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

August 25, 2022 updated by: HIV Prevention Trials Network
Cash transfers to young women for staying in school and its effect on acquiring HIV

Study Overview

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 Type

Interventional

Enrollment (Actual)

2537

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A--Monthly cash transfers
Monthly cash transfer payments
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.
Other: B--No cash transfers
No cash transfers.
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.
No monthly cash transfers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HPTN 068
  • UM1AI068619 (U.S. NIH Grant/Contract)
  • 11710 (Other Identifier: DAIDS ID: 11710)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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