## Protocol Section
### Identification Module
**NCT ID:** NCT00944879

**Acronym:** CATSA

**Brief Title:** Preparing for Adolescent HIV Vaccine Trials in South Africa:

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

#### Organization Study ID Info
**ID:** 35384
#### Organization
**Class:** OTHER
**Full Name:** Desmond Tutu HIV Centre
#### Secondary ID Infos
**ID:** CT.2006.33111.004
### Status Module
#### Completion Date
**Date:** 2011-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2009-08-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-08-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2011-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2009-08

**Status Verified Date:** 2009-07

#### Study First Post Date
**Date:** 2009-07-23
**Type:** ESTIMATED
**Study First Submit Date:** 2009-07-20
**Study First Submit QC Date:** 2009-07-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** European and Developing Countries Clinical Trials Partnership (EDCTP)

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** Desmond Tutu HIV Centre

#### Responsible Party

**Old Name Title:** Professor Linda-Gail Bekker

**Old Organization:** Desmond Tutu HIV Centre

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- HIV Infection

- HIV Infections

**Keywords:**

- HIV

- vaccine

- prevention

- HPV

- adolescents

### Design Module

#### Bio Spec

**Description:** Blood for HIV, syphilis and pregnancy testing

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Those choosing to receive the HPV vaccine

**Label:** HPV vaccine

#### Arm Group 2

**Description:** Those choosing not to receive the HPV vaccine

**Label:** no HPV vaccine

### Outcomes Module

#### Primary Outcomes

**Measure:** Recruitment and retention

**Time Frame:** 9 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 17 Years

**Minimum Age:** 12 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** South African adolescents aged 12 to 17

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cape Town

**Contacts:**

***Contact 1:***

- **Email:** melissa.wallace@hiv-research.org.za

- **Name:** Melissa L Wallace, MSc, PhD

- **Phone:** +27 21 650 6960

- **Role:** CONTACT

***Contact 2:***

- **Email:** agnes.ronan@hiv-research.org.za

- **Name:** Agnes Ronan, RGN, MBA

- **Phone:** +27 21 650 6962

- **Role:** CONTACT

***Contact 3:***

- **Name:** Linda-Gail Bekker, MBChB, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** South Africa

**Facility:** Desmond Tutu HIV Centre

#### Overall Officials

**Official 1:**

**Affiliation:** Desmond Tutu HIV Centre

**Name:** Linda-Gail Bekker, MBChB PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

- ID: D000012897

- Term: Slow Virus Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: HIGH

- As Found: HIV Infections

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV Infections

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15700

- Name: Slow Virus Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000015658

- Term: HIV Infections

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
