Shaping the Health of Adolescents in Zimbabwe

NCT ID: NCT02034214

Last Updated: 2014-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Full Intervention

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

Group Type EXPERIMENTAL

Life skills education

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Education and health services alone

Life skills education Reproductive health services

Group Type ACTIVE_COMPARATOR

Life skills education

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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UZ-UCSF Collaborative Research Programme

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Mi-Suk Kang Dufour

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Megan Dunbar, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Pangea Global AIDS Foundation

Locations

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South Medical

Chitungwiza, , Zimbabwe

Site Status

Countries

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Zimbabwe

References

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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.

Reference Type BACKGROUND
PMID: 20391061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18293132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17954681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25415455 (View on PubMed)

Other Identifiers

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R01HD045135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

037044

Identifier Type: -

Identifier Source: org_study_id

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