HIV serostatus
HIV serostatus surveys are very sensitive and need to be properly planned for confidentiality purposes and the use of GLP. There is a need to consider whether the testing is for screening purposes or for HIV prevalence, incidence and risk factors of HIV transmission and acquisition. The purpose will determine whether to use rapid tests, ELISA, confirmatory tests like Western Blots or tests for immunological and virological parameters.
In order for DSS sites to carry out HIV serostatus surveys there is a need to consider whether the results are going to be given back to study participants necessitating a VCT plan (see VCT). Since this is a sensitive exercise there is a need to administer a consent form that outlines who the investigators are, the objective of the study, the risks and benefits associated with the study, how confidentiality will be observed and contact persons in case of questions that need to be answered. The participants need to give consent to the mode of storage and any future testing of their samples. There is a need to use a coding system (computer labels or bar codes) that will be used for labeling samples. If it is anonymous then a system to ensure this should be well thought about and included in the consent.
The laboratory used should be certified for such a study with proven quality assurance. If it is being established then care must be taken to train phlebotomists and stock it with the necessary equipment for testing and storage of samples. The drawing off of blood samples from study participants needs to be planned whether to take place in the field or in a designated place like a health unit. This will also involve use of agreed upon types and sizes of vacutainers, cool boxes, transporting mechanism and preparing the samples for the tests (spinning and sample separation).
Checks in the laboratory and data management when results accruing to subsequent rounds are expected need to be determined (confirming incident cases and investigating sero reverters).
Examples of HIV sero status surveys include those that conduct baseline and follow-up surveys of knowledge and attitudes regarding risk reduction and participation in HIV prevention trials, monitoring the effects of ARV therapy, plus national sero surveys.
The study design depends on the goal of researchers and area of the study, with HIV prevention studies enrolling sexually active age groups, pregnant women and drug users.
A broad spectrum of staff is needed for such surveys including but not limited to medical officers, phlebotomists, counselors, nurses, social scientists and administrative staff.