跳至主要内容
临床试验/NCT03597243
NCT03597243Unknown不适用

Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behaviour - an Impact Evaluation

National Institute for Medical Research, Tanzania1 个研究点 分布在 1 个国家目标入组 3,120 人开始时间: 2017年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
3,120
试验地点
1
主要终点
HSV-2 Incidence

研究概览

简要总结

Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behavior. The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques. The study will inform policy makers on the impact of Cash transfer programs in AGYW as a tool to reduce vulnerability to HIV infection in Adolescent Girls and Young women.

详细描述

Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behaviour. Poverty and few alternative opportunities to generate income make AGYW prone to compensated and often inter-generational and unprotected sex.

The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques.

Cash transfer interacts with structural factors influencing sexual risk behavior in AGYW, providing alternative source to solve their social and economic needs and hence reducing the pressure to engage in compensated and unprotected sex which further reduces the risk of HSV-2 and HIV acquisition at the population level.

The proposed study (CARE study) is two parallel arms cluster-randomized controlled trial implemented in 3120 adolescent girls and young women (AGYW) aged 15-23 years followed up for 18 months. Participants in randomized clusters will receive a quarterly cash transfer payment through mobile money on their cellular phones in Arm I (Unconditional Cash Transfer) while Arm II will not receive cash transfer payments (Control). The study will be conducted in Kahama Town Council, Ushetu and Msalala District Councils in Shinyanga region in mainland Tanzania.

CARE study will enrol AGYW aged 15-23 years in 3 districts of Tanzania namely Msalala district, Ushetu district and Kahama town council in Shinyanga region. Villages in these areas will be eligible in the trial if they are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 23 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Adolescent girls and young women aged 15-23 years.
  • Graduated from ten hours of Sauti's BCC sessions.
  • Resident of the village of recruitment
  • Registered into Cash Transfer Program (CTP) (applicable in the CTP areas only).
  • Currently out of school (currently not enrolled in primary, secondary or tertiary education. Either they have never been to school or have dropped out of school for at least a month at time of study enrolment) as documented through a previous household survey of the CT Program (Girls roster).
  • Willing and able to give voluntary, informed consent/assent to all study procedures including HIV and HSV-2 testing and receive test results.
  • (If <18 years) guardian of the minor AGYW is willing to consent for the study procedures except for emancipated minors (i.e. minors who are married, have given birth or demonstrating full independence e.g. living alone or heading the household).

排除标准

  • Not willing or able to consent or assent to the study, in case of minor, no consent from guardian. All minors will require guardian consent except for emancipated minors.
  • AGYW not willing to test for HIV or HSV-2 or to receive test results.

研究组 & 干预措施

Intervention

Experimental

AGYW in the standard Sauti cash transfer (Arm I) will receive unconditional cash transfer (UCT) in the presence of behavioral and biomedical interventions in quarterly installments of 70,000 TSH. The first installment will take place after completion of 10 hours of BCC sessions and the AGYW has registered into CTP.

干预措施: Cash Transfer (Other)

Control

No Intervention

AGYW in the control group (Arm II) will not receive cash payment but will receive behavioral and biomedical interventions. The behavioral and biomedical interventions are provided by Sauti program to all project beneficiaries.

结局指标

主要结局

HSV-2 Incidence

时间窗: 18 months of follow-up

Proportion of HSV-2 negative girls who are still free of HSV-2 across the two arms

次要结局

  • HIV prevalence(18 months of follow-up)
  • reporting of compensated sex(18 months of follow-up)
  • reporting of intergenerational sexual partnerships(18 months of follow-up)

研究者

发起方
National Institute for Medical Research, Tanzania
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mwita Wambura

Principal Research Scientist

National Institute for Medical Research, Tanzania

研究点 (1)

Loading locations...

相似试验