Preparing for Adolescent HIV Vaccine Trials in South Africa: (CATSA)
Recruitment status was Not yet recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Preparing for Adolescent HIV Vaccine Trials in South Africa: a Multi-centre Study to Evaluate Acceptability of the HPV Vaccine in Adolescents|
- Recruitment and retention [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood for HIV, syphilis and pregnancy testing
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||February 2011|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Those choosing to receive the HPV vaccine
no HPV vaccine
Those choosing not to receive the HPV vaccine
This study will use the licensed HPV vaccine, an alternative STI vaccine, as a proxy for an HIV vaccine and thereby identify potential challenges to the inclusion of adolescents in HIV prevention trials. The study will allow for site capacity building in terms of recruiting and retaining an HIV-negative high-risk adolescent cohort, and assessing the acceptability of an STI vaccine to adolescents and their parents or guardians. Correlates of vaccine uptake, refusal, retention and attrition will be determined. In addition, the study will document the incidence of HIV, other sexually transmitted infections (STI's) and pregnancies and circumcisions in this age group. Different methods of assessing understanding in adolescents will be tested, to ensure that informed consent is being achieved. Experiences of privacy and confidentiality issues for adolescents in such research will be explored. Finally, psycho-social correlates of sexual risk and protective behaviour will be examined.
The study is designed as a longitudinal cohort study with a self-selected intervention and control group. Adolescents and parents will be recruited through community outreach and invited to attend a Vaccine Discussion Group (VDG) to learn more about the HPV vaccine. Parental/ legal guardian consent and adolescent assent will be obtained prior to screening. After screening to ensure volunteers meet inclusion criteria, 1400 participants will be enrolled across seven sites. At this point, they will decide whether or not they want to receive the HPV vaccine. Those who do will receive three doses, at 0, 2 and 6 months. All participants will undergo HIV and pregnancy testing, receive risk reduction counseling and complete questionnaires at 0, 2, 6 and 9 months. Recruitment and retention will be monitored and data as described above will be collected throughout the course of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944879
|Desmond Tutu HIV Centre||Not yet recruiting|
|Cape Town, South Africa|
|Contact: Melissa L Wallace, MSc, PhD +27 21 650 6960 email@example.com|
|Contact: Agnes Ronan, RGN, MBA +27 21 650 6962 firstname.lastname@example.org|
|Principal Investigator: Linda-Gail Bekker, MBChB, PhD|
|Principal Investigator:||Linda-Gail Bekker, MBChB PhD||Desmond Tutu HIV Centre|