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

28. März 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

298

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33136
        • Clinical Research Building

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: 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.
Verhalten: 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.
Aktiver Komparator: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Formation of a Sexual Agreement at 6 Months
Zeitfenster: 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
Zeitfenster: 6 month
Self-report of yes/no of adhering to a sexual agreement
6 month

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Formation of a Sexual Agreement at 3 Months
Zeitfenster: 3 month
Self-reports of yes/no to forming a sexual agreement via electronic survey
3 month
Adherence to a Sexual Agreement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Miami

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

  • Hauptermittler: Jason W Mitchell, PhD, University of Miami

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2015

Primärer Abschluss (Tatsächlich)

1. September 2016

Studienabschluss (Tatsächlich)

1. September 2016

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2015

Zuerst gepostet (Schätzen)

10. Juli 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. März 2019

Zuletzt verifiziert

1. März 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 20140561
  • R34MH102098 (US NIH Stipendium/Vertrag)

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