Trial record 3 of 26 for:    " July 14, 2010":" August 13, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Reducing HIV in Adolescents (RHIVA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Centre for the AIDS Programme of Research in South Africa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
MIET Africa
KwaZulu-Natal Department of Education
Embassy of the Kingdom of the Netherlands (EKN)
Information provided by (Responsible Party):
Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier:
NCT01187979
First received: August 12, 2010
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to assess the impact of a cash-incentivised prevention intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.


Condition Intervention Phase
HIV Infections
Behavioral: Cash incentives
Behavioral: Life skills curriculum
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Proof of Concept Cluster Randomised Controlled Trial to Evaluate the Impact of a Cash Incentivised Prevention Intervention to Reduce HIV Infection in High School Learners in Rural KwaZulu-Natal, South Africa

Resource links provided by NLM:


Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures:
  • HIV-incidence rates [ Time Frame: annually, after every 12 months of follow up ] [ Designated as safety issue: No ]
    To evaluate the efficacy of a cash-incentivised prevention intervention in reducing HIV-incidence rates in high-school learners


Secondary Outcome Measures:
  • Academic performance measured as an overall passing grade (50%) [ Time Frame: 6 monthly ] [ Designated as safety issue: No ]
    To support learners improving academic performance, attend school, complete schooling and improve their self-esteem, learners will be incentivised to pass their June and November examinations, with a minimum of a 50% average. Educators from the selected schools will design, administer and mark the June and November examination papers.

  • voluntary uptake of HIV testing [ Time Frame: annually, after every 12 months of follow up ] [ Designated as safety issue: No ]
    Learners must provide the receipt from the clinic that specifies that the learner was tested for HIV.

  • Substance use patterns [ Time Frame: annually, after every 12 months of follow up ] [ Designated as safety issue: No ]
    Urine specimens will be utilised for testing for the presence of recreational drugs.

  • Pregnancy rates in female learners [ Time Frame: annually, after every 12 months of follow up ] [ Designated as safety issue: No ]
    A dipstick pregnancy test will be performed on the urine sample of all female learners at baseline and at the two annual follow-up visits.

  • Contraceptive use patterns in female learners [ Time Frame: annually, after every 12 months of follow up ] [ Designated as safety issue: No ]
    Annual behavioural questionnaires will monitor self-reported contraceptive use.

  • Participation in extra-curricular activities [ Time Frame: annually, after every 12 months of follow up ] [ Designated as safety issue: No ]
    Attendance and participation in a life skills/sustainable livelihoods programme will be assessed. Self-reported participation in extra-curricular activities will be assessed in annual behavioural questionnaires.

  • HIV risk reduction behaviour [ Time Frame: Annually, after every 12 months of follow up ] [ Designated as safety issue: No ]

    The following will be assessed through a self-reported questionnaire:

    condom use; primary and/or secondary sexual abstinence rates; sexually transmitted disease rates intergenerational sexual coupling (age of sexual partner(s)) age of sexual debut; frequency of HIV testing; number of concurrent sex partners; frequency of partner change; medical male circumcision rates; anal sex rates



Estimated Enrollment: 4000
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
All eligibly enrolled learners in the intervention schools will receive a prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education. No cash incentives will be paid for meeting milestones
Behavioral: Life skills curriculum
Standard department of education lifeskills curriculum
Experimental: Cash incentive
All eligibly enrolled learners in the intervention schools will receive a cash incentivised prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education
Behavioral: Cash incentives
Cash incentives paid to learners for reaching pre-determined milestones

Detailed Description:

The impact of the cash incentivised intervention will be assessed using a matched pair, cluster randomised controlled trial design. The 14 selected high schools in the Vulindlela School Circuit will be matched in pairs. The matched pairs of schools will be the unit of randomisation. Baseline measurements, using a standardised tool (structured questionnaire and biological specimens) will be undertaken simultaneously in each matched pair and will include all eligibly enrolled and consenting learners in the respective schools. On completion of baseline measurements in each matched pair of schools, the randomisation code for the pair will be revealed and the intervention will be implemented in the intervention school. All schools will receive the same prevention intervention but only the intervention school will receive the cash incentives. Follow-up measurements will be undertaken approximately 12 and 24 months after implementation of the intervention using a similar standardised assessment tool to that used at baseline. At baseline and during follow-up assessments in intervention and control schools, linked HIV and substance use testing will be undertaken in all learners and pregnancy testing in female learners. Other secondary endpoints will be assessed using a structured questionnaire.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Learners must meet all of the following criteria at enrolment in order to be eligible for inclusion in the study:

  • Male or female learner in Grade 9 or 10 in one of the 14 selected schools
  • Willing and able to provide informed consent and/or assent to participate in the study
  • Willing to provide locator data for home visits if necessary
  • Not planning to move to another school or relocate in the next 36 months
  • Willing to be finger-printed to verify identity for study procedure purposes
  • Willing to participate in this study
  • Willing to complete all study procedures

Exclusion Criteria:

  • Refusal by the learner and/or parent or legal guardian to participate in the study.
  • Unable to provide necessary informed consents
  • Cognitively challenged learners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187979

Locations
South Africa
Vulindlela Clinical Research Site
Durban, KwaZulu-Natal, South Africa
Sponsors and Collaborators
Centre for the AIDS Programme of Research in South Africa
MIET Africa
KwaZulu-Natal Department of Education
Embassy of the Kingdom of the Netherlands (EKN)
Investigators
Principal Investigator: Quarraisha Abdool Karim, PhD Associate Scientific Director
  More Information

Additional Information:
Publications:
Responsible Party: Dr Quarraisha Abdool Karim, Principal Investigator and Protocol Chair, Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier: NCT01187979     History of Changes
Other Study ID Numbers: CAPRISA 007
Study First Received: August 12, 2010
Last Updated: February 23, 2012
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by Centre for the AIDS Programme of Research in South Africa:
Cash incentive
HIV prevention
Adolescents
South Africa
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 10, 2014