Shaping the Health of Adolescents in Zimbabwe

HIV Clinical Trial

— SHAZ!  

Official title:

Economic Opportunity for Zimbabwean Adolescent Orphans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034214
• Other study ID #: 037044
• Secondary ID: R01HD045135
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 9, 2014
• Start date: February 2006
• Est. completion date: October 2008

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZimbabwe: Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Zimbabwe	South Medical	Chitungwiza

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), UZ-UCSF Collaborative Research Programme

Country where clinical trial is conducted

Zimbabwe, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Epub 2007 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention completion	Completion of the intervention activities	Within 2 years of follow up	No
Secondary	Unintended pregnancy	Urine pregnancy test positive during 2 year follow up period, and pregnancy intendedness on self reported survey	during 2 year follow up	No
Secondary	Incident viral infection with HIV or HSV-2	Blood test for HIV and HSV-2 at each 6 month follow up for 2 years.	During 2 years of follow up	No