Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Public Health
Published in: BMC Public Health 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Lisa M. Kuhns, Matthew J. Mimiaga, Sari L. Reisner, Katie Biello, Robert Garofalo

Published in: BMC Public Health | Issue 1/2017

Login to get access

Abstract

Background

Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women.

Methods

This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits.

Discussion

Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population.

Trial registration

ClinicalTrials.gov number, NCT01575938, registered March 29, 2012.
Literature
1.
Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013;13(3):214–22.CrossRefPubMed
2.
Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N. Estimating HIV prevalence and risk behaviors of transgender persons in the united states: a systematic review. AIDS Behav. 2008;12(1):1–17.CrossRefPubMed
3.
Schulden JD, Song B, Barrosb A, Mares-DelGrasso A, Martind CW, Ramireze R, Smith LC, Wheeler DP, Oster AM, Sullivan PS, et al. Rapid HIV testing in transgender communities by community-based organizations in three cities. Public Health Rep. 2008;123:101–14.CrossRefPubMedPubMedCentral
4.
Garofalo R, Deleon J, Osmer E, Doll M, Harper G. Overlooked, misunderstood and at-risk: exploring the lives and HIV risk of ethnic minority male-to-female transgender youth. J Adolesc Health. 2006;38:230–6.CrossRefPubMed
5.
Reisner SL, Vetters R, White JM, Cohen EL, LeClerc M, Zaslow S, Wolfrum S, Mimiaga MJ. Laboratory-confirmed HIV and sexually transmitted infection seropositivity and risk behavior among sexually active transgender patients at an adolescent and young adult urban community health center. AIDS Care. 2015;27(8):1031–6.CrossRefPubMedPubMedCentral
6.
Smith DK, Herbst JH, Zhang X, Rose CE. Condom effectiveness for HIV prevention by consistency of use among men who have sex with men in the united states. Journal of acquired immune deficiency syndromes (1999). 2015;68(3):337–44.CrossRef
7.
Buchbinder SP, Glidden DV, Liu AY, McMahan V, Guanira JV, Mayer KH, Goicochea P, Grant RM. HIV pre-exposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial. Lancet Infectious Disease. 2014;14:468–75.CrossRef
8.
Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, Hosek S, Mosquera C, Casapia M, Montoya O, et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014;14(9):820–9.CrossRefPubMed
9.
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587–99.CrossRefPubMedPubMedCentral
10.
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;20(7):1470–7.CrossRefPubMedPubMedCentral
11.
Deutsch MB, Glidden DV, Sevelius J, Keatley J, McMahan V, Guanira J, Kallas EG, Chariyalertsak S, Grant RM. HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. The lancet HIV. 2015;2(12):e512–9.CrossRefPubMedPubMedCentral
12.
Smith DK, Herbst JH, Rose CE. Estimating HIV protective effects of method adherence with combinations of preexposure prophylaxis and condom use among african american men who have sex with men. Sex Transm Dis. 2015;42(2):88–92.CrossRefPubMed
13.
Centers for Disease Control and Prevention (CDC). Preexposure prophylaxis for the prevention of HIV infection in the united states – 2014 clinical practice guideline. Atlanta: Department of Health and Human Services; 2014.
14.
Garofalo R, Kuhns LM, Reisner SL, Mimiaga MJ. Behavioral interventions to prevent HIV transmission and acquisition for transgender women: a critical review. Journal of acquired immune deficiency syndromes (1999). 2016;72 Suppl 3:S220–5.CrossRef
15.
Leung M, Yen I, Minkler M. Community based participatory research: a promising approach for increasing epidemiology’s relevance in the 21st century. Int J Epidemiol. 2004;33(3):499–506.CrossRefPubMed
16.
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. Journal of urban health : bulletin of the New York Academy of Medicine. 2012;89(3):419–31.CrossRef
17.
Cotton C, Garofalo R. Project life skills: developing the content of a multidimensional HIV prevention curriculum for young transgender women aged 16-24. Journal of HIV/AIDS & Social Services. 2016;15(1):99–113.CrossRef
18.
Glanz K, Rimer BK, Viswanath K. Health behavior and health education: theory, research, and practice. 4th ed. San Francisco: Jossey-Bass, Wiley Inc.; 2008.
19.
Fawcett S, Paine-Andrews A, Francisco VT, et al. Using empowerment theory in collaborative partnerships for community health and development. Am J Community Psychol. 1995;23:677–97.CrossRefPubMed
20.
Rappaport J. Terms of empowerment/exemplars of prevention: toward a theory for community psychology. Am J Community Psychol. 1987;15:121–48.CrossRefPubMed
21.
Shearer N. Relationships of contextual and relational factors to health empowerment in women. Research and theory for nursing practice. 2004;18:357–70.CrossRefPubMed
22.
Bockting W, Kirk S. Transgender and HIV: risks, prevention, and care. New York: Haworth Press; 2001.
23.
Fergus S. Zimmerman, MA: adolescent resilience: a framework for understanding healthy development in the face of risk. Annu Rev Public Health. 2005;26:399–419.CrossRefPubMed
24.
Sharpe TT, Harrison KM, Dean HD. Summary of CDC consultation to address social determinants of health for prevention of disparities in HIV/AIDS, viral hepatitis, sexually transmitted diseases, and tuberculosis. December 9-10, 2008. Public Health Rep. 2010;125(Suppl 4):11–5.
25.
26.
Fisher WA, Fisher JD. A general social psychological model for changing AIDS risk behavior. In: The social psychology of HIV infection edn. Edited by Pryor JB, Reeder GD. Hillsdale: Erlbaum; 1993. p. 127-153.
27.
Metcalf C, Douglas J, Malotte C, Cross H, Dillon B, Paul S, Padilla S, Brookes L, Lindsey C, Byers R, et al. Relative efficacy of prevention counseling with rapid and standard HIV tesitng: a randomized, controlled trial (RESPECT-2). Sex Transm Dis. 2005;32:130–8.CrossRefPubMed
28.
Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001;40(6):642–53.CrossRefPubMedPubMedCentral
29.
Luhtanen R, Crocker J. Collective self-esteem scale: self-evaluation of one’s social identity. Personality & Social Psychology Bulletin. 1992;18:302–18.CrossRef
30.
Sjoberg M, Walch SE, Stanny CJ. Development and initial psychometric evaluation of the transgender adaptation and integration measure (TG AIM). International Journal of Transgenderism. 2006;9:35–45.CrossRef
31.
Sanchez F, Vilain E. Collective self-esteem as a coping resource for male-to-female transsexuals. J Counseling Psychology. 2009;56:202–9.CrossRef
32.
33.
Amico KR, Toro-Alfonso J, Fisher JD. An empirical test of the information, motivation and behavioral skills model of antiretroviral therapy adherence. AIDS Care 2005. 2005;17:661–73.
34.
Bryan AD, Fisher DJ, Benziger TJ. Determinants of HIV risk among Indian truck drivers. Soc Sci Med. 2001;53:1413–26.CrossRefPubMed
35.
Starace F, Massa A, Amico KR, et al. Adherence to antiretroviral therapy: an empirical test of the information-motivation-behavioral skills model. Health Psychol 2006. 2006;25:153–62.
36.
Singer J, Willett J. Applied longitudinal data analysis: modeling change and event occurrence. New York: Oxford University Press; 2003.CrossRef
37.
MacKinnon D. Introduction to statistical mediation analysis. New York: Lawrence Erlbaum Associates; 2008.
Metadata
Title
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
Authors
Lisa M. Kuhns
Matthew J. Mimiaga
Sari L. Reisner
Katie Biello
Robert Garofalo
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2017
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-017-4734-5

Other articles of this Issue 1/2017

BMC Public Health 1/2017 Go to the issue

Research article

Burden and characteristics of HIV infection among female sex workers in Kampala, Uganda – a respondent-driven sampling survey

Research article

The role of self-control and cognitive functioning in educational inequalities in adolescent smoking and binge drinking

Research article

Cancer survival disparities worsening by socio-economic disadvantage over the last 3 decades in new South Wales, Australia

Research article

Exposure to a community-wide campaign is associated with physical activity and sedentary behavior among Hispanic adults on the Texas-Mexico border

Research article

Social and health outcomes following upgrades to a national housing standard: a multilevel analysis of a five-wave repeated cross-sectional survey

Research article

Association between parent attitudes and receipt of human papillomavirus vaccine in adolescents