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Completed

NCT Number: NCT02888678

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

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.

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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

community Based Recruitment

Pretoria, Gauteng, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Economic Strengthening (Impumelelo)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. STI prevalence Endline 1

    Time frame: Nine months after baseline interview

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

  2. STI prevalence Endline 2

    Time frame: eighteen months after baseline interview

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

Secondary outcomes

  1. Prevalence of pregnancy Endline 1

    Time frame: Nine months after baseline interview

    Prevalence of pregnancy among female participants (lab report)

  2. Prevalence of pregnancy Endline 2

    Time frame: eighteen months after baseline interview

    Prevalence of pregnancy among female participants (lab report)

  3. Percent of adolescents engaging in protective sexual behavior Endline 1

    Time frame: In the 6 month time period prior to the date of the follow up visit

    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

  4. Percent of adolescents engaging in protective sexual behavior Endline 2

    Time frame: In the 6 month time period prior to the date of the follow up visit

    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

  5. Percent of adolescents engaging in transactional sex in past 6 months Endline 1

    Time frame: In the 6 months prior to the date of the follow up visit

    self-reported

  6. Percent of adolescents engaging in transactional sex in past 6 months Endline 2

    Time frame: In the 6 months prior to the date of the follow up visit

    self-reported

  7. Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 1

    Time frame: In the 6 months prior to the date of the follow up visit

    self-reported

  8. Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 2

    Time frame: In the 6 months prior to the date of the follow up visit

    self-reported

  9. Mean HIV knowledge score Endline 1

    Time frame: Nine months after baseline interview

    HIV knowledge score calculated based on the answers to survey questions

  10. Mean HIV knowledge score Endline 2

    Time frame: Eighteen months after baseline interview

    HIV knowledge score calculated based on the answers to survey questions

  11. Mean financial literacy score Endline 1

    Time frame: Nine months after baseline interview

    Financial literacy score calculated based on the answers to survey questions

  12. Mean financial literacy score Endline 2

    Time frame: eighteen months after baseline interview

    Financial literacy score calculated based on the answers to survey questions

  13. Percent of adolescents participating in savings group Endline 1

    Time frame: Nine months after baseline interview

    Percent of adolescents participating in savings group (self report)

  14. Percent of adolescents participating in savings group Endline 2

    Time frame: eighteen months after baseline interview

    Percent of adolescents participating in savings group (self report)

  15. Percent of adolescents opening savings account Endline 1

    Time frame: Nine months after baseline interview

    Percent of adolescents opening savings account (self report)

  16. Percent of adolescents opening savings account Endline 2

    Time frame: eighteen months after baseline interview

    Percent of adolescents opening savings account (self report)

  17. Mean total amount of savings in past 1 year Endline 1

    Time frame: In the one year prior to the date of the 9 month follow up visit

    Mean total amount of savings starting from prior to enrollment in the study up to 9 months of participation in the study

  18. Mean total amount of savings in past 1 year Endline 2

    Time frame: In the one year prior to the date of the 18 month follow up visit

    Mean total amount of savings in past 1 year reported by adolescents (self report)

  19. Percent of adolescents saving for education Endline 1

    Time frame: Nine months after baseline interview

    Percent of adolescents saving for education (self report)

  20. Percent of adolescents saving for education Endline 2

    Time frame: eighteen months after baseline interview

    Percent of adolescents saving for education (self report)

  21. Percent of adolescents whose caregiver provided money for savings Endline 1

    Time frame: Nine months after baseline interview

    Percent of adolescents whose caregiver provided money for savings (self report)

  22. Percent of adolescents whose caregiver provided money for savings Endline 2

    Time frame: eighteen months after baseline interview

    Percent of adolescents whose caregiver provided money for savings (self report)

  23. Percent of adolescents who participate in household budgeting Endline 1

    Time frame: Nine months after baseline interview

    Percent of adolescents who participate in household budgeting (self report)

  24. Percent of adolescents who participate in household budgeting Endline 2

    Time frame: eighteen months after baseline interview

    Percent of adolescents who participate in household budgeting (self report)

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • Foundation for Professional Development
  • Future Families

Registry information

Official study title

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

Acronym: ASPIRES

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2016
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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