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Completed

NCT Number: NCT02034214

Shaping the Health of Adolescents in Zimbabwe

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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Key information

Conditions

HIV

Age range

16 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South Medical

Chitungwiza, Zimbabwe

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life Skills Education

Behavioral

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 services

Other

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 livelihoods

Behavioral

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.

Primary outcomes

  1. Intervention completion

    Time frame: Within 2 years of follow up

    Completion of the intervention activities

Secondary outcomes

  1. Unintended pregnancy

    Time frame: during 2 year follow up

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

  2. Incident viral infection with HIV or HSV-2

    Time frame: During 2 years of follow up

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • UZ-UCSF Collaborative Research Programme

Registry information

Official study title

Economic Opportunity for Zimbabwean Adolescent Orphans

Acronym: SHAZ!

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 13, 2014
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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