Assessing the Impact of an Educational HIV Prevention Intervention in Zambia

HIV/AIDS Clinical Trial

Official title:

Assessing the Impact of an Educational HIV Prevention Intervention in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316040
• Other study ID #: AAAR2585
• Status: Completed
• Phase: N/A
• Start date: March 16, 2017
• Est. completion date: December 2, 2017

Study information

• Verified date: January 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8270
• Est. completion date: December 2, 2017
• Est. primary completion date: December 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Behavioral:
• JIC
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.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
Zambia	American Institutes for Research	Choma
Zambia	American Institutes for Research	Livingstone

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	American Institutes for Research, German Development Corporation

Countries where clinical trial is conducted

United States,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months after the study implementation
Secondary	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.	Up to 6 months after the study implementation