Effects of Cash Transfer for the Prevention of HIV in Young South African Women - Full Text View

Purpose

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

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effects of Cash Transfer for the Prevention of HIV in Young South African Women

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by HIV Prevention Trials Network:

Primary Outcome Measures:

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:

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.
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.


Enrollment:	2537
Study Start Date:	March 2011
Study Completion Date:	March 2015
Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


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

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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pettifor A, MacPhail C, Hughes JP, Selin A, Wang J, Gómez-Olivé FX, Eshleman SH, Wagner RG, Mabuza W, Khoza N, Suchindran C, Mokoena I, Twine R, Andrew P, Townley E, Laeyendecker O, Agyei Y, Tollman S, Kahn K. The effect of a conditional cash transfer on HIV incidence in young women in rural South Africa (HPTN 068): a phase 3, randomised controlled trial. Lancet Glob Health. 2016 Dec;4(12):e978-e988. doi: 10.1016/S2214-109X(16)30253-4. Epub 2016 Nov 1.


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 ( US NIH Grant/Contract Award Number )
Study First Received:	November 1, 2010
Last Updated:	January 20, 2016

ClinicalTrials.gov processed this record on May 25, 2017