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- Essai clinique NCT02887508
HIV Internet Sex Study: Internet-based STI/HIV Prevention for HIV+ Internet Users (HINTS)
29 août 2016 mis à jour par: Dean Cruess, University of Connecticut
Internet-based STI/HIV Prevention for HIV+ Internet Users
The goal of this study was to empirically test a newly developed online HIV sexual risk reduction intervention (HINTS) among a representative sample of gay and bisexual men living with HIV who meet sex partners online.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Internet-based venues such as websites, chat rooms, blogs, and bulletin boards are becoming an increasingly popular means for HIV-positive men who have sex with men (MSM) to meet potential sex partners.
The anonymity, quickness, and convenience offered by online venues allows for numerous potential sex partners to be identified and screened with the possibility to meet in person.
However, there are potential health hazards associated with meeting sex partners online, including an increased risk of sexually transmitted infections (STIs), and thus there is an urgent need for online behavioral interventions to help reduce STI/HIV risks associated with Internet-initiated sexual liaisons.
This research involves developmental intervention studies to design and field test an online, theory-based behavioral risk reduction intervention for HIV-positive MSM who use the Internet to meet potential sex partners.
Guided by the Information-Motivation-Behavioral Skills (IMB) model of health promoting behaviors the investigators will conduct 3 stages of intervention development research, as follows: (1) perform initial interviews and focus groups with HIV-positive MSM who use the Internet to meet sex partners.
Stage 1 will also bring together expert and community consultants to aid in the intervention development.
Based on information gained from rapid formative studies, this first stage of research will directly lead to the development a novel online theory-based sexual risk reduction intervention; (2) test the feasibility and acceptability of the newly developed online STI/HIV risk reduction intervention with a sample of HIV-positive MSM who use the Internet to meet sexual partners.
Stage 2 will also involve programming an audio-computer assisted interview for data collection; and (3) conduct a randomized field test to determine the potential efficacy of the risk reduction intervention for MSM who use the Internet to potentially meet sex partners.
Participants in the field test will be randomly assigned to either receive the newly developed intervention or a time-matched attention comparison condition.
Stage 3 will include testing for differences between groups on behavioral risk and Internet use outcomes across a 6-month follow-up period.
The investigators will also examine the intervention effects on mediating and moderating constructs of information, motivation, and behavioral skills.
The proposed intervention research will therefore develop new STI/HIV prevention strategies delivered exclusively online for use with people living with HIV/AIDS (PLWHA) who use the Internet to meet potential sex partners.
The results from this study will provide preliminary data on which to conduct a larger-scale, randomized controlled clinical trial in the future.
Type d'étude
Interventionnel
Inscription (Réel)
170
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- being over 18 years of age
- self-identifying as gay or bisexual
- living with HIV/AIDS
- reporting having used the Internet at least once to meet a potential sex partner
- reporting any history of unprotected anal sex with a male partner.
Exclusion Criteria:
- non-fluency in English
- inability to participate in online group intervention
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: HINTS Intervention
The HINTS intervention consisted of an online four-session group intervention for 45 minutes, twice a week for two weeks.
In each session, facilitators presented information, motivational skills, and behavioral skills related to a specific topic relevant to online partner seeking and transmission risk reduction, including Internet safety and communication, condom negotiation, and serostatus disclosure.
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HINTS is a four-session, group-based behavioral intervention delivered exclusively online and developed using the IMB model of health behavior change focused on sexual risk reduction.
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Comparateur actif: Healthy Living Control
The Healthy Living Control condition consisted of an online four-session group intervention for 45 minutes, twice a week for two weeks.
In each session, facilitators presented information, motivational skills, and behavioral skills to address non-sexual health-related topics particularly relevant to individuals living with HIV, such as nutrition, healthy eating, portion control, exercise and staying active, and stress reduction.
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The Healthy Living Control is a four-session, group-based behavioral intervention delivered exclusively online and developed using the IMB model of health behavior change focused on non-sexual health topics.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Sexual risk behavior, such as condomless anal sex with sexual partners, will be assessed via a self-report survey. Data will be aggregated and reported as counts or occurrences.
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dean G Cruess, PhD, University of Connecticut
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2010
Achèvement primaire (Réel)
1 novembre 2013
Achèvement de l'étude (Réel)
1 novembre 2014
Dates d'inscription aux études
Première soumission
24 août 2016
Première soumission répondant aux critères de contrôle qualité
29 août 2016
Première publication (Estimation)
2 septembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
2 septembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 août 2016
Dernière vérification
1 août 2016
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- H10-217
- R34MH087120 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .