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CompletedNCT02034214SHAZ!Updated Jan 13, 2014

Shaping the Health of Adolescents in Zimbabwe

An interventional study of Life skills education and Reproductive health services in HIV, sponsored by University of California, San Francisco. Completed at 1 site in Zimbabwe. Open to female participants aged 16 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-13.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
367
Allocation
Randomized
Ages
16 Years to 19 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • HIV

Keywords

  • HIV
  • adolescents
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In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 16 to 19 years old
  • out of school
  • orphaned
  • willing to participate in intervention activities
  • living in Chitungwiza

Exclusion criteria

Exclusion Criteria:

  • HIV infection
  • currently pregnant
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
367 participants (actual)

Study arms

  • Experimental
    Full Intervention

    Life skills education vocational counseling Economic livelihoods reproductive health services social support

    Behavioral: Life skills education · Other: Reproductive health services · Behavioral: Economic livelihoods

  • Active comparator
    Education and health services alone

    Life skills education Reproductive health services

    Behavioral: Life skills education · Other: Reproductive health services

Interventions

  • BehavioralLife skills education

    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.

  • OtherReproductive health services

    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.

  • BehavioralEconomic livelihoods

    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.

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What researchers measure

Primary outcomes

  1. Intervention completion

    Completion of the intervention activities

    Time frame: Within 2 years of follow up

Secondary outcomes

  1. Unintended pregnancy

    Urine pregnancy test positive during 2 year follow up period, and pregnancy intendedness on self reported survey

    Time frame: during 2 year follow up

  2. Incident viral infection with HIV or HSV-2

    Blood test for HIV and HSV-2 at each 6 month follow up for 2 years.

    Time frame: During 2 years of follow up

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Study locations

1 site
  • South Medical
    Chitungwiza, Zimbabwe
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References and documents

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 20391061 ↗
  • Kang 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 18293132 ↗
  • Krishnan 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 17954681 ↗
  • Dunbar 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02034214
Lead sponsor
University of California, San Francisco
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
Mi-Suk Kang Dufour (Assistant Professor, University of California, San Francisco) — Principal investigator
First posted
Jan 13, 2014
Start date
Feb 2006
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Jan 13, 2014

Study contacts

Megan Dunbar, DrPH, MPH
principal investigator · Pangea Global AIDS Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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