HIV InfectionCATSANCT00944879
Preparing for Adolescent HIV Vaccine Trials in South Africa:
An observational study of HIV Infection and HIV Infections, run by Desmond Tutu HIV Centre at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, HIV Infections
- Type of treatment
- Vaccines
- How many people
- 1,400 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: South African adolescents aged 12 to 17
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Desmond Tutu HIV Centre
Cape Town
Melissa L Wallace, MSc, PhD, +27 21 650 6960, melissa.wallace@hiv-research.org.za
Agnes Ronan, RGN, MBA, +27 21 650 6962, agnes.ronan@hiv-research.org.za
About this study
Official title: Preparing for Adolescent HIV Vaccine Trials in South Africa: a Multi-centre Study to Evaluate Acceptability of the HPV Vaccine in Adolescents
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.
Read the 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.
- Conditions
- HIV Infection, HIV Infections
- Keywords
- HIV, vaccine, prevention, HPV, adolescents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine | Those choosing to receive the HPV vaccine | |
| no HPV vaccine | Those choosing not to receive the HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Centre
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Merck Sharp & Dohme LLC
- Investigators
- Linda-Gail Bekker, MBChB PhD, Principal investigator, Desmond Tutu HIV Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944879
- Sponsor's protocol ID
- 35384
- Other IDs
- CT.2006.33111.004
- Acronym
- CATSA
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for Adolescent HIV Vaccine Trials in South Africa: a Multi-centre Study to Evaluate Acceptability of the HPV Vaccine in Adolescents
- ClinicalTrials.gov ID
- NCT00944879
- Acronym / sponsor ID
- CATSA / 35384
- Conditions
- HIV Infection, HIV Infections
- Keywords
- HIV, vaccine, prevention, HPV, adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Desmond Tutu HIV CentreUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Merck Sharp & Dohme LLC
- Study start
- Aug 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV vaccine | – | –Those choosing to receive the HPV vaccine |
| no HPV vaccine | – | –Those choosing not to receive the HPV vaccine |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- South African adolescents aged 12 to 17
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment and retention
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda-Gail Bekker, MBChB PhD principal investigator
Desmond Tutu HIV Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and HIV Infections, run by Desmond Tutu HIV Centre at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2009.