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Screening for human immunodeficiency virus: a survey of British clinical pharmacology units
M Thomson1, W G Haynes, D J Webb
1University of Edinburgh, Department of Medicine, Western General Hospital, Edinburgh EH4 2XU.
Insights
Most clinical pharmacology units did not screen healthy volunteers for human immunodeficiency virus (HIV) infection. Indirect methods like risk questionnaires are preferred over antibody testing due to perceived low risk and treatment benefits.
Area of Science:
- Clinical Pharmacology
- Infectious Disease Screening
- Public Health
Background:
- Human immunodeficiency virus (HIV) screening practices in clinical pharmacology units were surveyed.
- The survey covered June 1990 to May 1991, involving 74 units conducting Phase I and II studies.
Purpose of the Study:
- To assess current HIV screening practices in clinical pharmacology units.
- To understand the rationale behind testing or not testing healthy volunteers for HIV.
Main Methods:
- A survey was conducted among 74 clinical pharmacology units (45 commercial, 29 academic).
- A 92% response rate was achieved, with 43 questionnaires analyzed from units involved in healthy volunteer studies.
- Data collected included HIV antibody testing practices and reasons for or against testing.
Main Results:
- The majority of units did not perform HIV antibody testing on healthy volunteers.
- Only 35% of commercial and 12% of academic units reported conducting HIV antibody tests.
- Key reasons for not testing included perceived low risk, lack of treatment benefit, and insurance implications.
Conclusions:
- Indirect screening methods, such as HIV risk questionnaires, are considered more appropriate than direct antibody testing for healthy volunteers currently.
- Future screening patterns may evolve based on HIV prevalence, treatment benefits, and perceived disadvantages of testing.
Abstract:
1. A survey of screening practices used to detect infection with the human immunodeficiency virus (HIV), covering the 12 months from June 1990 to May 1991, was carried out in 74 clinical pharmacology units performing phase I and II studies. Forty-five units were identified from the Technomark commercial register, and 29 units were identified from the clinical academic membership of the British Pharmacological Society. 2. An overall response rate of 92% was obtained: 41 replies from commercial units; 27 replies from academic units. Seventeen commercial units and 26 academic units reported involvement with healthy volunteer studies; these were the 43 questionnaires analysed. 3. The majority of clinical pharmacology units did not believe that it was necessary to perform HIV screening by HIV antibody testing. Six commercial units (35%) and three academic units (12%) did perform HIV antibody testing in healthy volunteers. 4. Reasons frequently given for testing were protection of clinical and laboratory staff, and the advantages to the volunteer of prophylaxis and treatment at an early stage of HIV infection. Reasons for not testing included the perceived low risk of a positive test, a lack of benefit from treatment, and the adverse implications in relation to health insurance. Advice from an Ethics Review Committee was not generally a reason for testing. 5. In future, screening patterns may change, depending on prevalence of HIV positivity in the community, the benefits of diagnosis and treatment, and the perceived or real disadvantages of having an HIV antibody test. For the present, we believe that indirect methods, such as an HIV risks questionnaire, are more appropriate than direct antibody testing.
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