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Sexual Transmission of InfectionLifeSkillsNCT01575938

HIV Prevention Intervention for Young Transgender Women

A study testing HIV prevention intervention and Diet and Nutrition in people with Sexual Transmission of Infection, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sexual Transmission of Infection
What is being tested?
HIV prevention intervention and Diet and Nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesUnited States
Study dates
Mar 2012to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

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 16 to 29 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Fenway Institute

    Boston, Massachusetts, 02215

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

    Chicago, Illinois, 60611

Other trials in United States

About this study

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.

Read the detailed description

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. The study will test this intervention in a three-arm randomized controlled trial in two major U.S. cities with excellent access to and research experience with the population (Chicago, Boston). We will enroll at risk YTW, ages 16-29; two-fifths of the sample randomized to the intervention will participate in the 6-session group-based and manualized Life Skills intervention; two-fifths will be randomized to the standard-of-care (SOC) control condition; and one-fifth will be randomized to the time-matched attention control condition and receive standard health promotion information in a group-based multi-session format. All three arms will receive HIV and sexually transmitted infection (STI) (Chlamydia and gonorrhea) testing and pre-posttest risk reduction counseling (i.e., SOC). Sexual risk will be assessed at baseline, 4, 8 and 12 months post-randomization. Our specific aims are: 1) to determine the efficacy of the Life Skills intervention in comparison to a SOC arm and a time-matched attention control on the primary outcome: number of unprotected anal and vaginal sex acts in the previous 4 months among YTW, ages 16-29; and 2) to examine the degree to which improvements in sexual risk taking are mediated by the conceptual mediators of the intervention: transgender adaptation and integration, collective self-esteem/empowerment, information (HIV knowledge), motivation (attitudes, norms, and intentions for safer sex), and behavioral skills (discussing sex and condom use with sexual partners, acquiring and using condoms); and to explore whether reductions in sexual risk are associated with epidemiologically-linked moderators of sexual risk behavior: age, race/ethnicity, and psychosocial factors. An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample; in the SOC arm, we will assess the natural trajectory of sexual risk behavior and the acquisition of HIV and STIs (incidence rate) in YTW over a 12-month follow-up period.

Being tested
HIV prevention intervention, Diet and Nutrition
Keywords
HIV infection
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV prevention interventionBehavioural

    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.

  • Diet and NutritionBehavioural

    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.

Study groups in NCT01575938
Study groupRoleWhat they receive
HIV group-based prevention interventionExperimentalThe 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.
Receives: Behavioral: HIV prevention intervention
Diet and nutritionActive comparatorThe 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.
Receives: Behavioral: Diet and Nutrition
Standard-of-careNo interventionThis arm will receive HIV and STI testing and counseling only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 4-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2015
  4. Study completionOct 2016

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01575938
Sponsor's protocol ID
R01MH094323
Other IDs
R01MH094323
Acronym
LifeSkills
Status last verified
Jan 2021
First submitted
29 Mar 2012
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22223033

  • 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.

    PubMed 32897809

  • 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.

    PubMed 30105381

  • 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.

    PubMed 28915919

  • 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.

    PubMed 26336946

Questions about this trial

What is this clinical trial studying?

A study testing HIV prevention intervention and Diet and Nutrition in people with Sexual Transmission of Infection, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 2 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 27 Jan 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months (time frame: Baseline, 4-months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01575938, which also lists 5 linked publications.

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 27 Jan 2021.

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