HIV/AIDSNCT03316040
Assessing the Impact of an Educational HIV Prevention Intervention in Zambia
A study testing JIC in people with HIV/AIDS, run by Columbia University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- JIC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,270 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Mar 2017to 2 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria within the pre-defined schools
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Zambia2 sites
American Institutes for Research
Choma
American Institutes for Research
Livingstone
About this study
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- JIC
- Keywords
- HIV/AIDS, Join-in-Circuit
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JICBehavioural
Also called Join-In-Circuit on AIDS, Love & Sexuality
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.
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | No intervention | This arm represent control schools. No JIC will be implemented. |
| Treatment 1 | Experimental | This arm implements the JIC among a random subset of students within the pre-defined grade. Receives: Behavioral: JIC |
| Treatment 2 | Experimental | This arm implements the JIC among indegree central students within the pre-defined grade. Receives: Behavioral: JIC |
| Treatment 3 | Experimental | This arm implements the JIC among edge betweeness central students within the pre-defined grade. Receives: Behavioral: JIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after the study implementation
Secondary outcomes (1)
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.
Measured: Up to 6 months after the study implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start16 Mar 2017
- Primary completion2 Dec 2017
- Study completion2 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- German Development Corporation, American Institutes for Research
- Responsible party
- Principal investigator, Donald Green, Columbia University
- Investigators
- Donald Green, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316040
- Sponsor's protocol ID
- AAAR2585
- Status last verified
- Jan 2019
- First submitted
- 14 Oct 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of an Educational HIV Prevention Intervention in Zambia
- ClinicalTrials.gov ID
- NCT03316040
- Acronym / sponsor ID
- AAAR2585
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Join-in-Circuit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,270 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- German Development Corporation, American Institutes for Research
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 2 Dec 2017 (actual)
- Study completion
- 2 Dec 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control 1 | No intervention | –This arm represent control schools. No JIC will be implemented. |
| Treatment 1 | Experimental | Behavioral: JICThis arm implements the JIC among a random subset of students within the pre-defined grade. |
| Treatment 2 | Experimental | Behavioral: JICThis arm implements the JIC among indegree central students within the pre-defined grade. |
| Treatment 3 | Experimental | Behavioral: JICThis arm implements the JIC among edge betweeness central students within the pre-defined grade. |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria within the pre-defined schools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JICAlso: Join-In-Circuit on AIDS, Love & SexualityThe "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. | Behavioural | Treatment 1, Treatment 2, Treatment 3 |
Primary outcome
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.
1 secondary outcome
Standardized index of self-reported behavior
Time frame: Up to 6 months after the study implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Green, PhD principal investigator
Columbia University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JIC in people with HIV/AIDS, run by Columbia University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Zambia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized index of knowledge about sexual and reproductive health (time frame: Up to 6 months after the study implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.