Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa

HIV Infections Clinical Trial

— ASPIRES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888678
• Other study ID #: 741818
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1773
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Behavioral:
• Economic Strengthening (Impumelelo)
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.
• HIV Prevention Education (Vhutshilo 2.2)
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.

Locations

Country	Name	City	State
South Africa	community Based Recruitment	Pretoria	Gauteng

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	Foundation for Professional Development, Future Families

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STI prevalence Endline 1	Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)	Nine months after baseline interview
Primary	STI prevalence Endline 2	Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)	eighteen months after baseline interview
Secondary	Prevalence of pregnancy Endline 1	Prevalence of pregnancy among female participants (lab report)	Nine months after baseline interview
Secondary	Prevalence of pregnancy Endline 2	Prevalence of pregnancy among female participants (lab report)	eighteen months after baseline interview
Secondary	Percent of adolescents engaging in protective sexual behavior Endline 1	Percent of adolescents engaging in protective sexual behavior, defined as self-reported abstinence or consistent condom use (a condom used every time) over the past 6 months	In the 6 month time period prior to the date of the follow up visit
Secondary	Percent of adolescents engaging in protective sexual behavior Endline 2	Percent of adolescents engaging in protective sexual behavior, defined as self-reported abstinence or consistent condom use (a condom used every time) over the past 6 months	In the 6 month time period prior to the date of the follow up visit
Secondary	Percent of adolescents engaging in transactional sex in past 6 months Endline 1	self-reported	In the 6 months prior to the date of the follow up visit
Secondary	Percent of adolescents engaging in transactional sex in past 6 months Endline 2	self-reported	In the 6 months prior to the date of the follow up visit
Secondary	Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 1	self-reported	In the 6 months prior to the date of the follow up visit
Secondary	Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 2	self-reported	In the 6 months prior to the date of the follow up visit
Secondary	Mean HIV knowledge score Endline 1	HIV knowledge score calculated based on the answers to survey questions	Nine months after baseline interview
Secondary	Mean HIV knowledge score Endline 2	HIV knowledge score calculated based on the answers to survey questions	Eighteen months after baseline interview
Secondary	Mean financial literacy score Endline 1	Financial literacy score calculated based on the answers to survey questions	Nine months after baseline interview
Secondary	Mean financial literacy score Endline 2	Financial literacy score calculated based on the answers to survey questions	eighteen months after baseline interview
Secondary	Percent of adolescents participating in savings group Endline 1	Percent of adolescents participating in savings group (self report)	Nine months after baseline interview
Secondary	Percent of adolescents participating in savings group Endline 2	Percent of adolescents participating in savings group (self report)	eighteen months after baseline interview
Secondary	Percent of adolescents opening savings account Endline 1	Percent of adolescents opening savings account (self report)	Nine months after baseline interview
Secondary	Percent of adolescents opening savings account Endline 2	Percent of adolescents opening savings account (self report)	eighteen months after baseline interview
Secondary	Mean total amount of savings in past 1 year Endline 1	Mean total amount of savings starting from prior to enrollment in the study up to 9 months of participation in the study	In the one year prior to the date of the 9 month follow up visit
Secondary	Mean total amount of savings in past 1 year Endline 2	Mean total amount of savings in past 1 year reported by adolescents (self report)	In the one year prior to the date of the 18 month follow up visit
Secondary	Percent of adolescents saving for education Endline 1	Percent of adolescents saving for education (self report)	Nine months after baseline interview
Secondary	Percent of adolescents saving for education Endline 2	Percent of adolescents saving for education (self report)	eighteen months after baseline interview
Secondary	Percent of adolescents whose caregiver provided money for savings Endline 1	Percent of adolescents whose caregiver provided money for savings (self report)	Nine months after baseline interview
Secondary	Percent of adolescents whose caregiver provided money for savings Endline 2	Percent of adolescents whose caregiver provided money for savings (self report)	eighteen months after baseline interview
Secondary	Percent of adolescents who participate in household budgeting Endline 1	Percent of adolescents who participate in household budgeting (self report)	Nine months after baseline interview
Secondary	Percent of adolescents who participate in household budgeting Endline 2	Percent of adolescents who participate in household budgeting (self report)	eighteen months after baseline interview