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临床试验/NCT02888678
NCT02888678已完成不适用

A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs for Vulnerable Youth in South Africa

FHI 3601 个研究点 分布在 1 个国家目标入组 1,773 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
FHI 360
入组人数
1,773
试验地点
1
主要终点
STI prevalence Endline 1

研究概览

简要总结

This study evaluates whether the integration of an Economic Strengthening program with an HIV-prevention education program produce synergistic effects on economic and health outcomes for South African youth ages 14-17 years old.

详细描述

In South Africa, the overall HIV prevalence of 12.2% can be reviewed based on a number of factors: age, province, type of locality, race, economic household conditions, and marital status. Those to be reached through the ASPIRES intervention and evaluation are economically disadvantaged Black African youth, male and female, located in urban localities in Gauteng province, and are situated within a setting of high risk and vulnerability for HIV. The ASPIRES project is providing technical assistance to provide economic strengthening (ES) and HIV prevention education programming for adolescents. The ASPIRES ES intervention includes financial capability building through the provision of financial education in combination with access to appropriate youth-friendly savings mechanisms. The HIV prevention education intervention Vhutshilo 2.2 will be used in this study.

This study will assess whether the integration of an ES intervention with an HIV-prevention education intervention improves economic and health outcomes beyond singular interventions, estimate the resources required at the program level to support the ES and HIV-prevention education interventions; and describe whether the interventions were perceived as effective in addressing economic and health outcomes and to describe how and why the interventions were perceived as effective or not.

This study will enroll up to 2000 youth ages 14-17 and randomly assign them to either 1) ES intervention only, 2) HIV prevention intervention only, 3) combined ES and HIV intervention, or 4) no intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Beneficiary of Future Families in a study community
  • Parent or guardian consent allowing adolescent to participate in the study
  • Willing to sign or make their mark on an assent form
  • Willing to provide contact information
  • Only one adolescent is eligible per household

排除标准

  • 未提供

研究组 & 干预措施

ES + HIV Prevention

Experimental

Economic Strengthening + HIV prevention education combined intervention consists of 2 parts.

Impumelelo: This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.

Vhutshilo 2.2: . This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.

干预措施: Economic Strengthening (Impumelelo) (Behavioral)

ES + HIV Prevention

Experimental

Economic Strengthening + HIV prevention education combined intervention consists of 2 parts.

Impumelelo: This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.

Vhutshilo 2.2: . This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.

干预措施: HIV Prevention Education (Vhutshilo 2.2) (Behavioral)

ES only

Experimental

Economic Strengthening (Impumelelo): This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.

干预措施: Economic Strengthening (Impumelelo) (Behavioral)

HIV only

Experimental

HIV Prevention Education (Vhutshilo 2.2): This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.

干预措施: HIV Prevention Education (Vhutshilo 2.2) (Behavioral)

No intervention (control)

No Intervention

The control group will not receive the ES or HIV prevention interventions. They will receive the basic package of services available to all beneficiaries of Future Families.

结局指标

主要结局

STI prevalence Endline 1

时间窗: Nine months after baseline interview

Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)

STI prevalence Endline 2

时间窗: eighteen months after baseline interview

Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)

次要结局

  • Percent of adolescents engaging in transactional sex in past 6 months Endline 2(In the 6 months prior to the date of the follow up visit)
  • Prevalence of pregnancy Endline 1(Nine months after baseline interview)
  • Percent of adolescents engaging in protective sexual behavior Endline 2(In the 6 month time period prior to the date of the follow up visit)
  • Percent of adolescents engaging in transactional sex in past 6 months Endline 1(In the 6 months prior to the date of the follow up visit)
  • Mean HIV knowledge score Endline 2(Eighteen months after baseline interview)
  • Mean financial literacy score Endline 1(Nine months after baseline interview)
  • Mean HIV knowledge score Endline 1(Nine months after baseline interview)
  • Prevalence of pregnancy Endline 2(eighteen months after baseline interview)
  • Percent of adolescents engaging in protective sexual behavior Endline 1(In the 6 month time period prior to the date of the follow up visit)
  • Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 1(In the 6 months prior to the date of the follow up visit)
  • Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 2(In the 6 months prior to the date of the follow up visit)
  • Mean financial literacy score Endline 2(eighteen months after baseline interview)
  • Percent of adolescents opening savings account Endline 1(Nine months after baseline interview)
  • Mean total amount of savings in past 1 year Endline 2(In the one year prior to the date of the 18 month follow up visit)
  • Percent of adolescents saving for education Endline 2(eighteen months after baseline interview)
  • Percent of adolescents whose caregiver provided money for savings Endline 2(eighteen months after baseline interview)
  • Percent of adolescents who participate in household budgeting Endline 1(Nine months after baseline interview)
  • Percent of adolescents participating in savings group Endline 1(Nine months after baseline interview)
  • Percent of adolescents participating in savings group Endline 2(eighteen months after baseline interview)
  • Percent of adolescents opening savings account Endline 2(eighteen months after baseline interview)
  • Mean total amount of savings in past 1 year Endline 1(In the one year prior to the date of the 9 month follow up visit)
  • Percent of adolescents saving for education Endline 1(Nine months after baseline interview)
  • Percent of adolescents who participate in household budgeting Endline 2(eighteen months after baseline interview)
  • Percent of adolescents whose caregiver provided money for savings Endline 1(Nine months after baseline interview)

研究者

发起方
FHI 360
申办方类型
Other
责任方
Sponsor

研究点 (1)

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