HIV InfectionsNCT03155841
Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men
A study testing Life Skills Coaching and Community Resources in people with HIV Infections and Sexually Transmitted Diseases, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The investigators propose to deliver and test a life skills intervention targeting the key domains that fuel HIV disparities among adolescent (ages 13-18) same-sex attracted men in the United States. Read more about this study
- Who is it for?
- Ages 13 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior
- What is being tested?
- Life Skills Coaching and Community Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Assigned a male sex at birth and identifying as male at time of enrollment,
- Be between the ages of 13-18 (inclusive),
- Speak and read English,
- Report same-sex attractions and/or behaviors,
- Live in one of the zip codes of the 109 counties included in this trial,
- Access to internet
Who cannot join
- Being assigned a sex other than male at birth,
- Identifying as a gender other than male at time of enrollment,
- Being younger than 13 or older than 18 years of age,
- Not speaking and reading English,
- Reporting no same-sex attractions and/or behaviors,
- Living outside of the 109 counties included in the four regions selected for this trial,
- Currently incarcerated,
- No access to internet.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
About this study
The investigators propose to deliver and test a life skills intervention targeting the key domains that fuel HIV disparities among adolescent (ages 13-18) same-sex attracted men in the United States. This RCT will yield important information regarding the delivery of a developmentally-appropriate HIV prevention program that reaches racial/ethnic and socioeconomically diverse sample of adolescent men across four regions in the United States.
Read the detailed description
From 2000-2010, the annual number of new HIV diagnoses among MSM aged 13-24 years old more than doubled. There are stark racial and ethnic disparities in the incidence of new HIV infections among YMSM; 13- 24 year old racial and ethnic minority MSM now represent a rapidly growing share of all new HIV infections. Although the likelihood of HIV acquisition is greater at older ages, many of the cognitive and behavioral risk factors that contribute to the risk of HIV infection rates develop in adolescence. As adolescent MSM (AMSM; 13-18 years old) begin to develop and express gender and sexual identities, to experiment and begin sexual behaviors, and to begin to establish a sense of self, there is the opportunity to parallel this period of growth with targeted, tailored interventions that equip AMSM with the life skills they need to reduce their vulnerability to HIV risk and to establish the life skills necessary to manage risk. The investigators developed a mobile-friendly WebApp intervention focused on life skills training with links to local resources. In the proposed activities, the investigators will adapt the life skills intervention for four U.S regions heavily impacted by HIV, and revise the content to include materials that are age-appropriate for 13 to 18 year-olds. Given the role that stigma and social isolation plays in the lives of many AMSM, the investigators also propose to embed a peer-to-peer motivational interviewing component, allowing participants to access motivational interviewing counseling via VSee video-chat. With a large and diverse sample (n=500), the investigators will test the efficacy of the intervention, now referred to as iCON+, on cognitive and behavioral HIV-related outcomes using a two-arm randomized control design. In addition, the investigators examine whether structural characteristics in a region (e.g., race/ethnicity segregation, HIV prevalence) influence the efficacy of the proposed intervention.
The following Specific Aims are proposed:
- Adapt a multilevel, online life skills intervention to address HIV vulnerability among AMSM living in four heavily impacted regions constituting diverse racial/ethnic and geographic areas (Chicago-Detroit; Atlanta-Washington, DC; Memphis- New Orleans; San Francisco-San Diego) in the US.
- Test the efficacy of our intervention, as compared to a delayed intervention condition, to improve cognitive (e.g., comfort discussing sexuality; HIV prevention attitudes, norms, self-efficacy, behavioral intentions) and behavioral (e.g., condom use, HIV testing, PrEP use) factors using a prospective RCT design.
- Examine the differential efficacy of our intervention in improving psychosocial mediators (e.g., personal competency) associated with our outcomes; and,
- Examine how socio-ecological determinants at the individual (e.g., race/ethnicity, urbanity) and regional (e.g., socioeconomic disadvantage, HIV prevalence) level are associated with intervention efficacy.
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Adolescent Behavior, Homosexuality
- Being tested
- Life Skills Coaching, Community Resources
- Keywords
- Prevention, Internet, Adolescence, LGBT, Sexuality
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Adolescent Behavior, Homosexuality, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Skills CoachingBehavioural
The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
Community ResourcesBehavioural
The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
| Study group | Role | What they receive |
|---|---|---|
| Life Skills Coaching | Experimental | Participants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function. Receives: Behavioral: Life Skills Coaching |
| Community Resources | Active comparator | Participants in the control arm will receive access to a directory of local resources in their community. Receives: Behavioral: Community Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time
The investigators will measure HIV prevention self-efficacy over time, using a 4-point scale (1=Very Easily; 2=Easily; 3=Somewhat Easily; 4=Not Easily) where lower scores indicate a better outcome.
Measured: 6-month, 12-month
HIV Knowledge Over Time
The investigators will measure HIV prevention knowledge over time using 13 True or False statements (0=Incorrect; 1=Correct) regarding HIV transmission. Scores can range from 0 to 13, where higher scores indicate a better outcome.
Measured: 6-month, 12-month
Secondary outcomes (2)
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
The investigators will estimate participants' likelihood of engaging in one or more same-sex sexual partnerships during follow-up periods.
Measured: 6-month, 12-month
Number of Participants Engaging in HIV Testing Behavior
The investigators will estimate the number of participants who tested for HIV two or more times over the trial period.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start23 Mar 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Emory University, University of North Carolina, George Washington University, San Diego State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155841
- Sponsor's protocol ID
- U01MD011274
- Status last verified
- May 2023
- First submitted
- 10 May 2017
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men
- ClinicalTrials.gov ID
- NCT03155841
- Acronym / sponsor ID
- U01MD011274
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Adolescent Behavior, Homosexuality
- Keywords
- Prevention, Internet, Adolescence, LGBT, Sexuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Michigan, Emory University, University of North Carolina, George Washington University, San Diego State University
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to deliver and test a life skills intervention targeting the key domains that fuel HIV disparities among adolescent (ages 13-18) same-sex attracted men in the United States. This RCT will yield important information regarding the delivery of a developmentally-appropriate HIV prevention program that reaches racial/ethnic and socioeconomically diverse sample of adolescent men across four regions in the United States.
Detailed description
From 2000-2010, the annual number of new HIV diagnoses among MSM aged 13-24 years old more than doubled. There are stark racial and ethnic disparities in the incidence of new HIV infections among YMSM; 13- 24 year old racial and ethnic minority MSM now represent a rapidly growing share of all new HIV infections. Although the likelihood of HIV acquisition is greater at older ages, many of the cognitive and behavioral risk factors that contribute to the risk of HIV infection rates develop in adolescence. As adolescent MSM (AMSM; 13-18 years old) begin to develop and express gender and sexual identities, to experiment and begin sexual behaviors, and to begin to establish a sense of self, there is the opportunity to parallel this period of growth with targeted, tailored interventions that equip AMSM with the life skills they need to reduce their vulnerability to HIV risk and to establish the life skills necessary to manage risk. The investigators developed a mobile-friendly WebApp intervention focused on life skills training with links to local resources. In the proposed activities, the investigators will adapt the life skills intervention for four U.S regions heavily impacted by HIV, and revise the content to include materials that are age-appropriate for 13 to 18 year-olds. Given the role that stigma and social isolation plays in the lives of many AMSM, the investigators also propose to embed a peer-to-peer motivational interviewing component, allowing participants to access motivational interviewing counseling via VSee video-chat. With a large and diverse sample (n=500), the investigators will test the efficacy of the intervention, now referred to as iCON+, on cognitive and behavioral HIV-related outcomes using a two-arm randomized control design. In addition, the investigators examine whether structural characteristics in a region (e.g., race/ethnicity segregation, HIV prevalence) influence the efficacy of the proposed intervention.
The following Specific Aims are proposed:
- Adapt a multilevel, online life skills intervention to address HIV vulnerability among AMSM living in four heavily impacted regions constituting diverse racial/ethnic and geographic areas (Chicago-Detroit; Atlanta-Washington, DC; Memphis- New Orleans; San Francisco-San Diego) in the US.
- Test the efficacy of our intervention, as compared to a delayed intervention condition, to improve cognitive (e.g., comfort discussing sexuality; HIV prevention attitudes, norms, self-efficacy, behavioral intentions) and behavioral (e.g., condom use, HIV testing, PrEP use) factors using a prospective RCT design.
- Examine the differential efficacy of our intervention in improving psychosocial mediators (e.g., personal competency) associated with our outcomes; and,
- Examine how socio-ecological determinants at the individual (e.g., race/ethnicity, urbanity) and regional (e.g., socioeconomic disadvantage, HIV prevalence) level are associated with intervention efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life Skills Coaching | Experimental | Behavioral: Life Skills CoachingParticipants in the experimental arm will receive access to HIV prevention and life skills content, including opportunities for goal setting, a directory of local resources in their community, and the ability to discuss their goals with Youth Navigators through a video-chat function. |
| Community Resources | Active comparator | Behavioral: Community ResourcesParticipants in the control arm will receive access to a directory of local resources in their community. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Assigned a male sex at birth and identifying as male at time of enrollment,
- Be between the ages of 13-18 (inclusive),
- Speak and read English,
- Report same-sex attractions and/or behaviors,
- Live in one of the zip codes of the 109 counties included in this trial,
Key exclusion criteria (8 listed)
- Being assigned a sex other than male at birth,
- Identifying as a gender other than male at time of enrollment,
- Being younger than 13 or older than 18 years of age,
- Not speaking and reading English,
- Reporting no same-sex attractions and/or behaviors,
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 |
|---|---|---|
| Life Skills CoachingThe investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location. | Behavioural | Life Skills Coaching |
| Community ResourcesThe investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions. | Behavioural | Community Resources |
Primary outcome
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time
Time frame: 6-month, 12-month
The investigators will measure HIV prevention self-efficacy over time, using a 4-point scale (1=Very Easily; 2=Easily; 3=Somewhat Easily; 4=Not Easily) where lower scores indicate a better outcome.
HIV Knowledge Over Time
Time frame: 6-month, 12-month
The investigators will measure HIV prevention knowledge over time using 13 True or False statements (0=Incorrect; 1=Correct) regarding HIV transmission. Scores can range from 0 to 13, where higher scores indicate a better outcome.
2 secondary outcomes
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships
Time frame: 6-month, 12-month
Number of Participants Engaging in HIV Testing Behavior
Time frame: 12-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Skills Coaching and Community Resources in people with HIV Infections and Sexually Transmitted Diseases, run by University of Pennsylvania at 2 sites 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 8 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time (time frame: 6-month, 12-month). The study lists 2 primary outcomes in all. 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 6 May 2023.