Skip to content

Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men

Reducing HIV Vulnerability Through A Multilevel Life Skills Intervention For Adolescent Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03155841
Enrollment
600
Registered
2017-05-16
Start date
2018-03-23
Completion date
2022-02-28
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, HIV Infections, Homosexuality, Sexual Behavior, Sexually Transmitted Diseases

Keywords

Prevention, Internet, Adolescence, LGBT, Sexuality

Brief 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. 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: 1. 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. 2. 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. 3. Examine the differential efficacy of our intervention in improving psychosocial mediators (e.g., personal competency) associated with our outcomes; and, 4. 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.

Interventions

BEHAVIORALLife Skills Coaching

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.

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.

Sponsors

University of Michigan
CollaboratorOTHER
Emory University
CollaboratorOTHER
University of North Carolina
CollaboratorOTHER
George Washington University
CollaboratorOTHER
San Diego State University
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
13 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

1. Assigned a male sex at birth and identifying as male at time of enrollment, 2. Be between the ages of 13-18 (inclusive), 3. Speak and read English, 4. Report same-sex attractions and/or behaviors, 5. Live in one of the zip codes of the 109 counties included in this trial, 6. Access to internet

Exclusion criteria

1. Being assigned a sex other than male at birth, 2. Identifying as a gender other than male at time of enrollment, 3. Being younger than 13 or older than 18 years of age, 4. Not speaking and reading English, 5. Reporting no same-sex attractions and/or behaviors, 6. Living outside of the 109 counties included in the four regions selected for this trial, 7. Currently incarcerated, 8. No access to internet.

Design outcomes

Primary

MeasureTime frameDescription
Confidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time6-month, 12-monthThe 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 Time6-month, 12-monthThe 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.

Secondary

MeasureTime frameDescription
Number of Participants Engaging in 1+ Same-Sex Sexual Partnerships6-month, 12-monthThe investigators will estimate participants' likelihood of engaging in one or more same-sex sexual partnerships during follow-up periods.
Number of Participants Engaging in HIV Testing Behavior12-monthThe investigators will estimate the number of participants who tested for HIV two or more times over the trial period.

Countries

United States

Participant flow

Participants by arm

ArmCount
Life Skills Coaching
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. Life Skills Coaching: 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.
300
Community Resources
Participants in the control arm will receive access to a directory of local resources in their community. Community Resources: 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.
300
Total600

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation34

Baseline characteristics

CharacteristicLife Skills CoachingCommunity ResourcesTotal
Age, Customized
Ages 13-14
41 Participants37 Participants78 Participants
Age, Customized
Ages 15-16
136 Participants128 Participants264 Participants
Age, Customized
Ages 17-18
123 Participants135 Participants258 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
120 Participants104 Participants224 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
180 Participants196 Participants376 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
9 Participants11 Participants20 Participants
Race (NIH/OMB)
Asian
28 Participants36 Participants64 Participants
Race (NIH/OMB)
Black or African American
62 Participants62 Participants124 Participants
Race (NIH/OMB)
More than one race
54 Participants45 Participants99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
26 Participants35 Participants61 Participants
Race (NIH/OMB)
White
121 Participants109 Participants230 Participants
Same-sex sexual behaviors139 Participants136 Participants275 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
300 Participants300 Participants600 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3000 / 300
other
Total, other adverse events
2 / 3003 / 300
serious
Total, serious adverse events
0 / 3000 / 300

Outcome results

Primary

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.

Time frame: 6-month, 12-month

Population: Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table.

ArmMeasureGroupValue (MEAN)Dispersion
Life Skills CoachingConfidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time6 Month Follow-up1.72 units on a scaleStandard Deviation 0.69
Life Skills CoachingConfidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time12 Month Follow-up1.73 units on a scaleStandard Deviation 0.72
Community ResourcesConfidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time6 Month Follow-up1.71 units on a scaleStandard Deviation 0.69
Community ResourcesConfidence to Engage in HIV Prevention Behaviors When Engaging in Receptive Anal Sex Over Time12 Month Follow-up1.72 units on a scaleStandard Deviation 0.71
Primary

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.

Time frame: 6-month, 12-month

Population: Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table.

ArmMeasureGroupValue (MEAN)Dispersion
Life Skills CoachingHIV Knowledge Over Time6 Month Follow-up7.86 score on a scaleStandard Deviation 3.23
Life Skills CoachingHIV Knowledge Over Time12 Month Follow-up8.33 score on a scaleStandard Deviation 3
Community ResourcesHIV Knowledge Over Time6 Month Follow-up7.99 score on a scaleStandard Deviation 2.84
Community ResourcesHIV Knowledge Over Time12 Month Follow-up8.23 score on a scaleStandard Deviation 2.98
Secondary

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.

Time frame: 6-month, 12-month

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Life Skills CoachingNumber of Participants Engaging in 1+ Same-Sex Sexual Partnerships6 Month Follow-Up78 Participants
Life Skills CoachingNumber of Participants Engaging in 1+ Same-Sex Sexual Partnerships12 Month Follow-Up81 Participants
Community ResourcesNumber of Participants Engaging in 1+ Same-Sex Sexual Partnerships6 Month Follow-Up84 Participants
Community ResourcesNumber of Participants Engaging in 1+ Same-Sex Sexual Partnerships12 Month Follow-Up88 Participants
Secondary

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.

Time frame: 12-month

Population: Number analyzed in follow-up periods differ from the enrolled sample due to missing data resulting from attrition in follow-up periods. Only those participants who were measured at a given follow-up period contributed to the data reported in the table.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Life Skills CoachingNumber of Participants Engaging in HIV Testing Behavior19 Participants
Community ResourcesNumber of Participants Engaging in HIV Testing Behavior30 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026