Dataset Information

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.

ABSTRACT: 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.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.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.ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

SUBMITTER: Kuhns LM

PROVIDER: S-EPMC5603056 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Kuhns Lisa M LM Mimiaga Matthew J MJ Reisner Sari L SL Biello Katie K Garofalo Robert R

BMC public health 20170916 1

<h4>Background</h4>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 f ...[more]

PMID: 28915919

Similar Datasets

Project description:ImportanceThe incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group.ObjectiveTo determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years.Design, setting, and participantsRandomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach.InterventionsParticipants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time- and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board's recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period.Main outcomes and measuresPrimary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits.ResultsOf the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 [0.40] at baseline vs 1.22 [0.22] at 4 months) compared with the standard of care group (2.69 [0.59] at baseline vs 2.10 [0.47] at 4 months) (risk ratio [RR], 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 [0.13] vs 1.40 [0.32]; RR, 0.60; 95% CI, 0.50-0.72; P < .001).Conclusions and relevanceAmong YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW.Trial registrationClinicalTrials.gov Identifier: NCT01575938.

Project description:BackgroundRegular aerobic physical activity (PA) is an important component of healthy aging. However, only 27%-40% of African American women achieve national PA guidelines. Available data also show a clear decline in PA as African American women transition from young adulthood (ie, 25-44 years) into midlife. This decline in PA during midlife coincides with an increased risk for African American women developing cardiometabolic disease conditions, including obesity, type 2 diabetes, and cardiovascular disease. Thus, effective efforts are needed to promote PA among sedentary African American women during midlife.ObjectiveThis study aims to examine the acceptability and feasibility of a culturally tailored, smartphone-delivered PA intervention, originally developed to increase PA among African American women aged 24-49 years, among a slightly older sample of midlife African American women aged 50-65 years.MethodsA single-arm pretest-posttest study design was implemented. In total, 20 insufficiently active African American (ie, ≤60 min per week of PA) women between the ages of 50-65 years participated in the 4-month feasibility trial. The Smart Walk intervention was delivered through the study Smart Walk smartphone app and text messages. Features available on the Smart Walk app include personal profile pages, multimedia PA promotion modules, discussion board forums, and an activity tracking feature that integrates with Fitbit activity monitors. Self-reported PA and social cognitive theory mediators targeted by the intervention (ie, self-regulation, behavioral capability, outcome expectations, self-efficacy, and social support) were assessed at baseline and at 4 months. Feasibility and acceptability were assessed using a postintervention satisfaction survey that included multiple-choice and open-ended questions evaluating participant perceptions of the intervention and suggestions for intervention improvement. Wilcoxon signed-rank tests were used to examine pre- and postintervention changes in the PA and social cognitive theory variables. The effect size estimates were calculated using the Pearson r test statistic.ResultsParticipants increased moderate-to-vigorous PA (median 30 minutes per week increase; r=0.503; P=.002) and reported improvements in 2 theoretical mediators (self-regulation: r=0.397; P=.01; behavioral capability: r=0.440; P=.006). Nearly all participants (14/15, 93% completing the satisfaction survey) indicated that they would recommend the intervention to a friend. Participants' suggestions for improving the intervention included enhancing the intervention's provisions of social support for PA.ConclusionsThe results provide preliminary support for the feasibility of the smartphone-based approach to increase PA among midlife African American women. However, before larger-scale implementation among midlife African American women, enhancements to the social support components of the intervention are warranted.Trial registrationClinicalTrials.gov NCT04073355; https://clinicaltrials.gov/ct2/show/NCT04073355.

Project description:BACKGROUND:New cases of human immunodeficiency virus (HIV) among young men who have sex with men (YMSM), aged 18 to 24, underscore the importance of developmentally-informed HIV programs for YMSM. We developed an online intervention focused on risk reduction strategies across different sexual partner types. Intervention activities focus on assisting YMSM reflect on their partner-seeking behaviors, develop sexual decision-making rules to reduce their HIV risks, and consider the adoption of HIV prevention behaviors. OBJECTIVE:This pilot, randomized controlled trial (RCT) aims to examine the feasibility, acceptability, and preliminary efficacy of a tailored, Web-based HIV prevention intervention for single YMSM. METHODS:We designed a prospective RCT of online-recruited cis-gender men (N=180) who reported recent unprotected anal intercourse, self-report as HIV negative or are unaware of their HIV status, and meet sexual partners through online dating apps. Individuals in the control arm receive an attention-control condition that includes HIV/sexually transmitted infection (STI) information currently available on sex education websites. Individuals in the intervention arm receive a 6-session Web-based program tailored on their demographic information, partner-seeking behaviors and relationship desires, and prior sexual attitudes and behaviors. This tailored content will match HIV prevention messages and safer sex skills with YMSM's outcome expectancies when meeting new partners and thereby help them consider how to integrate safer sex practices into different partner types. Study assessments are taken at baseline, 30-, 60-, and 90-day follow-ups. Intervention acceptability and preliminary efficacy will be explored in sexual risk behaviors and HIV/STI testing. RESULTS:The RCT launched in November 2016 and is ongoing. To date, 180 eligible individuals have been enrolled, consented, and randomized. Of the 120 individuals in the intervention arm, 51.7% (62/120) identify as non-Hispanic white and half of the control arm identifies as non-Hispanic white. There were no differences observed by arm for race and/or ethnicity, age, or sexual orientation. CONCLUSIONS:Although there are in-person evidence-based interventions with proven efficacy for YMSM, few HIV/STI prevention interventions delivered online exist. Online interventions may ease access to comprehensive HIV/STI education among YMSM and allow personalized content to be delivered. The online intervention that we developed, myDEx, aims to alleviate the gaps within HIV prevention for YMSM by utilizing tailored, Web-based content with the goal of developing skills for same-sex dating and relationship building, while reducing their risks for HIV/STI. TRIAL REGISTRATION:ClinicalTrials.gov NCT02842060; https://clinicaltrials.gov/ct2/show/NCT02842060 (Archived by WebCite at http://www.webcitation.org/6rcJdxF9v).

Project description:OBJECTIVE:While transgender people report higher rates of risky drinking than the general population, no studies have examined transgender alcohol use longitudinally. This study investigated minority stress and identity development predictors of improvement in risky drinking among transgender individuals. METHODS:Data come from a multi-site, longitudinal cohort study of U.S. transgender individuals (N?=?330) and include measures of enacted stigma, felt stigma, identity development, and risky alcohol use. Theory-driven, hierarchical multivariable logistic regression was used to investigate the hypothesis that minority stress and identity development factors are related to improvement in risky drinking between baseline and 1-year follow-up. RESULTS:Baseline risky drinkers (n?=?106; 37.1%) were younger and more likely to have female sex assigned at birth. At 1-year follow-up, 68 baseline risky drinkers (64.2%) reported persistent risky drinking, while 38 (35.8%) reported improved drinking. Controlling for demographics and study site, female sex assigned at birth and enacted stigma were associated with lower odds of improved drinking. Non-white/Hispanic race/ethnicity, felt stigma, change in gender role/expression for 1-5?years, and diffuse-avoidant identity style were associated with higher odds of improvement. CONCLUSIONS/IMPORTANCE:This is the first study to identity predictors of improvement in risky drinking among transgender individuals. Compared to trans-feminine individuals (assigned male at birth), trans-masculine individuals (assigned female at birth) were more likely to report risky drinking at baseline and had lower odds of improvement at 1-year follow-up. Improved drinking may be facilitated by preventing anti-transgender discrimination. Felt stigma and diffuse-avoidant identity style may lower alcohol risk via avoidance of drinking venues. Further research is needed to explicate these relationships and to inform culturally-tailored alcohol interventions for this at-risk population.

Project description:ImportanceConcentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States. Accumulating research has highlighted the effectiveness of culturally tailored HIV/STI interventions for Black women; however, there is a dearth of such interventions for the large number of Black women in CSPs.ObjectiveTo determine the effectiveness of a 5-session culturally tailored group-based intervention (Empowering African-American Women on the Road to Health [E-WORTH]) with individualized computerized modules and streamlined HIV testing in reducing STIs and condomless sex vs a 1-session streamlined HIV testing control condition.Design, setting, and participantsThis randomized clinical trial was conducted from November 18, 2015, (first recruitment) to August 20, 2019 (last 12-month follow-up). Black women mandated to probation, parole, or alternative-to-incarceration programs in New York City who had a history of drug use were recruited and randomized to receive either E-WORTH or a streamlined HIV testing control condition. Both conditions were delivered by Black female staff at a large CSP. The analysis took an intention-to-treat approach.InterventionE-WORTH included a 1-hour individual HIV testing and orientation session and 4 weekly 90-minute group sessions. The control condition included one 30-minute session of HIV testing and information.Main outcomes and measuresPrimary outcomes were incidence of any STI (biologically assayed chlamydia, gonorrhea, and Trichomonas vaginalis) at the 12-month assessment and the number of condomless acts of vaginal or anal intercourse in the past 90 days during the 12-month period.ResultsA total of 352 participants who identified as Black or African American were enrolled, including 79 (22.5%) who also identified as Latinx. The mean (SD) age was 32.4 (11.0) years. A total of 172 participants (48.9%) were assigned to the E-WORTH condition, and 180 (51.1%) were assigned to the control condition. Compared with control participants, participants assigned to the E-WORTH condition had 54% lower odds of testing positive for any STI at the 12-month follow-up (odds ratio, 0.46; 95% CI, 0.25-0.88; P = .01) and reported 38% fewer acts of condomless vaginal or anal intercourse during the 12-month period (incidence rate ratio, 0.62; 95% CI, 0.39-0.97; P = .04).Conclusions and relevanceThe magnitudes of effects found across biological and behavioral outcomes in this randomized clinical trial indicate the feasibility and effectiveness of implementing E-WORTH in real-world CSPs. The findings lend further evidence to the promise of culturally tailored HIV/STI interventions for Black women.Trial registrationClinicalTrials.gov Identifier: NCT02391233.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure