Vanguard treatment programmes pave the way to scale up

“Over the past couple years, there has been a confluence of events and most importantly, the determination to meet the ethical, social and medical imperative to actually provide access to care and treatment to the millions of people living with HIV.”

Dr. Wafaa El-Sadr

Director

International Center for AIDS Care and Treatment Programs

Mailman School of Public Health, Columbia University

A few hours before Dr. Jim Kim of the World Health Organization gave the keynote lecture at the 12^th Conference on Retroviruses and Opportunistic Infections, on the scale-up of antiretroviral treatment (ART) in the developing world, Dr. Wafaa El-Sadr described some of the vanguard programmes and models of care that have pioneered delivering antiretroviral treatment in resource limited settings.

“At the forefront,” she said, have been the “creative” programmes of Medecins San Frontieres, which have enrolled 50,000 patients through 31 projects in sixteen countries. Around 12,000 have been put on ART.

The MSF participants are usually referred from community health or TB clinics. Despite that fact that many start treatment with very low CD4 cells, they respond well to ART — with 85% survival at two years.

Another vanguard programme, the Partners in Health HIV Equity Initiative, in Haiti, provides directly observed ART and social support to HIV positive patients enrolled in a TB control programme. The programme has achieved a marked reduction in mortality, opportunistic infections and improved weight for its participants.

Both MSF and the Haiti programme target very ill patients, but the identification of simple interventions to prevent mother to child transmission (MTCT) offered the opportunity to intervene and bring in individuals with earlier disease. But while MTCT programmes decrease transmission of HIV from mother to infant, they do not prevent the mothers (and fathers) from dying and the children from becoming orphans.

MTCT+

Columbia University established the MTCT-plus initiative to address the needs of these women and their families. Women attending antenatal clinics who are identified as HIV-positive are enrolled in the programme. Once enrolled, they can invite their HIV-infected partners, children, and other household members. Everyone receives a comprehensive package of care services including:

Dr. El-Sadr listed four fundamental pillars of MTCT+

• Family-centred care
• Comprehensive HIV primary care inclusive of ART
• Attention to psychosocial in addition to clinical issues
• Involvement of persons with HIV and outreach to community resources (including involvement of people with HIV)

MTCT+ now has projects set up in nine different countries, mostly in Africa. The sites range from district hospitals, to community clinics, to rural clinics with very few resources.

About 7000 individuals had been enrolled into the programme by the end of 2004. Close to 56% percent of the patients are the index women (those identified with HIV infection during pregnancy) and about a third are children mostly from the index pregnancy.

Despite concerns about disclosure and violence against women, 84.3% of the women have disclosed their HIV status to someone in their household. 24% of the women have enrolled their partners — which is a good proportion considering that some of the partners are HIV-negative while others have died.

The majority of participants have early stage disease. The median CD4 cell count is 371 in the index women and lower among other adults. About a third are eligible for ART. But by including those with earlier HIV disease, the programme enhances prevention, improves health and identifies patients who need ART before they become ill. “It is particularly important that all infants exposed to HIV in utero are followed prospectively,” said Dr. El-Sadr.

Like the other vanguard programmes, MTCT+ has observed excellent CD4 cell responses in treated adults, and CD4 cell percentage responses in treated children.

Scaling up with MCAP

Taking the lessons learned from the vanguard programmes, Dr. El-Sadr’s team is now launching the Multicountry Columbia Antiretroviral Program (MCAP). MCAP’s goal is to rapidly scale up and provide care to people in five countries: (Kenya, Mozambique, Rwanda, South Africa and Tanzania).

MCAP has encountered a number of challenges to scale-up. One is how to rapidly reach patients across the spectrum of HIV disease (not only the most ill). A place to start is by expanding voluntary counselling and testing (VCT) and support services.

Dr. El-Sadr suggested another approach would be to coordinate collaborative HIV and TB control programmes which (would refer patients to each other): “It’s a remarkable opportunity to try to have an impact on both epidemics by trying to develop programmes during scale-up that address the needs of [co-infected] patients.”

Another challenge is reaching children. “There is a tremendous urgency to reach children early,” said Dr. El-Sadr . If children with HIV are not identified, half will be dead by two years of age.

Another issue is who will provide care, especially in remote under-resourced areas? Dr. El-Sadr noted that many nurses and midwives have relocated to the UK. To address this, MCAP is trying to retain care providers by improving their livelihood and the conditions in which they work. But there is a need to identify new cadres of workers.

“We have been able to work very closely with non-physician providers,” said Dr. El-Sadr. “In some programmes, we have trained peer workers who are able to support clinical services in a very fundamental way."

Providing the support tools for such workers “is critical.” These need to be simple, standardized and rigorous enough that non-clinicians can use them to help in programme implementation.

A final challenge is reaching everyone who needs HIV care and treatment. In rural areas it is very difficult to access all the patients who need care and treatment.

But MCAP is off to a good start. Over the last few months, 12,000 patients have been enrolled and more than 5000 are on ART. A higher proportion of those in MCAP are on ART than in the MTCT+.

A mosaic of programmes and services

Dr. El-Sadr sees scale-up and treatment delivery as a mosaic: "In order to achieve scale-up in a true sense, one will need to develop a mosaic of various programmes… shaped for the population that they need to reach. By building a mosaic of different kinds of programmes, one can achieve scale-up in a community. These programmes are going to be very different, but it is important to have a diversity of programmes in a community in order to achieve coverage as well as depth.”

There is also a need for a “mosaic of services”, in order to provide quality care including HIV care for adults and children, women's health, mental health, peer programs, adherence support, nutrition, social support and counselling, outreach and monitoring and evaluation. “With the achievement of these services, programmes will take root,” said Dr. El-Sadr.

“Innovation must be encouraged,” she added, as well as “identifying key programmatic components… for the success of programmes. I think without innovation, it will be difficult to maintain the momentum for scale-up.”