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

The primary objective of this study is to test the efficacy of the LifeSkills intervention to reduce sexual risk for HIV acquisition and transmission among young transgender women, ages 16-29 years. A secondary objective is to test hypothesized social, cognitive and behavioral mediators of the intervention effect.

This study is a three-arm randomized controlled trial targeting young transgender women, ages 16-29 years who are at high risk of HIV acquisition or transmission due to sexual risk behavior, conducted in two cities in the U.S.: Boston and Chicago. Participants are randomized to receive the LifeSkills group-based intervention, standard-of-care preventive care only, or a time- and attention-matched group-based control intervention (non-active). All study groups receive repeat standard preventive care which consists of HIV testing with pre-posttest counseling and urogenital screening for gonorrhea and Chlamydia. Participants who are randomized are followed for 12 months with visits conducted at 4-month intervals: 4, 8, and 12-month post-randomization (Fig. 1).

Participants are recruited via outreach to community-based organizations and events, public spaces (e.g., bars and clubs), and social media outreach and advertisement (e.g., Facebook, Craig’s List); and through direct outreach by peer recruiters and transgender community leaders. Grounded in community-based participatory research principles [15], recruitment is carried out with input from local transgender communities in each city. Eligibility criteria include: (1) ages 16-29 years; (2) assigned male sex at birth and, at the time of enrollment, self-identify as a woman, female, transgender woman, transfemale, male-to-female (MTF), or on the trans feminine spectrum; (3) English-speaking; (4) no plans to move from the local area during the 12-month study period; and (5) self-reported sexual risk in the previous 4 months (i.e., condomless anal or vaginal intercourse; anal or vaginal intercourse with more than one sexual partner; anal or vaginal sex in exchange of money, food, shelter; or diagnosis with HIV or another sexually transmitted infection). Participants are excluded if they are unable to provide assent/consent due to severe mental/physical illness or intoxication; or if they are actively suicidal at the time of enrollment. Potential participants may enroll when these conditions resolve.

The LifeSkills intervention was developed to address the specific structural, developmental, and interpersonal challenges to sexual safety based upon the well-documented social realities of YTW [16, 17] and demonstrated feasibility and initial efficacy in a CDC-funded pilot trial [16]. Theorized mediators of the intervention effect include empowerment processes (e.g., increases in collective self-esteem and integration) as well as traditional HIV related prevention and health promotion targets (i.e., HIV-related knowledge, motivation, and behavioral skills). Empowerment has been described as a social process in which individuals (and communities) gain mastery over their lives [18]; it typically involves the development of skills, knowledge, and confidence which allows them to overcome obstacles in their personal and communal lives [18‐21]. Empowerment processes may facilitate behavior change, building on the resiliencies, strengths, and capabilities of YTW as a collective community [22, 23], and help to buffer the effects of social and economic marginalization. There is mounting evidence that social and economic factors are associated with high rates of HIV transmission and adverse HIV-related outcomes in high risk groups [24]. The Information, Motivation, Behavioral Skills (IMB) model integrates theory and research from both health and social psychology literatures and has been applied to a wide array of wellness-promotion and health behaviors [25, 26]. With respect to HIV prevention, IMB focuses on the set of informational, motivational, and behavioral skills that are conceptually and empirically associated with safer sex. The Life Skills intervention targets information, motivation, and behavioral components consistent with the IMB model for HIV sexual risk reduction in YTW.

The LifeSkills curriculum is manualized and includes six sessions (Table 1): 1: Pride, 2: communication and respect; 3: skills building, 4: knowledge and self-protection, 5: partner negotiation, 6: tying it all together) to communicate basic HIV-related information (e.g., transmission modes and related risks), develop motivation (e.g., to protect oneself), and promote behavioral skill development (e.g., condom use, sexual partner communication and negotiation) through an empowerment-based approach [17]. The Life Skills curriculum incorporates interactive activities, in-depth discussions, videos, games, and role-plays to help participants develop, practice, and integrate new skills into “real-life” situations. Integrated throughout the curriculum is information on gender transition/affirmation and experiences and scenarios specific to transgender women’s experiences. Each session begins by asking participants to share one proud moment that occurred in the previous week to focus on the positive aspects of their lives and set the tone for the intervention session. Each session ends with a ceremony in which participants are given a small gift (i.e., key chain, mirror) and asked to describe one thing they learned from the day’s session that they could teach other young women, which serves to reinforce key intervention messages. During the sixth session, participants develop a personal risk reduction plan designed to identify risk behavior and alternative behavior options. The intervention is delivered by two trained transgender women in 2-h small-group sessions twice a week for three consecutive weeks. Facilitators are trained using a standard protocol. To monitor intervention fidelity, intervention sessions are audio-recorded, reviewed, and rated by an outside evaluator. Study facilitators also complete self-rating forms. Feedback is provided in weekly supervision sessions by the study coordinator at each site based on review of rating forms.

The time and attention-matched control intervention is also manualized and delivered at the same time/place as the LifeSkills intervention in six sessions and facilitated by a transgender woman. Control manual content was drawn from recommendations of the United States Department of Agriculture (USDA; https://​www.​choosemyplate.​gov). The control intervention sessions include: an introductory session, followed by five sessions devoted to the major food groups. Control group sessions include interactive activities and games and are of similar length as the LS sessions.

Participants in all study conditions receive pre-posttest counseling coupled with HIV screening (i.e., third generation testing algorithms at each site for those reporting HIV-negative or unknown status) per the RESPECT-2 protocol [27] and urogenital gonorrhea and chlamydia sexually transmitted infections (STIs; first catch urine via nucleic acid amplification testing, NAAT).

Participants complete a baseline study visit comprised of standardized assessment via computer-assisted personal-interviewing (CAPI; including both interviewer- and self-administered questions) as well as screening for HIV/STIs. Follow-up CAPI assessments are conducted at 4, 8 and 12-month follow-ups, with repeat HIV/STI screening at the 4 and 12-month visits.

Primary Outcome: Condomless Anal or Vaginal Sex. Items assessing sexual behavior were self-administered and adapted for YTW from the AIDS Risk Behavior Assessment (ARBA) [28]. All items assessed sexual behavior in the prior 4 months. The basis for construction of the primary outcome is a set of sequential questions asking the participant to estimate the number of anal and vaginal sex partners they had in the recall period and the number of condomless sex acts by type of sex (vaginal, anal) and position (receptive, insertive) with these partners. A lead-in question asks about history of gender affirming vaginosplasty which determines deployment of questions regarding vaginal sex by position (receptive or insertive).

Mediators: Collective self-esteem, transgender adaptation and integration, HIV knowledge, motivation, behavioral skills. The collective self-esteem scale (CSES) [29] is a 16-item self-report measure that assesses a person’s thoughts and feelings regarding their social group (modified to include reference to the “transgender community”). Using a seven-point scale, participants indicated the degree to which they agree or disagree with statements regarding the reference group (1-strongly disagree to 7-strongly agree). The items form four subscales (four items each): membership (e.g., “I am a worthy member of the transgender community”); private (e.g.,“I feel good about the transgender community”); public (e.g., “In general, others respect the transgender community”); identity (e.g., “Being part of the transgender community is an important reflection of who I am”). The TG-AIM is a 15-item measure that assesses adjustment and experiences that are specific to gender identity [30]. This validated measure uses a 4-point Likert scale (0 = never, 1 = rarely, 2 = occasionally, 3 = frequently) to assess four subscales: (1) coping and gender reorientation efforts; (2) gender locus of control; (3) gender-related fears subscale; (4) psychosocial impact of gender status subscale. Although this scale has been used in previous research with transgender adults [30, 31], we have adapted this measure as appropriate for YTW.

To measure HIV knowledge, we adapted the brief HIV Knowledge Questionnaire (HIV-KQ-18) [32] for use with YTW (total 20 items). Motivation and behavioral skills are measured using items adapted from previous HIV prevention studies [33‐35]. Motivation to practice safer behavior is assessed as three separate dimensions: attitudes, norms, and behavioral intentions to engage in HIV-preventive actions (total scale = 24 items). Behavioral skills for HIV prevention is assessed with 12 items that asked how “hard” or “easy” it was for participants to implement a variety of skills, including discussing sex and condom use with sexual partners, and acquiring and using condoms. Response options range from 1 = “Very Hard to Do” to 5 = “Very Easy to Do.”

Initially, the distribution of all variables will be assessed, as will the correlations between all study variables and the primary and secondary outcomes. We will also assess for patterns of missing data. The primary anticipated reason for missing data is attrition due to loss to follow-up. We estimate 20% attrition to the 12-month follow-up assessment (375 randomized leading to 300 completers of the intervention). Outcome variables will be examined to determine which distributional models (e.g., Gaussian, Poisson) are most appropriate for subsequent statistical procedures. The primary analysis will compare differences in risk behavior at the month 4 visit between study arms using an intent-to-treat approach. Between-group differences at the month 8 and month 12 visits will similarly be compared. We will use mixed effects models with properly-chosen (based on the distribution of dependent variable) link functions to analyze longitudinal data for each study aim and examine the difference in the rate of change between intervention groups for the outcome variables. Mixed effects models explicitly model individual change across time and allow for unequal number of observations per individual (e.g., missing time points) [36]. If the 6-session Life Skills intervention does work to reduce sexual risk-taking behaviors among the sample in significantly greater magnitude than the comparison conditions, we will assess the extent to which this relationship works through several possible mediators, including increases in collective self-esteem/empowerment, transgender adaptation and integration, and HIV related information, motivation, and behavioral risk-reduction skills. For hypothesized mediators that are significantly changed by the intervention (i.e., the rate of change differed by treatment assignment), we will conduct mediation analysis to determine whether the effect of the intervention on the primary, acute outcome (i.e., at month 4 follow-up) was through the hypothesized mediator(s) [37].

The primary power analysis is based on detecting a 40% (or greater) difference in the number of condomless sex acts between groups over the course of the study (per estimate of effect size in the pilot study) [16], expecting all groups to show improvements from baseline. Based on these data, with a power of 85% and alpha level of 0.05 and factoring in 20% attrition, we estimate needing 300 completers of the proposed intervention (LS = 120; SOC arm = 120; DN time and attention-matched control = 60).