HPTN 068
Effects of cash transfer for the prevention of HIV in young South African women
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What is HPTN 068?
HPTN 068 was a Phase III research study determine whether providing cash transfers to young women and their household, conditional on school attendance, reduced young women’s risk of acquiring HIV. The overall goal of the Conditional Cash Transfer (CCT) intervention was to reduce structural barriers to education with the goal of increasing school attendance of young women, hereby decreasing their HIV risk.
Who participated in the study?
A total of 2,533 young women were enrolled between March 2011 and December 2012. Participants enrolled in the study were aged 13-20 years, in high school, not married or pregnant, and resided in the Medical Research Council (MRC) / Wits University Agincourt Health and Socio-Demographic Surveillance System (AHDSS) study site. This region is a rural area of Mpumalanga Province in South Africa that is characterized by high HIV prevalence, poverty, and migration for work.
What happened during the study?
In the trial, young women and their parent/guardian were randomized to one of two study arms: 1) a monthly cash transfer of 300 South-African rand per month conditional on 80 percent school attendance, or 2) a control arm that did not receive cash transfer.
Why is this study important?
Young women in South Africa face an extremely high risk of HIV infection. More than 11 percent of young women ages 14 to 24 are living with HIV, compared to less than three percent of men in the same age group. The effect of cash transfers on HIV prevention for young women may depend on the local context. Cash transfers to keep girls in school may have a greater impact in settings where secondary school enrollment is low for young women. The effect of cash transfers to reduce HIV risk behavior through mechanisms other than school attendance will likely be dependent on factors driving HIV risk and how likely it is that those behaviors can be altered by cash, which will largely be dependent on the local context.
Results
The study found that there was no difference in HIV acquisition between the young women who received the cash transfer and those that did not. There were 59 incident HIV infections in the intervention arm and 48 in the control arm (hazard ratio 1.17 (95% CI 0.80-1.71, p=0.43)). Overall HIV incidence was 1.8% during the study, lower than the study team expected. Surprisingly, school attendance was high during the study; 95% of girls in both arms attended school, and there was no difference in school attendance between study arms. In line with the original hypothesis of the trial, young women who stayed in school and attended school more of the time across both arms of the study had a two-thirds reduced risk of acquiring HIV.
Protocol Status
Concluded
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 2500 young women
2) Approximately 2500 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 approximately 4-5 years. Assessments for the young women and parent/legal guardians will take place at baseline and at 12, 24, and 36 months post-baseline (except for young women who are in the 11th grade at enrollment who will be in the study for only two years). An additional assessment will be conducted near the end of the school year for young women who are graduating or at the end of the school year December 2014, whichever comes first. Young women whose most recent visit date is after September 30 will not have this additional Graduation Visit. Young women 18 and older who complete scheduled visits through their anticipated graduation date will also be invited for a Post-Intervention Visit, in which the durability of intervention effect will be assessed.
Treatment Regime
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.
3) To determine, from the Post-Intervention Visit, whether young women who were randomized to receive CCTs have a lower incidence of HIV infection, a lower incidence of Herpes Simplex Virus type 2 (HSV-2) infections, 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, compared to young women who do not receive CCTs.
Other Objectives
Study Documents
HPTN 068 Version 5.0
HPTN 068 Version 3.0
HPTN 068 Version 2.0
HPTN 068 Version 1.0
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