Reducing HIV Health Disparities Among African American Transgender Women: An mHealth Approach to Improving Prevention, Testing, and Treatment Outcomes

The investigators will conduct a randomized controlled trial to test the efficacy of Shine, an mHealth HIV behavioral intervention for African American transgender women (TGW). Participants will be 215 African American TGW recruited by Trans Women of Color Collective (TWOCC) via in-person and online recruitment strategies. First, TWOCC's leadership and administrative teams will distribute palm cards and display posters describing the study during all community-based events that occur during the recruitment period. Second, ISA and TWOCC will develop an online strategy to disseminate a study flyer via social media (e.g., Facebook, Twitter). The flyer will be posted on both social media channels weekly during the study recruitment period. Interested women recruited via either method (in-person or online) will be instructed to contact the ISA field test manager for more information and to complete eligibility screening.

Interested participants who contact the field test manager will complete an eligibility screener. Specifically, participants must : 1) identify as a Black transgender woman using the recommended 2-step method (Step 1: assigned male birth sex, Step 2: current gender identity is female); 2) be aged 18 or older; 3) report risk of HIV transmission in the past 3 months (i.e., CAS with a serodiscordant or risky male partner AND either <90% ART adherence or <5 daily doses of PrEP per week); 4) own a smartphone; and 5) be able to read and speak English.

Ineligible women will be thanked, dismissed, and offered alternatives to the type of information being offered in this research study. Eligible women will provide contact information receive a detailed overview of the main points of the study. Once any participant questions are answered, the field test manager will trigger a text to be sent to the potential participant's study phone number. The text will include a link to an online version of the informed consent form presented on a secure web page (i.e., communication between the phone's browser and web page are encrypted). Women who agree to participate will acknowledge consent by clicking a button at the bottom of the online consent form that reads "I understand and CONSENT to participate." Women who choose not to participate after reading the informed consent form will press a button that reads "I understand and choose NOT to participate." These women will be thanked and all contact will cease.

Participants will be assigned to conditions using a permuted-blocks randomization scheme. Blocks of size 4 and 6 will be used. Assignments within blocks will be random but balanced among the two conditions and the order of the blocks (4 vs 6) also will be random. This procedure will ensure that the number of participants randomized to each condition will be equal, that any imbalance among the conditions at any point during the recruitment and randomization will be modest, and that it will be very difficult to guess the assignment of the next participant. After randomization has occurred, participants will complete the baseline research survey via telephone.

The primary outcome will be a dichotomous composite HIV risk transmission score, calculated by measuring whether a participant or the participant's partner consistently used at least one effective method for reducing HIV transmission risk (i.e., adherence to biomedical [ART or PrEP] and behavioral [condoms, serosorting] strategies) during each instance of anal sex over the past month. Every anal sex act must be protected by one of these methods to receive an overall composite score of 0. The individual behavioral components of the composite score (i.e., percentage of condomless anal sex, serosorting, PrEP or ART adherence) will serve as secondary measures. In addition, specific outcomes by HIV status will include HIV medical care utilization and adherence, HIV testing, and PrEP knowledge, interest, and uptake. Finally, further secondary measures will assess gender affirmation, well-being, social support, and sexual communication.