Effects of Cash Transfer for the Prevention of HIV in Young South African Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01233531
First received: November 1, 2010
Last updated: September 2, 2014
Last verified: September 2014

November 1, 2010
September 2, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
HIV Incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
To determine whether young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of HIV infection over time compared to young women who are not randomized to receive cash transfers.
HIV Incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Do young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of HIV infection over time compared to young women who are not randomized to receive cash transfers.
Complete list of historical versions of study NCT01233531 on ClinicalTrials.gov Archive Site
  • HSV-2 incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To determine whether young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of Herpes Simplex Virus type 2 (HSV-2) infections over time compared to young women who are not randomized to receive cash transfers.
  • HSV Incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To determine whether young women who receive the CCTs report less unprotected sex, fewer number of sexual partners, younger male partners, an older age of coital debut, a lower incidence of self-reported pregnancy, and greater school attendance compared to young women who do not receive the cash transfers.
  • HSV-2 incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To determine whether young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of Herpes Simplex Virus type 2 (HSV-2) infections over time compared to young women who are not randomized to receive cash transfers.
  • HSV Incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Do young women who receive the CCTs report less unprotected sex, fewer number of sexual partners, younger male partners, an older age of coital debut, a lower incidence of self-reported pregnancy, and greater school attendance compared to young women who do not receive the cash transfers.
Not Provided
Not Provided
 
Effects of Cash Transfer for the Prevention of HIV in Young South African Women
Effects of Cash Transfer for the Prevention of HIV in Young South African Women

Cash transfers to young women for staying in school and its effect on acquiring HIV

The overall purpose of this study is to determine whether providing cash transfers to young women and their household, conditional on school attendance, reduces young women's risk of acquiring Human Immunodeficiency Virus (HIV). The overall goal of the Conditional Cash Transfer (CCT) intervention is to reduce structural barriers to education with the goal of increasing school attendance of young women, thereby decreasing their HIV risk.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • Behavioral: monthly cash transfer payments for attending school
    In the intervention, young women and their households will be randomized in 1:1 ratio to receive monthly cash transfer payments, conditional on the young woman attending school, or to the control arm. Young women will be recruited at the beginning of grades 8 through 11 in the first year of the study.
  • Behavioral: B--No cash transfers
    No monthly cash transfers
  • A--Monthly cash transfers
    Monthly cash transfer payments
    Intervention: Behavioral: monthly cash transfer payments for attending school
  • B--No cash transfers
    No cash transfers.
    Interventions:
    • Behavioral: monthly cash transfer payments for attending school
    • Behavioral: B--No cash transfers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2500
June 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female aged 13 to 20 years.
  • Enrolled in grades 8, 9, 10 or 11 at the beginning of the study at schools in the AHDSS study site
  • Intending to continue to live in the study site until the end of the follow-up period.
  • Be willing and able to consent/assent to all study procedures including HIV and HSV-2 testing.
  • Able to read sufficiently to use ACASI.
  • Have a bank or post office account or have documentation to be able to open a bank or post office account (i.e., birth certificate, South African National Identification Book, or passport and proof of residence). Post Office accounts will only be required for participants in the Intervention arm.
  • Parent/Legal Guardian who lives with young woman, willing and able to consent to all study procedures including HIV and HSV-2 testing.
  • Parent/Legal Guardian has a bank or post office account or has documentation to be able to open a bank or post office account (i.e. South African National Identification Book, or passport and proof of residence). Note that the account may be opened in the name of any adult who resides in the household with the young woman.

Exclusion Criteria:

  • Pregnant by self-report at baseline.
  • Married at baseline.
  • No parent or legal guardian living in household.
  • Any other reason that the staff feels would jeopardize the health or well-being of the participant or staff or would prevent proper conduct of the study.
Female
13 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01233531
HPTN 068, 11710
Yes
HIV Prevention Trials Network
HIV Prevention Trials Network
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)
Study Chair: Audrey Pettifor University of North Carolina
Principal Investigator: Xavier Gomez-Olive Wits Rural Public Health and Health Transitions Research Unit
Principal Investigator: Kathleen Kahn University of Witwatersrand, South Africa
Principal Investigator: Catherine McPhail Reproductive Health & HIV Research Unit, University of Witwatersrand
HIV Prevention Trials Network
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP