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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00698529
Other study ID # R01MH079730
Secondary ID R01MH079730DAHBR
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2008
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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:

- Participating NGOs in Group 1 will receive the POL intervention through face-to-face training. Staff will receive 2-day training on the POL intervention and individualized telephone follow-up consultations concerning POL implementation.

- Participating NGOs in Group 2 will receive the POL intervention through Web-based training. Staff will receive training delivered entirely by means of a Web-based, distance learning curriculum. Staff will also be offered individualized telephone follow-up consultations concerning POL implementation.

- Participating NGOs in Group 3 will receive no intervention.

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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date July 1, 2019
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for NGOs:

- Located in Eastern Europe or Central Asia

- Currently offers direct HIV prevention interventions targeting sexual risk in a community population

- Director willing to provide organizational consent

- Director and staff members willing to provide individual consent

- Director and staff members fluent in either English or Russian

- Has reliable Internet access

Exclusion Criteria for NGOs:

- Participated in prior Medical College of Wisconsin dissemination study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Face-to-face training
NGOs will receive the POL intervention through face-to-face training. Staff will receive 2-day training on the POL intervention and individualized telephone follow-up consultations concerning POL implementation.
Distance training
NGOs will receive the POL intervention through Web-based training. Staff will receive training delivered entirely by means of a Web-based, distance learning curriculum and through individualized telephone follow-up consultations concerning POL implementation.
Popular Opinion Leader (POL)
POL is a community-level HIV intervention that recruits and trains opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers.

Locations

Country Name City State
United States Center for AIDS Intervention Research, Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Medical College of Wisconsin National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adoption of the full Popular Opinion Leader intervention by a nongovernmental organization (NGO) Measured at Months 12 and 24 after training
Secondary Number of core elements of the Popular Opinion Leader intervention incorporated into NGO HIV prevention interventions Measured at Months 12 and 24 after training
Secondary Cost effectiveness of training method Measured at Month 24 after training
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