NCT01575938

Brief Summary

The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or transmission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

3.6 years

First QC Date

March 29, 2012

Last Update Submit

January 25, 2021

Conditions

Sexual Transmission of Infection

Keywords

HIV infection

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months

    Self-reported unprotected anal and vaginal sex acts in the previous 4 months assessed via computer-assisted self-interviewing.

    Baseline, 4-months post-intervention

Study Arms (3)

HIV group-based prevention intervention

EXPERIMENTAL

The HIV prevention intervention is a 6-session group-based and manualized intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

Behavioral: HIV prevention intervention

Diet and nutrition

ACTIVE COMPARATOR

The comparison condition is a 6-session group-based and manualized health promotion intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

Behavioral: Diet and Nutrition

Standard-of-care

NO INTERVENTION

This arm will receive HIV and STI testing and counseling only.

Interventions

HIV prevention interventionBEHAVIORAL

The 6-session HIV prevention intervention curriculum, "LifeSkills," incorporates interactive activities, in-depth discussions, videos, games, and role-plays to help young transgender women develop, practice, and integrate new skills into "real-life" situations. Activities address each aspect our theoretical framework (information, motivation, behavior), including experiences that may pre-dispose young transgender women to HIV/STI risk. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

HIV group-based prevention intervention
Diet and NutritionBEHAVIORAL

The comparison condition is a 6-session group-based and manualized health promotion intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.

Diet and nutrition

Eligibility Criteria

Age16 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 16-29
  • self-identified as transgender, transsexual, and/or female with a male biological or birth sex
  • self-reported history of unprotected anal or vaginal intercourse, anal or vaginal sex with more than one sexual partner, anal or vaginal sex in exchange for money, food, shelter, or diagnosis with HIV or another STI in the previous 4 months
  • able to speak and understand English
  • willing and able to provide informed consent/assent
  • intention to reside in the local area throughout the 12 month follow-up period

You may not qualify if:

  • unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
  • active suicidal ideation at the time of baseline interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • Garofalo R, Johnson AK, Kuhns LM, Cotten C, Joseph H, Margolis A. Life skills: evaluation of a theory-driven behavioral HIV prevention intervention for young transgender women. J Urban Health. 2012 Jun;89(3):419-31. doi: 10.1007/s11524-011-9638-6.

    PMID: 22223033BACKGROUND

  • Jin H, Restar A, Goedel WC, Ogunbajo A, Biello K, Operario D, Kuhns L, Reisner SL, Garofalo R, Mimiaga MJ. Maternal Support Is Protective Against Suicidal Ideation Among a Diverse Cohort of Young Transgender Women. LGBT Health. 2020 Oct;7(7):349-357. doi: 10.1089/lgbt.2020.0219. Epub 2020 Sep 4.

    PMID: 32897809DERIVED

  • Garofalo R, Kuhns LM, Reisner SL, Biello K, Mimiaga MJ. Efficacy of an Empowerment-Based, Group-Delivered HIV Prevention Intervention for Young Transgender Women: The Project LifeSkills Randomized Clinical Trial. JAMA Pediatr. 2018 Oct 1;172(10):916-923. doi: 10.1001/jamapediatrics.2018.1799.

    PMID: 30105381DERIVED

  • Kuhns LM, Mimiaga MJ, Reisner SL, Biello K, Garofalo R. Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol. BMC Public Health. 2017 Sep 16;17(1):713. doi: 10.1186/s12889-017-4734-5.

    PMID: 28915919DERIVED

  • Kuhns LM, Reisner SL, Mimiaga MJ, Gayles T, Shelendich M, Garofalo R. Correlates of PrEP Indication in a Multi-Site Cohort of Young HIV-Uninfected Transgender Women. AIDS Behav. 2016 Jul;20(7):1470-7. doi: 10.1007/s10461-015-1182-z.

    PMID: 26336946DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

DietNutritional Status

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Robert Garofalo, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

  • Matthew Mimiaga, ScD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 12, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2016

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

US(2)