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Assessing the Impact of an Educational HIV Prevention Intervention in Zambia

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
JIC
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV/AIDS, Join-in-Circuit

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University
  • American Institutes for Research
  • American Institutes for Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control 1

Treatment 1

Treatment 2

Treatment 3

Arm Description

This arm represent control schools. No JIC will be implemented.

This arm implements the JIC among a random subset of students within the pre-defined grade.

This arm implements the JIC among indegree central students within the pre-defined grade.

This arm implements the JIC among edge betweeness central students within the pre-defined grade.

Outcomes

Primary Outcome Measures

Standardized index of knowledge about sexual and reproductive health
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.

Secondary Outcome Measures

Standardized index of self-reported behavior
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.

Full Information

First Posted
October 14, 2017
Last Updated
January 29, 2019
Sponsor
Columbia University
Collaborators
German Development Corporation, American Institutes for Research
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1. Study Identification

Unique Protocol Identification Number
NCT03316040
Brief Title
Assessing the Impact of an Educational HIV Prevention Intervention in Zambia
Official Title
Assessing the Impact of an Educational HIV Prevention Intervention in Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
December 2, 2017 (Actual)
Study Completion Date
December 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
German Development Corporation, American Institutes for Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Join-in-Circuit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control 1
Arm Type
No Intervention
Arm Description
This arm represent control schools. No JIC will be implemented.
Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
This arm implements the JIC among a random subset of students within the pre-defined grade.
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
This arm implements the JIC among indegree central students within the pre-defined grade.
Arm Title
Treatment 3
Arm Type
Experimental
Arm Description
This arm implements the JIC among edge betweeness central students within the pre-defined grade.
Intervention Type
Behavioral
Intervention Name(s)
JIC
Other Intervention Name(s)
Join-In-Circuit on AIDS, Love & Sexuality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Standardized index of knowledge about sexual and reproductive health
Description
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.
Time Frame
Up to 6 months after the study implementation
Secondary Outcome Measure Information:
Title
Standardized index of self-reported behavior
Description
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.
Time Frame
Up to 6 months after the study implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Green, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
American Institutes for Research
City
Choma
Country
Zambia
Facility Name
American Institutes for Research
City
Livingstone
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessing the Impact of an Educational HIV Prevention Intervention in Zambia

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