Elsevier

The Lancet

Volume 366, Issue 9495, 22–28 October 2005, Pages 1499-1503
The Lancet

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HIV prevention research in a resource-limited setting: the experience of planning a trial in Cambodia

https://doi.org/10.1016/S0140-6736(05)67146-2Get rights and content

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Trial researchers, sponsors, rationale, and setting

The study was planned as a collaboration between the University of California, San Francisco, CA, USA (UCSF); the University of New South Wales, Sydney, Australia (UNSW); and the National Centre for HIV/AIDS, Dermatology and Sexually Transmitted Infections, Phnom Penh, Cambodia (NCHADS). The funding sponsors were the US National Institutes of Health (NIH) and Family Health International, a US-based research organisation that had received a grant from the Bill and Melinda Gates Foundation to

Consultation and approval processes

Research of this kind involves multiple levels of approval. First, we required government approval before we could undertake any form of trial-related activity, including community consultation, in Cambodia. An early version of the study protocol was approved by the Cambodian Ministry of Health National Ethics Committee (NEC) in July, 2003. Approvals of this early version were obtained from the ethics committees at UCSF in March, 2003, and at UNSW in August, 2003. Contracts to develop the

HIV prevention in trial participants

The best standard of care for HIV prevention in individuals that is currently available is the provision of information about HIV transmission and how infection can be avoided, condoms to people who may be at risk through sexual exposure, and sterile injecting equipment to people at risk through injection practices. Participants in the planned prevention study in Cambodia were to receive safe-sex counselling and condoms at every monthly visit during their year's enrolment in the trial. Since

Provision of non-HIV-related health care to trial participants

With its extensive use to treat people with HIV infection, tenofovir disoproxil fumarate is recognised as having a very low side-effect profile compared with other antiretroviral drugs. However, data are scarce for the effects of tenofovir disoproxil fumarate in HIV-negative people and acceptability may be lower in these individuals than for those receiving therapeutic benefit. Therefore, a comprehensive series of biochemical, haematological, and clinical safety assessments was scheduled on a

Provision of HIV-related health care to trial participants

The occurrence of HIV infection in prevention trial participants was a primary endpoint of the trial, as well as being a serious adverse event. There would seem to be both a medical and ethical requirement for the study investigators to provide appropriate care to any participant who acquired HIV infection during the course of the trial, including antiretroviral drugs as clinically indicated.22, 25 As with non-HIV-related health care, sustained provision of medical care after the trial would be

What remains?

At the point when the trial planning was stopped, a new clinical facility had been built, the national laboratory had been supported to develop its procedures to an international standard of quality, and more than 40 local staff were working on study preparations. The laboratory remains functional, serving Cambodia for clinical and public health purposes, and several key staff were employed on other research projects.

Funding for the prevention trial was sought and obtained, on the premise that

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