JMIR Publications

ABSTRACT

Background:

The U.S. National HIV/AIDS Strategy 2020 calls for: increasing access to care and improving outcomes of people living with HIV; and targeting biomedical prevention efforts, including access to pre-exposure prophylaxis (PrEP) in communities where HIV is most heavily concentrated. Baltimore, MD, Washington, DC and Philadelphia, PA are disproportionately burdened by high rates of new cases of HIV infection, with highly elevated rates among young Black and Latinx men who have sex with men (YBLMSM) and transgender women (TW) aged 15 to 24.

Objective:

The three aims of the PUSH study focus on assessing the effectiveness of different strategies to identify the prevention and treatment continua of YBLMSM and YBLTW in the three cities (Aim 1); and using two embedded randomized controlled trials, experimentally examine the efficacy of a mobile enhanced coach-based intervention to achieve sustained retention and engagement in HIV care among youth living with HIV (YLWH) who are not virally suppressed (Aim 2), and examine the uptake of and adherence to PrEP and other preventive behaviors (e.g., condom use) among youth at elevated-risk for HIV infection (Aim 3).

Methods:

This study is a multi-phase mixed methods design. The first phase is formative, qualitative research with key informant interviews (KII) and focus group discussions to inform development and refinement of the methods utilized in the interventions. The second phase consists of evaluating multiple methods of recruitment including traditional venue-based outreach, clinic-based recruitment and modified respondent driven sampling with targeted seed identification. The third phase includes two embedded randomized controlled trials to examine the efficacy of a mobile enhanced coach-based intervention to achieve sustained retention and engagement in HIV care among YLWH who are not virally suppressed and examine the uptake of and adherence to PrEP and other preventive behaviors (e.g., condom use) among youth at elevated-risk for HIV infection. All Participants complete a baseline socio-behavioral survey, rapid HIV-1 testing, and eligible youth are randomized to one of two study arms: mobile enhanced intervention with coach or standard of care. Participants are asked to complete a web-based survey and provide biologic specimens (HIV-1 RNA (viral load) in YLWH, or 4th generation HIV-1 antibody test in youth at-risk for HIV; and urine drug screen) at baseline and 3, 6 and 12 months.

Results:

Formative qualitative research was conducted in February, 2017 and July, 2017 and led to further refinement of recruitment and study methods. Aim 1 recruitment began September 2017 with subsequent enrollment into Aims 2 and 3. Recruitment is on-going with 520 participants screened and 402 (77.3%) enrolled. Of these, 159 are enrolled in two randomized trials: 36 HIV-positive not virally suppressed and 123 high-risk HIV-negative.

Conclusions:

This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by making available rigorous scientific evidence outlining approaches and strategies that improve uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention cascade. Clinical Trial: NCT03194477