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

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Economic Strengthening (Impumelelo)
HIV Prevention Education (Vhutshilo 2.2)
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV focused on measuring ASPIRES

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • community Based Recruitment

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

ES + HIV Prevention

ES only

HIV only

No intervention (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

STI prevalence Endline 1
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
STI prevalence Endline 2
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)

Secondary Outcome Measures

Prevalence of pregnancy Endline 1
Prevalence of pregnancy among female participants (lab report)
Prevalence of pregnancy Endline 2
Prevalence of pregnancy among female participants (lab report)
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
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
Percent of adolescents engaging in transactional sex in past 6 months Endline 1
self-reported
Percent of adolescents engaging in transactional sex in past 6 months Endline 2
self-reported
Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 1
self-reported
Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 2
self-reported
Mean HIV knowledge score Endline 1
HIV knowledge score calculated based on the answers to survey questions
Mean HIV knowledge score Endline 2
HIV knowledge score calculated based on the answers to survey questions
Mean financial literacy score Endline 1
Financial literacy score calculated based on the answers to survey questions
Mean financial literacy score Endline 2
Financial literacy score calculated based on the answers to survey questions
Percent of adolescents participating in savings group Endline 1
Percent of adolescents participating in savings group (self report)
Percent of adolescents participating in savings group Endline 2
Percent of adolescents participating in savings group (self report)
Percent of adolescents opening savings account Endline 1
Percent of adolescents opening savings account (self report)
Percent of adolescents opening savings account Endline 2
Percent of adolescents opening savings account (self report)
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
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)
Percent of adolescents saving for education Endline 1
Percent of adolescents saving for education (self report)
Percent of adolescents saving for education Endline 2
Percent of adolescents saving for education (self report)
Percent of adolescents whose caregiver provided money for savings Endline 1
Percent of adolescents whose caregiver provided money for savings (self report)
Percent of adolescents whose caregiver provided money for savings Endline 2
Percent of adolescents whose caregiver provided money for savings (self report)
Percent of adolescents who participate in household budgeting Endline 1
Percent of adolescents who participate in household budgeting (self report)
Percent of adolescents who participate in household budgeting Endline 2
Percent of adolescents who participate in household budgeting (self report)

Full Information

First Posted
June 17, 2016
Last Updated
June 15, 2018
Sponsor
FHI 360
Collaborators
Foundation for Professional Development, Future Families
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1. Study Identification

Unique Protocol Identification Number
NCT02888678
Brief Title
Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa
Acronym
ASPIRES
Official Title
A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs for Vulnerable Youth in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
Foundation for Professional Development, Future Families

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
ASPIRES

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1773 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ES + HIV Prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
ES only
Arm Type
Experimental
Arm Description
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.
Arm Title
HIV only
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention (control)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Economic Strengthening (Impumelelo)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIV Prevention Education (Vhutshilo 2.2)
Intervention Description
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 Outcome Measure Information:
Title
STI prevalence Endline 1
Description
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
Time Frame
Nine months after baseline interview
Title
STI prevalence Endline 2
Description
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
Time Frame
eighteen months after baseline interview
Secondary Outcome Measure Information:
Title
Prevalence of pregnancy Endline 1
Description
Prevalence of pregnancy among female participants (lab report)
Time Frame
Nine months after baseline interview
Title
Prevalence of pregnancy Endline 2
Description
Prevalence of pregnancy among female participants (lab report)
Time Frame
eighteen months after baseline interview
Title
Percent of adolescents engaging in protective sexual behavior Endline 1
Description
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
Time Frame
In the 6 month time period prior to the date of the follow up visit
Title
Percent of adolescents engaging in protective sexual behavior Endline 2
Description
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
Time Frame
In the 6 month time period prior to the date of the follow up visit
Title
Percent of adolescents engaging in transactional sex in past 6 months Endline 1
Description
self-reported
Time Frame
In the 6 months prior to the date of the follow up visit
Title
Percent of adolescents engaging in transactional sex in past 6 months Endline 2
Description
self-reported
Time Frame
In the 6 months prior to the date of the follow up visit
Title
Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 1
Description
self-reported
Time Frame
In the 6 months prior to the date of the follow up visit
Title
Percent of adolescents reporting two or more sexual partners in the past 6 months Endline 2
Description
self-reported
Time Frame
In the 6 months prior to the date of the follow up visit
Title
Mean HIV knowledge score Endline 1
Description
HIV knowledge score calculated based on the answers to survey questions
Time Frame
Nine months after baseline interview
Title
Mean HIV knowledge score Endline 2
Description
HIV knowledge score calculated based on the answers to survey questions
Time Frame
Eighteen months after baseline interview
Title
Mean financial literacy score Endline 1
Description
Financial literacy score calculated based on the answers to survey questions
Time Frame
Nine months after baseline interview
Title
Mean financial literacy score Endline 2
Description
Financial literacy score calculated based on the answers to survey questions
Time Frame
eighteen months after baseline interview
Title
Percent of adolescents participating in savings group Endline 1
Description
Percent of adolescents participating in savings group (self report)
Time Frame
Nine months after baseline interview
Title
Percent of adolescents participating in savings group Endline 2
Description
Percent of adolescents participating in savings group (self report)
Time Frame
eighteen months after baseline interview
Title
Percent of adolescents opening savings account Endline 1
Description
Percent of adolescents opening savings account (self report)
Time Frame
Nine months after baseline interview
Title
Percent of adolescents opening savings account Endline 2
Description
Percent of adolescents opening savings account (self report)
Time Frame
eighteen months after baseline interview
Title
Mean total amount of savings in past 1 year Endline 1
Description
Mean total amount of savings starting from prior to enrollment in the study up to 9 months of participation in the study
Time Frame
In the one year prior to the date of the 9 month follow up visit
Title
Mean total amount of savings in past 1 year Endline 2
Description
Mean total amount of savings in past 1 year reported by adolescents (self report)
Time Frame
In the one year prior to the date of the 18 month follow up visit
Title
Percent of adolescents saving for education Endline 1
Description
Percent of adolescents saving for education (self report)
Time Frame
Nine months after baseline interview
Title
Percent of adolescents saving for education Endline 2
Description
Percent of adolescents saving for education (self report)
Time Frame
eighteen months after baseline interview
Title
Percent of adolescents whose caregiver provided money for savings Endline 1
Description
Percent of adolescents whose caregiver provided money for savings (self report)
Time Frame
Nine months after baseline interview
Title
Percent of adolescents whose caregiver provided money for savings Endline 2
Description
Percent of adolescents whose caregiver provided money for savings (self report)
Time Frame
eighteen months after baseline interview
Title
Percent of adolescents who participate in household budgeting Endline 1
Description
Percent of adolescents who participate in household budgeting (self report)
Time Frame
Nine months after baseline interview
Title
Percent of adolescents who participate in household budgeting Endline 2
Description
Percent of adolescents who participate in household budgeting (self report)
Time Frame
eighteen months after baseline interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Burke, PhD
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
Facility Information:
Facility Name
community Based Recruitment
City
Pretoria
State/Province
Gauteng
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32355569
Citation
Burke HM, Chen M, Murray K, Bezuidenhout C, Ngwepe P, Bernholc A, Medina-Marino A. The effects of the integration of an economic strengthening and HIV prevention education programme on the prevalence of sexually transmitted infections and savings behaviours among adolescents: a full-factorial randomised controlled trial in South Africa. BMJ Glob Health. 2020 Apr 7;5(4):e002029. doi: 10.1136/bmjgh-2019-002029. eCollection 2020.
Results Reference
derived

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

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