NCT01187979

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,217

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Sep 2010

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

3.9 years

First QC Date

August 12, 2010

Last Update Submit

January 18, 2017

Conditions

Keywords

Cash incentiveHIV preventionAdolescentsSouth AfricaHIV

Outcome Measures

Primary Outcomes (1)

  • HIV-incidence rates

    To evaluate the efficacy of a cash-incentivised prevention intervention in reducing HIV-incidence rates in high-school learners

    annually, after every 12 months of follow up

Secondary Outcomes (7)

  • Academic performance measured as an overall passing grade (50%)

    6 monthly

  • voluntary uptake of HIV testing

    annually, after every 12 months of follow up

  • Substance use patterns

    annually, after every 12 months of follow up

  • Pregnancy rates in female learners

    annually, after every 12 months of follow up

  • Contraceptive use patterns in female learners

    annually, after every 12 months of follow up

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Cash incentive

EXPERIMENTAL

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 incentivesBehavioral: Life skills curriculum

Interventions

Cash incentivesBEHAVIORAL

Cash incentives paid to learners for reaching pre-determined milestones

Cash incentive

Standard department of education lifeskills curriculum

Cash incentiveControl

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal by the learner and/or parent or legal guardian to participate in the study.
  • Unable to provide necessary informed consents
  • Cognitively challenged learners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vulindlela Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (4)

  • Pettifor AE, Rees HV, Kleinschmidt I, Steffenson AE, MacPhail C, Hlongwa-Madikizela L, Vermaak K, Padian NS. Young people's sexual health in South Africa: HIV prevalence and sexual behaviors from a nationally representative household survey. AIDS. 2005 Sep 23;19(14):1525-34. doi: 10.1097/01.aids.0000183129.16830.06.

    PMID: 16135907BACKGROUND
  • Fernald LC, Hou X, Gertler PJ. Oportunidades program participation and body mass index, blood pressure, and self-reported health in Mexican adults. Prev Chronic Dis. 2008 Jul;5(3):A81. Epub 2008 Jun 15.

    PMID: 18558031BACKGROUND
  • Hargreaves JR, Glynn JR. Educational attainment and HIV-1 infection in developing countries: a systematic review. Trop Med Int Health. 2002 Jun;7(6):489-98. doi: 10.1046/j.1365-3156.2002.00889.x.

    PMID: 12031070BACKGROUND
  • Ayton SG, Pavlicova M, Abdool Karim Q. Identification of adolescent girls and young women for targeted HIV prevention: a new risk scoring tool in KwaZulu Natal, South Africa. Sci Rep. 2020 Aug 3;10(1):13017. doi: 10.1038/s41598-020-69842-x.

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Quarraisha Abdool Karim, PhD

    Associate Scientific Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Protocol Chair

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 25, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations