Epidemiology of HIV infection in Vulindlela
In the past two years we have undertaken several studies to glean a better understanding of the HIV/AIDS epidemic in this community and
to generate baseline and preliminary data for other proposed studies in this community.
Cross-sectional, annual, anonymous surveys of ANC attendees demonstrate a rise of HIV infection from 26% in 2001, to 34% in 2002,
to 42% in 2003. In 2002, 39% of ANC attendees were under the age of 18, with the youngest being 12 years of age and the prevalence of
HIV infection in this group was an alarming 25.8%. In 2002, HIV prevalence in the 20-24 year age group and the 25-29 year age group was
45.8% and 42.9% respectively.
In another 2002 study, investigating the prevalence of HIV and aetiology of other sexually transmitted infections in family planning
clients, the overall HIV prevalence was 45.5%. The prevalence in women under the age was 27.5% compared to 54.7% in the 20-24 year age
group and 58.5% in the 25-29 year age group. The prevalence of genital tract infections in this population was high, with about 60%
having at least one bacterial STI.
The antenatal and family planning clients under the age of 30 represent a cohort of young women and very high risk of acquiring
infection with HIV. The family planning clients in particular represent an ideal population for phase II/III microbicide and vaccine
trials. Based on data from these populations, two proposals were developed and submitted for funding and are currently under review.
These are described below as i. Phase II Microbicide Trial of PRO 2000/5 gel submitted to EcoBio, a biotechnology centre funded by the
South African government and ii. Anal Sex and Adolescent HIV Risk submitted to NIH as a supplement to the current CIPRA grant.
Using verbal autopsies we have also established an alarmingly high rate of AIDS-related mortality in this community primarily
affecting young women under the age of 35 years.
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Understanding AIDS-related Stigma and Discrimination
Despite the high rates of HIV infection and rising morbidity and mortality there is pervasive AIDS-related stigma and discrimination.
Fear of stigma and discrimination precludes people from knowing their HIV status, and is a key barrier to accessing HIV prevention, care
and support services. As part of our community preparatory work we have had a number of focus group discussions with a number of social
groups in Vulindlela. While these groups report high levels of awareness and knowledge about HIV and AIDS including high rates of
AIDS-related mortality only one person in this community has publicly disclosed his HIV status. Uptake of the free VCT services is
low as is VCT linked to the pMTCT linked programme. We are currently identifying factors contributing to HIV/AIDS related stigma and
discrimination within this rural community. This study will provide important insights into understanding HIV-related stigma and
discrimination at a community level as a precursor to the development of interventions to reduce stigma and discrimination and thereby
enhance HIV/AIDS prevention, care and support programmes and minimize social harm to research participants that we are recruiting into a
number of HIV prevention and treatment projects in Vulindlela. Funding for this study was secured from the Joint Oxfam HIV/AIDS Programme
(JOHAP).
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HIV sero-incidence study
This study is being conducted in preparation for the implementation of the Phase II trial of PRO 2000/5 Gel (P). The primary objective
of this study is to estimate rates of HIV sero-incidence among women targeted for inclusion in the proposed Phase II microbicide trial.
In addition, it will enable the establishment of effective standard operating procedures to recruit and retain cohorts at high risk of
acquiring infection with HIV.
The cohorts for the HIV sero-incidence study are being established from volunteers utilizing the Vulindlela Primary Health Care
Clinics for Family Planning services. Women who screen HIV negative are enrolled into the HIV sero-incidence study and followed-up
monthly and have a HIV test quarterly. Women who seroconvert in the HIV sero-incidence study and the proposed Phase II Microbicide
trial will be referred to the CAPRISA Acute Infection Study.
Women who screen positive are referred to the Vulindlela CAPRISA AIDS Treatment Project (CAT). The CAT Project has helped in reducing
stigma associated with HIV testing and provides an important option for women who screen positive. About half of the family planning
clients are currently testing positive for HIV infection.
The HIV sero-incidence study is an important entry point for establishing a continuum of research from HIV prevention, pathogenesis to
treatment. In the context of a rapidly maturing HIV epidemic in South Africa the are many important research questions in these areas.
In addition, our close relationship with the Ministry of Health ensures that there is rapid feedback to the services for improvement such
as the establishment of adolescent friendly health services and strengthening of family planning services for HIV risk reduction and
improved reproductive health services.
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Phase II Microbicide Trial of Pro 2000/5 Gel (P)
There is an urgent need to develop safe and effective vaginal microbicides to prevent sexual transmission of HIV. As the number of
products completing Phase I testing increases there is a growing need to rapidly and objectively assess efficacy in terms of HIV prevention
potential of the various products to enable more informed decisions to be made in terms of which products to invest in for Phase III
testing.
In a traditional clinical development pathway, Phase I studies would be followed by Phase II studies. In the context of microbicide
product development, relatively low incidence rates make it difficult to design a classic, moderately sized Phase II trial that has
sufficient statistical power to provide an indication of effectiveness for HIV prevention. However, the high incidence rates in young
women between the ages of 18-30 in Vulindlela enables this Phase II study to be undertaken to evaluate the safety and provide preliminary
indication of effectiveness against HIV in this population of young women at very high risk for HIV infection.
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Progress so far:
| Study | Site | Number of Patients Screened | Number of Patients Enrolled |
| Sero Incidence | Vulindlela | 785 | 369 |
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