Shaping the Health of Adolescents in Zimbabwe

Study Overview
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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.

Official Title
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Economic Opportunity for Zimbabwean Adolescent Orphans

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Life skills education
* Other: Reproductive health services
* Behavioral: Economic livelihoods


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Intervention<br>Life skills education vocational counseling Economic livelihoods reproductive health services social support | Behavioral: Life skills education<br>* 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.<br>Other: Reproductive health services<br>* 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.<br>Behavioral: Economic livelihoods<br>* 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.<br>|
| Active Comparator: Education and health services alone<br>Life skills education Reproductive health services | Behavioral: Life skills education<br>* 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.<br>Other: Reproductive health services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unintended pregnancy | 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 | Blood test for HIV and HSV-2 at each 6 month follow up for 2 years. | During 2 years of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, adolescents