Prevention of HIV Infection, STI Prevention
Conditions
Keywords
HIV chemoprophylaxis (PrEP and PEP), Latina transgender women
Brief summary
The goal of this clinical trial is to evaluate the impact of the Juntas Adelante intervention on awareness and use of chemoprophylaxis for HIV prevention (Pre- and Post-Exposure prophylaxis, or PrEP and PEP) among Latina Transgender Women in the Washington DC Metropolitan Area. Secondary outcomes included awareness and use of Doxy-PEP (i.e., Doxycycline for prevention of Sexually Transmitted Infections - STI), and awareness of Undetectable = Untransmittable (U=U). The main questions are: 1. Is the Juntas Adelante intervention acceptable and feasible to implement with this population? 2. Is participating in the Juntas Adelante intervention associated with increased awareness and use of PrEP and PEP? All participants in the study will view 5 online short videos on HIV and STI prevention and will receive up to two virtual coaching sessions with a peer coach. They will also complete a brief survey after viewing each video (5 total) and three longer surveys/interviews over the course of 3 months.
Detailed description
Using a community-based participatory research (CBPR) approach, we developed Juntas Adelante, an intervention to increase awareness and use of PrEP and PEP for HIV prevention among Latina transgender women in the DC metropolitan area. The Juntas Adelante intervention includes two components: 1. Peer coaching sessions: Up to two virtual coaching sessions with another Latina transgender woman (peer coach) who has been trained to encourage dialogue around HIV prevention goals. 2. Video mini-series: Five short informational videos covering 5 topics (one per episode): 1) Latina transgender women and HIV (duration: 2:29 min); 2) Post-exposure prophylaxis - PEP (duration: 3:49 min); 3) Pre-exposure prophylaxis - PrEP (duration: 1:58 min); 4) Doxy-PEP (duration: 3:25 min); and 5) Undetectable equals Untransmittable - U=U (duration: 3:47 min). Videos were housed into the Vimeo platform, and were embedded into REDCap surveys for distribution. Participant recruitment and eligibility: Participants will be recruited via referrals from community members (i.e., members of the Community Council, other study participants). Eligibility criteria include: 1) Male sex assigned at birth, currently identifying as a woman, transgender woman, transgender, or transsexual, irrespective of gender transition stage; 2) identifying as Latina, regardless of country of birth; 3) being 18 years old or older; 4) living in the DC metropolitan area; 5) self-reporting HIV negative status at study enrollment 6) reporting having receptive anal and/or neovaginal sex with at least one cisgender man or transgender woman in the previous 12 months; 7) not currently using PrEP or report less than 3 months of use; 8) have access to a cellphone with internet capabilities, and 9) not planning to move from the DC metropolitan area in the next 12 months.
Interventions
BEHAVIORALJuntas Adelante: A Peer coaching Intervention to Promote Chemoprophylaxis for HIV Prevention among Latina Transgender Women in the Washington DC Metropolitan Area.
The Juntas Adelante intervention includes two components: 1. Peer coaching sessions: Up to two virtual coaching sessions with another Latina transgender woman (peer coach) who has been trained to encourage dialogue around HIV prevention goals. Sessions occur via Zoom, and are scheduled at the convenience of participants. In addition to HIV and STI prevention, participants may bring other topics they want to discuss during the coaching sessions. 2. Video mini-series: Five short informational videos covering 5 topics (one per episode): 1) Latina transgender women and HIV (duration: 2:29 min); 2) Post-exposure prophylaxis - PEP (duration: 3:49 min); 3) Pre-exposure prophylaxis - PrEP (duration: 1:58 min); 4) Doxy-PEP (duration: 3:25 min); and 5) Undetectable equals Untransmittable - U=U (duration: 3:47 min). Videos were housed into the Vimeo platform, and were embedded into REDCap surveys for distribution.
Sponsors
George Washington University
Department of Health of the District of Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male sex assigned at birth, currently identifying as a woman, transgender woman, transgender, or transsexual, irrespective of gender transition stage; * Identifying as Latina, regardless of country of birth; * Being 18 years old or older; * Living in the DC metropolitan area; * Self-reporting HIV negative status at study enrollment * Reporting having receptive anal and/or neovaginal sex with at least one cisgender man or transgender woman in the previous 12 months; * Not currently using PrEP or report less than 3 months of use; * Must have access to a cellphone with internet capabilities, * Not planning to move from the DC metropolitan area in the next 12 months
Exclusion criteria
\- Not meeting all of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation/persistence and/or PEP use | "Final follow up, 3 months after last coaching session" | Our primary outcome is PrEP initiation/persistence or PEP use at the 3-month follow up, defined as the combination of any: 1. PrEP Initiation: Participants who reported having never used PrEP at baseline AND report starting PrEP between baseline and 3-month follow up OR participants who reported having ever used PrEP but were not currently using at baseline AND report re-starting PrEP between baseline and 3-month follow up. 2. PrEP Persistence: Participants who reported using PrEP at baseline AND continued using at 3-month follow up. For daily oral PrEP, persistence is defined as still taking PrEP at 3 month follow-up. Persistence for long-acting injectable PrEP will be defined as receiving at least 1 injection since baseline visit. 3. PEP Use: Any instance of PEP use by a non-PrEP user between baseline and 3-month follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PrEP awareness | Baseline survey to final follow-up 3 months after last coaching session. | Whether participant knows about PrEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys. |
| Change in PEP awareness | Baseline survey to final follow-up 3 months after last coaching session. | Whether participant knows about PEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys. |
| Change in Doxy-PEP awareness and use | Baseline survey to final follow-up 3 months after last coaching session. | Whether participant knows about (awareness) or has used Doxy-PEP for STI prevention, evaluated by comparing baseline to 3-month follow-up surveys. |
| Change in U=U awareness | Baseline survey to final follow-up 3 months after last coaching session. | Whether participant knows about Undetectable equals Untransmittable as a treatment-as-prevention message, evaluated by comparing baseline to 3-month follow-up surveys. |
Countries
United States
Outcome results
None listed