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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233531
• Other study ID #: HPTN 068
• Secondary ID: 11710UM1AI068619
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2022
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2537
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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 monthly cash transfers

Locations

Country	Name	City	State
South Africa	Agincourt	Acornhoek

Sponsors (4)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Incidence	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.	4 years
Secondary	HSV-2 incidence	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.	4 years
Secondary	HSV Incidence	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.	4 years