Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men

The investigators will conduct a randomized controlled trial (RCT) with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER HIV prevention and relationship education intervention or an attention-matched couples-based positive affect enhancement program. Each program (both 2GETHER and control) delivers 4 sessions over 1-month; 2 group sessions of 4-8 couples focused on relationship skills building, and 2 individual couple sessions focused on skill utilization. Couples complete skills practice homework between sessions and receive community-based resources.

Eligibility Screening. Participants will be screened either online, over the phone with a member of the study staff, or in-person at Howard Brown Health Center, depending on the mode of recruitment (recruitment activities described below). (a) Online screening - young men who have sex with men (YMSM) who are recruited via social media ads or via email contact (i.e., email listservs, HBHC Primary Care patients) will be linked directly to the online eligibility screener, and YMSM recruited from flyer postings will be given a URL and the option to screen online. Potential participants will be greeted with a brief description of the project and will be asked if they are willing to answer some questions to assess their eligibility. Those who agree to participate will answer questions about their age, gender, and relationship status. Participants who meet initial eligibility criteria will be shown a message telling them that they are preliminarily eligible for the study. These participants will be asked to provide contact information for themselves and for their partner. If they do not consent to give contact information for their partner, the participant will be responsible for ensuring the partner also completes the screener. If they provide contact information for their partner, study staff will contact the partner and provide him with a link to complete the screener. (b) Phone screening - YMSM who opt to call the study phone number on the flyer will be screened by a study staff member. They will be given an overview of the study, the ability to ask questions, and will then be asked if they are interested in participating and asking their partner to participate. If they agree, the staff member will administer the online screener over the phone. All other procedures are analogous to the online screening. (c) In-person screening at Howard Brown Health Center - Upon completion of their HIV testing and counseling session or their primary care visit at Howard Brown, YMSM will be provided with a brief description of the 2GETHER project asked if they are interested in participating in the study. If interested, participants will complete the online eligibility screener. All other eligibility screener procedures are analogous to those described above for online screening. Screening data will be retained during the course of the study in order to help identify duplicate participants or participants faking eligibility.

Couple Confirmation. In order to participate in this study, both partners in the couple must complete the screener, meet all eligibility criteria, and be confirmed by study staff to be an actual couple. Couple confirmation will involve separate calls to each partner with a series of questions to elicit information about the individual, his partner, and their relationship (i.e., information only an actual couple would know about one another). After these phone calls, study staff will review the responses to determine agreement. Once staff has confirmed that the two participants are a couple, they will be contacted to schedule an in-person meeting where they will complete a consent form and the baseline assessment.

Baseline Assessment. After couple confirmation, the couple will be scheduled for an in-person appointment. After consenting to participate in the study in-person (consent process described below), the 2 partners will be directed to complete a baseline assessment. This approximately 60-minute questionnaire will assess demographics, relationship characteristics, HIV knowledge and motivations, HIV risk and prevention behaviors, and other relevant psychosocial outcomes (e.g., substance use, mental health). The couple will then be given additional information about the structure of the intervention and scheduling options. The baseline assessment will occur 1 week prior to the first session of the 2GETHER intervention. Urethral/rectal STI testing will also occur at baseline.

Randomization. Dyads will be randomized to the 2GETHER intervention or attention-matched control using stratified block randomization, which involves performing simple randomization many times within blocks (e.g., ABBA, AABB, etc.), ensuring equal N in each condition while avoiding temporal imbalance. The eligibility screener will assess age and known HIV status. Blocks will be stratified to ensure equal numbers of couples assigned to each condition in which: (a) at least 1 member is HIV+; and (b) 1 member is aged 30+. Randomization will occur at completion of baseline survey. Baseline interviews will occur 1 week prior to 2GETHER/control session 1, and dyads will only be baselined if they are available for all sessions. Scheduling conflicts arise; 2 group cohorts are run simultaneously, so dyads that miss a group session can be scheduled for the same session in the other cohort.