Preparing for Adolescent HIV Vaccine Trials in South Africa: (NCT00944879) | Clinical Trial Compass
UnknownNot Applicable
Preparing for Adolescent HIV Vaccine Trials in South Africa:
South Africa1,400 participantsStarted 2009-08
Plain-language summary
This study will use the licensed HPV vaccine, Gardasil, as a surrogate for an HIV vaccine, in order to explore some of the ethico-legal,psycho-social and logistical challenges involved in running an HIV vaccine trial in adolescents.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Youth age 12-17 years
* For 12-15 year olds - no sexual risk criteria
* For 16-17 year olds (the age of lawful consent to sex in South Africa): sexually active (ever had sexual intercourse)
* Willing to participate in HIV testing and counseling
* Willing and able to assent to study
* Parent or legal guardian willing to provide written consent
* HIV-negative serostatus at screening and enrolment
* Females must have a negative pregnancy test at screening/enrolment
* Females must not be breastfeeding
* Additional inclusion criteria for those accepting HPV vaccination:
* No HPV immunizations
* Females should agree to avoid pregnancy through to the end of the study and to take contraceptives throughout the study (access provided)
Exclusion Criteria:
* Exclusion criteria for those accepting HPV vaccination:
* Presence of any serious illness requiring treatment with systemic medications, excluding short course oral steroids or inhaled steroid treatment for asthma
* Contra-indication to vaccination, such as bleeding disorder
* Previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
* Current immunomodulator therapy
* Receipt of immunosuppressor therapy (more than 10mg/day of prednisone or equivalent for \>1 week) in the 6 months preceding enrollment date
* Receipt of any vaccine within two weeks preceding enrollment date
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.