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

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ClinicalTrials.gov Identifier: NCT01233531
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : January 21, 2016
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
HIV Prevention Trials Network

Study Description
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Brief Summary:
Cash transfers to young women for staying in school and its effect on acquiring HIV

Condition or disease Intervention/treatment Phase
HIV Behavioral: monthly cash transfer payments for attending school Behavioral: B--No cash transfers Phase 3

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2537 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Cash Transfer for the Prevention of HIV in Young South African Women
Study Start Date : March 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
A--Monthly cash transfers
Monthly cash transfer payments
 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.
B--No cash transfers
No cash transfers.
 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


Outcome Measures
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Primary Outcome Measures :
  1. HIV Incidence [ Time Frame: 4 years ]
    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.


Secondary Outcome Measures :
  1. HSV-2 incidence [ Time Frame: 4 years ]
    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.

  2. HSV Incidence [ Time Frame: 4 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233531


Locations
South Africa
Agincourt
Acornhoek, South Africa
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Investigators
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT01233531     History of Changes
Other Study ID Numbers: HPTN 068
11710 ( Other Identifier: DAIDS ID: 11710 )
UM1AI068619 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016