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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH094323 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Standard-of-care | No Intervention | This arm will receive HIV and STI testing and counseling only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV prevention intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Garofalo, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Matthew Mimiaga, ScD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| The Fenway Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22223033 | Background | 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. | |
| 32897809 | Derived | 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. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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|
| Diet and Nutrition | Behavioral | 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. |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| 30105381 | Derived | 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. |
| 28915919 | Derived | 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. |
| 26336946 | Derived | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003710 | Demography |
| D011154 | Population Characteristics |