HIVNCT02665091
Peer Education Program for HIV/AIDS Related Sexual Behaviors of Secondary School Students
A study testing Peer Education Program in people with HIV, run by NMP Medical Research Institute.
Trial summary
Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Peer Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- at least 14 years of age;
- non-injecting use of heroin, cocaine or crack cocaine in the last six months;
- test HIV antibody negative;
- agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
- willing to return for visits at 1, 6, and 9 months post-enrollment;
- willing and able to provide informed consent.
Who cannot join
- history of injection drug use in the previous 3 years;
- pregnant;
About this study
Official title: Impact of Peer Education Program on HIV/AIDS Related Sexual Behaviors of Secondary School Students in Rural Communities, India: a Quasi-experimental Study.
Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Peer-based interventions have become a common method to effect important health-related behavior changes and address the HIV/AIDS pandemic. This study therefore aimed to evaluate the effectiveness of peer education in improving HIV knowledge, attitude, and preventive practices among in-school adolescents
- Conditions
- HIV
- Being tested
- Peer Education Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Education ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Peer Education Group | Experimental | Group was self compared after the intervention Receives: Behavioral: Peer Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score of HIV
Measured: From baseline to 6 Months
Secondary outcomes (3)
willingness to HIV testing
Measured: From Baseline to 6 Months
willingness to participate in HIV counseling services
Measured: From Baseline to 6 Months
frequency of use of Condoms
Measured: From baseline to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hitesh Nayak, Principal investigator, NMP Medical Research InstituteNeha Sharma, PhD, Study director, Warwick Research ServicesValerie Murray, MA, Study chair, Goldington Family Centre, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665091
- Sponsor's protocol ID
- nmp/22189
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: YES
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peer Education Program on HIV/AIDS Related Sexual Behaviors of Secondary School Students in Rural Communities, India: a Quasi-experimental Study.
- ClinicalTrials.gov ID
- NCT02665091
- Acronym / sponsor ID
- nmp/22189
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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.
Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Peer-based interventions have become a common method to effect important health-related behavior changes and address the HIV/AIDS pandemic. This study therefore aimed to evaluate the effectiveness of peer education in improving HIV knowledge, attitude, and preventive practices among in-school adolescents
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer Education Group | Experimental | Behavioral: Peer Education ProgramGroup was self compared after the intervention |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- at least 14 years of age;
- non-injecting use of heroin, cocaine or crack cocaine in the last six months;
- test HIV antibody negative;
- agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
- willing to return for visits at 1, 6, and 9 months post-enrollment;
Key exclusion criteria (2 listed)
- history of injection drug use in the previous 3 years;
- pregnant;
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 |
|---|---|---|
| Peer Education Program | Behavioural | Peer Education Group |
Primary outcome
Knowledge score of HIV
Time frame: From baseline to 6 Months
3 secondary outcomes
willingness to HIV testing
Time frame: From Baseline to 6 Months
willingness to participate in HIV counseling services
Time frame: From Baseline to 6 Months
frequency of use of Condoms
Time frame: From baseline to 6 month
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 27 Jan 2016.
- Individual participant dataSharing planned: Yes. YES
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Hitesh Nayak principal investigator
NMP Medical Research Institute
Neha Sharma, PhD study director
Warwick Research Services
Valerie Murray, MA study chair
Goldington Family Centre, UK
Questions about this trial
What is this clinical trial studying?
A study testing Peer Education Program in people with HIV, run by NMP Medical Research Institute.
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 6 inclusion and 2 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Knowledge score of HIV (time frame: From baseline to 6 Months). 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 27 Jan 2016.