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

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ClinicalTrials.gov Identifier: NCT02888678
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
Foundation for Professional Development
Future Families
Information provided by (Responsible Party):
FHI 360

Brief 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.

Condition or disease Intervention/treatment Phase
HIV HIV Infections Behavioral: Economic Strengthening (Impumelelo) Behavioral: HIV Prevention Education (Vhutshilo 2.2) Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1773 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs for Vulnerable Youth in South Africa
Actual Study Start Date : February 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: ES + HIV Prevention

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.

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.

Behavioral: 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.

Experimental: ES only
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.
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.

Experimental: HIV only
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.
Behavioral: 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.

No Intervention: No intervention (control)
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888678


Locations
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South Africa
community Based Recruitment
Pretoria, Gauteng, South Africa
Sponsors and Collaborators
FHI 360
Foundation for Professional Development
Future Families
Investigators
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Principal Investigator: Holly Burke, PhD FHI 360

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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT02888678     History of Changes
Other Study ID Numbers: 741818
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by FHI 360:
ASPIRES
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases