Clinical trial NCT01233531: Effects of Cash Transfer for the Prevention of HIV in Young South African Women
Official title: Effects of Cash Transfer for the Prevention of HIV in Young South African Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Mental Health (NIMH)
name: National Institutes of Health (NIH)
First posted: 2010-11-03
Enrollment: 2537
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Primary outcomes:
measure: HIV Incidence
timeFrame: 4 years
Secondary outcomes:
measure: HSV-2 incidence
timeFrame: 4 years
measure: HSV Incidence
timeFrame: 4 years
Other outcomes:
Locations:
city: Acornhoek
country: South Africa
facility: Agincourt
Study officials:
affiliation: University of North Carolina
name: Audrey Pettifor
role: STUDY_CHAIR
affiliation: Wits Rural Public Health and Health Transitions Research Unit
name: Xavier Gomez-Olive
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Witwatersrand, South Africa
name: Kathleen Kahn
role: PRINCIPAL_INVESTIGATOR
affiliation: Reproductive Health & HIV Research Unit, University of Witwatersrand
name: Catherine McPhail
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jayaweera RT, Goin D, Twine R, Neilands TB, Wagner RG, Lippman SA, Kahn K, Pettifor A, Ahern J. Associations between WASH-related violence and depressive symptoms in adolescent girls and young women in South Africa (HPTN 068): a cross-sectional analysis. BMJ Open. 2022 Jul 5;12(7):e061032. doi: 10.1136/bmjopen-2022-061032.
citation: DeLong SM, Powers KA, Pence BW, Maman S, Dunkle KL, Selin A, Twine R, Wagner RG, Gomez-Olive FX, MacPhail C, Kahn K, Pettifor A. Longitudinal Trajectories of Physical Intimate Partner Violence Among Adolescent Girls in Rural South Africa: Findings From HPTN 068. J Adolesc Health. 2020 Jul;67(1):69-75. doi: 10.1016/j.jadohealth.2019.12.016. Epub 2020 Feb 13.
citation: MacPhail C, Khoza N, Selin A, Julien A, Twine R, Wagner RG, Gomez-Olive X, Kahn K, Wang J, Pettifor A. Cash transfers for HIV prevention: what do young women spend it on? Mixed methods findings from HPTN 068. BMC Public Health. 2017 Jul 11;18(1):10. doi: 10.1186/s12889-017-4513-3.
citation: Pettifor A, MacPhail C, Hughes JP, Selin A, Wang J, Gomez-Olive 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.