Clinical Research Directory

Quantitative surveys will be conducted through Alchemer, a HIPPA-compliant online survey system previously used by our group in collaborative research with CDC and supported by the Emory University Center for AIDS Research (CFAR). Surveys will be optimized for participants to take them through a personal computer, mobile phone, tablet, or the SMART study app. For participants who do not have any of these devices or prefer not to take the survey from their device, each city will have a research space where participants can schedule a convenient time to take the survey on a computer or tablet that the study will provide for that purpose.

The research team has developed and validated procedures for self-collection of specimens for testing for STIs (syphilis, urethral, rectal, and pharyngeal gonorrhea/chlamydia) and HIV self-testing. All participants will be mailed self-collection kits to provide samples for STIs (urine, rectal swab, and pharyngeal swab for gonorrhea/chlamydia; dried blood spot (DBS) for syphilis testing) and HIV (HIV 4th generation testing on DBS specimens in a CLIA-certified laboratory). Participants will be asked to collect specimens for their STI and HIV testing (every 6 months) and return them to Molecular Testing Labs. For participants who prefer in-person procedures, they will meet study staff who will provide them with the STI and HIV self-collection kit and instructions and provide a room for participants to collect their specimens.

Focus group discussions (n=up to 48 men for 3 qualitative assessments; total n=up to 144 men) as a part of the study consisting of 9 to 12 focus group discussions (FGD) with an average of 8 (range 3-10) participants in each (3 per city). These focus groups will be conducted once during the first year of the study. FGD will be conducted by a trained moderator using a semi-structured interview guide developed in collaboration with CDC scientists. For the FGD, in each city, there will be one FGD with men who have never used PrEP, one with men who are using PrEP and report no adherence issues, and one with men who are currently using PrEP or used PrEP previously and report sub-optimal adherence. In-Depth Interviews (IDIs) A series of 90 in-depth interviews (same n=up to 45 men for each of 3 qualitative assessments) will be conducted over 18 months: up to 45 IDIs each 6 months apart, with up to 15 IDIs per city each wave.