Unsafe SexPhase 1/2PowerNCT01376895
Project Power: An HIV Risk Reduction Intervention for Black Men Who Have Sex With Men and Women (BMSM/W)
A Phase 1/2 study testing PROJECT POWER and Power Health in people with Unsafe Sex and Risk Reduction, run by Nova Southeastern University at 1 site in United States.
Trial summary
The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Unsafe Sex, Risk Reduction
- What is being tested?
- PROJECT POWER and Power Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2014
- Phase
- Phase 1/2
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self identify as Black or African descent
- At least 18 years of age
- Resident of Chicago MSA
- Sexually active with men and women
Who cannot join
- Previously participated in the study
- Identify as transgendered
Trial locations and contacts
1 site in 1 country.
United States1 site
John H. Stroger Hospital of Cook county
Chicago, Illinois, 60612
About this study
Official title: Developing and Testing of an HIV Prevention Intervention Targeting Black Men Who Have Sex With Men and Women (BMSM/W)
The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.
Read the detailed description
The purpose of this study is to examine the preliminary efficacy, feasibility and acceptability of delivering a culturally and developmentally tailored HIV risk reduction intervention via the Internet in real-time that promotes risk reduction among black men who have sex with men and women (BMSMW). During the Developmental Phase, our activities will consist of completing development (finalizing sessions, completing the manuals) of a theoretically grounded, culturally based, individual intervention, Project POWER, to reduce risk of HIV acquisition and transmission among BMSMW.
The investigators will then conduct a randomized controlled trial (RCT) to test the preliminary efficacy, acceptability, and feasibility of POWER compared to HEALTH. Using chain referral methods, the investigators will recruit 200 BMSMW (100 per arm) and assign them to 1 of 2 conditions (POWER or HEALTH). Participants will complete an assessment battery delivered via ACASI at baseline, immediate post intervention and at 3 months post intervention. The investigators will also measure uptake of HIV and STI testing. Participants will also complete acceptability/feasibility assessments after the
- Conditions
- Unsafe Sex, Risk Reduction
- Being tested
- PROJECT POWER, Power Health
- Keywords
- Black MSM/W, HIV
- Medical subject headings
- Unsafe Sex, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROJECT POWERBehavioural
POWER is a three session intervention to help Black men who have sex with men and women lead healthier lives, make informed sexual choices and reduce their chances of getting or giving HIV to their sex partners. Interventions are designed to be delivered via the internet in real time by a trained health educator. Each session will last between 1 and 2 hours. The sessions are grounded on the social learning theory and use cognitive behavioral approaches. Participants learn the multiple influences on their behavior, how to identify their triggers and then use problem solving skills to develop a safer strategy for life. The sessions use videos and games to teach the lessons; participants are also given work that they must complete between the sessions.
Power HealthBehavioural
Power Health is a one session intervention designed to help Black men who have sex with men and women improve their general health. It focuses on health issues (including HIV) that affect Black men. The program consists of 1 session delivered via the internet in real time by a trained health educator and last approximately 2 hours
| Study group | Role | What they receive |
|---|---|---|
| POWER | Experimental | Power is a 3 session intervention delivered through the internet in real time by a trained health educator. It focuses on reducing HIV risk. Each session last from 1 to 2 hours. Receives: Behavioral: PROJECT POWER |
| Power Health | Active comparator | Power Health is a 1 session general health promotion program designed to be delivered via the internet in real time by a trained health educator. The sessions focus on healthy life styles, cardiovascular health, and prostate health. Participants also receive information regarding safe sex. Receives: Behavioral: Power Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
unprotected sex
Unprotected sex refers to either vaginal or anal sex
Measured: last 3 month
Secondary outcomes (1)
number of sex partners
number of sex partners refers to either male or female sex partners
Measured: last 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unsafe SexStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Cook County Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376895
- Sponsor's protocol ID
- POWER
- Other IDs
- 5UR6PS0011095
- Acronym
- Power
- Status last verified
- Mar 2014
- First submitted
- 16 Jun 2011
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing of an HIV Prevention Intervention Targeting Black Men Who Have Sex With Men and Women (BMSM/W)
- ClinicalTrials.gov ID
- NCT01376895
- Acronym / sponsor ID
- Power / POWER
- Conditions
- Unsafe Sex, Risk Reduction
- Keywords
- Black MSM/W, HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Cook County Health
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Jun 2011 (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.
The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.
Detailed description
The purpose of this study is to examine the preliminary efficacy, feasibility and acceptability of delivering a culturally and developmentally tailored HIV risk reduction intervention via the Internet in real-time that promotes risk reduction among black men who have sex with men and women (BMSMW). During the Developmental Phase, our activities will consist of completing development (finalizing sessions, completing the manuals) of a theoretically grounded, culturally based, individual intervention, Project POWER, to reduce risk of HIV acquisition and transmission among BMSMW.
The investigators will then conduct a randomized controlled trial (RCT) to test the preliminary efficacy, acceptability, and feasibility of POWER compared to HEALTH. Using chain referral methods, the investigators will recruit 200 BMSMW (100 per arm) and assign them to 1 of 2 conditions (POWER or HEALTH). Participants will complete an assessment battery delivered via ACASI at baseline, immediate post intervention and at 3 months post intervention. The investigators will also measure uptake of HIV and STI testing. Participants will also complete acceptability/feasibility assessments after the
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POWER | Experimental | Behavioral: PROJECT POWERPower is a 3 session intervention delivered through the internet in real time by a trained health educator. It focuses on reducing HIV risk. Each session last from 1 to 2 hours. |
| Power Health | Active comparator | Behavioral: Power HealthPower Health is a 1 session general health promotion program designed to be delivered via the internet in real time by a trained health educator. The sessions focus on healthy life styles, cardiovascular health, and prostate health. Participants also receive information regarding safe sex. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Self identify as Black or African descent
- At least 18 years of age
- Resident of Chicago MSA
- Sexually active with men and women
Key exclusion criteria (2 listed)
- Previously participated in the study
- Identify as transgendered
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 |
|---|---|---|
| PROJECT POWERPOWER is a three session intervention to help Black men who have sex with men and women lead healthier lives, make informed sexual choices and reduce their chances of getting or giving HIV to their sex partners. Interventions are designed to be delivered via the internet in real time by a trained health educator. Each session will last between 1 and 2 hours. The sessions are grounded on the social learning theory and use cognitive behavioral approaches. Participants learn the multiple influences on their behavior, how to identify their triggers and then use problem solving skills to develop a safer strategy for life. The sessions use videos and games to teach the lessons; participants are also given work that they must complete between the sessions. | Behavioural | POWER |
| Power HealthPower Health is a one session intervention designed to help Black men who have sex with men and women improve their general health. It focuses on health issues (including HIV) that affect Black men. The program consists of 1 session delivered via the internet in real time by a trained health educator and last approximately 2 hours | Behavioural | Power Health |
Primary outcome
unprotected sex
Time frame: last 3 month
Unprotected sex refers to either vaginal or anal sex
1 secondary outcome
number of sex partners
Time frame: last 3 months
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 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PROJECT POWER and Power Health in people with Unsafe Sex and Risk Reduction, run by Nova Southeastern University 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 4 inclusion and 2 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 Mar 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
unprotected sex (time frame: last 3 month). 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 Mar 2014.