HIV InfectionsPhase 2NCT00698529
Effectiveness of Communication Technology in Disseminating HIV Prevention Training to Non-governmental Organizations
A Phase 2 study testing Face-to-face training, Distance training and Popular Opinion Leader (POL) in people with HIV Infections, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Face-to-face training, Distance training and Popular Opinion Leader (POL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to 1 Jul 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participated in prior Medical College of Wisconsin dissemination study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for AIDS Intervention Research, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Communication Technology to Disseminate Evidence-Based HIV Interventions to NGOs
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.
Read the 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:
- 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.
- Conditions
- HIV Infections
- Being tested
- Face-to-face training, Distance training, Popular Opinion Leader (POL)
- Keywords
- Technology Transfer, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face trainingBehavioural
Also called Traditional, Seminar
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 trainingBehavioural
Also called On-line, Internet, Distance learning
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No POL Training | No intervention | Participating NGOs and their staff will receive no specialized training. |
| Face-to-Face | Experimental | Participating NGOs and their staff will receive training through face-to-face seminars held at the NGOs and through post-seminar consultation telephone calls. Receives: Behavioral: Face-to-face training; Behavioral: Popular Opinion Leader (POL) |
| Distance Learning | Experimental | Participating NGOs and their staff will receive training through Web-based seminars and through post-seminar consultation telephone calls. Receives: Behavioral: Distance training; Behavioral: Popular Opinion Leader (POL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of the full Popular Opinion Leader intervention by a nongovernmental organization (NGO)
Measured: Measured at Months 12 and 24 after training
Secondary outcomes (2)
Number of core elements of the Popular Opinion Leader intervention incorporated into NGO HIV prevention interventions
Measured: Measured at Months 12 and 24 after training
Cost effectiveness of training method
Measured: Measured at Month 24 after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2013
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jeffrey Kelly, Medical College of Wisconsin
- Investigators
- Jeffrey A. Kelly, PhD, Principal investigator, Medical College of WisconsinYuri A. Amirkhanian, PhD, Study director, Medical College of WisconsinTimothy L. McAuliffe, PhD, Study director, Medical College of WisconsinLaura R. Glasman, PhD, Study director, Medical College of WisconsinSteven D. Pinkerton, PhD, Study director, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698529
- Sponsor's protocol ID
- R01MH079730
- Other IDs
- R01MH079730, DAHBR 9A-ASPQ
- Status last verified
- Jul 2019
- First submitted
- 13 Jun 2008
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Technology to Disseminate Evidence-Based HIV Interventions to NGOs
- ClinicalTrials.gov ID
- NCT00698529
- Acronym / sponsor ID
- R01MH079730
- Conditions
- HIV Infections
- Keywords
- Technology Transfer, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 17 Jun 2008 (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.
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.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No POL Training | No intervention | –Participating NGOs and their staff will receive no specialized training. |
| Face-to-Face | Experimental | Behavioral: Face-to-face training, Behavioral: Popular Opinion Leader (POL)Participating NGOs and their staff will receive training through face-to-face seminars held at the NGOs and through post-seminar consultation telephone calls. |
| Distance Learning | Experimental | Behavioral: Distance training, Behavioral: Popular Opinion Leader (POL)Participating NGOs and their staff will receive training through Web-based seminars and through post-seminar consultation telephone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Participated in prior Medical College of Wisconsin dissemination study
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 |
|---|---|---|
| Face-to-face trainingAlso: Traditional, SeminarNGOs 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. | Behavioural | Face-to-Face |
| Distance trainingAlso: On-line, Internet, Distance learningNGOs 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. | Behavioural | Distance Learning |
| 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. | Behavioural | Distance Learning, Face-to-Face |
Primary outcome
Adoption of the full Popular Opinion Leader intervention by a nongovernmental organization (NGO)
Time frame: Measured at Months 12 and 24 after training
2 secondary outcomes
Number of core elements of the Popular Opinion Leader intervention incorporated into NGO HIV prevention interventions
Time frame: Measured at Months 12 and 24 after training
Cost effectiveness of training method
Time frame: Measured at Month 24 after training
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 11 Jul 2019.
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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.
Jeffrey A. Kelly, PhD principal investigator
Medical College of Wisconsin
Yuri A. Amirkhanian, PhD study director
Medical College of Wisconsin
Timothy L. McAuliffe, PhD study director
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Face-to-face training, Distance training and Popular Opinion Leader (POL) in people with HIV Infections, run by Medical College of Wisconsin at 1 site in United States.
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 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adoption of the full Popular Opinion Leader intervention by a nongovernmental organization (NGO) (time frame: Measured at Months 12 and 24 after training). 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 11 Jul 2019.