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HIV Prevention Toolkit for HIV-negative Male Couples (MCAP)

28 marzo 2019 aggiornato da: Daniel J Feaster, University of Miami

Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples

Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design. Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules. The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples. For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project. After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

298

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • Clinical Research Building

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

Eligible male couples:

  1. are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
  2. are at least 18 years of age;
  3. are self-reported as being HIV-negative;
  4. had been practicing CAS in their relationship for > 6 months;
  5. report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
  6. have had no current sexual agreement; and
  7. own a smartphone and have an alternate method to access the Internet (e.g., computer).

Exclusion Criteria:

  1. Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study.
  2. Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
  3. Adults who are unable to consent;
  4. Individuals who are not yet adults;
  5. Pregnant and non-pregnant women, and prisoners.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Control group
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Comportamentale: Male Couples Agreement Project
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Comparatore attivo: Intervention group
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Comportamentale: Male Couples Agreement Project
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Formation of a Sexual Agreement at 6 Months
Lasso di tempo: 6 month
Self-reports of yes/no to forming a sexual agreement via electronic survey
6 month
Adherence to a Sexual Agreement at 6 Months
Lasso di tempo: 6 month
Self-report of yes/no of adhering to a sexual agreement
6 month

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Formation of a Sexual Agreement at 3 Months
Lasso di tempo: 3 month
Self-reports of yes/no to forming a sexual agreement via electronic survey
3 month
Adherence to a Sexual Agreement
Lasso di tempo: 3 month
Self-reports of yes/no to adhering to a sexual agreement via electronic survey
3 month
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Lasso di tempo: 3 month
Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey
3 month
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Lasso di tempo: month 6
Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).
month 6
Test for HIV During Past 3 Months (Months 0-3)
Lasso di tempo: 3 month
Self-reports of yes/no via electronic survey taken at 3 month.
3 month
Test for HIV During the Last 3 Months (Months 3-6)
Lasso di tempo: month 6
Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.
month 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Miami

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

  • Investigatore principale: Jason W Mitchell, PhD, University of Miami

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2015

Completamento primario (Effettivo)

1 settembre 2016

Completamento dello studio (Effettivo)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

7 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2015

Primo Inserito (Stima)

10 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 20140561
  • R34MH102098 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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