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Shaping the Health of Adolescents in Zimbabwe (SHAZ!)

This study has been completed.
Sponsor:
Collaborators:
UZ-UCSF Collaborative Programme on Women's Health
Information provided by (Responsible Party):
Mi-Suk Kang Dufour, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02034214
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

January 9, 2014
January 9, 2014
February 2006
October 2008   (final data collection date for primary outcome measure)
Intervention completion [ Time Frame: Within 2 years of follow up ] [ Designated as safety issue: No ]
Completion of the intervention activities
Same as current
No Changes Posted
  • Unintended pregnancy [ Time Frame: during 2 year follow up ] [ Designated as safety issue: No ]
    Urine pregnancy test positive during 2 year follow up period, and pregnancy intendedness on self reported survey
  • Incident viral infection with HIV or HSV-2 [ Time Frame: During 2 years of follow up ] [ Designated as safety issue: No ]
    Blood test for HIV and HSV-2 at each 6 month follow up for 2 years.
Same as current
Not Provided
Not Provided
 
Shaping the Health of Adolescents in Zimbabwe
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
HIV
  • Behavioral: Life 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.
  • Other: Reproductive 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.
  • Behavioral: Economic 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.
  • Experimental: Full Intervention
    Life skills education vocational counseling Economic livelihoods reproductive health services social support
    Interventions:
    • Behavioral: Life skills education
    • Other: Reproductive health services
    • Behavioral: Economic livelihoods
  • Active Comparator: Education and health services alone
    Life skills education Reproductive health services
    Interventions:
    • Behavioral: Life skills education
    • Other: Reproductive health services

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV infection
  • currently pregnant
Female
16 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Zimbabwe
 
NCT02034214
037044, R01HD045135
No
Mi-Suk Kang Dufour, University of California, San Francisco
University of California, San Francisco
  • UZ-UCSF Collaborative Programme on Women's Health
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Megan Dunbar, DrPH, MPH Pangea Global AIDS Foundation
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP