NCT01640392

Brief Summary

The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old African American men who have sex with men (MSM). Specifically, the project will test whether participants of the MyLife MyStyle program will report at least a 15% absolute decrease in frequency of unprotected anal sex with male partners at three and six months post-intervention compared with the wait-list control participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

July 11, 2012

Last Update Submit

August 13, 2019

Conditions

Unsafe Sex

Keywords

Gay menAfrican American malesUnprotected anal sexHIV riskbehavioral interventiongroup-level intervention

Outcome Measures

Primary Outcomes (1)

  • Reduced unprotected anal sex with male partners

    Proportion of intervention participants reporting any unprotected anal intercourse (either insertive or receptive) with male partners at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm.

    up to 6 months following Intervention groups' third (final) session

Secondary Outcomes (4)

  • Increased communication with partners

    3 months and 6 months following intervention groups' third (final) session

  • Decrease unprotected sex because condom was not available

    3 months and 6 months following Intervention groups' third (final) session

  • Decrease number of sexual partners

    3 months and 6 months following Intervention groups' third (final) session

  • Increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings

    3 months and 6 months following Intervention groups' third (final) session

Study Arms (2)

HIV prevention groups

EXPERIMENTAL

Participants randomly assigned to the MyLife Intervention arm receive three 1.5-hour HIV behavioral risk-reduction group sessions over a 1-3 week period.

Behavioral: MyLife MyStyle group-level intervention

Wait-list control

NO INTERVENTION

Participants randomly assigned to the Wait-list Control arm receive the MyLife MyStyle group sessions once they have completed a 6-month follow-up assessment.

Interventions

MyLife MyStyle group-level interventionBEHAVIORAL

Three 1.5-hour HIV behavioral risk-reduction group sessions conducted with up to 12 young African American/Black men (ages 18-29 years) over a 1-3 week period.

HIV prevention groups

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Identify as African American or Black
  • Identify as male
  • Age 18 to 29 years
  • Reside within Los Angeles County
  • Self-reported anal sex with a male partner in the past 12 months
  • Has not participated in an HIV prevention intervention in the past 3 months
  • Able to complete ACASI and MyLife sessions in English

You may not qualify if:

  • Identify as a transgender female
  • Plan to move out of Los Angeles County before the end of their follow-up period (within 7 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

In The Meantime Men's Group, Inc.

Los Angeles, California, 90019, United States

Location

MeSH Terms

Conditions

Unsafe Sex

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Trista Bingham, MPH, PhD

    Los Angeles County Department of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 13, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

US(1)