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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 November 2012 |
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Main ID: |
NCT00000928 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
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Scientific title:
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Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples |
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Date of first enrolment:
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October 1999 |
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Target sample size:
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90 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00000928 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Contacts
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Name:
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David D. Celentano |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Janet McGrath |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Behavioral: Group counseling intervention
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Primary Outcome(s)
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Assess acceptability and participation
[Time Frame: Throughout study]
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Assess the potential for the intervention to result in increased condom use among stable sexual partners
[Time Frame: Throughout study]
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Secondary Outcome(s)
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Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate
[Time Frame: Throughout study]
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Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing
[Time Frame: Throughout study]
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Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership
[Time Frame: Throughout study]
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Secondary ID(s)
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HIVNET 013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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