HIVSHAZ!NCT02034214
Shaping the Health of Adolescents in Zimbabwe
A study testing Life skills education, Reproductive health services and Economic livelihoods in people with HIV, run by University of California, San Francisco at 1 site in Zimbabwe.
Trial summary
The SHAZ! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. Read more about this study
- Who is it for?
- Ages 16 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Life skills education, Reproductive health services and Economic livelihoods
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 1 siteZimbabwe
- Study dates
- Feb 2006to Oct 2008
- 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 16 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16 to 19 years old
- out of school
- orphaned
- willing to participate in intervention activities
- living in Chitungwiza
Who cannot join
- HIV infection
- currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Economic Opportunity for Zimbabwean Adolescent Orphans
The SHAZ! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. SHAZ! enrolled young women 16 to 19 years old who had been orphaned and who were currently out of school and not infected with HIV. Individuals participated in the project for up to two years.
- Conditions
- HIV
- Being tested
- Life skills education, Reproductive health services, Economic livelihoods
- Keywords
- HIV, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life skills educationBehavioural
The life skills curriculum drew upon Stepping Stones and CDC-Zimbabwe Talk Time, developed with input from the target population. It consisted of 14 modules delivered to groups of 25 over 4-6 weeks on: HIV/STI and reproductive health; relationship negotiation; strategies to avoid violence;and identification of safe and risky places in the community. Participants also attended a six-weeks-long home-based care training conducted through Red Cross Zimbabwe, to gain skills on safely caring for people living with HIV.
Reproductive health servicesOther
All participants were provided a health screening at every study visit and were treated for treatable STIs and minor ailments. They received condoms, and contraceptive pills or injectable free upon request. Participants who tested positive for HIV were referred to local clinics, where the study team assisted with ART registration including payment for CD4 tests required for enrolment.
Economic livelihoodsBehavioural
The Livelihoods intervention consisted of financial literacy and a choice of vocational training at local training institutes. Courses were 6-months-long, conducted in English, with a practical and a theoretical component. In spite of encouragement to venture outside of accepted gender norms, the most popular courses were hairdressing, garment-making, and receptionist/secretarial and nurse-aid training. Participants who passed developed business plans that were supported with a micro-grant valued at $100US in the form of capital equipment, supplies or additional training.
| Study group | Role | What they receive |
|---|---|---|
| Full Intervention | Experimental | Life skills education vocational counseling Economic livelihoods reproductive health services social support Receives: Behavioral: Life skills education; Other: Reproductive health services; Behavioral: Economic livelihoods |
| Education and health services alone | Active comparator | Life skills education Reproductive health services Receives: Behavioral: Life skills education; Other: Reproductive health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention completion
Completion of the intervention activities
Measured: Within 2 years of follow up
Secondary outcomes (2)
Unintended pregnancy
Urine pregnancy test positive during 2 year follow up period, and pregnancy intendedness on self reported survey
Measured: during 2 year follow up
Incident viral infection with HIV or HSV-2
Blood test for HIV and HSV-2 at each 6 month follow up for 2 years.
Measured: During 2 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- UZ-UCSF Collaborative Research Programme, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mi-Suk Kang Dufour, University of California, San Francisco
- Investigators
- Megan Dunbar, DrPH, MPH, Principal investigator, Pangea Global AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034214
- Sponsor's protocol ID
- 037044
- Other IDs
- R01HD045135
- Acronym
- SHAZ!
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunbar MS, Maternowska MC, Kang MS, Laver SM, Mudekunye-Mahaka I, Padian NS. Findings from SHAZ!: a feasibility study of a microcredit and life-skills HIV prevention intervention to reduce risk among adolescent female orphans in Zimbabwe. J Prev Interv Community. 2010;38(2):147-61. doi: 10.1080/10852351003640849.
PubMed 20391061Kang M, Dunbar M, Laver S, Padian N. Maternal versus paternal orphans and HIV/STI risk among adolescent girls in Zimbabwe. AIDS Care. 2008 Feb;20(2):214-7. doi: 10.1080/09540120701534715.
PubMed 18293132Krishnan S, Dunbar MS, Minnis AM, Medlin CA, Gerdts CE, Padian NS. Poverty, gender inequities, and women's risk of human immunodeficiency virus/AIDS. Ann N Y Acad Sci. 2008;1136:101-10. doi: 10.1196/annals.1425.013. Epub 2007 Oct 22.
PubMed 17954681Dunbar MS, Kang Dufour MS, Lambdin B, Mudekunye-Mahaka I, Nhamo D, Padian NS. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe. PLoS One. 2014 Nov 21;9(11):e113621. doi: 10.1371/journal.pone.0113621. eCollection 2014.
PubMed 25415455
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Opportunity for Zimbabwean Adolescent Orphans
- ClinicalTrials.gov ID
- NCT02034214
- Acronym / sponsor ID
- SHAZ! / 037044
- Conditions
- HIV
- Keywords
- HIV, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- UZ-UCSF Collaborative Research Programme, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Jan 2014 (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.
The SHAZ! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. SHAZ! enrolled young women 16 to 19 years old who had been orphaned and who were currently out of school and not infected with HIV. Individuals participated in the project for up to two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Intervention | Experimental | Behavioral: Life skills education, Other: Reproductive health services, Behavioral: Economic livelihoodsLife skills education vocational counseling Economic livelihoods reproductive health services social support |
| Education and health services alone | Active comparator | Behavioral: Life skills education, Other: Reproductive health servicesLife skills education Reproductive health services |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 16 to 19 years old
- out of school
- orphaned
- willing to participate in intervention activities
- living in Chitungwiza
Key exclusion criteria (2 listed)
- HIV infection
- currently pregnant
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 |
|---|---|---|
| Life skills educationThe life skills curriculum drew upon Stepping Stones and CDC-Zimbabwe Talk Time, developed with input from the target population. It consisted of 14 modules delivered to groups of 25 over 4-6 weeks on: HIV/STI and reproductive health; relationship negotiation; strategies to avoid violence;and identification of safe and risky places in the community. Participants also attended a six-weeks-long home-based care training conducted through Red Cross Zimbabwe, to gain skills on safely caring for people living with HIV. | Behavioural | Education and health services alone, Full Intervention |
| Reproductive health servicesAll participants were provided a health screening at every study visit and were treated for treatable STIs and minor ailments. They received condoms, and contraceptive pills or injectable free upon request. Participants who tested positive for HIV were referred to local clinics, where the study team assisted with ART registration including payment for CD4 tests required for enrolment. | Other | Education and health services alone, Full Intervention |
| Economic livelihoodsThe Livelihoods intervention consisted of financial literacy and a choice of vocational training at local training institutes. Courses were 6-months-long, conducted in English, with a practical and a theoretical component. In spite of encouragement to venture outside of accepted gender norms, the most popular courses were hairdressing, garment-making, and receptionist/secretarial and nurse-aid training. Participants who passed developed business plans that were supported with a micro-grant valued at $100US in the form of capital equipment, supplies or additional training. | Behavioural | Full Intervention |
Primary outcome
Intervention completion
Time frame: Within 2 years of follow up
Completion of the intervention activities
2 secondary outcomes
Unintended pregnancy
Time frame: during 2 year follow up
Incident viral infection with HIV or HSV-2
Time frame: During 2 years of follow up
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 13 Jan 2014.
- Background: PubMed 20391061Dunbar MS, Maternowska MC, Kang MS, Laver SM, Mudekunye-Mahaka I, Padian NS. Findings from SHAZ!: a feasibility study of a microcredit and life-skills HIV prevention intervention to reduce risk among adolescent female orphans in Zimbabwe. J Prev Interv Community. 2010;38(2):147-61. doi: 10.1080/10852351003640849.
- Background: PubMed 18293132Kang M, Dunbar M, Laver S, Padian N. Maternal versus paternal orphans and HIV/STI risk among adolescent girls in Zimbabwe. AIDS Care. 2008 Feb;20(2):214-7. doi: 10.1080/09540120701534715.
- Background: PubMed 17954681Krishnan S, Dunbar MS, Minnis AM, Medlin CA, Gerdts CE, Padian NS. Poverty, gender inequities, and women's risk of human immunodeficiency virus/AIDS. Ann N Y Acad Sci. 2008;1136:101-10. doi: 10.1196/annals.1425.013. Epub 2007 Oct 22.
- Derived from this study: PubMed 25415455Dunbar MS, Kang Dufour MS, Lambdin B, Mudekunye-Mahaka I, Nhamo D, Padian NS. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe. PLoS One. 2014 Nov 21;9(11):e113621. doi: 10.1371/journal.pone.0113621. eCollection 2014.
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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.
Megan Dunbar, DrPH, MPH principal investigator
Pangea Global AIDS Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life skills education, Reproductive health services and Economic livelihoods in people with HIV, run by University of California, San Francisco at 1 site in Zimbabwe.
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 2 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 13 Jan 2014. 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 Zimbabwe. 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?
Intervention completion (time frame: Within 2 years of follow up). 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 NCT02034214, which also lists 4 linked publications.
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 13 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.