Att minska samtidigt förekommande missbruk och HIV-risk bland stimulantanvändande män med hög risk för HIV i USA.
Att minska samtidigt förekommande substansbruk och HIV-risk bland stimulant-användande män med hög risk för HIV i USA.
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jose Colon-Burgos, DrPH
- Telefonnummer: (352) 273-9188
- E-post: jcolonburgos@phhp.ufl.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- be 18 years of age or older;
- be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;
- report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
- have HIV-negative serostatus;
- be bilingual (Spanish and English), or Spanish or English monolingual;
- meet CDC criteria for PrEP eligibility.
Exclusion Criteria:
- display diminished capacity to consent (e.g., cognitive impairment); or
- severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;
- if they are HIV positive or living with HIV;
- if they are already taking PrEP; and
- if the participant can't consent to participate in English or Spanish.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Attention-Control condition
Participants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises. |
Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP. |
|
Experimentell: Experimental condition
Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. T The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks;(3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of PrEP uptake
Tidsram: From enrollment to 6 months
|
Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP. |
From enrollment to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stimulant use (self-report)
Tidsram: Enrollment to 6 months
|
Changes in the severity of participant stimulant use as measured by the Alcohol, Smoking, and Substance Involvement Screen Test (ASSIST) composite scores for cocaine and amphetamine-type stimulants. |
Enrollment to 6 months
|
|
Condomless Anal Sex (CAS)
Tidsram: From enrollment to 6 months
|
Changes in the number of CAS partners who are not taking PrEP or virally suppressed. |
From enrollment to 6 months
|
|
Social Network Composition
Tidsram: From enrollment to 6 months
|
Changes in the number of social network alters who use stimulants and increases in the number of social network alters who are taking PrEP. |
From enrollment to 6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jose Colon-Burgos, DrPH, University of Florida
Publikationer och användbara länkar
Allmänna publikationer
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- Padilla M, Colon-Burgos JF, Varas-Diaz N, Matiz-Reyes A, Parker CM. Tourism Labor, Embodied Suffering, and the Deportation Regime in the Dominican Republic. Med Anthropol Q. 2018 Dec;32(4):498-519. doi: 10.1111/maq.12447. Epub 2018 May 8.
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Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB202501242
- 5R00DA053158-05 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
De-identified datasets from the study will be shared.
Tidsram för IPD-delning
12 months after completion of the study
Kriterier för IPD Sharing Access
Data will be accessible via UF data repository
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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