Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
To assess the acceptability of and participation in a group counseling intervention, including an assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate. To evaluate the profile of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing and attempts to initiate condom use within a stable HIV serodiscordant partnership. To assess the potential for the intervention to result in increased condom use among stable sexual partners.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: A
All study participants
|
Participants will engage in a multi-session group-based condom promotion program for approximately 12 months
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Assess acceptability and participation
Tijdsspanne: Throughout study
|
Throughout study
|
|
Assess the potential for the intervention to result in increased condom use among stable sexual partners
Tijdsspanne: Throughout study
|
Throughout study
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate
Tijdsspanne: Throughout study
|
Throughout study
|
|
Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing
Tijdsspanne: Throughout study
|
Throughout study
|
|
Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership
Tijdsspanne: Throughout study
|
Throughout study
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: David D. Celentano
- Studie stoel: Janet McGrath
Studie record data
Bestudeer belangrijke data
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- HIVNET 013
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