Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
Group counseling intervention
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown. A pilot study to assess the acceptability of intervention precedes the main study. The Phase I study recruits 15 HIV-infected men and 15 HIV-infected women and their partners at each of three sites (India, Thailand, and Uganda). Volunteers participate in a multi-session group-based condom promotion program for approximately 12 months. Couples are organized into small groups consisting of 4 to 6 couples per group. Each group meets for a total of 4 sessions within a 2- to 4-week period. Follow-up interviews are conducted at Months 1 and 3 following completion of the intervention.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.90 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Volunteers must be: HIV-positive through HIVNET testing or HIV-seronegative by EIA. Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study. Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus. Willing to receive counseling and HIV testing (HIV-seronegative partners only). Willing to agree to be interviewed with their partner and individually. Willing to continue engaging in sex with their partner. Willing to participate in a couples-based condom promotion intervention. Willing and able to attend each scheduled intervention/follow-up study visit. Exclusion Criteria Volunteers with the following are excluded: History of domestic violence. Current consistent condom use.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires