Juntas Adelante: A Peer-Coaching Intervention to Promote Chemoprophylaxis for HIV Prevention Among Latina Transgender Women in the Washington DC Metropolitan Area.
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:
- Is the Juntas Adelante intervention acceptable and feasible to implement with this population?
- 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.
調査の概要
状態
詳細な説明
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:
- 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.
- 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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20037
- The George Washington University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:介入
|
The Juntas Adelante intervention includes two components:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PrEP initiation/persistence and/or PEP use
時間枠:"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:
|
"Final follow up, 3 months after last coaching session"
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in PrEP awareness
時間枠: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.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in PEP awareness
時間枠: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.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in Doxy-PEP awareness and use
時間枠: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.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in U=U awareness
時間枠: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.
|
Baseline survey to final follow-up 3 months after last coaching session.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRBPH 2024.16
- U01PS005218 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。