- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888678
Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa (ASPIRES)
A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs for Vulnerable Youth in South Africa
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gauteng
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Pretoria, Gauteng, South Africa
- Community Based Recruitment
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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. |
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): 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
STI prevalence Endline 1
Time Frame: Nine months after baseline interview
|
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
|
Nine months after baseline interview
|
STI prevalence Endline 2
Time Frame: eighteen months after baseline interview
|
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
|
eighteen months after baseline interview
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of pregnancy Endline 1
Time Frame: Nine months after baseline interview
|
Prevalence of pregnancy among female participants (lab report)
|
Nine months after baseline interview
|
Prevalence of pregnancy Endline 2
Time Frame: eighteen months after baseline interview
|
Prevalence of pregnancy among female participants (lab report)
|
eighteen months after baseline interview
|
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
|
In the 6 month time period prior to the date of the follow up visit
|
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
|
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
Time Frame: In the 6 months prior to the date of the follow up visit
|
self-reported
|
In the 6 months prior to the date of the follow up visit
|
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
|
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 1
Time Frame: In the 6 months prior to the date of the follow up visit
|
self-reported
|
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
Time Frame: In the 6 months prior to the date of the follow up visit
|
self-reported
|
In the 6 months prior to the date of the follow up visit
|
Mean HIV knowledge score Endline 1
Time Frame: Nine months after baseline interview
|
HIV knowledge score calculated based on the answers to survey questions
|
Nine months after baseline interview
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Mean HIV knowledge score Endline 2
Time Frame: Eighteen months after baseline interview
|
HIV knowledge score calculated based on the answers to survey questions
|
Eighteen months after baseline interview
|
Mean financial literacy score Endline 1
Time Frame: Nine months after baseline interview
|
Financial literacy score calculated based on the answers to survey questions
|
Nine months after baseline interview
|
Mean financial literacy score Endline 2
Time Frame: eighteen months after baseline interview
|
Financial literacy score calculated based on the answers to survey questions
|
eighteen months after baseline interview
|
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)
|
Nine months after baseline interview
|
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)
|
eighteen months after baseline interview
|
Percent of adolescents opening savings account Endline 1
Time Frame: Nine months after baseline interview
|
Percent of adolescents opening savings account (self report)
|
Nine months after baseline interview
|
Percent of adolescents opening savings account Endline 2
Time Frame: eighteen months after baseline interview
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Percent of adolescents opening savings account (self report)
|
eighteen months after baseline interview
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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
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Mean total amount of savings starting from prior to enrollment in the study up to 9 months of participation in the study
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In the one year prior to the date of the 9 month follow up visit
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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
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Mean total amount of savings in past 1 year reported by adolescents (self report)
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In the one year prior to the date of the 18 month follow up visit
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Percent of adolescents saving for education Endline 1
Time Frame: Nine months after baseline interview
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Percent of adolescents saving for education (self report)
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Nine months after baseline interview
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Percent of adolescents saving for education Endline 2
Time Frame: eighteen months after baseline interview
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Percent of adolescents saving for education (self report)
|
eighteen months after baseline interview
|
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)
|
Nine months after baseline interview
|
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)
|
eighteen months after baseline interview
|
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)
|
Nine months after baseline interview
|
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)
|
eighteen months after baseline interview
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Holly Burke, PhD, FHI 360
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 741818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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