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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
  Purpose

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.


Condition Intervention
HIV
Behavioral: Life skills education
Other: Reproductive health services
Behavioral: Economic livelihoods

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Economic Opportunity for Zimbabwean Adolescent Orphans

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Intervention completion [ Time Frame: Within 2 years of follow up ] [ Designated as safety issue: No ]
    Completion of the intervention activities


Secondary Outcome Measures:
  • 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.


Enrollment: 367
Study Start Date: February 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full Intervention
Life skills education vocational counseling Economic livelihoods reproductive health services social support
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.
Active Comparator: Education and health services alone
Life skills education Reproductive health services
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.

  Eligibility

Ages Eligible for Study:   16 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034214

Locations
Zimbabwe
South Medical
Chitungwiza, Zimbabwe
Sponsors and Collaborators
University of California, San Francisco
UZ-UCSF Collaborative Programme on Women's Health
Investigators
Principal Investigator: Megan Dunbar, DrPH, MPH Pangea Global AIDS Foundation
  More Information

Publications:
Responsible Party: Mi-Suk Kang Dufour, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02034214     History of Changes
Other Study ID Numbers: 037044, R01HD045135
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board
Zimbabwe: Medical Research Council

Keywords provided by University of California, San Francisco:
HIV
adolescents

ClinicalTrials.gov processed this record on November 27, 2014