Peer Education Program for HIV/AIDS Related Sexual Behavi... | NCT02665091

Studies
Peer Education Program for HIV/AIDS Related Sexual Behaviors of Secondary School Students

NCT02665091

Sponsor

NMP Medical Research Institute

Status

Completed

Last Update Posted

Jan 27, 2016Estimated

Enrollment

560Actual

Phase

Not Applicable

Conditions

Interventions

Peer Education Program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 22, 2016

First Submission Date that Met QC Criteria

Jan 22, 2016

First Posted Date

Jan 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2016

Last Update Posted Date

Jan 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

560Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peer Education Group	Experimental	Group was self compared after the intervention	Behavioral: Peer Education Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peer Education Program	Behavioral		Peer Education Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knowledge score of HIV		From baseline to 6 Months

Secondary Outcomes

Measure	Description	Time Frame
willingness to HIV testing		From Baseline to 6 Months
willingness to participate in HIV counseling services		From Baseline to 6 Months
frequency of use of Condoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

history of injection drug use in the previous 3 years;
pregnant;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hitesh Nayak	NMP Medical Research Institute	Principal Investigator
Neha Sharma, PhD	Warwick Research Services	Study Director
Valerie Murray, MA	Goldington Family Centre, UK	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

YES

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided