Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01771237 |
| Other study ID # |
R34MH079707 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2007 |
| Est. completion date |
January 2011 |
Study information
| Verified date |
January 2021 |
| Source |
Ann & Robert H Lurie Children's Hospital of Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This exploratory study aims to design and test an HIV prevention intervention for young men
who have sex with men (MSM) between the ages of 16-20 as this group comprises the US
adolescent population most at-risk for HIV infection through sexual contact. To help develop
the content and format of our intervention we will first conduct in-depth interviews with
twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact
between ages 16-20 (i.e., the target age of our intended intervention). We will then design a
group-based primary intervention for young MSM between ages 16-20, relying on the information
we gathered from these interviews, as well as consultation from an advisory board of young
MSM and HIV prevention experts. Last, we will use an experimental design to compare our
intervention to a control condition. We hypothesize that, relative to a control condition of
sexual health education and risk reduction, participants in our intervention will demonstrate
lower rates of HIV risk behavior, find participation more feasible, and endorse greater
acceptability of our intervention.
Description:
The purpose of this three year study is to develop and then test the feasibility and
acceptability of a uniquely targeted HIV risk reduction intervention for young men who have
sex with men (MSM), ages 16 to 20, at risk for HIV acquisition or transmission. In year one,
the preliminary components of a primary prevention intervention for young MSM aged 16-20 will
result from the findings of qualitative interviews conducted among a multiethnic sample of 21
young MSM (aged 18-24) who acquired HIV through male-to-male sexual contact between ages
16-20. In year two, a preliminary primary prevention intervention curriculum will be
completed and subsequently refined through community advisory board review. In year three,
the feasibility and acceptability of the intervention will be tested in a two-arm randomized
controlled trial in a community-based agency with excellent access to and research experience
with the population. We will enroll 100 at-risk young MSM ages 16-20; two-thirds of the
sample (N=66)will be randomized to the intervention condition while one-third (N=34) will be
randomized to the time-matched attention control condition and receive standard health
promotion information in a group-based format. Sexual risk will be assessed at baseline, 6,
and 12 weeks post-intervention. The specific aims of this exploratory study are: 1) to design
an HIV and substance use primary prevention program for 16-20 year-old urban,
ethnically-diverse YMSM; 2) to pilot test and refine study methods; 3) to test the revised
multi-ethnic intervention with 100 young YMSM and examine preliminary effects on risky sexual
behavior, alcohol/drug use, and psychosocial intermediate outcomes specified by our
theoretical framework in preparation for a large-scale, efficacy study. An additional
exploratory aim is to describe the prevalence of HIV and STIs in the community recruited
sample.
