Preparing for Adolescent HIV Vaccine Trials in South Africa:

Preparing for Adolescent HIV Vaccine Trials in South Africa: a Multi-centre Study to Evaluate Acceptability of the HPV Vaccine in Adolescents

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00944879

Acronym

CATSA

Enrollment

1400

Registered

2009-07-23

Start date

2009-08-31

Completion date

2011-02-28

Last updated

2009-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, HIV Infections

Keywords

HIV, vaccine, prevention, HPV, adolescents

Brief 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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Recruitment and retention	9 months

Countries

South Africa

Outcome results