- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03316040
Assessing the Impact of an Educational HIV Prevention Intervention in Zambia
In Zambia, 13% of the 15 to 49 year old population lives with HIV. The highest number of new HIV infections is among young people. To counter the spread of the disease, developmental and governmental actors are increasingly relying on educational behavior change tools. A particularly widely used tool, implemented by the German Development Corporation (henceforth, GIZ), is the so-called "Join-In-Circuit on AIDS, Love Sexuality" (JIC). The tool aims to improve a) HIV and sexual reproductive health knowledge, b) HIV testing uptake, and c) demand for health services. Previous research has investigated the direct effect of the JIC on knowledge about Sexually Transmitted Infections (STIs) as well as self-reported sexual behavior in Zimbabwe, and has found positive effects in both domains.
The research project evaluates the JIC in Zambia. The study randomly assigns 170 participating schools to five different JIC treatment arms. The first two arms represent control schools. Here, no JIC will be implemented. The third arm implements the JIC among a random subset of students. The fourth arm implements the JIC among indegree central students. The fifth arm implements the JIC among edge betweeness central students. In each school, the JIC will be implemented in one pre-determined grade. Within each school at least 30 students will be selected. For larger schools, 20 percent of students in the selected grade are selected.
Study Overview
Detailed Description
The study's population is schools in the Choma and Livingstone provinces of Zambia (a final set of 170 schools). The schools were provided by the Zambian Ministry of Education. The schools are split between primary (grade 1 to 7) and secondary schools (grade 8 to 12). In order to not interfere with exam periods, the Ministry of General Education and GIZ decided to implement the JIC among children in grade 6 in primary schools, and grade 11 in secondary schools.
On average, the schools have 80 students and 74 percent of the sample are in Choma. 88 percent of schools are considered rural, i.e., they do not lie in a major town. 4 percent of the sample have received a JIC before.
The 170 schools were randomly assigned to one of five treatment conditions.
- Control 1 (No intervention) (34 schools)
- Control 2 (No intervention) (34 schools)
- Treatment 1 (Random selection) (34 of schools)
- Treatment 2 (Indegree centrality) (34 of schools)
- Treatment 3 (Betweenness centrality) (34 of schools)
The Columbia University (CU) team advised GIZ on the design of the study, and the intervention will be solely run by GIZ. The CU team is not involved in the implementation of the study. Data will be collected by the American Institutes of Research (AIR). The CU team will only analyze fully de-identified data produced by the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10027
- Columbia University
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Choma, Zambia
- American Institutes for Research
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Livingstone, Zambia
- American Institutes for Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Students must be enrolled in the selected grade in one of the study schools and present on the day of the interview (for piloting) or on the day of baseline and endline (for main evaluation)
- Students must have informed consent
- Students must speak English or Tonga
Exclusion Criteria:
- There are no exclusion criteria within the pre-defined schools
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control 1
This arm represent control schools.
No JIC will be implemented.
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Experimental: Treatment 1
This arm implements the JIC among a random subset of students within the pre-defined grade.
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The "Join In Circuit on HIV, love and sexuality" is a mobile learning system on the core topics of reproductive health and HIV and AIDS, targeting young people.
JIC works with person-to-person communication in order to give an opportunity for discussion and for providing information in an open, engaging atmosphere.
The JIC uses interactive exercises, pictorial aids and edutainment strategies to promote behavior change among young people aged 15 years and older.
Other Names:
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Experimental: Treatment 2
This arm implements the JIC among indegree central students within the pre-defined grade.
|
The "Join In Circuit on HIV, love and sexuality" is a mobile learning system on the core topics of reproductive health and HIV and AIDS, targeting young people.
JIC works with person-to-person communication in order to give an opportunity for discussion and for providing information in an open, engaging atmosphere.
The JIC uses interactive exercises, pictorial aids and edutainment strategies to promote behavior change among young people aged 15 years and older.
Other Names:
|
Experimental: Treatment 3
This arm implements the JIC among edge betweeness central students within the pre-defined grade.
|
The "Join In Circuit on HIV, love and sexuality" is a mobile learning system on the core topics of reproductive health and HIV and AIDS, targeting young people.
JIC works with person-to-person communication in order to give an opportunity for discussion and for providing information in an open, engaging atmosphere.
The JIC uses interactive exercises, pictorial aids and edutainment strategies to promote behavior change among young people aged 15 years and older.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized index of knowledge about sexual and reproductive health
Time Frame: Up to 6 months after the study implementation
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The investigators created an overall index that standardizes the outcome variables, which is split into a knowledge index and a self-reported behavior.
This index will be constructed from a battery of survey items pertaining to knowledge about condoms, HIV/Aids and other STIs.
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Up to 6 months after the study implementation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized index of self-reported behavior
Time Frame: Up to 6 months after the study implementation
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The investigators created an overall index that standardizes the outcome variables, which is split into a knowledge index and a self-reported behavior.
This index will be constructed form a battery of survey items measuring self-reported behavior pertaining to sex, HIV testing, and access of health facilities.
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Up to 6 months after the study implementation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donald Green, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAR2585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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