HPTN 068

Effects of cash transfer for the prevention of HIV in young South African women

What is HPTN 068?

Protocol Status: Closed to Accrual

Study Summary

Study Purpose: 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, hereby decreasing their HIV risk.

Study Design: A phase III, randomized, controlled factorial design study.

Study Population: 1) Conditional Cash Transfer Intervention: Young women ages 13-20 years, living in approximately 24 villages in South Africa who are enrolled in grades 8, 9, 10 or 11 of high school during recruitment. 2) Focus group discussions (FGDs), in-depth interviews (IDIs), and Case Studies young women, young men in the study grades of young women in the CCT intervention, teachers/educators, and community members living in the study villages.

Study Size: 1) Approximately 2900 young women 2) Approximately 2900 parents/legal guardians of the young women 3) Qualitative data collection activities. Case studies: approximately 30 with girls with both arms; Focus group discussions: approximately 12 groups w/teachers/educators; approximately 18 groups w/young women; approximately 12 groups w/young men in study grades.

Study Duration: The study will last for approximately 4 years. Screening and enrollment of young women and parent/legal guardians are expected to take place during the first 5 months of study. Assessments for the young women and parent/legal guardians will take place at baseline and at 12, 24 and 36 months post-baseline.

Treatment Regimen: In the intervention, young women and their households will be randomized 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.

Primary Objectives: To determine whether young women who are randomized to receive cash transfers 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 Objectives: 1) 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) To determine whether young women who receive the CCTs report less unprotected sex, fewer number of sex 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.

SDMC Protocol Specialist: James Hughes get info

SDMC Protocol Specialist: Peter McDonnell get info

SDMC Project Manager: Diana Lynn get info

Protocol Team Member: Amanda Selin get info

Protocol Team Member: Harsha Thirumurthy get info

Protocol Team Member: Helen Rees get info

Protocol Team Member: James Hargreaves get info

Protocol Team Member: Jing Wang get info

Protocol Team Member: Kathleen Kahn get info

Protocol Team Member: Lynda Marie Emel get info

Protocol Team Member: Mary Jane Hill get info

Protocol Team Member: Michelle Adato get info

Protocol Team Member: Paul Mee get info

Protocol Team Member: Rhian Twine get info

Protocol Team Member: Stephen Tollman get info

Protocol Team Member: Sudhanshu Handa get info

Protocol Team Member: Susan Eshleman get info

Protocol Team Member: Susannah Allison get info

Protocol Team Member: Suzanne Maman get info

Protocol Team Member: Xavier Gomez-Olive get info

Protocol Chair: Audrey Pettifor get info

DAIDS Medical Officer: Paul Sato get info

CORE Protocol Specialist: Erica Hamilton get info

CORE Protocol Specialist: Philip Andrew get info