HIV InfectionsPhase 2NCT00705705
Effectiveness of an HIV Prevention Program That Targets the Inner Workings of High-risk Social Networks
A Phase 2 study testing Network leader training and Standard HIV risk-reduction counseling in people with HIV Infections, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study will determine whether an HIV prevention program that targets the inner workings of social networks at high risk for HIV and other sexually transmitted diseases is effective in reducing frequency of high-risk sexual behaviors among network members. 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?
- Network leader training and Standard HIV risk-reduction counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Sep 2009
- 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
- Identified by the network leader as a member of the social group (e.g., men who have sex with men, young heterosexual men and women)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53202
About this study
Official title: Targeted Social Network HIV Prevention Intervention
This study will determine whether an HIV prevention program that targets the inner workings of social networks at high risk for HIV and other sexually transmitted diseases is effective in reducing frequency of high-risk sexual behaviors among network members.
Read the detailed description
Over the past decade, the number of new HIV infections in the United States has remained on a steady level, with approximately 40,000 Americans contracting the disease each year. Risk of contracting HIV is not evenly distributed throughout the population, with groups such as intravenous drug users, men who have sex with men (MSM), and impoverished people in inner cities being disproportionately affected. Many members of these groups have already made risk-reduction behavior changes, but there are certain clusters or networks of people within these populations who remain at a greater risk of HIV infection and who account for the majority of new infections. Therefore, more effective HIV prevention approaches directed toward high-risk social networks are needed. Training social leaders within the high-risk networks to communicate HIV prevention messages directly to their members may be an effective means of reaching these vulnerable population segments. This study will evaluate the effectiveness of an HIV prevention program that targets the inner workings of high-risk social networks (particularly young MSM and young high-risk heterosexual adult men and women) in reducing frequency of risky sexual behaviors among network members.
Participation in this study will last up to 2 years and will include the leaders and general members of multiple social networks. First, the eligibility of a given social network will be determined through a period of in-depth formative ethnographic research that will include a 20-minute interview with members of the social networks. During the eligibility interview, participants will be asked to provide personal information about themselves and their close friends, called a friendship group in this study. After the interview, participants will be asked to distribute a flyer about participating in the study to their friendship group. If enough members of the friendship group agree to complete the initial interview and the group meets the eligibility criteria, then members of the group will be asked to participate in the assessment interviews.
The first 1-hour assessment interview will be conducted at baseline and will include two parts. During the first part of the interview, participants will complete a survey about the friendship group, including questions about their most and least trusted members and communication among group members. The second part of the interview will include taking a computer survey with questions about sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. After completing the interview, participants will undergo a brief HIV/AIDS prevention counseling session. Participants will repeat this assessment interview 12 and 24 months later.
When at least half of the friendship group has completed the first assessment interview, the group will be assigned randomly to one of two conditions:
- For groups assigned to Condition 1, participants will receive a phone call when it is time for their repeat assessment interviews. In addition, a computer program will identify one person as the leader of the friendship group, and this person will be asked to attend nine 3-hour meetings over 17 weeks. These meetings will train and encourage leaders to provide positive HIV/AIDS prevention advice to the members of their friendship group.
- For groups assigned to Condition 2, participants will receive a phone call when it is time for their repeat assessment interviews. If the leadership program in Condition 1 appears to be effective, participants may be offered the same program at a later time.
Study participation will be complete after the 24-month assessment interview.
- Conditions
- HIV Infections
- Being tested
- Network leader training, Standard HIV risk-reduction counseling
- Keywords
- High-Risk Behavior, Men Who Have Sex With Men, HIV Seronegativity
- Medical subject headings
- HIV Infections, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Network leader trainingBehavioural
Network leaders will receive a nine-session training segment designed to enable them to motivate their peer networks to reduce sexual risk. The sessions will teach the identified leader of each network how to communicate HIV prevention messages to other members of his or her personal social network. Leaders will be asked to share these messages with other members of their groups.
Standard HIV risk-reduction counselingBehavioural
Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participating social networks will receive standard HIV risk-reduction counseling and network leadership training on HIV prevention. Receives: Behavioral: Network leader training; Behavioral: Standard HIV risk-reduction counseling |
| 2 | Active comparator | Participating social networks will receive standard HIV risk-reduction counseling. Receives: Behavioral: Standard HIV risk-reduction counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of high-risk sexual practices
Measured: Measured at baseline and Months 12 and 24
Secondary outcomes (1)
Effectiveness and usefulness of HIV prevention intervention as a public health approach for reaching population segments that remain vulnerable to HIV and other STDs
Measured: Measured at baseline and Months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startJul 2004
- Primary completionMar 2009
- Study completionSep 2009
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 852 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, Yuri A. Amirkhanian, PhD, Medical College of Wisconsin
- Investigators
- Yuri A. Amirkhanian, PhD, Principal investigator, Medical College of WisconsinDavid W. Seal, PhD, Study director, Medical College of WisconsinJeffrey A. Kelly, PhD, Study director, Medical College of WisconsinCarol L. Galletly, JD, PhD, Study director, Medical College of WisconsinLaura R. Glasman, PhD, Study director, Medical College of WisconsinTimothy L. McAuliffe, PhD, Study director, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705705
- Sponsor's protocol ID
- R01MH070316
- Other IDs
- R01MH070316, DAHBR 9A-ASPQ
- Status last verified
- Nov 2011
- First submitted
- 24 Jun 2008
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Social Network HIV Prevention Intervention
- ClinicalTrials.gov ID
- NCT00705705
- Acronym / sponsor ID
- R01MH070316
- Conditions
- HIV Infections
- Keywords
- High-Risk Behavior, Men Who Have Sex With Men, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 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 determine whether an HIV prevention program that targets the inner workings of social networks at high risk for HIV and other sexually transmitted diseases is effective in reducing frequency of high-risk sexual behaviors among network members.
Detailed description
Over the past decade, the number of new HIV infections in the United States has remained on a steady level, with approximately 40,000 Americans contracting the disease each year. Risk of contracting HIV is not evenly distributed throughout the population, with groups such as intravenous drug users, men who have sex with men (MSM), and impoverished people in inner cities being disproportionately affected. Many members of these groups have already made risk-reduction behavior changes, but there are certain clusters or networks of people within these populations who remain at a greater risk of HIV infection and who account for the majority of new infections. Therefore, more effective HIV prevention approaches directed toward high-risk social networks are needed. Training social leaders within the high-risk networks to communicate HIV prevention messages directly to their members may be an effective means of reaching these vulnerable population segments. This study will evaluate the effectiveness of an HIV prevention program that targets the inner workings of high-risk social networks (particularly young MSM and young high-risk heterosexual adult men and women) in reducing frequency of risky sexual behaviors among network members.
Participation in this study will last up to 2 years and will include the leaders and general members of multiple social networks. First, the eligibility of a given social network will be determined through a period of in-depth formative ethnographic research that will include a 20-minute interview with members of the social networks. During the eligibility interview, participants will be asked to provide personal information about themselves and their close friends, called a friendship group in this study. After the interview, participants will be asked to distribute a flyer about participating in the study to their friendship group. If enough members of the friendship group agree to complete the initial interview and the group meets the eligibility criteria, then members of the group will be asked to participate in the assessment interviews.
The first 1-hour assessment interview will be conducted at baseline and will include two parts. During the first part of the interview, participants will complete a survey about the friendship group, including questions about their most and least trusted members and communication among group members. The second part of the interview will include taking a computer survey with questions about sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. After completing the interview, participants will undergo a brief HIV/AIDS prevention counseling session. Participants will repeat this assessment interview 12 and 24 months later.
When at least half of the friendship group has completed the first assessment interview, the group will be assigned randomly to one of two conditions:
- For groups assigned to Condition 1, participants will receive a phone call when it is time for their repeat assessment interviews. In addition, a computer program will identify one person as the leader of the friendship group, and this person will be asked to attend nine 3-hour meetings over 17 weeks. These meetings will train and encourage leaders to provide positive HIV/AIDS prevention advice to the members of their friendship group.
- For groups assigned to Condition 2, participants will receive a phone call when it is time for their repeat assessment interviews. If the leadership program in Condition 1 appears to be effective, participants may be offered the same program at a later time.
Study participation will be complete after the 24-month assessment interview.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Network leader training, Behavioral: Standard HIV risk-reduction counselingParticipating social networks will receive standard HIV risk-reduction counseling and network leadership training on HIV prevention. |
| 2 | Active comparator | Behavioral: Standard HIV risk-reduction counselingParticipating social networks will receive standard HIV risk-reduction counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Identified by the network leader as a member of the social group (e.g., men who have sex with men, young heterosexual men and women)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Network leader trainingNetwork leaders will receive a nine-session training segment designed to enable them to motivate their peer networks to reduce sexual risk. The sessions will teach the identified leader of each network how to communicate HIV prevention messages to other members of his or her personal social network. Leaders will be asked to share these messages with other members of their groups. | Behavioural | 1 |
| Standard HIV risk-reduction counselingParticipants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview. | Behavioural | 1, 2 |
Primary outcome
Frequency of high-risk sexual practices
Time frame: Measured at baseline and Months 12 and 24
1 secondary outcome
Effectiveness and usefulness of HIV prevention intervention as a public health approach for reaching population segments that remain vulnerable to HIV and other STDs
Time frame: Measured at baseline and Months 12 and 24
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 Nov 2011.
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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.
Yuri A. Amirkhanian, PhD principal investigator
Medical College of Wisconsin
David W. Seal, PhD study director
Medical College of Wisconsin
Jeffrey A. Kelly, 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 Network leader training and Standard HIV risk-reduction counseling 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 1 inclusion and 0 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 Nov 2011. 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?
Frequency of high-risk sexual practices (time frame: Measured at baseline and Months 12 and 24). 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 Nov 2011.