Assessing the Impact of an Educational HIV Prevention Intervention in Zambia

January 29, 2019 updated by: Donald Green, Columbia University

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

8270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10027
        • Columbia University
      • Choma, Zambia
        • American Institutes for Research
      • Livingstone, Zambia
        • American Institutes for Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control 1
This arm represent control schools. No JIC will be implemented.
Experimental: Treatment 1
This arm implements the JIC among a random subset of 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:
  • Join-In-Circuit on AIDS, Love & Sexuality
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:
  • Join-In-Circuit on AIDS, Love & Sexuality
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:
  • Join-In-Circuit on AIDS, Love & Sexuality

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
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.
Up to 6 months after the study implementation

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
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.
Up to 6 months after the study implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Donald Green, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Actual)

December 2, 2017

Study Completion (Actual)

December 2, 2017

Study Registration Dates

First Submitted

October 14, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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