Progesterone release from a silicone intravaginal ring in pigtailed macaques

Background: Heterosexual HIV transmission continues to spread worldwide. Intravaginal rings (IVRs) formulated with antiretroviral drugs hold great promise for HIV prevention in women. IVRs provide the benefit of being coitally-independent and coitally-covert for an extended period. As a proof-of-concept, we tested the in vivo release of progesterone from a silicone elastomer vaginal ring device. Methods: Six female pig-tailed macaques were treated with a GnRH agonist (Lupron) prior to ring placement. Four macaques received a progesterone-loaded silicone ring, and two macaques received a blank silicone ring. Blood, vaginal swabs, CVL, and/or biopsies were collected during ring placement, and after ring removal. Results: The median plasma progesterone levels for macaques with a progesterone IVR were 13,973 pg/ml (day 3), 12,342 pg/ml (day 7), 10,112 pg/ml (day 14), 8445 pg/ml (day 21) and 8061 pg/ml (day 28), with a significant decrease from day 14 to day 21 (P = 0.0286). The median plasma progesterone levels for macaques with a blank IVR were 221±±± ±±88 pg/ml. Macaques with a progesterone IVR had CVL progesterone levels of 20,935 pg/ml (day 7), 6892 pg/ml (day 21) and 11,515 pg/ml (day 28). Macaques with a blank IVR had CVL progesterone levels of 29 �± 13 pg/ml. There were no disturbances to the normal vaginal microflora, and plasma and CVL cytokine analysis did not indicate a proinflammatory response due to ring placement. The vaginal biopsies did not display any pathology following ring removal. Overall, the IVRs were well tolerated without any indication of inflammation or significant changes in the vaginal compartment.

Adapting Mpowerment to a Rural Area

As HIV/AIDS continues to disproportionately impact men who have sex with men (MSM) (CDC, 2010a), effective and timely prevention strategies for this population must be developed. Specifically, evidence-based interventions that can be easily adapted and have proven effectiveness are needed. Hence, the purpose of the current study was to assess the impact of the Mpowerment Project (Hayes, Rebchook, & Kegeles, 2003), a community level HIV prevention program originally designed for young urban gay men, when adapted for rural gay men. The Mpowerment Project is recognized as evidence- based intervention by the CDC (CDC, 2009b). The current study is an extension of this research, assessing Mpowerment model fidelity and the behavioral and attitudinal changes that occurred among participants. Data were collected from participants in a rural area of southeast Idaho from 2002-2004. Data were collected prior to M-Group participation and at a three months follow-up. The 66 individuals completing the M-Group pre and posttest assessment also attended a minimum of three study events and a maximum of 226 events. Results revealed no significant changes in attitudinal variables and all but one behavioral variable among Rural Mpowerment (R-MP) participants. The one significant behavior change was an increase in reported safer sex discussion among friends, indicating a possible change in the social norm regarding safer sex. Results also indicate that program fidelity was maintained and the Mpowerment Project is adaptable to rural areas. However, there was no indication of attitudinal changes in participants of this study. There were no changes in behavioral variables aside from discussion about safer sex with friends increasing. The lack of evidence-based interventions for rural gay men highlights the need for further research on the community impact of the Mpowerment Project on rural participants.

Adapting Mpowerment to a rural area

As HIV/AIDS continues to disproportionately impact men who have sex with men (MSM) (CDC, 2010a), effective and timely prevention strategies for this population must be developed. Specifically, evidence-based interventions that can be easily adapted and have proven effectiveness are needed. Hence, the purpose of the current study was to assess the impact of the Mpowerment Project (Hayes, Rebchook, & Kegeles, 2003), a community level HIV prevention program originally designed for young urban gay men, when adapted for rural gay men. The Mpowerment Project is recognized as evidence- based intervention by the CDC (CDC, 2009b). The current study is an extension of this research, assessing Mpowerment model fidelity and the behavioral and attitudinal changes that occurred among participants. Data were collected from participants in a rural area of southeast Idaho from 2002-2004. Data were collected prior to M-Group participation and at a three months follow-up. The 66 individuals completing the M-Group pre and posttest assessment also attended a minimum of three study events and a maximum of 226 events. Results revealed no significant changes in attitudinal variables and all but one behavioral variable among Rural Mpowerment (R-MP) participants. The one significant behavior change was an increase in reported safer sex discussion among friends, indicating a possible change in the social norm regarding safer sex. Results also indicate that program fidelity was maintained and the Mpowerment Project is adaptable to rural areas. However, there was no indication of attitudinal changes in participants of this study. There were no changes in behavioral variables aside from discussion about safer sex with friends increasing. The lack of evidence-based interventions for rural gay men highlights the need for further research on the community impact of the Mpowerment Project on rural participants.

The Perspectives of Gay, Bisexual, and Queer Adolescent Males with Parent-Child Sex Communication

Problem: Gay, bisexual, and queer (GBQ) adolescent males are disproportionately affected by negative sexual health outcomes compared to their heterosexual counterparts. Their sex education needs are not sufficiently addressed in the home and the larger ecological systems. The omission of their sex education needs at a time when they are forming a sexual identity during adolescence compels GBQ males to seek information in unsupervised settings. Evidence-based interventions aimed at ensuring positive sexual health outcomes through sex communication cannot be carried out with these youth as research on how parents and GBQ males discuss sex in the home has been largely uninvestigated.

Methods: This naturalistic qualitative study focused on the interpretive reports of 15- to 20-year-old GBQ males’ discussions about sex-related topics with their parents. From a purposive sample of 30 male adolescents who self-identified as GBQ, participants who could recall at least one conversation about sex with their parents were recruited for one-time interviews and card sorts. This strategy revealed, using Bronfenbrenners’ Bioecological Theory, their perceptions about sex communication in the context of their reciprocal relationship and the ecological systems that GBQ males and their parents navigate.

Results: Parents received poor ratings as sex educators, were generally viewed as not confident in their communication approach, and lacked knowledge about issues pertinent to GBQ sons. Nevertheless, participants viewed parents as their preferred source of sex information and recognized multiple functions of sex communication. The value placed by GBQ youth on sex communication underscores their desire to ensure an uninterrupted parent-child relationship in spite of their GBQ sexual orientation. For GBQ children, inclusive sex communication is a proxy for parental acceptance.

Results show that the timing, prompts, teaching aids, and setting of sex communication for this population are similar to what has been reported with heterosexual samples. However, most GBQ sons rarely had inclusive guidance about sex and sexuality that matched their attraction, behavior, and identities. Furthermore, the assumption of heterosexuality resulted in the early awareness of being different from their peers which led them to covertly search for sex information. The combination of assumed heterosexuality and their early reliance on themselves for applicable information is a missed parental opportunity to positively impact the health of GBQ sons. More importantly, due to the powerful reach of new media, there is a critical period of maximum receptiveness that has been identified which makes inclusive sex communication paramount in the pre-sexual stage for this population. Our findings also indicate that there are plenty of opportunities for systemic improvements to meet this population’s sexual education needs.

Matrix and reservoir-type multipurpose vaginal rings for controlled release of dapivirine and levonorgestrel

A matrix-type silicone elastomer vaginal ring providing 28-day continuous release of dapivirine (DPV) - a lead candidate human immunodeficiency virus type 1 (HIV-1) microbicide compound - has recently demonstrated moderate levels of protection in two Phase III clinical studies. Here, next-generation matrix and reservoir-type silicone elastomer vaginal rings are reported for the first time offering simultaneous and continuous in vitro release of DPV and the contraceptive progestin levonorgestrel (LNG) over a period of between 60 and 180days. For matrix-type vaginal rings comprising initial drug loadings of 100, 150 or 200mg DPV and 0, 16 or 32mg LNG, Day 1 daily DPV release values were between 4132 and 6113μg while Day 60 values ranged from 284 to 454μg. Daily LNG release ranged from 129 to 684μg on Day 1 and 2-91μg on Day 60. Core-type rings comprising one or two drug-loaded cores provided extended duration of in vitro release out to 180days, and maintained daily drug release rates within much narrower windows (either 75-131μg/day or 37-66μg/day for DPV, and either 96-150μg/day or 37-57μg/day for LNG, depending on core ring configuration and ignoring initial lag release effect for LNG) compared with matrix-type rings. The data support the continued development of these devices as multi-purpose prevention technologies (MPTs) for HIV prevention and long-acting contraception.

Should female health providers be involved in medical male circumcision? Narratives of newly circumcised men in Malawi

Background The Malawi government has endorsed voluntary medical male circumcision (VMMC) as a biomedical strategy for HIV prevention after a decade of debating its effectiveness in the local setting. The “policy” recommends that male circumcision (MC) should be clinically based, as opposed to the alternative of traditional male circumcision (TMC). Limited finances, acceptability concerns, and the health system’s limited capacity to meet demand are among the challenges threatening the mass rollout of VMMC. In terms of acceptability, the gender of clinicians conducting the operations may particularly influence health facility-based circumcision. This study explored the acceptability, by male clients, of female clinicians taking part in the circumcision procedure. Methods Six focus group discussions (FGDs) were conducted, with a total of 47 newly circumcised men from non-circumcising ethnic groups in Malawi participating in this study. The men had been circumcised at three health facilities in Lilongwe District in 2010. Data were audio recorded and transcribed verbatim. Data were analysed using narrative analysis. Results Participants in the FGDs indicated that they were not comfortable with women clinicians being part of the circumcising team. While few mentioned that they were not entirely opposed to female health providers’ participation, arguing that their involvement was similar to male clinicians’ involvement in child delivery, most of them opposed to female involvement, arguing that MC was not an illness that necessitates the involvement of clinicians regardless of their gender. Most of the participants said that it was not negotiable for females to be involved, as they could wait until an all-male clinician team could be available. Thematically, the arguments against female clinicians’ involvement include sexual undertones and the influences of traditional male circumcision practices, among others. Conclusion Men preferred that VMMC should be conducted by male health providers only. Traditionally, male circumcision has been a male-only affair shrouded in secrecy and rituals. Although being medical, this study strongly suggested that it may be difficult for VMMC to immediately move to a public space where female health providers can participate, even for men coming from traditionally non-circumcising backgrounds.

Interpreting and dismissing the relevance of the “wait and wipe” finding from the circumcision studies conducted in Africa

Some of the secondary findings from the circumcision studies conducted in Africa, are both interesting and difficult to explain. This paper focuses on the finding that uncircumcised men who waited for ten minutes after sexual intercourse and then wiped their penises using a dry cloth, had lower rates of HIV infection compared to those who cleaned using a wet cloth or those who cleaned within three minutes of having intercourse. The paper also focuses on the finding on men who became infected and yet they reported no sexual acts or 100% condom use. Interpretations that have been provided so far in trying to explain these two interesting findings are somewhat inadequate. Because of the inadequate interpretation that has been provided, anti-circumcision lobbyist are presenting the “wait and wipe strategy” as an alternative to circumcision for HIV prevention. In this paper, we argue that waiting for ten minutes and wiping with a dry cloth does not prevent men from becoming infected by HIV. We therefore attempt to present some alternative views.

From 'what' to 'how' : capacity building in health promotion for HIV/AIDS prevention in the Solomon Islands

This paper describes a capacity building process undertaken within the HIV/AIDS prevention project of the Adventist Development and Relief Agency (ADRA) in the Solomon Islands. ADRA HIV/AIDS has recently reoriented its project structure, moving beyond its awareness raising approach to incorporate health promotion frameworks, theories, strategies and assumptions. These have been used to inform project practice in project planning, delivery and evaluation. This paper shares what has worked and not worked in the capacity building process, including a project evaluation of the initial HIV/AIDS awareness raising project and the application of a number of capacity building strategies, including utilising a volunteer Australian Youth Ambassador for Development (AYAD) funded by the Australian Agency for International Development (AusAID). Existing and new projects are outlined. The underlying theme is that any capacity building exercise must include structural support (e.g. management, national frameworks) to ensure the incorporation of new initiatives and approaches. With time this enables ownership by counterparts and external partnerships to develop. The presence of an AYAD volunteer has been an effective strategy to achieve this. Reflections from the evaluators, the AYAD volunteer and the HIV/AIDS team are included.

Treatment for prevention of HIV transmission in a localised epidemic : the case for South Australia

Background: Discussion is currently taking place among international HIV/AIDS groups around increasing HIV testing and initiating earlier use of antiretroviral therapy (ART) among people diagnosed with HIV as a method to reduce the spread of HIV. In this study, we explore the expected epidemiological impact of this strategy in a small population in which HIV transmission is predominantly confined to men who have sex with men (MSM). Methods: A deterministic mathematical transmission model was constructed to investigate the impacts of strategies that increase testing and treatment rates, and their likely potential to mitigate HIV epidemics among MSM. Our novel model distinguishes men in the population who are more easily accessible to prevention campaigns through engagement with the gay community from men who are not. This model is applied to the population of MSM in South Australia. Results: Our model-based findings suggest that increasing testing rates alone will have minimal impact on reducing the expected number of infections compared to current conditions. However, in combination with increases in treatment coverage, this strategy could lead to a 59–68% reduction in the number of HIV infections over the next 5 years. Targeting men who are socially engaged with the gay community would result in the majority of potential reductions in incidence, with only minor improvements possible by reaching all other MSM. Conclusions: Investing in strategies that will achieve higher coverage and earlier initiation of treatment to reduce infectiousness of HIV-infected individuals could be an effective strategy for reducing incidence in a population of MSM.

Beyond HIV microbicides: multipurpose prevention technology (MPT) products

Multi-purpose prevention technologies (MPTs) that aim to simultaneously prevent unintended pregnancy, human immunodeficiency virus type 1 (HIV-1) infection and other sexually transmitted infections (STIs) are among the most innovative and complex products currently in development within women’s sexual and reproductive healthcare. In this review article, MPTs are placed within the wider context of combination products, combination drug products and multi-indication products. The current MPT product landscape is mapped and assessed with reference to existing products for the corresponding single indications, before identifying the gaps in the current MPT product pipeline and highlighting priority products and challenges moving forward.

Economic evaluation of prevention of mother – to – child – transmission of HIV/AIDS interventions in developing countries : a systematic review

Les gouvernements mondiaux et les organismes internationaux ont placé une haute priorité dans la prévention de la transmission mère-enfant du VIH. Cependant, bien qu'il y ait eu des progrès énormes rapportés dans des nations industrialisées, la situation dans les pays en voie de développement est encore déplorable; on y constate un grand écart entre l’engagement international pour réduire cette voie de transmission et l'accès aux interventions. Ceci peut être attribué à la situation économique déplorable dans plusieurs pays en voie de développement. Des interventions prioritaires en santé doivent donc être soigneusement sélectionnées afin de maximiser l'utilisation efficace des ressources limitées. L’évaluation économique est un outil efficace qui peut aider des décideurs à identifier quelles stratégies choisir. L'objectif de cette revue systématique est de recenser toutes les études d'évaluation économique existantes qui ont été effectuées dans les pays en voie de développement sur la prévention de la transmission mère-enfant du VIH. Notre revue a retenu 16 articles qui ont répondu aux critères d'inclusion. Nous avons conçu un formulaire pour l’extraction de données, puis nous avons soumis les articles à un contrôle rigoureux de qualité. Nos résultats ont exposé un certain nombre de défauts dans la qualité des études choisies. Nous avons également noté une forte hétérogénéité dans les estimations des paramètres de coût et d'efficacité de base, dans la méthodologie appliquée, ainsi que dans les écarts utilisés dans les analyses de sensibilité. Quelques interventions comportant la thérapie à la zidovudine ou à la nevirapine à court terme se sont avérées rentables, et ont enregistré des valeurs acceptables de coût-utilité. Les résultats des évaluations économiques analysées dans cette revue ont varié sur la base des facteurs suivants : la prévalence du VIH, la classification du pays selon le revenu, les infrastructures disponible, les coûts du personnel, et finalement les coûts des interventions, particulièrement les prix des médicaments.