To address the unmet HIV-prevention needs of Romanian GBM, our established US-Romanian team proposes to introduce a culturally-responsive PrEP program in Romania. We will integrate and adapt two tools that we developed and tested in the US 1) SPARK, an in-person motivational intervention for uptake of and adherence to PrEP using an empowering sexual health approach; and 2) P3 (Prepared, Protected, emPowered), a PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling.
Despite the globally proven effectiveness of PrEP in preventing the transmission of HIV, PrEP is not currently medically prescribed in Romania. However, the demand for PrEP is increasing, as is evidence-based knowledge on effective rollout strategies. Romania has the second highest increasing HIV incidence amongst the 15 countries that make up the Central-Eastern European region. Gay and bisexual men (GBM) overwhelmingly account for this epidemic-driven group; however, despite such findings there is no targeted national programming for the GBM population. According to a large GBM report in 2019, Romania was the 8th of 44 European countries with the largest gap between PrEP use (1%) and PrEP demand (70%). Additionally, Romania exhibits some of the highest homophobic attitudes amongst Central-Eastern European countries. As a result of this stigma, GBM remain hidden and proper healthcare services are underutilized. Therefore, Romanian GBM obtain PrEP on their own without proper medical guidance, resulting in increased HIV incidence.
To address the unmet HIV-prevention needs of GBM in Romania, the established US-Romanian team has introduced a culturally competent PrEP program in Romania integrating two tools that have been developed and tested in the US. First, SPARK is an in-person motivational intervention for PrEP adherence utilizing an empowering sexual health approach. PrEP Romania, a mobile app, serves as the adherence support tool used within the program. Adapted and customized from HMP in the study’s two formative phases, the Prepare Romania app utilizes engaging social networking, game-based elements and an in-app portal for tailored live adherence counseling to support PrEP uptake and adherence.
Aim 1 consisted of the creation of Prepare Romania by integrating and
tailoring to the local context the in-person intervention (SPARK) and the mHealth app for Romanian GBM.
In months 2-7 the US team worked alongside a Romanian Partner Consortium and GBM community experts to culturally adapt and combine both SPARK and HMP. Qualitative data from working groups and survey data (groups included HIV counselors, infectious disease physicians, psychologists, US-based investigators, directors of LGBTQ Romanian resource centers and members of the Romanian GBM community) were analyzed and integrated into Prepare Romania to meet local needs.
During months 8-9 the full Prepare Romania protocol was field-tested amongst 10 GBM for one month, in Bucharest and Cluj-Napoca. Components tested included PrEP counseling, prescription fills, app use and adherence support. During this time piloting of Dried Blood Spot (DBS) samples were collected by the study physicians at the baseline and follow-up visits, and stored within the clinic at -20 degrees Celsius.
Aim 2 included pilot testing app usability, feasibility, and acceptability of Prepare Romania with 20 GBM in the same two cities.
During months 12-20, 20 GBM were recruited, screened and consented to be a part of the research study. Eligible participants completed the baseline survey, attended their first clinic visit and were prescribed PrEP for three months. The PrEP counselor checked in with participants via the app at the two and six week mark post PrEP initiation. Participants engaged in noncontrolled pilot-testing for three months, followed by a second clinic visit for a prescription refill and a follow-up survey. As in Aim 1, DBS samples were collected at baseline and follow-up, and shipped to the UNC School of Pharmacy Clinical Pharmacology and Analytical Chemistry Lab for analyses, together with the samples collected in Aim 1.
Aim 3 of Prepare Romania (July 2022-June 2025) will implement a randomized controlled trial (RCT) to test the early efficacy of PrEP Romania and identify necessary adjustments to be made to improve the PrEP counseling and adherence protocol, as well as app usability.
During this time, 120 GBM from Bucharest and Cluj-Napoca will be randomized to receive either Prepare Romania (counseling, self-directed app use and in-app text support for six months) or a PrEP education condition. Evaluation of differences within PrEP uptake, adherence, and persistence from both groups will be measured.
Aim 4 of Prepare Romania is to identify institutional and individual barriers regarding the access and adherence of PrEP consumption to help inform a future multi-city effectiveness-implementation hybrid trial.
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Findings and Takeaways
Findings from the RCT coming soon!
The RCT is planned to begin Fall 2022. Results from the completion of Prepare Romania will serve as evidence to create a scaled-up effectiveness implementation hybrid trial across several Romanian cities.