Shaping the Health of Adolescents in Zimbabwe (SHAZ!)

January 9, 2014 updated by: Mi-Suk Kang Dufour, University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Chitungwiza, Zimbabwe
        • South Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention completion
Time Frame: Within 2 years of follow up
Completion of the intervention activities
Within 2 years of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 2 year follow up
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.
During 2 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Investigators

  • Principal Investigator: Megan Dunbar, DrPH, MPH, Pangea Global AIDS Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 037044
  • R01HD045135 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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