NCT02034214

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

2.7 years

First QC Date

January 9, 2014

Last Update Submit

January 9, 2014

Conditions

Keywords

HIVadolescents

Outcome Measures

Primary Outcomes (1)

  • Intervention completion

    Completion of the intervention activities

    Within 2 years of follow up

Secondary Outcomes (2)

  • Unintended pregnancy

    during 2 year follow up

  • Incident viral infection with HIV or HSV-2

    During 2 years of follow up

Study Arms (2)

Full Intervention

EXPERIMENTAL

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

Behavioral: Life skills educationOther: Reproductive health servicesBehavioral: Economic livelihoods

Education and health services alone

ACTIVE COMPARATOR

Life skills education Reproductive health services

Behavioral: Life skills educationOther: Reproductive health services

Interventions

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.

Education and health services aloneFull Intervention

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.

Education and health services aloneFull Intervention

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.

Full Intervention

Eligibility Criteria

Age16 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • HIV infection
  • currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Medical

Chitungwiza, Zimbabwe

Location

Related Publications (4)

  • 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.

    PMID: 20391061BACKGROUND
  • 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.

    PMID: 18293132BACKGROUND
  • 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.

    PMID: 17954681BACKGROUND
  • 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.

MeSH Terms

Interventions

Reproductive Health Services

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Megan Dunbar, DrPH, MPH

    Pangea Global AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

February 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations