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EPIDEMIOLOGY, PREVENTION
AND PUBLIC HEALTH - TRACK C
Closing Comments 29 June - 3 July, 1998

July 3, 1998 GENEVA. ---

Slide 1 - Rapporteur team members
Good morning. I would like to thank the tremendous track C rapporteur team members who assisted me in the impossible task of doing justice to a very rich and diverse track as well as the secretariat for their assistance. Rapporteur team: Alix Adrien, Eddy Beck, Gary Dowsett, Tom Mboya Okeyo, Marie-Louise Newell, Colleen Perez, Elise Roy, Steffanie Strathdee, Kong Lai Zhang.

Slide 2 - Overview
I will briefly review a few saliant points concerning descriptive epidemiology, mother-to-child transmission, technological developments, methodological progress, areas to be reassessed and examples of good news stories.

Slide 3 - HIV prevalence among pregnant women across Europe
The dynamic nature of the HIV pandemic continues to pose challenges for prevention, treatment and support. Recent explosive HIV epidemics among injection drug users in Eastern Europe have dramatic implications for continued transmission, with the potential for secondary spread to sexual partners and offspring. For example, in this slide, which depicts HIV prevalence among pregnant women across Europe, antenatal prevalence is already 1.5 per 1000 in the Ukrainian City of Odessa.

Slide 4 - Life expectancy among males and females in Thailand]
In established epidemics in countries such as Thailand, sustaining prevention efforts and preparing for high social, health and economic burdens are critical. Following considerable success implementing interventions, especially among sex workers, unacceptably high HIV incidence rates are reported among injection drug users in Bangkok and Northern Thailand, where stable or decreasing HIV prevalence masks very dynamic patterns of HIV incidence. The large number of HIV infections that occurred in Thailand a decade ago is now having a huge impact on morbidity and mortality. Ninety percent of the decrease in life expectancy in Northern Thailand is attributable to HIV. Worldwide, the evolution of the pandemic remains uncertain, and careful monitoring is required to assess whether high incidence rates are masked by high mortality rates and whether the potential exists for rapid spread into sub-groups.

Slide 5 - Network configuration
With AIDS case surveillance in industrialised countries rapidly becoming an indication of treatment failure and losing its value in monitoring the epidemic, other tools are being developed. Network analysis is a promising tool for understanding epidemics at a micro level and its use should be expanded to mapping, evaluation and modelling. At the macro-level, second generation surveillance systems must be country-specific, provide incidence data, collect behavioural data, and provide adequate coverage of key populations.

Slide 6 Migration
Migration continues to fuel the pandemic, through both ‘push’ and ‘pull’ forces. Examples of ‘push’ include war, famine and other natural disasters. High levels of sexual violence and rape were reported from Bosnia and Herzegovina, and from other continents including Central and Southern Africa. Examples of ‘pull’ included labour migrants in India, and in China over one hundred and twenty million people are currently on the move seeking better working and living conditions. Given the lessons to be learned from Africa, it is very disappointing to see the opportunities being missed to reduce the HIV-related consequences of migration in Asia, Eastern Europe and other regions of the world. Research and intervention programs need to focus on conditions in countries of exodus, during the process of migration itself, and in the country of destination

Slide 7 - Mother-to-Child Transmission
Since 1994, AZT prophylaxis has made perinatal HIV infection a preventable disease in industrialised countries. Now, reports of a transmission reduction of 50% in a study conducted in a non-breast feeding population in Thailand using a cheaper short course of oral AZT in pregnancy and during labour and delivery has raised hopes that women in developing countries may also be able to protect their infants from HIV infection. Decreases in maternal viral load at delivery were estimated to account for 80% of the reduction in the vertical transmission rate. In a similar study in a breastfeeding population in Côte d’Ivoire, AZT tolerance was good, but adherence to the intrapartum component was a problem. Women were to take AZT at onset of labour and every three hours thereafter, but concerns that husbands and family members might suspect their HIV infection meant that many women could not benefit from the most effective component of the regimen. Technical advances are being blocked by real fears of discrimination and rejection.

Slide 8 - Post-natal Transmission through Breastfeeding
Post-natal transmission through breastfeeding remains a problem. The rate of acquisition of HIV through breastfeeding in infants who had negative virus tests in the first three months of life was 7.4% in one study and 9.6% in another by 24 months of age. Not only could AZT prophylaxis in pregnancy produce more susceptible children to acquire HIV through breastfeeding, but the possibility of a viral load rebound with increased breastmilk concentration of virus in the mother after AZT is stopped needs to be ruled out. Studies on current breast-feeding practices and preferences are urgently needed in addition to information on the impact on HIV transmission and infant morbidity and mortality of possible options for women such as shorter duration of breastfeeding, mixed feeding, and breast milk substitutes. Counselling resources to support women and to help them make informed decisions based on their individual circumstances are essential.

Slide 9 - Context of Mother-to-Child Transmission
Simple cleansing of the birth canal can reduce HIV transmission when membranes have been ruptured for more than 4 hours and has the added benefit of reducing postpartum infectious complications in the mother and newborn. Putting the HIV transmission dilemma into context, more than 40% of women do not have a skilled attendant during labour and delivery, while more than 30% of women do not receive adequate antenatal care. A randomised-placebo controlled trial in Tanzania, found that administration of simple multi-vitamins resulted in a significant decrease in adverse pregnancy outcomes, measured as fetal deaths, low birthweight, preterm birth and small for gestational age. This brought home the message that programmes addressing mother-to-child transmission should act to strengthen basic antenatal care programming to benefit the wellbeing of all pregnant women and their infants. There was a call for phased implementation with close monitoring and evaluation after positive situational analyses of resources, infrastructure, acceptability, and opportunity cost. National strategies to prevent mother-to-child transmission must promote maternal and child health, ensure respect for human rights and be part of broader strategies to prevent and treat STD and HIV. We must not fall prey to the immediate gratification of a quick fix solution and yet we need to boldly move ahead since there are spinoffs for the broader picture.

Slide 10 - Technological Developments: Rapid HIV Testing
Among technical developments, same day HIV testing in Uganda permits clients to receive counselling and test results within 2 hours, using an algorithm based on the Capillus test followed by the Serocard test for confirmation. A tiebreaker test, the Multispot , is used for indeterminate specimens. This and other voluntary counselling and testing programmes in developing countries were shown to be cost-effective. Although rapid tests would allow for timely initiation of antiretroviral prophylaxis in pregnancy, further debate is required. Women often may want and need to consult with spouses, family members and friends about whether to have an HIV test.

Slide 11 - Significance of Viral Load
Two developments concerning viral load measurements deserve quick mention. First, in a study of long-term non-progressors, plasma viral load was the only independent predictor of loss of non-progressor status, providing a strong argument for the inclusion of viral load in a new definition of long term non-progressor. Second, in a study comparing cases who developed AIDS prior to 1996 and controls who were AIDS-free at the time of analysis, gender differences in plasma viral load measurements despite similar pathogenesis were found. If this is confirmed in other studies, it may have important implications for the definition of cut-points for the initiation of antiretroviral therapy in women.

Slide 12 - Vaccines
In a bridging session on overcoming obstacles to human trials of vaccines, it was clear that challenging questions remain concerning correlates of protection, the possibility of cross-clade protection, the value of animal models, and the need on the one hand to test new concepts and on the other to get on with clinical trials even if the perfect candidate vaccine is not at hand. It was encouraging to learn that a Phase III efficacy trial of a clade B gp120 vaccine began this month and will recruit 5000 gay men and women in serodiscordant partnerships in the United States. A similar trial of a mixed clade B and E vaccine among injection drug users is currently in the approval process in Thailand and is expected to start this Autumn.

Slide 13 - Ethical Issues in Trials of HIV Prevention Technologies
The process of addressing ethical issues concerning vaccine trials has application to clinical trials of other prevention technologies such as microbicides, population-based STD treatment strategies, and female (internal) and male condoms. In the face of continuing high HIV incidence in many countries around the world, there is an ethical imperative to move ahead swiftly, but key ethical issues in the design, implementation and aftermath of trials must be faced if the rights and well-being of participants are to be protected. For vaccine trials, regional consultations, held in Brazil, Thailand and Uganda, were followed by meetings in Washington and in Geneva just last week at which consensus was achieved on the need for individual informed consent for participation and for clear mechanisms for scientific and ethical review established in advance of any trial. In a departure from a previous position, vaccine trials in less-developed countries may be conducted prior to trials in industrialised countries. However, participants in the Geneva meeting did not succeed in reaching consensus on what level of treatment should be provided to participants in a vaccine trial who become infected during the trial. Some people at the meeting argued that the "best proven therapy" should be provided, in compliance with the current CIOMS international guidelines. Others at the meeting argued in favor of what they believe to be a more realistic" standard--"the highest practically attainable" level of treatment. No amount of further discussion brought these two different opinions closer together. Rather than leave the matter entirely unresolved, participants agreed to set aside for the present any attempt to set a substantive standard, and agreed instead on a "procedural" solution. That solution is to leave decisions about the level of care to the host country in a vaccine trial, those decisions to be made in full collaboration with sponsors of the trial. The result is that different countries will almost certainly decide upon different standards to apply to their own situation. However, in no case may the host country and the sponsor decide on a level of care that is lower than the "highest practically attainable" level.

Slide 14 - Advocacy Points
Active community involvement to address ethical concerns and mobilise both political and population commitment is critical for vaccine, female condom and microbicide development. The science is not perfect but we must move rapidly forward with strategies that will increase the scientific capacity and health infrastructure of participating countries. Innovative strategies to overcome the current dismal economics plaguing prevention technology development include private sector incentives, multisectoral partnerships, and firm financing commitments from multilateral institutions, bilateral donors, and developing country governments assisted through contingency loans. Facilitated by the International AIDS Vaccine Initiative, global collaborations are being forged to accelerate vaccine development in a way that will have potential spin-offs for the development and uptake of non-HIV vaccines in the developing world. The international advocacy group Friends of Female Condoms is calling for reframing of the cost of the female condom and support to complete outstanding research, after reports of more than 30 studies on acceptability , reuse safety, and effectiveness for STD protection at this conference. Women advocates from Thailand and Zimbabwe presented strategies for community and decision maker mobilisation for microbicides, the poor sister in HIV prevention technology. Investment in therapeutic research remains the king of private and public sector investment - and benefits primarily the industrialised world. Where are our priorities?

Slide 15 - Methodological Developments
Several methodological developments now require documentation in the formal literature. Rapid assessment, based on principles of triangulation with multiple methods, multiple disciplines, many data sources, and the use of induction, can inform the development of rapid responses. A fine example was provided by a peer education brothel-based project in Bangladesh, which used ethnographic mapping and colour-coded tracking of outcomes. This facilitated feedback to illiterate sex workers and continued involvement of the community.

Cost-effectiveness studies examined projects, programs and strategies. In this developing field, future studies should include not only direct costs but also productivity or social costs. It appears that highly active antiretroviral therapy or HAART may produce cost-savings and that net costs per Quality Adjusted Life Year in the longer term may be seen. A crucial and yet unknown parameter involves the number of life years gained on HAART. For the developing world, at present, HAART is neither cost-saving nor cost-effective, and major problems exist with the current commercial pricing policies.

An elegant approach to evaluating NEP from Poland involved studying the life cycle of syringes.

Slide 16 - Sexually Transmitted Diseases and Tuberculosis: need for re-assessment
Comprehensive case management, utilising early diagnosis and adequate treatment complemented by appropriate prevention remains the cornerstone of STD control. Progress is being made in developing low-cost diagnostic tests and in resource poor areas, syndromic management can be successful as demonstrated by the Mwanza study. However, sustained success requires a stable supply of effective and affordable drugs.

Although the incidence of a number of STDs was significantly reduced in the Rakai mass treatment study, the failure to reduce the incidence of HIV infection in the treated communities, compared with the control communities, was attributed to the high rates of untreated STDs, the intense HIV exposure and the low-population ‘attributable risk’ of STD. If all STD had been eradicated, in Rakai the HIV transmission rate would have been reduced by about 30%. Bacterial vaginosis accounted for half of this: when BV was excluded, total eradication of the remaining STDs would have reduced HIV incidence by only 15%. The difficulty in operationalising findings from the Mwanza study in real life settings, and the failure of the Rakai study to reduce HIV incidence, are sobering. We must continue to encourage uptake of STD services through integration with primary care and reproductive health care services.

Given the increasing incidence of tuberculosis fuelled by the HIV pandemic, and troubling increases in multi-resistant TB, we urgently need to reassess TB containment strategies. Programs focusing on increased community involvement are being developed in a number of African countries but appropriate resources will be needed to make this effective. This has often been lacking in industrialised countries, where community services have been developed as an alternative to hospital-based service provision without adequate funding.

Slide 17 - Post-exposure prophylaxis
Post-exposure prophylaxis is also proving a problem. In occupational exposure, there is a high frequency of minor and reversible side effects and poor compliance to completion of therapy. For non-occupational exposures through sexual and injecting activities, efficacy is unknown and the cost per case averted in developed countries is high. This is a striking example of the gap between industrialised and resource-poor countries.

Slide 18 - Communities and Marginalisation
More public health interventions now use a "community-based" approach, requiring a clearer idea of what communities are, what they can do, and how diverse communities can be. For example, the use of ‘negotiated safety’ as a successful safe sex strategy was confirmed in new Australian data, highlighting the importance and utility of promoting and providing access to voluntary counselling and testing. Risk-taking among young gay men continues to be investigated and debated without resolution, with one study reporting enhanced risk while another reported that risk-taking was lowest in the 16 to 21 age group. This suggests that young people should not be regarded, by definition, as a population always at enhanced risk. The idea that multiple loss and grief might lead to sexual risk-taking by gay men was not supported in a study that found such loss contributing to gay men’s resolve to stay safe in their sexual practices.

Reports of changing patterns of sexual activity among some gay and homosexually active men need to be monitored since successful responses are occurring that may be of great relevance to other populations. In developing countries, remarkable efforts in research and successes in prevention were reported in contexts of daunting discrimination, oppressive illegality, active persecution and continuous marginalisation. The distance between the North and South has strong effects here, often masked by the commonality provided by the term ‘gay’. These communities of gay and homosexually active men have more in common with other marginalised populations in their resource-poor nations and deserve inclusion in debates on migration, law, public health resources, and human rights.

Slide 19 - Quotation:

"We only ask to be treated with respect and dignity and to be recognized and accepted as one of the many faces of the human family."

This theme of human rights was strong in a number of Track C sessions reminding us that successful prevention and good public health are as much issues of social and cultural marginalisation as of technical wizardry and scientific proof. This theme was best represented in the session on transsexuals, whose call for recognition as a legitimate part of the HIV/AIDS world can no longer be disregarded.

Slide 20 - Good News Stories
There were many good news stories. For example, fears in developed countries that needle exchange programmes or NEP might inadvertently facilitate high-risk social networks were not supported by studies which showed that very few NEP attendees met new needle-sharing partners at the exchange. There was evidence that needle exchanges continue to be associated with reductions in high-risk behaviours and HIV incidence, with former NEP attendees more likely to reduce or cease injecting.

Exciting examples of community-based interventions for IDUs were reported from Madras, India and Bangladesh. In Madras a randomised-controlled trial of a personal network intervention used needle exchange as a vehicle to encourage supportive networks between ex-IDUs and current injectors , reduce high-risk behaviour and facilitate referrals to drug treatment. In Bangladesh a successful community-based intervention was designed after an 18-month situation assessment that involved the entire community (IDUs, their families, religious and political leaders, and police) in a ‘best-practice’ case story, from which other countries might gain valuable experience. Innovative projects for women partners of bisexual men in Sydney, Australia and for African-American women in California were reported.

An important harm reduction success story from Brazil, involved the implementation of a comprehensive approach including 12 needle exchange projects. Despite a delay in implementation of interventions, the leadership and political will Brazil has shown is setting an example for similar programs in other countries in Latin America.

Slide off - Conclusion
In conclusion, progression in the pandemic is daunting and despite strong technological and methodological advances there have been setbacks. There are good news stories and we need to build on these. But our work is cut out for us. Increasingly we are forced to confront a range of broad structural forces that influence the epidemic and responses to it. As has been so cogently argued in this conference, it is time for us to channel our resourcefulness, skills, anger and determination in a renewed pledge of commitment to the struggle.

Thank you for your attention.

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