communities in Malawi

Three randomised controlled trials in Africa indicated that voluntary medical male circumcision (VMMC) is an effective method to reduce a man’s risk of becoming infected through sex with an HIV-positive female partner. The success of recent public health initiatives to increase numbers of circumcised men in Malawi has been very limited. We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) with men, women, and male adolescents from non-circumcising and circumcising communities in southern Malawi to better understand their beliefs about male circumcision and the promotion of VMMC for HIV prevention. Results revealed that beliefs about male circumcision, in general, are strongly mediated by Malawian culture and history. Participants have attempted to develop a new meaning for circumcision in light of the threat of HIV infection and the publicised risk reduction benefits of VMMC. Several study participants found it difficult to distinguish VMMC from traditional circumcision practices (jando and lupanda), despite awareness that the new form of circumcision was an expression of (western) modern medicine performed largely for public health purposes. Greater recognition of background cultural beliefs and practices could inform future efforts to promote medical male circumcision as an HIV prevention strategy in this context

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation

Using Formative Research to Develop a Context-Specific Approach to Informed Consent for Clinical Trials

Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research

Applying Research Ethics Guidelines: The View from a Sub-Saharan Research Ethics Committee

Considerable variation has been demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of international regulations. We conducted a qualitative descriptive pilot study with members of the national REC in Malawi to determine criteria they use to review research, and their views on international collaborations. Qualitative content analysis demonstrated that international guidelines are interpreted in light of local African conditions such that emphasis is placed on examining benefit to the community and ensuring the informed consent process translates concepts in locally-meaningful ways. Members suggest that RECs often must comply with regulations that do not fit local conditions. Recommendations are provided for improving such international collaborations

Couple communication and contraception use in urban Senegal

Objectives: Couple communication about family planning has been shown to increase uptake of contraception. However, couple communication is often measured based solely on one partner?s report of communication. This research investigates the influence of couple-reported communication about family planning on current and future use of contraception using couple-level data. Methods: We used baseline data from the Measurement, Learning, and Evaluation (MLE) project collected through household surveys in 2011 from a cross-sectional representative sample of women and men in urban Senegal to conduct secondary data analysis. We used multivariable logit models to estimate the average marginal effects of couple communication about family planning on current contraception use and future intention to use contraception. Results: Couple communication about family planning reported by both partners was significantly associated with an increased likelihood of current use of contraception and with future intention to use contraception among non-contracepting couples. Couples where one partner reported discussing family planning had a 25% point greater likelihood of current contraception use than couples where neither partner reported discussing, while couples where both partners reported discussing family planning had a 56% point greater likelihood of current contraception use, representing more than twice the effect size. Among couples not using contraception, couples where one partner reported discussing family planning had a 15% point greater likelihood of future intention to use contraception than couples where neither partner reported discussing, while couples where both partners reported discussing family planning had a 38% point greater likelihood of future intention to use contraception. Conclusion: These findings underscore the importance of the inclusion of both partners in family planning programs to increase communication about contraception and highlight the need for future research using couple-level data, measures, and analysis

Differences between international recommendations on breastfeeding in the presence of HIV and the attitudes and counselling messages of health workers in Lilongwe, Malawi

BACKGROUND: To prevent postnatal transmission of HIV in settings where safe alternatives to breastfeeding are unavailable, the World Health Organization (WHO) recommends exclusive breastfeeding followed by early, rapid cessation of breastfeeding. Only limited data are available on the attitudes of health workers toward this recommendation and the impact of these attitudes on infant feeding counselling messages given to mothers. METHODS: As part of the Breastfeeding, Antiretroviral, and Nutrition (BAN) clinical trial, we carried out an in-depth qualitative study of the attitudes, beliefs, and counselling messages of 19 health workers in Lilongwe, Malawi. RESULTS: Although none of the workers had received formal training, several reported having counseled HIV-positive mothers about infant feeding. Health workers with counselling experience believed that HIV-infected mothers should breastfeed exclusively, rather than infant formula feed, citing poverty as the primary reason. Because of high levels of malnutrition, all the workers had concerns about early cessation of breastfeeding. CONCLUSION: Important differences were observed between the WHO recommendations and the attitudes and practices of the health workers. Understanding these differences is important for designing effective interventions

A survey of South Carolina pharmacists\u27 readiness to prescribe human immunodeficiency virus pre-exposure prophylaxis

Introduction: Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is largely underutilized in the Southern United States. Given their community presence, pharmacists are well positioned to provide PrEP within rural, Southern regions. However, pharmacists\u27 readiness to prescribe PrEP in these communities remains unknown. Objective: To determine the perceived feasibility and acceptability of prescribing PrEP by pharmacists in South Carolina (SC). Methods: We distributed a 43-question online descriptive survey through the University of South Carolina Kennedy Pharmacy Innovation Center\u27s listserv of licensed SC pharmacists. We assessed pharmacists\u27 comfort, knowledge, and readiness to provide PrEP. Results: A total of 150 pharmacists responded to the survey. The majority were White (73%, n = 110), female (62%, n = 93), and non-Hispanic (83%, n = 125). Pharmacists practiced in retail (25%, n = 37), hospital (22%, n = 33), independent (17%, n = 25), community (13%, n = 19), specialty (6%, n = 9), and academic settings (3%, n = 4); 11% (n = 17) practiced in rural locales. Pharmacists viewed PrEP as both effective (97%, n = 122/125) and beneficial (74% n = 97/131) for their clients. Many pharmacists reported being ready (60% n = 79/130) and willing (86% n = 111/129) to prescribe PrEP, although over half (62% n = 73/118) cited lack of PrEP knowledge as a barrier. Pharmacists described pharmacies as an appropriate location to prescribe PrEP (72% n = 97/134). Conclusions: Most SC pharmacists surveyed considered PrEP to be effective and beneficial for individuals who frequent their pharmacy and are willing to prescribe this therapy if statewide statutes allow. Many felt that pharmacies are an appropriate location to prescribe PrEP but lack a complete understanding of required protocols to manage these patients. Further investigation into facilitators and barriers of pharmacy-driven PrEP is needed to enhance utilization within communities

Research on HIV cure: Mapping the ethics landscape

According to current estimates, 36.7 million people are infected with HIV worldwide. Despite large-scale and growing programs to prevent and treat HIV infection, possible approaches to achieve a cure for HIV infection are of strong interest. In the development of candidate approaches to achieve an HIV cure, issues of future translation to human study participants, evidence-based practice, clinical care, diverse populations, and populations in low- and middle-income countries should all be considered. An HIV cure should be effective, safe, simple, affordable, and scalable. Acceptability research is a critical adjunct to ongoing biomedical HIV cure research efforts. Anticipating some of the ethical and implementation challenges related to HIV cure strategies is necessary before the availability of effective interventions. Ongoing engagement of stakeholders is needed to resolve ethical, logistical, social, cultural, policy, regulatory, and implementation challenges at all stages of the HIV cure research development process