Effectiveness of Communication Technology in Disseminating HIV Prevention Training to Non-governmental Organizations
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| First Received Date ICMJE | June 13, 2008 | ||||||||||||||||||||||||
| Last Updated Date | June 1, 2012 | ||||||||||||||||||||||||
| Start Date ICMJE | November 2008 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Adoption of the full Popular Opinion Leader intervention by a nongovernmental organization (NGO) [ Time Frame: Measured at Months 12 and 24 after training ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Adoption of the full Popular Opinion Leader intervention by a non-governmental organization (NGO) [ Time Frame: Measured at Months 12 and 24 after training ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00698529 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Effectiveness of Communication Technology in Disseminating HIV Prevention Training to Non-governmental Organizations | ||||||||||||||||||||||||
| Official Title ICMJE | Communication Technology to Disseminate Evidence-Based HIV Interventions to NGOs | ||||||||||||||||||||||||
| Brief Summary | This study will compare the effectiveness of face-to-face training versus Web-based training seminars in disseminating HIV prevention interventions to nongovernmental organizations in Eastern Europe and Central Asia. |
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| Detailed Description | An estimated total of 60 million people have been infected with HIV since the first cases were reported in the early 1980s. Although the HIV/AIDS pandemic is a global crisis, certain regions have been affected more than others. The Eastern European and Central Asian region, in particular, has one of the fastest growing rates of HIV infections in the world. Most new HIV infections in this region have been occurring among injection drug users, commercial sex workers, and men who have sex with men, but the virus continues to increasingly affect the general population, too. HIV prevention interventions that are able to be disseminated to a large population are necessary. The Popular Opinion Leader (POL) intervention is an HIV prevention program that recruits and trains opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers. Administering the POL intervention to nongovernmental organizations (NGOs) may be an effective means of assuring that the intervention is extended throughout the region. However, the best means of disseminating the POL program and assuring its full adoption by NGOs is unknown. This study will compare the effectiveness of face-to-face training versus Web-based training seminars in disseminating the POL intervention to NGOs in Eastern Europe and Central Asia. Participation in this study will last 24 months. Potential NGOs will first undergo baseline assessments that will include an in-depth 90-minute phone interview with the NGO director and completion of attitude scales about the POL HIV intervention. NGOs will then be assigned randomly to one of three study groups:
All participating NGOs will undergo follow-up assessments 12 and 24 months after completing the intervention training. Assessments will include a 90-minute phone interview with the NGO director and a 10-minute phone interview with NGO staff members to assess attitudes concerning the intervention, their adoption of the core elements of the intervention model, and the extent of usage of training materials. A number of NGOs that report full adoption of the POL intervention will be selected randomly to undergo a 2-day validation site visit by an assessment team member. Site visits will be used to conduct interviews with NGO staff and the opinion leaders, validate reports of intervention adoption, observe POL sessions, and review materials used in training sessions. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Phase 2 | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | HIV Infections | ||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 99 | ||||||||||||||||||||||||
| Estimated Completion Date | May 2013 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for NGOs:
Exclusion Criteria for NGOs:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT00698529 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | R01 MH079730, R01MH079730, DAHBR 9A-ASPQ | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Jeffrey Kelly, Medical College of Wisconsin | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||||||||||||||||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Medical College of Wisconsin | ||||||||||||||||||||||||
| Verification Date | June 2012 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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