Protocol
The ethical committees of all participating institutions have approved the general study protocol. Additional approval from the ethical committees may be requested for certain nested projects (e.g. intervention studies).
Any person living with HIV being at least 18 years old can be enrolled in the SHCS. A signed informed consent is required from all participants.
Demographic data and specific data are registered at enrollment: date of birth, sex, nationality, ethnicity, educational degree and last held professional position, sexual preference.
Other specific data are collected: results of earlier HIV tests, the most probable mode of HIV transmission, history of antiretroviral treatment, smoking history, and hypertension awareness and treatment.
Many data are collected every six months at the follow-up visits, such as: source of income, ability to work, family situation, sexual partnership and condom use. A gynecological form enquires whether the participant has undergone a gynecological examination and if a cervical smear has been performed.
At each follow-up visit, the physician reports on the following events: opportunistic diseases, comorbidities, serious infections, sexually transmitted infections, any diagnosis of cancer, myocardial infarction, stroke, diabetes and lipodystrophy. Follow-up visits include the measurement of weight, blood pressure as well as waist and hip circumference.
At registration and at each follow-up visit, a spectrum of laboratory results are collected (all belonging to the standard of care of persons living with HIV). Results concerning CD3, CD4 and CD8 cell counts and plasma viral load have to be notified, including the method used for viral load measurement and in case of undetectable viremia, the detection limit of the given analysis.
The following laboratory analyses are collected every six months: leukocyte and lymphocyte counts, hemoglobin and platelets; cholesterol, HDL cholesterol, triglyceride, glucose, ALAT, ASAT, alkaline phosphatase and creatinine also have to be reported.
Some laboratory analyses have to be done only once, normally at registration: tuberculosis tests, the hepatitis B markers, serology for Toxoplasma gondii and cytomegalovirus. Antibodies against Hepatitis C are determined at registration and, if the result is negative every one to two years thereafter. Any HCV viremia and available HCV genotypes are documented.
At registration and at every follow-up visit, plasma samples are frozen for further analysis. Once a year, a sample of viable cells is stored. The laboratory informs the data centre about the number of aliquots and the attributed storage number of each frozen sample.
Information on all medications, comedications and vaccines including dosage and brand names, adherence and stopping reasons is systematically collected in all SHCS participants.
A special form is used to capture information about participants who are lost from follow-up or have died. For participants lost from follow-up, the latest date of contact is documented. For participants who have died, the centre has to indicate the cause of death using the ICD-10 codes.
All these data are registered in a central database. All SHCS participants obtain a study identifier, with the link of the participants’ name and study identifier being kept locally at the participating clinics.