HIVASPIRESNCT02888678
Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa
A study testing Economic Strengthening (Impumelelo) and HIV Prevention Education (Vhutshilo 2.2) in people with HIV and HIV Infections, run by FHI 360 at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Economic Strengthening (Impumelelo) and HIV Prevention Education (Vhutshilo 2.2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,773 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2016to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs 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.
Read the 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.
- Conditions
- HIV, HIV Infections
- Being tested
- Economic Strengthening (Impumelelo), HIV Prevention Education (Vhutshilo 2.2)
- Keywords
- ASPIRES
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Economic Strengthening (Impumelelo)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ES + HIV Prevention | Experimental | 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. Receives: Behavioral: Economic Strengthening (Impumelelo); Behavioral: HIV Prevention Education (Vhutshilo 2.2) |
| ES only | Experimental | 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. Receives: Behavioral: Economic Strengthening (Impumelelo) |
| HIV only | Experimental | 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. Receives: Behavioral: HIV Prevention Education (Vhutshilo 2.2) |
| No intervention (control) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
STI prevalence Endline 1
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
Measured: Nine months after baseline interview
STI prevalence Endline 2
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
Measured: eighteen months after baseline interview
Secondary outcomes (24)
Prevalence of pregnancy Endline 1
Prevalence of pregnancy among female participants (lab report)
Measured: Nine months after baseline interview
Prevalence of pregnancy Endline 2
Prevalence of pregnancy among female participants (lab report)
Measured: eighteen months after baseline interview
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
Measured: 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
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
Measured: 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
self-reported
Measured: 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
self-reported
Measured: 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
self-reported
Measured: 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
self-reported
Measured: In the 6 months prior to the date of the follow up visit
Mean HIV knowledge score Endline 1
HIV knowledge score calculated based on the answers to survey questions
Measured: Nine months after baseline interview
Mean HIV knowledge score Endline 2
HIV knowledge score calculated based on the answers to survey questions
Measured: Eighteen months after baseline interview
Mean financial literacy score Endline 1
Financial literacy score calculated based on the answers to survey questions
Measured: Nine months after baseline interview
Mean financial literacy score Endline 2
Financial literacy score calculated based on the answers to survey questions
Measured: eighteen months after baseline interview
Percent of adolescents participating in savings group Endline 1
Percent of adolescents participating in savings group (self report)
Measured: Nine months after baseline interview
Percent of adolescents participating in savings group Endline 2
Percent of adolescents participating in savings group (self report)
Measured: eighteen months after baseline interview
Percent of adolescents opening savings account Endline 1
Percent of adolescents opening savings account (self report)
Measured: Nine months after baseline interview
Percent of adolescents opening savings account Endline 2
Percent of adolescents opening savings account (self report)
Measured: eighteen months after baseline interview
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
Measured: In the one year prior to the date of the 9 month follow up visit
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)
Measured: In the one year prior to the date of the 18 month follow up visit
Percent of adolescents saving for education Endline 1
Percent of adolescents saving for education (self report)
Measured: Nine months after baseline interview
Percent of adolescents saving for education Endline 2
Percent of adolescents saving for education (self report)
Measured: eighteen months after baseline interview
Percent of adolescents whose caregiver provided money for savings Endline 1
Percent of adolescents whose caregiver provided money for savings (self report)
Measured: Nine months after baseline interview
Percent of adolescents whose caregiver provided money for savings Endline 2
Percent of adolescents whose caregiver provided money for savings (self report)
Measured: eighteen months after baseline interview
Percent of adolescents who participate in household budgeting Endline 1
Percent of adolescents who participate in household budgeting (self report)
Measured: Nine months after baseline interview
Percent of adolescents who participate in household budgeting Endline 2
Percent of adolescents who participate in household budgeting (self report)
Measured: eighteen months after baseline interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Professional Development, Future Families
- Responsible party
- Sponsor
- Investigators
- Holly Burke, PhD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888678
- Sponsor's protocol ID
- 741818
- Acronym
- ASPIRES
- Status last verified
- Jun 2018
- First submitted
- 17 Jun 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32355569
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating an Intervention Integrating Economic Strengthening and HIV Prevention Programs for Vulnerable Youth in South Africa
- ClinicalTrials.gov ID
- NCT02888678
- Acronym / sponsor ID
- ASPIRES / 741818
- Conditions
- HIV, HIV Infections
- Keywords
- ASPIRES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,773 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Foundation for Professional Development, Future Families
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ES + HIV Prevention | Experimental | Behavioral: Economic Strengthening (Impumelelo), Behavioral: HIV Prevention Education (Vhutshilo 2.2)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. |
| ES only | Experimental | 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 only | Experimental | 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 (control) | No intervention | –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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ES + HIV Prevention, ES only |
| 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. | Behavioural | ES + HIV Prevention, HIV only |
Primary outcome
STI prevalence Endline 1
Time frame: Nine months after baseline interview
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
STI prevalence Endline 2
Time frame: eighteen months after baseline interview
Prevalence of gonorrhea, trichomoniasis or chlamydia infection (lab report)
24 secondary outcomes
Prevalence of pregnancy Endline 1
Time frame: Nine months after baseline interview
Prevalence of pregnancy Endline 2
Time frame: 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 Endline 2
Time frame: 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
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
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
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
Mean HIV knowledge score Endline 1
Time frame: Nine months after baseline interview
Mean HIV knowledge score Endline 2
Time frame: Eighteen months after baseline interview
Mean financial literacy score Endline 1
Time frame: Nine months after baseline interview
Mean financial literacy score Endline 2
Time frame: 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 Endline 2
Time frame: 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 Endline 2
Time frame: eighteen months after baseline interview
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 in past 1 year Endline 2
Time frame: In the one year prior to the date of the 18 month follow up visit
Percent of adolescents saving for education Endline 1
Time frame: Nine months after baseline interview
Percent of adolescents saving for education Endline 2
Time frame: 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 Endline 2
Time frame: 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 Endline 2
Time frame: eighteen months after baseline interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Derived from this study: PubMed 32355569Burke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Burke, PhD principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Economic Strengthening (Impumelelo) and HIV Prevention Education (Vhutshilo 2.2) in people with HIV and HIV Infections, run by FHI 360 at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STI prevalence Endline 1 (time frame: Nine months after baseline interview). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.